0A4F4F9BD490A749D5437F821CF06DF1
21st Century Cures Act
https://www.congress.gov/bill/114th-congress/house-bill/34/text
http://leaux.net/URLS/ConvertAPI Text Files/8A8E464269BBE76D06349D12744262B6.en.txt
Examining the file media/Synopses/8A8E464269BBE76D06349D12744262B6.html:
This file was generated: 2020-07-14 04:40:54
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator felony:
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p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
p.(None): or property of another may be used in the course of
p.(None): committing the offense.''.
p.(None): SEC. 14029. GRANT ACCOUNTABILITY.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (l), as added by section 14022, the following:
p.(None): ``(m) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
p.(None): of Justice that the audited grantee has utilized grant
p.(None): funds for an unauthorized expenditure or otherwise
p.(None): unallowable cost that is not closed or resolved within
p.(None): 12 months from the date when the final audit report is
p.(None): issued.
p.(None): ``(B) Audits.--Beginning in the first fiscal year
p.(None): beginning after the date of enactment of this
p.(None): subsection, and in each fiscal year thereafter, the
p.(None): Inspector General of the Department of Justice shall
p.(None): conduct audits of recipients of grants under this
p.(None): section to prevent waste, fraud, and abuse of funds by
p.(None): grantees. The Inspector General shall determine the
...
Political / Illegal Activity
Searching for indicator crime:
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p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
p.(None): Sec. 15004. Regulatory relief for LTCHs.
...
p.(None): EATING DISORDERS.
p.(None):
p.(None): The Secretary of Health and Human Services may facilitate the
p.(None): identification of model programs and materials for educating and
p.(None): training health professionals in effective strategies to--
p.(None): (1) identify individuals with eating disorders;
p.(None): (2) provide early intervention services for individuals with
p.(None): eating disorders;
p.(None): (3) refer patients with eating disorders for appropriate
p.(None): treatment;
p.(None): (4) prevent the development of eating disorders; and
p.(None): (5) provide appropriate treatment services for individuals
p.(None): with eating disorders.
p.(None): SEC. 13007. <> CLARIFICATION OF
p.(None): EXISTING PARITY RULES.
p.(None):
p.(None): If a group health plan or a health insurance issuer offering group
p.(None): or individual health insurance coverage provides coverage for eating
p.(None): disorder benefits, including residential treatment, such group health
p.(None): plan or health insurance issuer shall provide such benefits consistent
p.(None): with the requirements of section 2726 of the Public Health Service Act
p.(None): (42 U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal
p.(None): Revenue Code of 1986.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS,
p.(None): MENTAL HEALTH PURPOSES.
p.(None):
p.(None): (a) Edward Byrne Memorial Justice Assistance Grant Program.--Section
p.(None): 501(a)(1) of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the end the
p.(None): following:
p.(None): ``(H) Mental health programs and related law
p.(None): enforcement and corrections programs, including
p.(None): behavioral programs and crisis intervention teams.''.
p.(None):
p.(None): [[Page 130 STAT. 1288]]
p.(None):
p.(None): (b) Community Oriented Policing Services Program.--Section 1701(b)
p.(None): of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42
p.(None): U.S.C. 3796dd(b)) is amended--
p.(None): (1) in paragraph (17), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (18) as paragraph (22);
p.(None): (3) by inserting after paragraph (17) the following:
p.(None): ``(18) to provide specialized training to law enforcement
p.(None): officers to--
p.(None): ``(A) recognize individuals who have a mental
p.(None): illness; and
p.(None): ``(B) properly interact with individuals who have a
p.(None): mental illness, including strategies for verbal de-
p.(None): escalation of crises;
p.(None): ``(19) to establish collaborative programs that enhance the
p.(None): ability of law enforcement agencies to address the mental
p.(None): health, behavioral, and substance abuse problems of individuals
p.(None): encountered by law enforcement officers in the line of duty;
p.(None): ``(20) to provide specialized training to corrections
p.(None): officers to recognize individuals who have a mental illness;
p.(None): ``(21) to enhance the ability of corrections officers to
p.(None): address the mental health of individuals under the care and
p.(None): custody of jails and prisons, including specialized training and
p.(None): strategies for verbal de-escalation of crises; and''; and
p.(None): (4) in paragraph (22), as redesignated, by striking
p.(None): ``through (17)'' and inserting ``through (21)''.
p.(None):
p.(None): (c) Modifications to the Staffing for Adequate Fire and Emergency
p.(None): Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention and
p.(None): Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting
p.(None): before the period at the end the following: ``and to provide specialized
p.(None): training to paramedics, emergency medical services workers, and other
p.(None): first responders to recognize individuals who have mental illness and
p.(None): how to properly intervene with individuals with mental illness,
p.(None): including strategies for verbal de-escalation of crises''.
p.(None): SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
p.(None):
p.(None): (a) In General.--Section 2201 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
...
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
...
p.(None): subsection (d)(1), the Attorney General shall--
p.(None):
p.(None): [[Page 130 STAT. 1291]]
p.(None):
p.(None): (1) obtain the approval, in writing, of the United States
p.(None): Attorney for the United States judicial district being
p.(None): designated;
p.(None): (2) obtain the approval, in writing, of the chief judge for
p.(None): the United States judicial district being designated; and
p.(None): (3) determine that the United States judicial district being
p.(None): designated has adequate behavioral health systems for treatment,
p.(None): including substance abuse and mental health treatment.
p.(None):
p.(None): (f) Assistance From Other Federal Entities.--The Administrative
p.(None): Office of the United States Courts and the United States Probation
p.(None): Offices shall provide such assistance and carry out such functions as
p.(None): the Attorney General may request in monitoring, supervising, providing
p.(None): services to, and evaluating eligible offenders placed in a drug or
p.(None): mental health court under this section.
p.(None): (g) Reports.--The Attorney General, in consultation with the
p.(None): Director of the Administrative Office of the United States Courts, shall
p.(None): monitor the drug and mental health courts under this section, and shall
p.(None): submit a report to Congress on the outcomes of the program at the end of
p.(None): the period described in subsection (d)(2).
p.(None): SEC. 14004. <> MENTAL HEALTH IN THE
p.(None): JUDICIAL SYSTEM.
p.(None):
p.(None): Part V of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
p.(None): the following:
p.(None): ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
p.(None):
p.(None): ``(a) Pretrial Screening and Supervision.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand pretrial services programs to improve the
p.(None): identification and outcomes of individuals with mental illness.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be may be used for--
p.(None): ``(A) behavioral health needs and risk screening of
p.(None): defendants, including verification of interview
p.(None): information, mental health evaluation, and criminal
p.(None): history screening;
p.(None): ``(B) assessment of risk of pretrial misconduct
p.(None): through objective, statistically validated means, and
p.(None): presentation to the court of recommendations based on
p.(None): such assessment, including services that will reduce the
p.(None): risk of pre-trial misconduct;
p.(None): ``(C) followup review of defendants unable to meet
p.(None): the conditions of pretrial release;
p.(None): ``(D) evaluation of process and results of pre-trial
p.(None): service programs;
p.(None): ``(E) supervision of defendants who are on pretrial
p.(None): release, including reminders to defendants of scheduled
p.(None): court dates;
p.(None): ``(F) reporting on process and results of pretrial
...
p.(None): Appropriations of the House of Representatives an annual
p.(None): certification--
p.(None): ``(A) indicating whether--
p.(None): ``(i) all final audit reports issued by the
p.(None): Office of the Inspector General under paragraph
p.(None): (1) have been completed and reviewed by the
p.(None): appropriate Assistant Attorney General or
p.(None): Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(D) have been issued; and
p.(None): ``(iii) any reimbursements required under
p.(None): paragraph (1)(F) have been made; and
p.(None):
p.(None): [[Page 130 STAT. 1295]]
p.(None):
p.(None): ``(B) that includes a list of any grantees excluded
p.(None): under paragraph (1)(D) from the previous year.
p.(None):
p.(None): ``(i) Preventing Duplicative Grants.--
p.(None): ``(1) In general.--Before the Attorney General awards a
p.(None): grant to an applicant under this section, the Attorney General
p.(None): shall compare the possible grant with any other grants awarded
p.(None): to the applicant under this Act to determine whether the grants
p.(None): are for the same purpose.
p.(None): ``(2) Report.--If the Attorney General awards multiple
p.(None): grants to the same applicant for the same purpose, the Attorney
p.(None): General shall submit to the Committee on the Judiciary of the
p.(None): Senate and the Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(A) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any such grants
p.(None): awarded; and
p.(None): ``(B) the reason the Attorney General awarded the
p.(None): duplicate grants.''.
p.(None): SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
p.(None):
p.(None): Section 2991 of the Omnibus Crime Control and Safe Streets Act of
p.(None): 1968 (42 U.S.C. 3797aa) is amended by--
p.(None): (1) redesignating subsection (j) as subsection (o); and
p.(None): (2) inserting after subsection (i) the following:
p.(None):
p.(None): ``(j) Forensic Assertive Community Treatment (FACT) Initiative
p.(None): Program.--
p.(None): ``(1) In general.--The Attorney General may make grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand Assertive Community Treatment initiatives
p.(None): to develop forensic assertive community treatment (referred to
p.(None): in this subsection as `FACT') programs that provide high
p.(None): intensity services in the community for individuals with mental
p.(None): illness with involvement in the criminal justice system to
p.(None): prevent future incarcerations.
p.(None): ``(2) Allowable uses.--Grant funds awarded under this
p.(None): subsection may be used for--
p.(None): ``(A) multidisciplinary team initiatives for
p.(None): individuals with mental illnesses with criminal justice
p.(None): involvement that address criminal justice involvement as
p.(None): part of treatment protocols;
p.(None): ``(B) FACT programs that involve mental health
p.(None): professionals, criminal justice agencies, chemical
...
p.(None): outreach and engagement, community-based service
p.(None): provision at participants' residence or in the
p.(None): community, psychiatric rehabilitation, recovery oriented
p.(None): services, services to address criminogenic risk factors,
p.(None): and community tenure;
p.(None): ``(D) payments for treatment providers that are
p.(None): approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide needed treatment to eligible
p.(None): offenders
p.(None):
p.(None): [[Page 130 STAT. 1296]]
p.(None):
p.(None): participating in the program, including behavioral
p.(None): health services and aftercare supervision; and
p.(None): ``(E) training for all FACT teams to promote high-
p.(None): fidelity practice principles and technical assistance to
p.(None): support effective and continuing integration with
p.(None): criminal justice agency partners.
p.(None): ``(3) Supplement and not supplant.--Grants made under this
p.(None): subsection shall be used to supplement, and not supplant, non-
p.(None): Federal funds that would otherwise be available for programs
p.(None): described in this subsection.
p.(None): ``(4) Applications.--To request a grant under this
p.(None): subsection, a State, unit of local government, territory, Indian
p.(None): Tribe, or nonprofit agency shall submit an application to the
p.(None): Attorney General in such form and containing such information as
p.(None): the Attorney General may reasonably require.''.
p.(None): SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
p.(None): SYSTEMS.
p.(None):
p.(None): Section 2976(f) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
p.(None): (1) in paragraph (5), by striking ``and'' at the end;
p.(None): (2) in paragraph (6), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(7) provide mental health treatment and transitional
p.(None): services for those with mental illnesses or with co-occurring
p.(None): disorders, including housing placement or assistance; and''.
p.(None): SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN DRUG COURTS.
p.(None):
p.(None): Part EE of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797u et seq.) is amended--
p.(None): (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
p.(None): inserting ``, including co-occurring substance abuse and mental
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
p.(None):
p.(None): The Attorney General, as part of the Preventing Violence Against Law
p.(None): Enforcement and Ensuring Officer Resilience and Survivability Initiative
p.(None): (VALOR) of the Department of Justice, may provide safety training and
p.(None): technical assistance to local law enforcement agencies, including
p.(None): active-shooter response training.
p.(None): SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN RESIDENTIAL SUBSTANCE
p.(None): ABUSE TREATMENT PROGRAMS.
p.(None):
p.(None): Section 1901(a) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
...
p.(None): ``(i) all audits issued by the Office of the
p.(None): Inspector General under paragraph (1) have been
p.(None): completed and reviewed by the appropriate
p.(None): Assistant Attorney General or Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(C) have been issued; and
p.(None): ``(iii) all reimbursements required under
p.(None): paragraph (1)(E) have been made; and
p.(None): ``(B) that includes a list of any grant recipients
p.(None): excluded under paragraph (1) from the previous year.
p.(None): ``(5) Preventing duplicative grants.--
p.(None): ``(A) In general.--Before the Attorney General
p.(None): awards a grant to an applicant under this section, the
p.(None): Attorney General shall compare potential grant awards
p.(None): with other grants awarded under this Act to determine if
p.(None): duplicate grant awards are awarded for the same purpose.
p.(None): ``(B) Report.--If the Attorney General awards
p.(None): duplicate grants to the same applicant for the same
p.(None): purpose the Attorney General shall submit to the
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None):
p.(None): [[Page 130 STAT. 1303]]
p.(None):
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14014. <> NATIONAL CRIMINAL JUSTICE
p.(None): AND MENTAL HEALTH TRAINING AND
p.(None): TECHNICAL ASSISTANCE.
p.(None):
p.(None): Part HH of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end the
p.(None): following:
p.(None): ``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING
p.(None): AND TECHNICAL ASSISTANCE.
p.(None):
p.(None): ``(a) Authority.--The Attorney General may make grants to eligible
p.(None): organizations to provide for the establishment of a National Criminal
p.(None): Justice and Mental Health Training and Technical Assistance Center.
p.(None): ``(b) Eligible Organization.--For purposes of subsection (a), the
p.(None): term `eligible organization' means a national nonprofit organization
p.(None): that provides technical assistance and training to, and has special
p.(None): expertise and broad, national-level experience in, mental health, crisis
p.(None): intervention, criminal justice systems, law enforcement, translating
p.(None): evidence into practice, training, and research, and education and
p.(None): support of people with mental illness and the families of such
p.(None): individuals.
p.(None): ``(c) Use of Funds.--Any organization that receives a grant under
p.(None): subsection (a) shall collaborate with other grant recipients to
p.(None): establish and operate a National Criminal Justice and Mental Health
...
p.(None): certification--
p.(None): ``(A) indicating whether--
p.(None): ``(i) all final audit reports issued by the
p.(None): Office of the Inspector General under paragraph
p.(None): (1) have been completed and reviewed by the
p.(None): appropriate Assistant Attorney General or
p.(None): Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(D) have been issued; and
p.(None): ``(iii) any reimbursements required under
p.(None): paragraph (1)(F) have been made; and
p.(None): ``(B) that includes a list of any grantees excluded
p.(None): under paragraph (1)(D) from the previous year.
p.(None): ``(5) Preventing duplicative grants.--
p.(None): ``(A) In general.--Before the Attorney General
p.(None): awards a grant to an applicant under this section, the
p.(None): Attorney General shall compare potential grant awards
p.(None): with other grants awarded under this Act to determine if
p.(None): duplicate grant awards are awarded for the same purpose.
p.(None): ``(B) Report.--If the Attorney General awards
p.(None): duplicate grants to the same applicant for the same
p.(None): purpose the Attorney General shall submit to the
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
...
p.(None): for the beneficiary by the Secretary under this title unless such
p.(None): beneficiary has been provided all of the following, subject to the
p.(None): procedures and timelines prescribed by the Secretary for determinations
p.(None): of incompetency:
p.(None): ``(1) Notice of the proposed adverse determination and the
p.(None): supporting evidence.
p.(None): ``(2) An opportunity to request a hearing.
p.(None): ``(3) An opportunity to present evidence, including an
p.(None): opinion from a medical professional or other person, on the
p.(None): capacity of the beneficiary to manage monetary benefits paid to
p.(None): or for the beneficiary by the Secretary under this title.
p.(None): ``(4) An opportunity to be represented at no expense to the
p.(None): Government (including by counsel) at any such hearing and to
p.(None): bring a medical professional or other person to provide relevant
p.(None): testimony at any such hearing.''.
p.(None):
p.(None): (b) <> Clerical Amendment.--The table of
p.(None): sections at the beginning of such chapter 55 is amended by inserting
p.(None): after the item relating to section 5501 the following new item:
p.(None):
p.(None): ``5501A. Beneficiaries' rights in mental competence determinations''.
p.(None):
p.(None): (c) <> Effective Date.--Section 5501A of
p.(None): title 38, United States Code, as added by subsection (a), shall apply to
p.(None): determinations made by the Secretary of Veterans Affairs on or after the
p.(None): date of the enactment of this Act.
p.(None): SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.
p.(None):
p.(None): Subsection (o) of section 2991 of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated by section
p.(None): 14006, is amended--
p.(None): (1) in paragraph (1)(C), by striking ``2009 through 2014''
p.(None): and inserting ``2017 through 2021''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(3) Limitation.--Not more than 20 percent of the funds authorized
p.(None): to be appropriated under this section may be used for purposes described
p.(None): in subsection (i) (relating to veterans).''.
p.(None):
p.(None): [[Page 130 STAT. 1308]]
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section 14005, is
p.(None): amended by inserting after subsection (j), the following:
p.(None): ``(k) Sequential Intercept Grants.--
p.(None): ``(1) Definition.--In this subsection, the term `eligible
p.(None): entity' means a State, unit of local government, Indian tribe,
p.(None): or tribal organization.
p.(None): ``(2) Authorization.--The Attorney General may make grants
p.(None): under this subsection to an eligible entity for sequential
p.(None): intercept mapping and implementation in accordance with
p.(None): paragraph (3).
p.(None): ``(3) Sequential intercept mapping; implementation.--An
p.(None): eligible entity that receives a grant under this subsection may
p.(None): use funds for--
p.(None): ``(A) sequential intercept mapping, which--
p.(None): ``(i) shall consist of--
p.(None): ``(I) convening mental health and
p.(None): criminal justice stakeholders to--
p.(None): ``(aa) develop a shared
p.(None): understanding of the flow of
p.(None): justice-involved individuals
p.(None): with mental illnesses through
p.(None): the criminal justice system; and
p.(None): ``(bb) identify
p.(None): opportunities for improved
p.(None): collaborative responses to the
p.(None): risks and needs of individuals
p.(None): described in item (aa); and
p.(None): ``(II) developing strategies to
p.(None): address gaps in services and bring
p.(None): innovative and effective programs to
p.(None): scale along multiple intercepts,
p.(None): including--
p.(None): ``(aa) emergency and crisis
p.(None): services;
p.(None): ``(bb) specialized police-
p.(None): based responses;
p.(None): ``(cc) court hearings and
p.(None): disposition alternatives;
p.(None): ``(dd) reentry from jails
p.(None): and prisons; and
p.(None): ``(ee) community
p.(None): supervision, treatment and
p.(None): support services; and
p.(None): ``(ii) may serve as a starting point for the
p.(None): development of strategic plans to achieve positive
p.(None): public health and safety outcomes; and
p.(None): ``(B) implementation, which shall--
p.(None): ``(i) be derived from the strategic plans
p.(None): described in subparagraph (A)(ii); and
p.(None): ``(ii) consist of--
p.(None): ``(I) hiring and training personnel;
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
p.(None): services and substance abuse treatment services;
p.(None): and
p.(None): ``(iii) alternatives to solitary confinement
p.(None): and segregated housing and mental health screening
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
p.(None): incidents involving inmates with mental health or co-
p.(None): occurring mental health and substance abuse
p.(None): disorders.''.
p.(None): SEC. 14023. ALLOWABLE USES.
p.(None):
p.(None): Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and
p.(None): Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by
p.(None): adding at the end the following:
p.(None): ``(v) Teams addressing frequent users of
p.(None): crisis services.--Multidisciplinary teams that--
p.(None): ``(I) coordinate, implement, and
p.(None): administer community-based crisis
p.(None): responses and long-term plans for
p.(None): frequent users of crisis services;
p.(None): ``(II) provide training on how to
p.(None): respond appropriately to the unique
p.(None): issues involving frequent users of
p.(None): crisis services for public service
p.(None): personnel,
p.(None):
p.(None): [[Page 130 STAT. 1310]]
p.(None):
p.(None): including criminal justice, mental
p.(None): health, substance abuse, emergency room,
p.(None): healthcare, law enforcement,
p.(None): corrections, and housing personnel;
p.(None): ``(III) develop or support
p.(None): alternatives to hospital and jail
p.(None): admissions for frequent users of crisis
p.(None): services that provide treatment,
p.(None): stabilization, and other appropriate
p.(None): supports in the least restrictive, yet
p.(None): appropriate, environment; and
p.(None): ``(IV) develop protocols and systems
p.(None): among law enforcement, mental health,
p.(None): substance abuse, housing, corrections,
p.(None): and emergency medical service operations
p.(None): to provide coordinated assistance to
p.(None): frequent users of crisis services.''.
p.(None): SEC. 14024. LAW ENFORCEMENT TRAINING.
p.(None):
p.(None): Section 2991(h) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
p.(None): mental health and substance abuse professions develop and
p.(None): administer cooperatively.''.
p.(None): SEC. 14025. <> FEDERAL LAW
p.(None): ENFORCEMENT TRAINING.
p.(None):
p.(None): Not later than 1 year after the date of enactment of this Act, the
p.(None): Attorney General shall provide direction and guidance for the following:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training, in procedures to identify and
p.(None): appropriately respond to incidents in which the unique needs of
p.(None): individuals who have a mental illness are involved, to first
p.(None): responders and tactical units of--
...
p.(None): improve the response of such employees to situations involving
p.(None): individuals who have a mental illness.
p.(None): SEC. 14026. GAO REPORT.
p.(None):
p.(None): No later than 1 year after the date of enactment of this Act, the
p.(None): Comptroller General of the United States, in coordination with the
p.(None): Attorney General, shall submit to Congress a report on--
p.(None):
p.(None): [[Page 130 STAT. 1311]]
p.(None):
p.(None): (1) the practices that Federal first responders, tactical
p.(None): units, and corrections officers are trained to use in responding
p.(None): to individuals with mental illness;
p.(None): (2) procedures to identify and appropriately respond to
p.(None): incidents in which the unique needs of individuals who have a
p.(None): mental illness are involved, to Federal first responders and
p.(None): tactical units;
p.(None): (3) the application of evidence-based practices in criminal
p.(None): justice settings to better address individuals with mental
p.(None): illnesses; and
p.(None): (4) recommendations on how the Department of Justice can
p.(None): expand and improve information sharing and dissemination of best
p.(None): practices.
p.(None): SEC. 14027. EVIDENCE BASED PRACTICES.
p.(None):
p.(None): Section 2991(c) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
p.(None): (1) in paragraph (3), by striking ``or'' at the end;
p.(None): (2) by redesignating paragraph (4) as paragraph (6); and
p.(None): (3) by inserting after paragraph (3), the following:
p.(None): ``(4) propose interventions that have been shown by
p.(None): empirical evidence to reduce recidivism;
p.(None): ``(5) when appropriate, use validated assessment tools to
p.(None): target preliminarily qualified offenders with a moderate or high
p.(None): risk of recidivism and a need for treatment and services; or''.
p.(None): SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT
p.(None): OF LOCAL AUTHORITY.
p.(None):
p.(None): (a) In General.--Section 2991(a) of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
p.(None): (1) in paragraph (7)--
p.(None): (A) in the heading, by striking ``Mental illness''
p.(None): and inserting ``Mental illness; mental health
p.(None): disorder''; and
p.(None): (B) by striking ``term `mental illness' means'' and
p.(None): inserting ``terms `mental illness' and `mental health
p.(None): disorder' mean''; and
p.(None): (2) by striking paragraph (9) and inserting the following:
p.(None): ``(9) Preliminarily qualified offender.--
p.(None): ``(A) In general.--The term `preliminarily qualified
p.(None): offender' means an adult or juvenile accused of an
p.(None): offense who--
p.(None): ``(i)(I) previously or currently has been
p.(None): diagnosed by a qualified mental health
p.(None): professional as having a mental illness or co-
p.(None): occurring mental illness and substance abuse
p.(None): disorders;
p.(None): ``(II) manifests obvious signs of mental
p.(None): illness or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or
p.(None): confinement or before any court; or
p.(None): ``(III) in the case of a veterans treatment
p.(None): court provided under subsection (i), has been
...
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
p.(None): mental health or substance abuse agency representative
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
p.(None): or property of another may be used in the course of
p.(None): committing the offense.''.
p.(None): SEC. 14029. GRANT ACCOUNTABILITY.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (l), as added by section 14022, the following:
p.(None): ``(m) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
p.(None): of Justice that the audited grantee has utilized grant
p.(None): funds for an unauthorized expenditure or otherwise
p.(None): unallowable cost that is not closed or resolved within
p.(None): 12 months from the date when the final audit report is
p.(None): issued.
p.(None): ``(B) Audits.--Beginning in the first fiscal year
p.(None): beginning after the date of enactment of this
p.(None): subsection, and in each fiscal year thereafter, the
p.(None): Inspector General of the Department of Justice shall
p.(None): conduct audits of recipients of grants under this
p.(None): section to prevent waste, fraud, and abuse of funds by
p.(None): grantees. The Inspector General shall determine the
p.(None): appropriate number of grantees to be audited each year.
p.(None): ``(C) Mandatory exclusion.--A recipient of grant
p.(None): funds under this section that is found to have an
p.(None): unresolved audit finding shall not be eligible to
p.(None): receive grant funds under this section during the first
p.(None): 2 fiscal years beginning after the end of the 12-month
p.(None): period described in subparagraph (A).
p.(None): ``(D) Priority.--In awarding grants under this
...
Political / Indigenous
Searching for indicator native:
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p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
...
p.(None): under the State plan, requires the enrollment of the physician
p.(None): or provider with the State agency, a physician or a provider
p.(None): that--
p.(None): ``(A) is enrolled with the agency as of the date on
p.(None): which the directory is published or updated (as
p.(None): applicable) under subsection (a)(83); and
p.(None): ``(B) received payment under the State plan in the
p.(None): 12-month period preceding such date; and
p.(None): ``(2) in the case of a physician or provider of a provider
p.(None): type for which the State agency does not require such
p.(None): enrollment, a physician or provider that received payment under
p.(None): the State plan (or a waiver of the plan) in the 12-month period
p.(None): preceding the date on which the directory is published or
p.(None): updated (as applicable) under subsection (a)(83).''.
p.(None):
p.(None): (c) <> Rule of Construction.--
p.(None): (1) In general.--The amendment made by subsection (a) shall
p.(None): not be construed to apply in the case of a State (as defined for
p.(None): purposes of title XIX of the Social Security Act) in which all
p.(None): the individuals enrolled in the State plan under such title (or
p.(None): under a waiver of such plan), other than individuals described
p.(None): in paragraph (2), are enrolled with a medicaid managed care
p.(None): organization (as defined in section 1903(m)(1)(A) of such Act
p.(None): (42 U.S.C. 1396b(m)(1)(A))), including prepaid inpatient health
p.(None): plans and prepaid ambulatory health plans (as defined by the
p.(None): Secretary of Health and Human Services).
p.(None): (2) Individuals described.--An individual described in this
p.(None): paragraph is an individual who is an Indian (as defined in
p.(None): section 4 of the Indian Health Care Improvement Act (25 U.S.C.
p.(None): 1603)) or an Alaska Native.
p.(None):
p.(None): (d) <> Exception for State Legislation.--
p.(None): In the case of a State plan under title XIX of the Social Security Act
p.(None): (42 U.S.C. 1396 et seq.), which the Secretary of Health and Human
p.(None): Services determines requires State legislation in order for the
p.(None): respective plan to meet one or more additional requirements imposed by
p.(None): amendments made by this section, the respective plan shall not be
p.(None): regarded as failing to comply with the requirements of such title
p.(None):
p.(None): [[Page 130 STAT. 1197]]
p.(None):
p.(None): solely on the basis of its failure to meet such an additional
p.(None): requirement before the first day of the first calendar quarter beginning
p.(None): after the close of the first regular session of the State legislature
p.(None): that begins after the date of enactment of this Act. For purposes of the
p.(None): previous sentence, in the case of a State that has a 2-year legislative
p.(None): session, each year of the session shall be considered to be a separate
p.(None): regular session of the State legislature.
p.(None): SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.
p.(None):
p.(None): (a) In General.--Section 1917(d)(4)(A) of the Social Security Act
p.(None): (42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ``the individual,''
p.(None): after ``for the benefit of such individual by''.
p.(None): (b) <> Effective Date.--The amendment
p.(None): made by subsection (a) shall apply to trusts established on or after the
p.(None): date of the enactment of this Act.
p.(None): SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH
p.(None): RESPECT TO EXPENDITURES UNDER MEDICAID
p.(None): FOR AGENTS USED FOR COSMETIC PURPOSES OR
p.(None): HAIR GROWTH.
p.(None):
p.(None): (a) In General.--Section 1903(i)(21) of the Social Security Act (42
...
p.(None): is amended--
p.(None): (1) in the section heading, by inserting ``mental health
p.(None): awareness'' before ``training''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Illness'' and inserting ``Health'';
p.(None): (B) in paragraph (1), by inserting ``veterans, law
p.(None): enforcement, and other categories of individuals, as
p.(None): determined by the Secretary,'' after ``emergency
p.(None): services personnel'';
p.(None): (C) in paragraph (5)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``to'' and inserting ``for evidence-
p.(None): based programs that provide training and education
p.(None): in accordance with paragraph (1) on matters
p.(None): including''; and
p.(None): (ii) by striking subparagraphs (A) through (C)
p.(None): and inserting the following:
p.(None): ``(A) recognizing the signs and symptoms of mental
p.(None): illness; and
p.(None): ``(B)(i) resources available in the community for
p.(None): individuals with a mental illness and other relevant
p.(None): resources; or
p.(None): ``(ii) safely de-escalating crisis situations
p.(None): involving individuals with a mental illness.''; and
p.(None): (D) in paragraph (7), by striking ``, $25,000,000''
p.(None): and all that follows through the period at the end and
p.(None): inserting ``$14,693,000 for each of fiscal years 2018
p.(None): through 2022.''.
p.(None): SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND
p.(None): ALASKA NATIVE YOUTH WITHIN SUICIDE
p.(None): PREVENTION PROGRAMS.
p.(None):
p.(None): (a) Findings.--The Congress finds as follows:
p.(None): (1) Suicide is the eighth leading cause of death among
p.(None): American Indians and Alaska Natives across all ages.
p.(None): (2) Among American Indians and Alaska Natives who are 10 to
p.(None): 34 years of age, suicide is the second leading cause of death.
p.(None): (3) The suicide rate among American Indian and Alaska Native
p.(None): adolescents and young adults ages 15 to 34 (17.9 per
p.(None):
p.(None): [[Page 130 STAT. 1245]]
p.(None):
p.(None): 100,000) is approximately 1.3 times higher than the national
p.(None): average for that age group (13.3 per 100,000).
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that the
p.(None): Secretary of Health and Human Services, in carrying out suicide
p.(None): prevention and intervention programs, should prioritize programs and
p.(None): activities for populations with disproportionately high rates of
p.(None): suicide, such as American Indians and Alaska Natives.
p.(None): SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
p.(None):
p.(None): Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 32(e)) is amended by adding at the end the following:
p.(None): ``(3) Geriatric mental disorders.--The Secretary shall, as
p.(None): appropriate, provide technical assistance to grantees regarding
p.(None): evidence-based practices for the prevention and treatment of
p.(None): geriatric mental disorders and co-occurring mental health and
p.(None): substance use disorders among geriatric populations, as well as
p.(None): disseminate information about such evidence-based practices to
p.(None): States and nongrantees throughout the United States.''.
p.(None): SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
p.(None):
p.(None): The Secretary of Health and Human Services, acting through the
p.(None): Director of the Centers for Disease Control and Prevention, is
p.(None): encouraged to improve, particularly through the inclusion of additional
p.(None): States, the National Violent Death Reporting System as authorized by
p.(None): title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
...
p.(None): with primary care in community-based settings;
p.(None): ``(C) demonstrate experience in using health
p.(None): information technology and, as appropriate, telehealth
p.(None): to support--
p.(None): ``(i) the delivery of mental and substance use
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
...
p.(None): ``(B) Except as provided in subparagraph (C), any person to whom a
p.(None): certificate is issued under subparagraph (A) to protect the privacy of
p.(None): individuals described in such subparagraph shall not disclose or provide
p.(None): to any other person not connected with the research the name of such an
p.(None): individual or any information, document, or biospecimen that contains
p.(None): identifiable, sensitive information about such an individual and that
p.(None): was created or compiled for purposes of the research.
p.(None): ``(C) The disclosure prohibition in subparagraph (B) shall not apply
p.(None): to disclosure or use that is--
p.(None): ``(i) required by Federal, State, or local laws, excluding
p.(None): instances described in subparagraph (D);
p.(None): ``(ii) necessary for the medical treatment of the individual
p.(None): to whom the information, document, or biospecimen pertains and
p.(None): made with the consent of such individual;
p.(None): ``(iii) made with the consent of the individual to whom the
p.(None): information, document, or biospecimen pertains; or
p.(None): ``(iv) made for the purposes of other scientific research
p.(None): that is in compliance with applicable Federal regulations
p.(None): governing the protection of human subjects in research.
p.(None):
p.(None): ``(D) Any person to whom a certificate is issued under subparagraph
p.(None): (A) to protect the privacy of an individual described in such
p.(None): subparagraph shall not, in any Federal, State, or local civil, criminal,
p.(None): administrative, legislative, or other proceeding, disclose or provide
p.(None): the name of such individual or any such information, document, or
p.(None): biospecimen that contains identifiable, sensitive information about the
p.(None): individual and that was created or compiled for purposes of the
p.(None): research, except in the circumstance described in subparagraph (C)(iii).
p.(None): ``(E) Identifiable, sensitive information protected under
p.(None): subparagraph (A), and all copies thereof, shall be immune from the legal
p.(None): process, and shall not, without the consent of the individual to whom
p.(None): the information pertains, be admissible as evidence or used
p.(None):
p.(None): [[Page 130 STAT. 1050]]
p.(None):
p.(None): for any purpose in any action, suit, or other judicial, legislative, or
p.(None): administrative proceeding.
p.(None): ``(F) Identifiable, sensitive information collected by a person to
p.(None): whom a certificate has been issued under subparagraph (A), and all
p.(None): copies thereof, shall be subject to the protections afforded by this
p.(None): section for perpetuity.
p.(None): ``(G) The Secretary shall take steps to minimize the burden to
p.(None): researchers, streamline the process, and reduce the time it takes to
p.(None): comply with the requirements of this subsection.
p.(None): ``(2) The Secretary shall coordinate with the heads of other
p.(None): applicable Federal agencies to ensure that such departments have
p.(None): policies in place with respect to the issuance of a certificate of
p.(None): confidentiality pursuant to paragraph (1) and other requirements of this
p.(None): subsection.
...
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
p.(None): and report on required performance measures; and
p.(None): ``(E) the extent to which the grantee is proposing
p.(None): to use evidence-based practices; and
p.(None): ``(25) advance, through existing programs, the use of
p.(None): performance metrics, including those based on the
p.(None): recommendations on performance metrics from the Assistant
p.(None): Secretary for Planning and Evaluation under section 6021(d) of
p.(None): the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016.''; and
...
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
p.(None): services for adults with a serious mental illness or children
p.(None): with a serious emotional disturbance.
p.(None):
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
...
p.(None): disturbance;
p.(None): (C) at least 1 member shall be a representative of a
p.(None): leading research, advocacy, or service organization for
p.(None): adults with a serious mental illness;
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
p.(None): experience treating serious mental illnesses or
p.(None): serious emotional disturbances; or
p.(None): (iv) a licensed psychiatric nurse, nurse
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
p.(None): justice or serious mental illness;
p.(None): (J) at least 1 member shall be a law enforcement
p.(None): officer or corrections officer with extensive experience
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
...
p.(None): $19,000,000 for each of fiscal years 2019 and 2020, and
p.(None): $18,000,000 for each of fiscal years 2021 and 2022''.
p.(None): SEC. 9015. <> ASSERTIVE COMMUNITY
p.(None): TREATMENT GRANT PROGRAM.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.), as amended by section 9009, is further amended by adding at
p.(None): the end the following:
p.(None): ``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall award grants to
p.(None): eligible entities--
p.(None): ``(1) to establish assertive community treatment programs
p.(None): for adults with a serious mental illness; or
p.(None): ``(2) to maintain or expand such programs.
p.(None):
p.(None): [[Page 130 STAT. 1246]]
p.(None):
p.(None): ``(b) Eligible Entities.--To be eligible to receive a grant under
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act), mental health system, health care facility, or any other entity
p.(None): the Assistant Secretary deems appropriate.
p.(None): ``(c) Special Consideration.--In selecting among applicants for a
p.(None): grant under this section, the Assistant Secretary may give special
p.(None): consideration to the potential of the applicant's program to reduce
p.(None): hospitalization, homelessness, and involvement with the criminal justice
p.(None): system while improving the health and social outcomes of the patient.
p.(None): ``(d) Additional Activities.--The Assistant Secretary shall--
p.(None): ``(1) not later than the end of fiscal year 2021, submit a
p.(None): report to the appropriate congressional committees on the grant
p.(None): program under this section, including an evaluation of--
p.(None): ``(A) any cost savings and public health outcomes
p.(None): such as mortality, suicide, substance use disorders,
p.(None): hospitalization, and use of services;
p.(None): ``(B) rates of involvement with the criminal justice
p.(None): system of patients;
p.(None): ``(C) rates of homelessness among patients; and
p.(None): ``(D) patient and family satisfaction with program
p.(None): participation; and
p.(None): ``(2) provide appropriate information, training, and
p.(None): technical assistance to grant recipients under this section to
p.(None): help such recipients to establish, maintain, or expand their
p.(None): assertive community treatment programs.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--
p.(None): ``(1) In general.--To carry out this section, there is
p.(None): authorized to be appropriated $5,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None): ``(2) Use of certain funds.--Of the funds appropriated to
p.(None): carry out this section in any fiscal year, not more than 5
p.(None): percent shall be available to the Assistant Secretary for
p.(None): carrying out subsection (d).''.
p.(None): SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
p.(None): REAUTHORIZATION.
p.(None):
p.(None): Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
p.(None): is amended--
p.(None): (1) in subsection (c)(3), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (2) in subsection (d)(4), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (3) in subsection (e)(1)(I), by striking ``fiscal year
p.(None): 2007'' and all that follows through the period at the end and
p.(None): inserting ``each of the fiscal years 2018 through 2022.'';
p.(None): (4) in subsection (f)(2), by striking ``$6,000,000 for
...
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
...
p.(None): services to, and evaluating eligible offenders placed in a drug or
p.(None): mental health court under this section.
p.(None): (g) Reports.--The Attorney General, in consultation with the
p.(None): Director of the Administrative Office of the United States Courts, shall
p.(None): monitor the drug and mental health courts under this section, and shall
p.(None): submit a report to Congress on the outcomes of the program at the end of
p.(None): the period described in subsection (d)(2).
p.(None): SEC. 14004. <> MENTAL HEALTH IN THE
p.(None): JUDICIAL SYSTEM.
p.(None):
p.(None): Part V of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
p.(None): the following:
p.(None): ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
p.(None):
p.(None): ``(a) Pretrial Screening and Supervision.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand pretrial services programs to improve the
p.(None): identification and outcomes of individuals with mental illness.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be may be used for--
p.(None): ``(A) behavioral health needs and risk screening of
p.(None): defendants, including verification of interview
p.(None): information, mental health evaluation, and criminal
p.(None): history screening;
p.(None): ``(B) assessment of risk of pretrial misconduct
p.(None): through objective, statistically validated means, and
p.(None): presentation to the court of recommendations based on
p.(None): such assessment, including services that will reduce the
p.(None): risk of pre-trial misconduct;
p.(None): ``(C) followup review of defendants unable to meet
p.(None): the conditions of pretrial release;
p.(None): ``(D) evaluation of process and results of pre-trial
p.(None): service programs;
p.(None): ``(E) supervision of defendants who are on pretrial
p.(None): release, including reminders to defendants of scheduled
p.(None): court dates;
p.(None): ``(F) reporting on process and results of pretrial
p.(None): services programs to relevant public and private mental
p.(None): health stakeholders; and
p.(None): ``(G) data collection and analysis necessary to make
p.(None): available information required for assessment of risk.
p.(None):
p.(None): ``(b) Behavioral Health Assessments and Intervention.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None):
p.(None): [[Page 130 STAT. 1292]]
p.(None):
p.(None): implement, or expand a behavioral health screening and
p.(None): assessment program framework for State or local criminal justice
p.(None): systems.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be used for--
p.(None): ``(A) promotion of the use of validated assessment
p.(None): tools to gauge the criminogenic risk, substance abuse
p.(None): needs, and mental health needs of individuals;
p.(None): ``(B) initiatives to match the risk factors and
p.(None): needs of individuals to programs and practices
p.(None): associated with research-based, positive outcomes;
p.(None): ``(C) implementing methods for identifying and
p.(None): treating individuals who are most likely to benefit from
p.(None): coordinated supervision and treatment strategies, and
p.(None): identifying individuals who can do well with fewer
p.(None): interventions; and
p.(None): ``(D) collaborative decision-making among the heads
p.(None): of criminal justice agencies, mental health systems,
p.(None): judicial systems, substance abuse systems, and other
p.(None): relevant systems or agencies for determining how
p.(None): treatment and intensive supervision services should be
p.(None): allocated in order to maximize benefits, and developing
p.(None): and utilizing capacity accordingly.
p.(None):
p.(None): ``(c) Use of Grant Funds.--A State, unit of local government,
p.(None): territory, Indian Tribe, or nonprofit agency that receives a grant under
p.(None): this section shall, in accordance with subsection (b)(2), use grant
p.(None): funds for the expenses of a treatment program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including costs relating to enforcement;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the State or Indian Tribe and licensed, if necessary, to provide
p.(None): needed treatment to program participants, including aftercare
p.(None): supervision, vocational training, education, and job placement;
p.(None): and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide alcohol and drug addiction treatment to
p.(None): offenders participating in the program.
p.(None):
p.(None): ``(d) Supplement of Non-Federal Funds.--
...
p.(None): shall compare the possible grant with any other grants awarded
p.(None): to the applicant under this Act to determine whether the grants
p.(None): are for the same purpose.
p.(None): ``(2) Report.--If the Attorney General awards multiple
p.(None): grants to the same applicant for the same purpose, the Attorney
p.(None): General shall submit to the Committee on the Judiciary of the
p.(None): Senate and the Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(A) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any such grants
p.(None): awarded; and
p.(None): ``(B) the reason the Attorney General awarded the
p.(None): duplicate grants.''.
p.(None): SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
p.(None):
p.(None): Section 2991 of the Omnibus Crime Control and Safe Streets Act of
p.(None): 1968 (42 U.S.C. 3797aa) is amended by--
p.(None): (1) redesignating subsection (j) as subsection (o); and
p.(None): (2) inserting after subsection (i) the following:
p.(None):
p.(None): ``(j) Forensic Assertive Community Treatment (FACT) Initiative
p.(None): Program.--
p.(None): ``(1) In general.--The Attorney General may make grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand Assertive Community Treatment initiatives
p.(None): to develop forensic assertive community treatment (referred to
p.(None): in this subsection as `FACT') programs that provide high
p.(None): intensity services in the community for individuals with mental
p.(None): illness with involvement in the criminal justice system to
p.(None): prevent future incarcerations.
p.(None): ``(2) Allowable uses.--Grant funds awarded under this
p.(None): subsection may be used for--
p.(None): ``(A) multidisciplinary team initiatives for
p.(None): individuals with mental illnesses with criminal justice
p.(None): involvement that address criminal justice involvement as
p.(None): part of treatment protocols;
p.(None): ``(B) FACT programs that involve mental health
p.(None): professionals, criminal justice agencies, chemical
p.(None): dependency specialists, nurses, psychiatrists,
p.(None): vocational specialists, forensic peer specialists,
p.(None): forensic specialists, and dedicated administrative
p.(None): support staff who work together to provide recovery
p.(None): oriented, 24/7 wraparound services;
p.(None): ``(C) services such as integrated evidence-based
p.(None): practices for the treatment of co-occurring mental
p.(None): health and substance-related disorders, assertive
p.(None): outreach and engagement, community-based service
p.(None): provision at participants' residence or in the
p.(None): community, psychiatric rehabilitation, recovery oriented
p.(None): services, services to address criminogenic risk factors,
p.(None): and community tenure;
p.(None): ``(D) payments for treatment providers that are
p.(None): approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide needed treatment to eligible
p.(None): offenders
p.(None):
p.(None): [[Page 130 STAT. 1296]]
p.(None):
p.(None): participating in the program, including behavioral
p.(None): health services and aftercare supervision; and
p.(None): ``(E) training for all FACT teams to promote high-
p.(None): fidelity practice principles and technical assistance to
p.(None): support effective and continuing integration with
p.(None): criminal justice agency partners.
p.(None): ``(3) Supplement and not supplant.--Grants made under this
p.(None): subsection shall be used to supplement, and not supplant, non-
p.(None): Federal funds that would otherwise be available for programs
p.(None): described in this subsection.
p.(None): ``(4) Applications.--To request a grant under this
p.(None): subsection, a State, unit of local government, territory, Indian
p.(None): Tribe, or nonprofit agency shall submit an application to the
p.(None): Attorney General in such form and containing such information as
p.(None): the Attorney General may reasonably require.''.
p.(None): SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
p.(None): SYSTEMS.
p.(None):
p.(None): Section 2976(f) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
p.(None): (1) in paragraph (5), by striking ``and'' at the end;
p.(None): (2) in paragraph (6), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(7) provide mental health treatment and transitional
p.(None): services for those with mental illnesses or with co-occurring
p.(None): disorders, including housing placement or assistance; and''.
p.(None): SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN DRUG COURTS.
p.(None):
p.(None): Part EE of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797u et seq.) is amended--
p.(None): (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
p.(None): inserting ``, including co-occurring substance abuse and mental
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
...
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
...
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
p.(None): 2007);
p.(None): ``(C) demonstrate that evidence-based treatment
p.(None): practices will be utilized; and
p.(None): ``(D) demonstrate that evidence-based screening and
p.(None): assessment tools will be used to place participants in
p.(None): the treatment alternative to incarceration program.
p.(None):
p.(None): ``(d) Requirements.--Each eligible entity awarded a grant for a
p.(None): treatment alternative to incarceration program under this section
p.(None): shall--
p.(None): ``(1) determine the terms and conditions of participation in
p.(None): the program by eligible participants, taking into consideration
p.(None): the collateral consequences of an arrest, prosecution or
p.(None): criminal conviction;
p.(None): ``(2) ensure that each substance abuse and mental health
p.(None): treatment component is licensed and qualified by the relevant
p.(None): jurisdiction;
p.(None): ``(3) for programs described in subsection (b)(2), organize
p.(None): an enforcement unit comprised of appropriately trained law
p.(None): enforcement professionals under the supervision of the State,
p.(None): Tribal, or local criminal justice agency involved, the duties of
p.(None): which shall include--
p.(None): ``(A) the verification of addresses and other
p.(None): contact information of each eligible participant who
p.(None): participates or desires to participate in the program;
p.(None): and
p.(None): ``(B) if necessary, the location, apprehension,
p.(None): arrest, and return to custody of an eligible participant
p.(None): in the program who has absconded from the facility of a
p.(None): treatment provider or has otherwise significantly
p.(None): violated the terms and conditions of the program,
p.(None): consistent with Federal and State confidentiality
p.(None): requirements;
p.(None):
p.(None): [[Page 130 STAT. 1300]]
p.(None):
p.(None): ``(4) notify the relevant criminal justice entity if any
p.(None): eligible participant in the program absconds from the facility
p.(None): of the treatment provider or otherwise violates the terms and
p.(None): conditions of the program, consistent with Federal and State
p.(None): confidentiality requirements;
p.(None): ``(5) submit periodic reports on the progress of treatment
p.(None): or other measured outcomes from participation in the program of
p.(None): each eligible participant in the program to the relevant State,
p.(None): Tribal, or local criminal justice agency, including mental
p.(None): health courts, drug courts, co-occurring mental health and
p.(None): substance abuse courts, DWI courts, and veterans treatment
p.(None): courts;
p.(None): ``(6) describe the evidence-based methodology and outcome
p.(None): measurements that will be used to evaluate the program, and
p.(None): specifically explain how such measurements will provide valid
p.(None): measures of the impact of the program; and
p.(None): ``(7) describe how the program could be broadly replicated
p.(None): if demonstrated to be effective.
p.(None):
p.(None): ``(e) Use of Funds.--An eligible entity shall use a grant received
p.(None): under this section for expenses of a treatment alternative to
p.(None): incarceration program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including the enforcement unit;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the relevant State or Tribal jurisdiction and licensed, if
p.(None): necessary, to provide needed treatment to eligible offenders
p.(None): participating in the program, including aftercare supervision,
p.(None): vocational training, education, and job placement; and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Tribal jurisdiction and licensed,
p.(None): if necessary, to provide alcohol and drug addiction treatment to
...
p.(None): Judiciary and the Committee on Appropriations of the Senate and
p.(None): the Committee on the Judiciary and the Committee on
p.(None): Appropriations of the House of Representatives, an annual
p.(None): certification--
p.(None): ``(A) indicating whether--
p.(None): ``(i) all audits issued by the Office of the
p.(None): Inspector General under paragraph (1) have been
p.(None): completed and reviewed by the appropriate
p.(None): Assistant Attorney General or Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(C) have been issued; and
p.(None): ``(iii) all reimbursements required under
p.(None): paragraph (1)(E) have been made; and
p.(None): ``(B) that includes a list of any grant recipients
p.(None): excluded under paragraph (1) from the previous year.
p.(None): ``(5) Preventing duplicative grants.--
p.(None): ``(A) In general.--Before the Attorney General
p.(None): awards a grant to an applicant under this section, the
p.(None): Attorney General shall compare potential grant awards
p.(None): with other grants awarded under this Act to determine if
p.(None): duplicate grant awards are awarded for the same purpose.
p.(None): ``(B) Report.--If the Attorney General awards
p.(None): duplicate grants to the same applicant for the same
p.(None): purpose the Attorney General shall submit to the
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None):
p.(None): [[Page 130 STAT. 1303]]
p.(None):
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14014. <> NATIONAL CRIMINAL JUSTICE
p.(None): AND MENTAL HEALTH TRAINING AND
p.(None): TECHNICAL ASSISTANCE.
p.(None):
p.(None): Part HH of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end the
p.(None): following:
p.(None): ``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING
p.(None): AND TECHNICAL ASSISTANCE.
p.(None):
p.(None): ``(a) Authority.--The Attorney General may make grants to eligible
p.(None): organizations to provide for the establishment of a National Criminal
p.(None): Justice and Mental Health Training and Technical Assistance Center.
p.(None): ``(b) Eligible Organization.--For purposes of subsection (a), the
p.(None): term `eligible organization' means a national nonprofit organization
p.(None): that provides technical assistance and training to, and has special
p.(None): expertise and broad, national-level experience in, mental health, crisis
p.(None): intervention, criminal justice systems, law enforcement, translating
p.(None): evidence into practice, training, and research, and education and
p.(None): support of people with mental illness and the families of such
p.(None): individuals.
p.(None): ``(c) Use of Funds.--Any organization that receives a grant under
p.(None): subsection (a) shall collaborate with other grant recipients to
p.(None): establish and operate a National Criminal Justice and Mental Health
p.(None): Training and Technical Assistance Center to--
p.(None): ``(1) provide law enforcement officer training regarding
p.(None): mental health and working with individuals with mental
p.(None): illnesses, with an emphasis on de-escalation of encounters
p.(None): between law enforcement officers and those with mental disorders
p.(None): or in crisis, which shall include support the development of in-
p.(None): person and technical information exchanges between systems and
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
p.(None): training and technical assistance for criminal justice agencies;
p.(None): ``(5) develop a receiving center system and pilot strategy
p.(None): that provides, for a jurisdiction, a single point of entry into
p.(None): the mental health and substance abuse system for assessments and
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
p.(None): criminal justice agencies evaluation tools, mechanisms, and
p.(None): measures to better assess and document performance measures and
p.(None): outcomes relating to the provision of mental health services;
p.(None): ``(8) disseminate information to States, units of local
p.(None): government, criminal justice agencies, law enforcement agencies,
p.(None): and other relevant entities about best practices, policy
p.(None): standards, and research findings relating to the provision of
p.(None): mental health services; and
p.(None): ``(9) provide education and support to individuals with
p.(None): mental illness involved with, or at risk of involvement with,
p.(None): the criminal justice system, including the families of such
p.(None): individuals.
p.(None):
p.(None): ``(d) Accountability.--Grants awarded under this section shall be
p.(None): subject to the following accountability provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
p.(None): of Justice under subparagraph (C) that the audited
p.(None): grantee has used grant funds for an unauthorized
p.(None): expenditure or otherwise unallowable cost that is not
p.(None): closed or resolved within 1 year after the date on which
p.(None): the final audit report is issued.
p.(None): ``(B) Audits.--Beginning in the first fiscal year
p.(None): beginning after the date of enactment of this section,
p.(None): and in each fiscal year thereafter, the Inspector
p.(None): General of the Department of Justice shall conduct
p.(None): audits of grantees under this section to prevent waste,
p.(None): fraud, and abuse of funds by grantees. The Inspector
p.(None): General shall determine the appropriate number of
p.(None): grantees to be audited each year.
p.(None): ``(C) Final audit report.--The Inspector General of
p.(None): the Department of Justice shall submit to the Attorney
p.(None): General a final report on each audit conducted under
p.(None): subparagraph (B).
p.(None): ``(D) Mandatory exclusion.--Grantees under this
p.(None): section about which there is an unresolved audit finding
p.(None): shall not be eligible to receive a grant under this
...
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
p.(None): VETERANS AFFAIRS OF MENTAL CAPACITY OF
p.(None): BENEFICIARIES.
p.(None):
p.(None): (a) In General.--Chapter 55 of title 38, United States Code, is
p.(None): amended by inserting after section 5501 the following new section:
...
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated by section
p.(None): 14006, is amended--
p.(None): (1) in paragraph (1)(C), by striking ``2009 through 2014''
p.(None): and inserting ``2017 through 2021''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(3) Limitation.--Not more than 20 percent of the funds authorized
p.(None): to be appropriated under this section may be used for purposes described
p.(None): in subsection (i) (relating to veterans).''.
p.(None):
p.(None): [[Page 130 STAT. 1308]]
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section 14005, is
p.(None): amended by inserting after subsection (j), the following:
p.(None): ``(k) Sequential Intercept Grants.--
p.(None): ``(1) Definition.--In this subsection, the term `eligible
p.(None): entity' means a State, unit of local government, Indian tribe,
p.(None): or tribal organization.
p.(None): ``(2) Authorization.--The Attorney General may make grants
p.(None): under this subsection to an eligible entity for sequential
p.(None): intercept mapping and implementation in accordance with
p.(None): paragraph (3).
p.(None): ``(3) Sequential intercept mapping; implementation.--An
p.(None): eligible entity that receives a grant under this subsection may
p.(None): use funds for--
p.(None): ``(A) sequential intercept mapping, which--
p.(None): ``(i) shall consist of--
p.(None): ``(I) convening mental health and
p.(None): criminal justice stakeholders to--
p.(None): ``(aa) develop a shared
p.(None): understanding of the flow of
p.(None): justice-involved individuals
p.(None): with mental illnesses through
p.(None): the criminal justice system; and
p.(None): ``(bb) identify
p.(None): opportunities for improved
p.(None): collaborative responses to the
p.(None): risks and needs of individuals
p.(None): described in item (aa); and
p.(None): ``(II) developing strategies to
p.(None): address gaps in services and bring
p.(None): innovative and effective programs to
p.(None): scale along multiple intercepts,
p.(None): including--
p.(None): ``(aa) emergency and crisis
p.(None): services;
p.(None): ``(bb) specialized police-
p.(None): based responses;
p.(None): ``(cc) court hearings and
p.(None): disposition alternatives;
p.(None): ``(dd) reentry from jails
p.(None): and prisons; and
p.(None): ``(ee) community
p.(None): supervision, treatment and
p.(None): support services; and
p.(None): ``(ii) may serve as a starting point for the
p.(None): development of strategic plans to achieve positive
p.(None): public health and safety outcomes; and
p.(None): ``(B) implementation, which shall--
p.(None): ``(i) be derived from the strategic plans
p.(None): described in subparagraph (A)(ii); and
p.(None): ``(ii) consist of--
p.(None): ``(I) hiring and training personnel;
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
p.(None): services and substance abuse treatment services;
p.(None): and
p.(None): ``(iii) alternatives to solitary confinement
p.(None): and segregated housing and mental health screening
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
p.(None): incidents involving inmates with mental health or co-
p.(None): occurring mental health and substance abuse
p.(None): disorders.''.
p.(None): SEC. 14023. ALLOWABLE USES.
p.(None):
p.(None): Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and
p.(None): Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by
p.(None): adding at the end the following:
p.(None): ``(v) Teams addressing frequent users of
p.(None): crisis services.--Multidisciplinary teams that--
p.(None): ``(I) coordinate, implement, and
p.(None): administer community-based crisis
p.(None): responses and long-term plans for
p.(None): frequent users of crisis services;
p.(None): ``(II) provide training on how to
p.(None): respond appropriately to the unique
p.(None): issues involving frequent users of
p.(None): crisis services for public service
p.(None): personnel,
p.(None):
p.(None): [[Page 130 STAT. 1310]]
p.(None):
p.(None): including criminal justice, mental
p.(None): health, substance abuse, emergency room,
p.(None): healthcare, law enforcement,
p.(None): corrections, and housing personnel;
p.(None): ``(III) develop or support
p.(None): alternatives to hospital and jail
p.(None): admissions for frequent users of crisis
p.(None): services that provide treatment,
p.(None): stabilization, and other appropriate
p.(None): supports in the least restrictive, yet
p.(None): appropriate, environment; and
p.(None): ``(IV) develop protocols and systems
p.(None): among law enforcement, mental health,
p.(None): substance abuse, housing, corrections,
p.(None): and emergency medical service operations
p.(None): to provide coordinated assistance to
p.(None): frequent users of crisis services.''.
p.(None): SEC. 14024. LAW ENFORCEMENT TRAINING.
p.(None):
p.(None): Section 2991(h) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
p.(None): mental health and substance abuse professions develop and
p.(None): administer cooperatively.''.
p.(None): SEC. 14025. <> FEDERAL LAW
p.(None): ENFORCEMENT TRAINING.
p.(None):
p.(None): Not later than 1 year after the date of enactment of this Act, the
p.(None): Attorney General shall provide direction and guidance for the following:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training, in procedures to identify and
p.(None): appropriately respond to incidents in which the unique needs of
p.(None): individuals who have a mental illness are involved, to first
p.(None): responders and tactical units of--
p.(None): (A) Federal law enforcement agencies; and
p.(None): (B) other Federal criminal justice agencies such as
p.(None): the Bureau of Prisons, the Administrative Office of the
p.(None): United States Courts, and other agencies that the
p.(None): Attorney General determines appropriate.
p.(None): (2) Improved technology.--The establishment of, or
p.(None): improvement of existing, computerized information systems to
p.(None): provide timely information to employees of Federal law
p.(None): enforcement agencies, and Federal criminal justice agencies to
p.(None): improve the response of such employees to situations involving
p.(None): individuals who have a mental illness.
p.(None): SEC. 14026. GAO REPORT.
p.(None):
p.(None): No later than 1 year after the date of enactment of this Act, the
p.(None): Comptroller General of the United States, in coordination with the
p.(None): Attorney General, shall submit to Congress a report on--
p.(None):
p.(None): [[Page 130 STAT. 1311]]
p.(None):
p.(None): (1) the practices that Federal first responders, tactical
p.(None): units, and corrections officers are trained to use in responding
p.(None): to individuals with mental illness;
p.(None): (2) procedures to identify and appropriately respond to
p.(None): incidents in which the unique needs of individuals who have a
p.(None): mental illness are involved, to Federal first responders and
p.(None): tactical units;
p.(None): (3) the application of evidence-based practices in criminal
p.(None): justice settings to better address individuals with mental
p.(None): illnesses; and
p.(None): (4) recommendations on how the Department of Justice can
p.(None): expand and improve information sharing and dissemination of best
p.(None): practices.
p.(None): SEC. 14027. EVIDENCE BASED PRACTICES.
p.(None):
p.(None): Section 2991(c) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
p.(None): (1) in paragraph (3), by striking ``or'' at the end;
p.(None): (2) by redesignating paragraph (4) as paragraph (6); and
p.(None): (3) by inserting after paragraph (3), the following:
p.(None): ``(4) propose interventions that have been shown by
p.(None): empirical evidence to reduce recidivism;
p.(None): ``(5) when appropriate, use validated assessment tools to
p.(None): target preliminarily qualified offenders with a moderate or high
p.(None): risk of recidivism and a need for treatment and services; or''.
p.(None): SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT
p.(None): OF LOCAL AUTHORITY.
p.(None):
p.(None): (a) In General.--Section 2991(a) of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
p.(None): (1) in paragraph (7)--
p.(None): (A) in the heading, by striking ``Mental illness''
p.(None): and inserting ``Mental illness; mental health
p.(None): disorder''; and
...
p.(None): ``(dd) judge; and
p.(None): ``(II) a representative from the
p.(None): relevant mental health agency described
p.(None): in subsection (b)(5)(B)(i);
p.(None): ``(iii) has been determined, by each person
p.(None): described in clause (ii) who is involved in
p.(None): approving the adult or juvenile for participation
p.(None): in a program funded under this section, to not
p.(None): pose a risk of violence to any person in the
p.(None): program, or the public, if selected to participate
p.(None): in the program; and
p.(None): ``(iv) has not been charged with or convicted
p.(None): of--
p.(None): ``(I) any sex offense (as defined in
p.(None): section 111 of the Sex Offender
p.(None): Registration and Notification Act (42
p.(None): U.S.C. 16911)) or any offense relating
p.(None): to the sexual exploitation of children;
p.(None): or
p.(None): ``(II) murder or assault with intent
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
p.(None): mental health or substance abuse agency representative
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
p.(None): or property of another may be used in the course of
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): end the following:
p.(None):
p.(None): ``(2) Where research substances and living organisms are made
p.(None): available under paragraph (1) through contractors, the Secretary may
p.(None): direct such contractors to collect payments on behalf of the Secretary
p.(None): for the costs incurred to make available such substances and organisms
p.(None): and to forward amounts so collected to the Secretary, in the time and
p.(None): manner specified by the Secretary.
p.(None): ``(3) Amounts collected under paragraph (2) shall be credited to the
p.(None): appropriations accounts that incurred the costs to make available the
p.(None): research substances and living organisms involved, and shall remain
p.(None): available until expended for carrying out activities under such
p.(None): accounts.''.
p.(None): SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF
p.(None): UNDERREPRESENTED POPULATIONS IN CLINICAL
p.(None): TRIALS.
p.(None):
p.(None): It is the sense of Congress that the National Institute on Minority
p.(None): Health and Health Disparities should include within its strategic plan
p.(None): under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m))
p.(None): ways to increase representation of underrepresented populations in
p.(None): clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
p.(None):
p.(None): Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
p.(None): 282(j)(2)(D)) is amended--
p.(None): (1) in clause (ii)(I), by inserting before the semicolon ``,
p.(None): unless the responsible party affirmatively requests that the
p.(None): Director of the National Institutes of Health publicly post such
p.(None): clinical trial information for an applicable device clinical
p.(None): trial prior to such date of clearance or approval''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(iii) Option to make certain clinical trial
p.(None): information available earlier.--The Director of
p.(None): the National Institutes of Health shall inform
p.(None): responsible parties of the option to request that
p.(None): clinical trial information for an applicable
p.(None): device clinical trial be publicly posted prior to
p.(None): the date of clearance or approval, in accordance
p.(None): with clause (ii)(I).
p.(None): ``(iv) Combination products.--An applicable
p.(None): clinical trial for a product that is a combination
p.(None): of drug, device, or biological product shall be
p.(None): considered--
p.(None):
p.(None): [[Page 130 STAT. 1075]]
p.(None):
p.(None): ``(I) an applicable drug clinical
p.(None): trial, if the Secretary determines under
p.(None): section 503(g) of the Federal Food,
p.(None): Drug, and Cosmetic Act that the primary
p.(None): mode of action of such product is that
p.(None): of a drug or biological product; or
p.(None): ``(II) an applicable device clinical
p.(None): trial, if the Secretary determines under
p.(None): such section that the primary mode of
p.(None): action of such product is that of a
p.(None): device.''.
p.(None): SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
p.(None):
p.(None): (a) Definitions.--In this section:
p.(None): (1) Applicable clinical trial.--The term ``applicable
...
p.(None): ``(ii) the extent to which the software function is
p.(None): intended to support the clinical judgment of a health
p.(None): care professional;
p.(None): ``(iii) whether there is a reasonable opportunity
p.(None): for a health care professional to review the basis of
p.(None): the information or treatment recommendation provided by
p.(None): the software function; and
p.(None): ``(iv) the intended user and user environment, such
p.(None): as whether a health care professional will use a
p.(None): software function of a type described in subparagraph
p.(None): (E) of paragraph (1).
p.(None): ``(4) Nothing in this subsection shall be construed as
p.(None): limiting the authority of the Secretary to--
p.(None): ``(A) exercise enforcement discretion as to any
p.(None): device subject to regulation under this Act;
p.(None): ``(B) regulate software used in the manufacture and
p.(None): transfusion of blood and blood components to assist in
p.(None): the prevention of disease in humans; or
p.(None): ``(C) regulate software as a device under this Act
p.(None): if such software meets the criteria under section
p.(None): 513(a)(1)(C).''.
p.(None):
p.(None): (b) <> Reports.--The Secretary of Health
p.(None): and Human Services (referred to in this subsection as the
p.(None): ``Secretary''), after consultation with agencies and offices of the
p.(None): Department of Health and Human Services involved in health information
p.(None): technology, shall publish a report, not later than 2 years after the
p.(None): date of enactment of this Act and every 2 years thereafter, that--
p.(None): (1) includes input from outside experts, such as
p.(None): representatives of patients, consumers, health care providers,
p.(None): startup companies, health plans or other third-party payers,
p.(None): venture capital investors, information technology vendors,
p.(None): health information technology vendors, small businesses,
p.(None): purchasers, employers, and other stakeholders with relevant
p.(None): expertise, as determined by the Secretary;
p.(None):
p.(None): [[Page 130 STAT. 1133]]
p.(None):
p.(None): (2) examines information available to the Secretary on any
p.(None): risks and benefits to health associated with software functions
p.(None): described in section 520(o)(1) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a));
p.(None): and
p.(None): (3) summarizes findings regarding the impact of such
p.(None): software functions on patient safety, including best practices
p.(None): to promote safety, education, and competency related to such
p.(None): functions.
p.(None):
p.(None): (c) Classification of Accessories.--Section 513(b) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding at
p.(None): the end the following:
p.(None): ``(9) The Secretary shall classify an accessory under this section
p.(None): based on the intended use of the accessory, notwithstanding the
p.(None): classification of any other device with which such accessory is intended
p.(None): to be used.''.
p.(None): (d) Conforming Amendment.--Section 201(h) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the
p.(None): following: ``The term `device' does not include software functions
p.(None): excluded pursuant to section 520(o).''.
p.(None):
...
p.(None): appointed only for the remainder of that term. A member
p.(None): may serve after the expiration of that member's term
p.(None): until a successor has been appointed. A vacancy in the
p.(None): HIT Advisory Committee shall be filled in the manner in
p.(None): which the original appointment was made.
p.(None): ``(C) Limits.--Members of the HIT Advisory Committee
p.(None): shall be limited to two 3-year terms, for a total of not
p.(None): to exceed 6 years of service on the Committee.
p.(None): ``(5) Outside involvement.--The HIT Advisory Committee shall
p.(None): ensure an opportunity for the participation in activities of the
p.(None): Committee of outside advisors, including individuals with
p.(None): expertise in the development of policies and standards for the
p.(None): electronic exchange and use of health information,
p.(None):
p.(None): [[Page 130 STAT. 1174]]
p.(None):
p.(None): including in the areas of health information privacy and
p.(None): security.
p.(None): ``(6) Quorum.--A majority of the members of the HIT Advisory
p.(None): Committee shall constitute a quorum for purposes of voting, but
p.(None): a lesser number of members may meet and hold hearings.
p.(None): ``(7) Consideration.--The National Coordinator shall ensure
p.(None): that the relevant and available recommendations and comments
p.(None): from the National Committee on Vital and Health Statistics are
p.(None): considered in the development of policies.
p.(None): ``(8) Assistance.--For the purposes of carrying out this
p.(None): section, the Secretary may provide or ensure that financial
p.(None): assistance is provided by the HIT Advisory Committee to defray
p.(None): in whole or in part any membership fees or dues charged by such
p.(None): Committee to those consumer advocacy groups and not-for-profit
p.(None): entities that work in the public interest as a party of their
p.(None): mission.
p.(None):
p.(None): ``(e) Application of FACA.--The Federal Advisory Committee Act (5
p.(None): U.S.C. App.), other than section 14 of such Act, shall apply to the HIT
p.(None): Advisory Committee.
p.(None): ``(f) Publication.--The Secretary shall provide for publication in
p.(None): the Federal Register and the posting on the Internet website of the
p.(None): Office of the National Coordinator for Health Information Technology of
p.(None): all policy recommendations made by the HIT Advisory Committee under this
p.(None): section.''.
p.(None): (2) Technical and conforming amendments.--Title XXX of the
p.(None): Public Health Service Act (42 U.S.C. 300jj et seq.) is amended--
p.(None): (A) by striking--
p.(None): (i) ``HIT Policy Committee'' and ``HIT
p.(None): Standards Committee'' each place that such terms
p.(None): appear (other than within the term ``HIT Policy
p.(None): Committee and the HIT Standards Committee'' or
p.(None): within the term ``HIT Policy Committee or the HIT
p.(None): Standards Committee'') and inserting ``HIT
p.(None): Advisory Committee'';
p.(None): (ii) ``HIT Policy Committee and the HIT
p.(None): Standards Committee'' each place that such term
p.(None): appears and inserting ``HIT Advisory Committee'';
p.(None): and
p.(None): (iii) ``HIT Policy Committee or the HIT
p.(None): Standards Committee'' each place that such term
p.(None): appears and inserting ``HIT Advisory Committee'';
p.(None): (B) in section 3000 (42 U.S.C. 300jj)--
p.(None): (i) by striking paragraphs (7) and (8) and
p.(None): redesignating paragraphs (9) through (14) as
p.(None): paragraphs (8) through (13), respectively; and
p.(None): (ii) by inserting after paragraph (6) the
p.(None): following paragraph:
p.(None): ``(7) Hit advisory committee.--The term `HIT Advisory
p.(None): Committee' means such Committee established under section
p.(None): 3002(a).'';
...
p.(None): information exchange (or other relevant platform) that provide
p.(None): protections to patients that are greater than the protections
p.(None): otherwise provided for under applicable Federal law.
p.(None):
p.(None): ``(d) Efforts To Promote Access to Health Information.--The National
p.(None): Coordinator and the Office for Civil Rights of the Department of Health
p.(None): and Human Services shall jointly promote patient access to health
p.(None): information in a manner that would ensure that such information is
p.(None): available in a form convenient for the patient, in a reasonable manner,
p.(None): without burdening the health care provider involved.
p.(None): ``(e) Accessibility of Patient Records.--
p.(None): ``(1) Accessibility and updating of information.--
p.(None): ``(A) In general.--The Secretary, in consultation
p.(None): with the National Coordinator, shall promote policies
p.(None): that ensure that a patient's electronic health
p.(None): information is accessible to that patient and the
p.(None): patient's designees, in a manner that facilitates
p.(None): communication with the patient's health care providers
p.(None): and other individuals, including researchers, consistent
p.(None): with such patient's consent.
p.(None): ``(B) Updating education on accessing and exchanging
p.(None): personal health information.--To promote awareness that
p.(None): an individual has a right of access to inspect, obtain a
p.(None): copy of, and transmit to a third party a copy of such
p.(None): individual's protected health information pursuant to
p.(None): the Health Information Portability and Accountability
p.(None): Act, Privacy Rule (subpart E of part 164 of title 45,
p.(None): Code of Federal Regulations), the Director of the Office
p.(None): for Civil Rights, in consultation with the National
p.(None): Coordinator, shall assist individuals and health care
p.(None): providers in understanding a patient's rights to access
p.(None): and protect personal health information under the Health
p.(None): Insurance Portability and Accountability Act of 1996
p.(None): (Public Law 104-191), including providing best practices
p.(None):
p.(None): [[Page 130 STAT. 1183]]
p.(None):
p.(None): for requesting personal health information in a
p.(None): computable format, including using patient portals or
p.(None): third-party applications and common cases when a
p.(None): provider is permitted to exchange and provide access to
p.(None): health information.''.
p.(None): ``(2) Certifying usability for patients.--In carrying out
p.(None): certification programs under section 3001(c)(5), the National
p.(None): Coordinator may require that--
p.(None): ``(A) the certification criteria support--
p.(None): ``(i) patient access to their electronic
p.(None): health information, including in a single
p.(None): longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically;
p.(None): ``(ii) the patient's ability to electronically
p.(None): communicate patient-reported information (such as
p.(None): family history and medical history); and
p.(None): ``(iii) patient access to their personal
p.(None): electronic health information for research at the
p.(None): option of the patient; and
p.(None): ``(B) the HIT Advisory Committee develop and
p.(None): prioritize standards, implementation specifications, and
p.(None): certification criteria required to help support patient
p.(None): access to electronic health information, patient
p.(None): usability, and support for technologies that offer
p.(None): patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to
p.(None): understand, secure, and may be updated automatically.''.
p.(None):
...
p.(None): this Act, the Comptroller General shall submit to the appropriate
p.(None): committees of Congress a report concerning the findings of the study
p.(None): conducted under subsection (a).
p.(None): SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
p.(None):
p.(None): (a) Study.--
p.(None): (1) In general.--The Comptroller General of the United
p.(None): States (referred to in this section as the ``Comptroller
p.(None): General'') shall build on prior Government Accountability Office
p.(None): studies and other literature review and conduct a study to
p.(None): review patient access to their own protected health information,
p.(None): including barriers to such patient access and complications or
p.(None): difficulties providers experience in providing access to
p.(None): patients. In conducting such study, the Comptroller General
p.(None): shall consider the increase in adoption of health information
p.(None): technology and the increasing prevalence of protected health
p.(None): information that is maintained electronically.
p.(None): (2) Areas of concentration.--In conducting the review under
p.(None): paragraph (1), the Comptroller General shall consider--
p.(None): (A) instances when covered entities charge
p.(None): individuals, including patients, third parties, and
p.(None): health care providers, for record requests, including
p.(None): records that are requested in an electronic format;
p.(None): (B) examples of the amounts and types of fees
p.(None): charged to individuals for record requests, including
p.(None): instances when the record is requested to be transmitted
p.(None): to a third party;
p.(None): (C) the extent to which covered entities are unable
p.(None): to provide the access requested by individuals in the
p.(None): form
p.(None):
p.(None): [[Page 130 STAT. 1185]]
p.(None):
p.(None): and format requested by the individual, including
p.(None): examples of such instances;
p.(None): (D) instances in which third parties may request
p.(None): protected health information through patients'
p.(None): individual right of access, including instances where
p.(None): such requests may be used to circumvent appropriate fees
p.(None): that may be charged to third parties;
p.(None): (E) opportunities that permit covered entities to
p.(None): charge appropriate fees to third parties for patient
p.(None): records while providing patients with access to their
p.(None): protected health information at low or no cost;
p.(None): (F) the ability of providers to distinguish between
p.(None): requests originating from an individual that require
p.(None): limitation to a cost-based fee and requests originating
p.(None): from third parties that may not be limited to cost-based
p.(None): fees; and
p.(None): (G) other circumstances that may inhibit the ability
p.(None): of providers to provide patients with access to their
p.(None): records, and the ability of patients to gain access to
p.(None): their records.
p.(None):
p.(None): (b) Report.--Not later than 18 months after the date of enactment of
p.(None): this Act, the Comptroller General shall submit a report to Congress on
p.(None): the findings of the study conducted under subsection (a).
p.(None): SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
...
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
p.(None): accordance with subsection (a), a State shall submit to the
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
p.(None): based system of care for individuals with mental
p.(None): illness, and describe available services and
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
...
p.(None): is approved by the Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State fails to enter
p.(None): into or comply with a negotiated agreement, the Secretary may
p.(None): take action under this paragraph or the terms of the negotiated
p.(None): agreement.''.
p.(None):
p.(None): (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
p.(None): Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
p.(None): ``substance abuse'' and inserting ``substance use disorders''.
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
p.(None): pregnant women, women with dependent children,
p.(None): individuals with a co-occurring mental health and
p.(None): substance use disorder, persons who inject drugs,
p.(None): and persons who are experiencing homelessness;
p.(None): ``(iii) provides aggregate information on the
p.(None): number of individuals in treatment within the
p.(None): State, including the number of such individuals
p.(None): who are pregnant women, women with dependent
p.(None): children, individuals with a co-occurring mental
p.(None): health and substance use disorder, persons who
p.(None): inject drugs, and persons who are experiencing
p.(None): homelessness;
p.(None): ``(iv) provides a description of the system
p.(None): that is available to provide services by modality,
...
p.(None): circumstances of the emergency reasonably require and for the period of
p.(None): the emergency, grant an extension, or waive application deadlines or
p.(None): compliance with any other requirement, of a grant authorized under
p.(None): section 521, 1911, or 1921 or an allotment authorized under Public Law
p.(None): 99-319 (42 U.S.C. 10801 et seq.).
p.(None): ``SEC. 1958. <> JOINT APPLICATIONS.
p.(None):
p.(None): ``The Secretary, acting through the Assistant Secretary for Mental
p.(None): Health and Substance Use, shall permit a joint application to be
p.(None): submitted for grants under subpart I and subpart II upon the request of
p.(None): a State. Such application may be jointly reviewed and approved by the
p.(None): Secretary with respect to such subparts, consistent with the purposes
p.(None): and authorized activities of each such grant program. A State submitting
p.(None): such a joint application shall otherwise meet the requirements with
p.(None): respect to each such subpart.''.
p.(None): SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
p.(None): ABUSE PREVENTION AND TREATMENT BLOCK
p.(None): GRANT AND THE COMMUNITY MENTAL HEALTH
p.(None): SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Mental Health and Substance Use,
p.(None): shall through a grant or contract, or through an agreement with a third
p.(None): party, conduct a study on the formulas for distribution of funds under
p.(None): the substance abuse prevention and treatment block grant, and the
p.(None): community mental health services block grant, under part B of title XIX
p.(None): of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend
p.(None): changes if necessary. Such study shall include--
p.(None): (1) an analysis of whether the distributions under such
p.(None): block grants accurately reflect the need for the services under
p.(None): the grants in the States;
p.(None): (2) an examination of whether the indices used under the
p.(None): formulas for distribution of funds under such block grants are
p.(None): appropriate, and if not, alternatives recommended by the
p.(None): Secretary;
p.(None): (3) where recommendations are included under paragraph (2)
p.(None): for the use of different indices, a description of the variables
p.(None): and data sources that should be used to determine the indices;
p.(None): (4) an evaluation of the variables and data sources that are
p.(None): being used for each of the indices involved, and whether such
p.(None): variables and data sources accurately represent the need for
p.(None): services, the cost of providing services, and the ability of the
p.(None): States to pay for such services;
p.(None): (5) the effect that the minimum allotment requirements for
p.(None): each such block grant have on each State's final allotment and
p.(None): the effect of such requirements, if any, on each State's
p.(None): formula-based allotment;
p.(None):
p.(None): [[Page 130 STAT. 1234]]
p.(None):
p.(None): (6) recommendations for modifications to the minimum
p.(None): allotment provisions to ensure an appropriate distribution of
p.(None): funds; and
...
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
p.(None): practitioner shall for purposes of this subsection be considered to be a
p.(None): health professional volunteer at an entity described in subsection
p.(None): (g)(4) if the following conditions are met:
p.(None): ``(A) The service is provided to the individual at the
p.(None): facilities of an entity described in subsection (g)(4), or
p.(None): through offsite programs or events carried out by the entity.
p.(None): ``(B) The entity is sponsoring the health care practitioner
p.(None): pursuant to paragraph (3)(B).
p.(None): ``(C) The health care practitioner does not receive any
p.(None): compensation for the service from the individual, the entity
p.(None): described in subsection (g)(4), or any third-party payer
p.(None): (including reimbursement under any insurance policy or health
p.(None): plan, or under any Federal or State health benefits program),
p.(None): except that the health care practitioner may receive repayment
p.(None): from the entity described in subsection (g)(4) for reasonable
p.(None): expenses incurred by the health care practitioner in the
p.(None): provision of the service to the individual, which may include
p.(None): travel expenses to or from the site of services.
p.(None): ``(D) Before the service is provided, the health care
p.(None): practitioner or the entity described in subsection (g)(4) posts
p.(None): a clear
p.(None):
p.(None): [[Page 130 STAT. 1255]]
p.(None):
p.(None): and conspicuous notice at the site where the service is provided
p.(None): of the extent to which the legal liability of the health care
p.(None): practitioner is limited pursuant to this subsection.
p.(None): ``(E) At the time the service is provided, the health care
p.(None): practitioner is licensed or certified in accordance with
p.(None): applicable Federal and State laws regarding the provision of the
p.(None): service.
p.(None): ``(F) At the time the service is provided, the entity
p.(None): described in subsection (g)(4) maintains relevant documentation
p.(None): certifying that the health care practitioner meets the
p.(None): requirements of this subsection.
p.(None):
p.(None): ``(3) Subsection (g) (other than paragraphs (3) and (5)) and
p.(None): subsections (h), (i), and (l) apply to a health care practitioner for
p.(None): purposes of this subsection to the same extent and in the same manner as
p.(None): such subsections apply to an officer, governing board member, employee,
p.(None): or contractor of an entity described in subsection (g)(4), subject to
p.(None): paragraph (4), and subject to the following:
...
p.(None): this paragraph with respect to applicable items
p.(None): and services furnished during 2018 or a subsequent
p.(None): year, the term `off-campus outpatient department
p.(None): of a provider' also shall not include a department
p.(None): of a provider (as so defined) that is not
p.(None): described in clause (ii) if--
p.(None): ``(I) the Secretary receives from
p.(None): the provider an attestation (pursuant to
p.(None): such section 413.65(b)(3)) not later
p.(None): than December 31, 2016 (or, if later, 60
p.(None): days after the date of the enactment of
p.(None): this clause), that such department met
p.(None): the requirements of a department of a
p.(None): provider specified in section 413.65 of
p.(None): title 42 of the Code of Federal
p.(None): Regulations;
p.(None): ``(II) the provider includes such
p.(None): department as part of the provider on
p.(None): its enrollment form in accordance with
p.(None): the enrollment process under section
p.(None): 1866(j); and
p.(None): ``(III) the department met the mid-
p.(None): build requirement of clause (v) and the
p.(None): Secretary receives, not later than 60
p.(None): days after the date
p.(None):
p.(None): [[Page 130 STAT. 1325]]
p.(None):
p.(None): of the enactment of this clause, from
p.(None): the chief executive officer or chief
p.(None): operating officer of the provider a
p.(None): written certification that the
p.(None): department met such requirement.
p.(None): ``(v) Mid-build requirement described.--The
p.(None): mid-build requirement of this clause is, with
p.(None): respect to a department of a provider, that before
p.(None): November 2, 2015, the provider had a binding
p.(None): written agreement with an outside unrelated party
p.(None): for the actual construction of such department.
p.(None): ``(vii) Audit.--Not later than December 31,
p.(None): 2018, the Secretary shall audit the compliance
p.(None): with requirements of clause (iv) with respect to
p.(None): each department of a provider to which such clause
p.(None): applies. If the Secretary finds as a result of an
p.(None): audit under this clause that the applicable
p.(None): requirements were not met with respect to such
p.(None): department, the department shall not be excluded
p.(None): from the term `off-campus outpatient department of
p.(None): a provider' under such clause.
p.(None): ``(viii) Implementation.--For purposes of
p.(None): implementing clauses (iii) through (vii):
p.(None): ``(I) Notwithstanding any other
p.(None): provision of law, the Secretary may
p.(None): implement such clauses by program
p.(None): instruction or otherwise.
p.(None): ``(II) Subchapter I of chapter 35 of
p.(None): title 44, United States Code, shall not
p.(None): apply.
p.(None): ``(III) For purposes of carrying out
p.(None): this subparagraph with respect to
p.(None): clauses (iii) and (iv) (and clause (vii)
p.(None): insofar as it relates to clause (iv)),
p.(None): $10,000,000 shall be available from the
p.(None): Federal Supplementary Medical Insurance
p.(None): Trust Fund under section 1841, to remain
p.(None): available until December 31, 2018.'';
p.(None): and
p.(None): (2) in subparagraph (E), by adding at the end the following
p.(None): new clause:
p.(None): ``(iv) The determination of an audit under
p.(None): subparagraph (B)(vii).''.
p.(None):
p.(None): (b) <> Effective Date.--The amendments
p.(None): made by this section shall be effective as if included in the enactment
p.(None): of section 603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).
p.(None): SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT
...
Searching for indicator political:
(return to top)
p.(None): chronic diseases, attendance at scheduled medical and
p.(None): mental health appointments, compliance with prescribed
p.(None): medication regimes, and participation in learning
p.(None): opportunities related to improved health and lifestyle
p.(None): practices; and
p.(None): ``(C) with respect to children and adolescents with
p.(None): a serious emotional disturbance who have co-occurring
p.(None): physical health conditions and chronic diseases,
p.(None): attendance at scheduled medical and mental health
p.(None): appointments, compliance with prescribed medication
p.(None): regimes, and participation in learning opportunities at
p.(None): school and extracurricular activities.
p.(None):
p.(None): ``(g) Technical Assistance for Primary-Behavioral Health Care
p.(None): Integration.--
p.(None): ``(1) In general.--The Secretary may provide appropriate
p.(None): information, training, and technical assistance to eligible
p.(None): entities that receive a grant or cooperative agreement under
p.(None): this section, in order to help such entities meet the
p.(None): requirements of this section, including assistance with--
p.(None): ``(A) development and selection of integrated care
p.(None): models;
p.(None): ``(B) dissemination of evidence-based interventions
p.(None): in integrated care;
p.(None): ``(C) establishment of organizational practices to
p.(None): support operational and administrative success; and
p.(None): ``(D) other activities, as the Secretary determines
p.(None): appropriate.
p.(None): ``(2) Additional dissemination of technical information.--
p.(None): The information and resources provided by the Secretary under
p.(None): paragraph (1) shall, as appropriate, be made available to
p.(None): States, political subdivisions of States, Indian tribes or
p.(None): tribal organizations (as defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act), outpatient
p.(None): mental health and addiction treatment centers, community mental
p.(None): health centers that meet the criteria under section 1913(c),
p.(None): certified community behavioral health clinics described in
p.(None): section 223 of the Protecting Access to Medicare Act of 2014,
p.(None): primary care organizations such as Federally qualified health
p.(None): centers or rural health clinics as defined in section 1861(aa)
p.(None):
p.(None): [[Page 130 STAT. 1238]]
p.(None):
p.(None): of the Social Security Act, other community-based organizations,
p.(None): or other entities engaging in integrated care activities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): ``(h) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $51,878,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
p.(None): HOMELESSNESS.
p.(None):
p.(None): (a) Formula Grants to States.--Section 521 of the Public Health
p.(None): Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through
p.(None): 1994'' and inserting ``2018 through 2022''.
p.(None): (b) Purpose of Grants.--Section 522 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-22) is amended--
p.(None): (1) in subsection (a)(1)(B), by striking ``substance abuse''
...
p.(None): containing such information as the Secretary may reasonably require, a
p.(None): report, including an evaluation of the effect of such grant on--
p.(None): ``(1) local crisis response services and measures for
p.(None): individuals receiving crisis planning and early intervention
p.(None): supports;
p.(None): ``(2) individuals reporting improved functional outcomes;
p.(None): and
p.(None): ``(3) individuals receiving regular followup care following
p.(None): a crisis.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section, $12,500,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
p.(None):
p.(None): (a) Suicide Prevention Technical Assistance Center.--Section 520C of
p.(None): the Public Health Service Act (42 U.S.C. 290bb-34), as amended by
p.(None): section 6001, is further amended--
p.(None): (1) in the section heading, by striking ``youth interagency
p.(None): research, training, and technical assistance centers'' and
p.(None): inserting ``suicide prevention technical assistance center'';
p.(None): (2) in subsection (a), by striking ``acting through the
p.(None): Assistant Secretary for Mental Health and Substance Use'' and
p.(None): all that follows through the period at the end of paragraph (2)
p.(None): and inserting ``acting through the Assistant Secretary, shall
p.(None): establish a research, training, and technical assistance
p.(None): resource
p.(None):
p.(None): [[Page 130 STAT. 1242]]
p.(None):
p.(None): center to provide appropriate information, training, and
p.(None): technical assistance to States, political subdivisions of
p.(None): States, federally recognized Indian tribes, tribal
p.(None): organizations, institutions of higher education, public
p.(None): organizations, or private nonprofit organizations regarding the
p.(None): prevention of suicide among all ages, particularly among groups
p.(None): that are at a high risk for suicide.'';
p.(None): (3) by striking subsections (b) and (c);
p.(None): (4) by redesignating subsection (d) as subsection (b);
p.(None): (5) in subsection (b), as so redesignated--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Additional Center'' and inserting ``Responsibilities
p.(None): of the Center'';
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``The additional research'' and all that
p.(None): follows through ``nonprofit organizations for'' and
p.(None): inserting ``The center established under subsection (a)
p.(None): shall conduct activities for the purpose of'';
p.(None): (C) by striking ``youth suicide'' each place such
p.(None): term appears and inserting ``suicide'';
p.(None): (D) in paragraph (1)--
p.(None): (i) by striking ``the development or
p.(None): continuation of'' and inserting ``developing and
p.(None): continuing''; and
p.(None): (ii) by inserting ``for all ages, particularly
p.(None): among groups that are at a high risk for suicide''
p.(None): before the semicolon at the end;
p.(None): (E) in paragraph (2), by inserting ``for all ages,
p.(None): particularly among groups that are at a high risk for
p.(None): suicide'' before the semicolon at the end;
...
p.(None):
p.(None): Section 224 of the Protecting Access to Medicare Act of 2014 (42
p.(None): U.S.C. 290aa note) is amended--
p.(None): (1) in subsection (e), by striking ``and 2018,'' and
p.(None): inserting ``2018, 2019, 2020, 2021, and 2022,''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in paragraph (1), by striking ``2018'' and
p.(None): inserting ``2022''; and
p.(None): (B) in paragraph (2), by striking ``is authorized to
p.(None): be appropriated to carry out this section $15,000,000
p.(None): for each of fiscal years 2015 through 2018'' and
p.(None): inserting ``are authorized to be appropriated to carry
p.(None): out this section $15,000,000 for each of fiscal years
p.(None): 2015 through 2017, $20,000,000 for fiscal year 2018,
p.(None): $19,000,000 for each of fiscal years 2019 and 2020, and
p.(None): $18,000,000 for each of fiscal years 2021 and 2022''.
p.(None): SEC. 9015. <> ASSERTIVE COMMUNITY
p.(None): TREATMENT GRANT PROGRAM.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.), as amended by section 9009, is further amended by adding at
p.(None): the end the following:
p.(None): ``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall award grants to
p.(None): eligible entities--
p.(None): ``(1) to establish assertive community treatment programs
p.(None): for adults with a serious mental illness; or
p.(None): ``(2) to maintain or expand such programs.
p.(None):
p.(None): [[Page 130 STAT. 1246]]
p.(None):
p.(None): ``(b) Eligible Entities.--To be eligible to receive a grant under
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act), mental health system, health care facility, or any other entity
p.(None): the Assistant Secretary deems appropriate.
p.(None): ``(c) Special Consideration.--In selecting among applicants for a
p.(None): grant under this section, the Assistant Secretary may give special
p.(None): consideration to the potential of the applicant's program to reduce
p.(None): hospitalization, homelessness, and involvement with the criminal justice
p.(None): system while improving the health and social outcomes of the patient.
p.(None): ``(d) Additional Activities.--The Assistant Secretary shall--
p.(None): ``(1) not later than the end of fiscal year 2021, submit a
p.(None): report to the appropriate congressional committees on the grant
p.(None): program under this section, including an evaluation of--
p.(None): ``(A) any cost savings and public health outcomes
p.(None): such as mortality, suicide, substance use disorders,
p.(None): hospitalization, and use of services;
p.(None): ``(B) rates of involvement with the criminal justice
p.(None): system of patients;
p.(None): ``(C) rates of homelessness among patients; and
p.(None): ``(D) patient and family satisfaction with program
p.(None): participation; and
p.(None): ``(2) provide appropriate information, training, and
...
p.(None): (d) General Provisions.--Section 565 of the Public Health Service
p.(None): Act (42 U.S.C. 290ff-4) is amended--
p.(None): (1) in subsection (b)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``receiving a grant under section 561(a)'' and
p.(None): inserting ``, regardless of whether such public entity
p.(None): is receiving a grant under section 561(a)''; and
p.(None): (B) in subparagraph (B), by striking ``pursuant to''
p.(None): and inserting ``described in'';
p.(None): (2) in subsection (d)(1), by striking ``not more than 21
p.(None): years of age'' and inserting ``through the age of 21 years'';
p.(None): and
p.(None): (3) in subsection (f)(1), by striking ``$100,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$119,026,000
p.(None): for each of fiscal years 2018 through 2022''.
p.(None): SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.
p.(None):
p.(None): Title III of the Public Health Service Act is amended by inserting
p.(None): after section 330L of such Act (42 U.S.C. 254c-18) the following new
p.(None): section:
p.(None):
p.(None): [[Page 130 STAT. 1263]]
p.(None):
p.(None): ``SEC. 330M <> PEDIATRIC MENTAL HEALTH
p.(None): CARE ACCESS GRANTS.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Administrator
p.(None): of the Health Resources and Services Administration and in coordination
p.(None): with other relevant Federal agencies, shall award grants to States,
p.(None): political subdivisions of States, and Indian tribes and tribal
p.(None): organizations (for purposes of this section, as such terms are defined
p.(None): in section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act (25 U.S.C. 450b)) to promote behavioral health integration in
p.(None): pediatric primary care by--
p.(None): ``(1) supporting the development of statewide or regional
p.(None): pediatric mental health care telehealth access programs; and
p.(None): ``(2) supporting the improvement of existing statewide or
p.(None): regional pediatric mental health care telehealth access
p.(None): programs.
p.(None):
p.(None): ``(b) Program Requirements.--
p.(None): ``(1) In general.--A pediatric mental health care telehealth
p.(None): access program referred to in subsection (a), with respect to
p.(None): which a grant under such subsection may be used, shall--
p.(None): ``(A) be a statewide or regional network of
p.(None): pediatric mental health teams that provide support to
p.(None): pediatric primary care sites as an integrated team;
p.(None): ``(B) support and further develop organized State or
p.(None): regional networks of pediatric mental health teams to
p.(None): provide consultative support to pediatric primary care
p.(None): sites;
p.(None): ``(C) conduct an assessment of critical behavioral
p.(None): consultation needs among pediatric providers and such
p.(None): providers' preferred mechanisms for receiving
p.(None): consultation, training, and technical assistance;
p.(None): ``(D) develop an online database and communication
p.(None): mechanisms, including telehealth, to facilitate
...
p.(None): and referral of children with behavioral health
p.(None): conditions;
p.(None): ``(G) provide information to pediatric providers
p.(None): about, and assist pediatric providers in accessing,
p.(None): pediatric mental health care providers, including child
p.(None): and adolescent psychiatrists, and licensed mental health
p.(None): professionals, such as psychologists, social workers, or
p.(None): mental health counselors and in scheduling and
p.(None): conducting technical assistance;
p.(None): ``(H) assist with referrals to specialty care and
p.(None): community or behavioral health resources; and
p.(None): ``(I) establish mechanisms for measuring and
p.(None): monitoring increased access to pediatric mental health
p.(None): care services by pediatric primary care providers and
p.(None): expanded capacity of pediatric primary care providers to
p.(None): identify, treat, and refer children with mental health
p.(None): problems.
p.(None): ``(2) Pediatric mental health teams.--In this subsection,
p.(None): the term `pediatric mental health team' means a team consisting
p.(None): of at least one case coordinator, at least one child and
p.(None): adolescent psychiatrist, and at least one licensed clinical
p.(None):
p.(None): [[Page 130 STAT. 1264]]
p.(None):
p.(None): mental health professional, such as a psychologist, social
p.(None): worker, or mental health counselor. Such a team may be
p.(None): regionally based.
p.(None):
p.(None): ``(c) Application.--A State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization seeking a grant under this section
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may require,
p.(None): including a plan for the comprehensive evaluation of activities that are
p.(None): carried out with funds received under such grant.
p.(None): ``(d) Evaluation.--A State, political subdivision of a State, Indian
p.(None): tribe, or tribal organization that receives a grant under this section
p.(None): shall prepare and submit an evaluation of activities that are carried
p.(None): out with funds received under such grant to the Secretary at such time,
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
p.(None): under this section unless the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization involved agrees, with respect to
p.(None): the costs to be incurred by the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization in carrying out the purpose
p.(None): described in this section, to make available non-Federal contributions
p.(None): (in cash or in kind) toward such costs in an amount that is not less
p.(None): than 20 percent of Federal funds provided in the grant.
p.(None): ``(g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated, $9,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
p.(None): INTERVENTION SERVICES FOR CHILDREN AND
p.(None): ADOLESCENTS.
p.(None):
p.(None): The first section 514 of the Public Health Service Act (42 U.S.C.
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
...
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p.(None): Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives a report containing the results
p.(None): of the study under subsection (a).
p.(None): (c) Contents of Reports.--The report submitted under subsection (b)
p.(None): shall address--
p.(None): (1) for each drug for which a priority review voucher has
p.(None): been awarded as of initiation of the study--
p.(None): (A) the indications for which the drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262(a));
p.(None): (B) whether, and to what extent, the voucher
p.(None): impacted the sponsor's decision to develop the drug; and
p.(None): (C) whether, and to what extent, the approval or
p.(None): licensure of the drug, as applicable and appropriate--
p.(None): (i) addressed a global unmet need related to
p.(None): the treatment or prevention of a neglected
p.(None): tropical disease, including whether the sponsor of
p.(None): a drug coordinated with international development
p.(None): organizations;
p.(None):
p.(None): [[Page 130 STAT. 1094]]
p.(None):
p.(None): (ii) addressed an unmet need related to the
p.(None): treatment of a rare pediatric disease; or
p.(None): (iii) affected the Nation's preparedness
p.(None): against a chemical, biological, radiological, or
p.(None): nuclear threat, including naturally occurring
p.(None): threats;
p.(None): (2) for each drug for which a priority review voucher has
p.(None): been used--
p.(None): (A) the indications for which such drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262);
p.(None): (B) the value of the voucher, if transferred; and
p.(None): (C) the length of time between the date on which the
p.(None): voucher was awarded and the date on which the voucher
p.(None): was used; and
p.(None): (3) an analysis of the priority review voucher programs
p.(None): described in subsection (a), including--
p.(None): (A) the resources used by the Food and Drug
p.(None): Administration in reviewing drugs for which vouchers
p.(None): were used, including the effect of the programs on the
p.(None): Food and Drug Administration's review of drugs for which
p.(None): priority review vouchers were not awarded or used;
p.(None): (B) whether any improvements to such programs are
p.(None): necessary to appropriately target incentives for the
p.(None): development of drugs that would likely not otherwise be
p.(None): developed, or developed in as timely a manner, and, as
p.(None): applicable and appropriate--
p.(None): (i) address global unmet needs related to the
...
p.(None): (42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
p.(None):
p.(None): [[Page 130 STAT. 1141]]
p.(None):
p.(None): ``(5) Clarification on contracting authority.--The
p.(None): Secretary, acting through the Director of the Biomedical
p.(None): Advanced Research and Development Authority, shall carry out the
p.(None): programs funded by the special reserve fund (for the procurement
p.(None): of security countermeasures under subsection (c) and for
p.(None): carrying out section 319L), including the execution of
p.(None): procurement contracts, grants, and cooperative agreements
p.(None): pursuant to this section and section 319L.''.
p.(None):
p.(None): (b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public
p.(None): Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``,
p.(None): including the execution of procurement contracts, grants, and
p.(None): cooperative agreements pursuant to this section'' before the period.
p.(None): SEC. 3083. COUNTERMEASURE BUDGET PLAN.
p.(None):
p.(None): Section 2811(b)(7) of the Public Health Service Act (42 U.S.C.
p.(None): 300hh-10(b)(7)) is amended--
p.(None): (1) in the matter preceding subparagraph (A), by striking
p.(None): the first sentence and inserting ``Develop, and update not later
p.(None): than March 1 of each year, a coordinated 5-year budget plan
p.(None): based on the medical countermeasure priorities described in
p.(None): subsection (d), including with respect to chemical, biological,
p.(None): radiological, and nuclear agent or agents that may present a
p.(None): threat to the Nation, including such agents that are novel or
p.(None): emerging infectious diseases, and the corresponding efforts to
p.(None): develop qualified countermeasures (as defined in section 319F-
p.(None): 1), security countermeasures (as defined in section 319F-2), and
p.(None): qualified pandemic or epidemic products (as defined in section
p.(None): 319F-3) for each such threat.'';
p.(None): (2) in subparagraph (C), by striking ``; and'' and inserting
p.(None): a semicolon;
p.(None): (3) in subparagraph (D), by striking ``to the appropriate
p.(None): committees of Congress upon request.'' and inserting ``, not
p.(None): later than March 15 of each year, to the Committee on
p.(None): Appropriations and the Committee on Health, Education, Labor,
p.(None): and Pensions of the Senate and the Committee on Appropriations
p.(None): and the Committee on Energy and Commerce of the House of
p.(None): Representatives; and''; and
p.(None): (4) by adding at the end the following:
p.(None): ``(E) not later than March 15 of each year, be made
p.(None): publicly available in a manner that does not compromise
p.(None): national security.''.
p.(None): SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
p.(None):
p.(None): Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
p.(None): 7e(c)(4)) is amended by adding at the end the following:
p.(None): ``(E) Medical countermeasures innovation partner.--
p.(None): ``(i) In general.--To support the purposes
p.(None): described in paragraph (2), the Secretary, acting
p.(None): through the Director of BARDA, may enter into an
p.(None): agreement (including through the use of grants,
p.(None): contracts, cooperative agreements, or other
p.(None): transactions as described in paragraph (5)) with
p.(None): an independent, nonprofit entity to--
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): nonspecified use.
p.(None): ``(2) Standards of evidence and secretary's authority.--This
p.(None): section shall not be construed to alter--
p.(None): ``(A) the standards of evidence under--
p.(None): ``(i) subsection (c) or (d) of section 505,
p.(None): including the substantial evidence standard in
p.(None): such subsection (d); or
p.(None):
p.(None): [[Page 130 STAT. 1098]]
p.(None):
p.(None): ``(ii) section 351(a) of the Public Health
p.(None): Service Act; or
p.(None): ``(B) the Secretary's authority to require
p.(None): postapproval studies or clinical trials, or the
p.(None): standards of evidence under which studies or trials are
p.(None): evaluated.''.
p.(None): SEC. 3023. <> PROTECTION OF HUMAN
p.(None): RESEARCH SUBJECTS.
p.(None):
p.(None): (a) In General.--In order to simplify and facilitate compliance by
p.(None): researchers with applicable regulations for the protection of human
p.(None): subjects in research, the Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall, to the extent
p.(None): practicable and consistent with other statutory provisions, harmonize
p.(None): differences between the HHS Human Subject Regulations and the FDA Human
p.(None): Subject Regulations in accordance with subsection (b).
p.(None): (b) Avoiding Regulatory Duplication and Unnecessary Delays.--The
p.(None): Secretary shall, as appropriate--
p.(None): (1) make such modifications to the provisions of the HHS
p.(None): Human Subject Regulations, the FDA Human Subject Regulations,
p.(None): and the vulnerable populations rules as may be necessary--
p.(None): (A) to reduce regulatory duplication and unnecessary
p.(None): delays;
p.(None): (B) to modernize such provisions in the context of
p.(None): multisite and cooperative research projects; and
p.(None): (C) to protect vulnerable populations, incorporate
p.(None): local considerations, and support community engagement
p.(None): through mechanisms such as consultation with local
p.(None): researchers and human research protection programs, in a
p.(None): manner consistent with subparagraph (B); and
p.(None): (2) ensure that human subject research that is subject to
p.(None): the HHS Human Subject Regulations and to the FDA Human Subject
p.(None): Regulations may--
p.(None): (A) use joint or shared review;
p.(None): (B) rely upon the review of--
p.(None): (i) an independent institutional review board;
p.(None): or
p.(None): (ii) an institutional review board of an
p.(None): entity other than the sponsor of the research; or
p.(None): (C) use similar arrangements to avoid duplication of
p.(None): effort.
p.(None):
p.(None): (c) Consultation.--In harmonizing or modifying regulations or
p.(None): guidance under this section, the Secretary shall consult with
p.(None): stakeholders (including researchers, academic organizations, hospitals,
p.(None): institutional research boards, pharmaceutical, biotechnology, and
p.(None): medical device developers, clinical research organizations, patient
p.(None): groups, and others).
p.(None): (d) Timing.--The Secretary shall complete the harmonization
p.(None): described in subsection (a) not later than 3 years after the date of
p.(None): enactment of this Act.
p.(None): (e) Progress Report.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Secretary shall submit to Congress a report
p.(None): on the progress made toward completing such harmonization.
p.(None): (f) Definitions.--
p.(None): (1) Human subject regulations.--In this section:
p.(None): (A) FDA human subject regulations.--The term ``FDA
p.(None): Human Subject Regulations'' means the provisions
p.(None):
p.(None): [[Page 130 STAT. 1099]]
p.(None):
p.(None): of parts 50, 56, 312, and 812 of title 21, Code of
p.(None): Federal Regulations (or any successor regulations).
p.(None): (B) HHS human subject regulations.--The term ``HHS
p.(None): Human Subject Regulations'' means the provisions of
p.(None): subpart A of part 46 of title 45, Code of Federal
p.(None): Regulations (or any successor regulations).
p.(None): (C) Vulnerable population rules.--The term
p.(None): ``vulnerable population rules'' means--
p.(None): (i) except in the case of research described
p.(None): in clause (ii), the provisions of subparts B
p.(None): through D of part 46, Code of Federal Regulations
p.(None): (or any successor regulations); and
p.(None): (ii) in the case of research that is subject
p.(None): to FDA Human Subject Regulations, the provisions
p.(None): applicable to vulnerable populations under part 56
p.(None): of title 21, Code of Federal Regulations (or any
p.(None): successor regulations) and subpart D of part 50 of
p.(None): such title 21 (or any successor regulations).
p.(None): (2) Institutional review board defined.--In this section,
p.(None): the term ``institutional review board'' has the meaning that
p.(None): applies to the term ``institutional review board'' under the HHS
p.(None): Human Subject Regulations.
p.(None): SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL
p.(None): INVESTIGATIONS.
p.(None):
p.(None): (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
p.(None): (1) in subparagraph (D), by striking ``except where subject
p.(None): to such conditions as the Secretary may prescribe, the
p.(None): investigator'' and inserting the following: ``except where,
p.(None): subject to such conditions as the Secretary may prescribe--
p.(None): ``(i) the proposed clinical testing poses no more
p.(None): than minimal risk to the human subject and includes
p.(None): appropriate safeguards to protect the rights, safety,
p.(None): and welfare of the human subject; or
p.(None): ``(ii) the investigator''; and
p.(None): (2) in the matter following subparagraph (D), by striking
p.(None): ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
p.(None):
p.(None): (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where
...
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
...
p.(None): to support--
p.(None): ``(i) the delivery of mental and substance use
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.(None): Secretary containing recommendations on whether the uses and
p.(None): disclosures of protected health information for research
p.(None): purposes should be modified to allow protected health
p.(None): information to be available, as appropriate, for research
p.(None): purposes, including studies to obtain generalizable knowledge,
p.(None): while protecting individuals' privacy rights. In conducting the
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
p.(None): policy related to protecting the privacy of
p.(None): individuals, and
p.(None): (vi) existing barriers to research related to
p.(None): the current restrictions on the uses and
p.(None): disclosures of protected health information; and
p.(None): (B) consider, at a minimum--
p.(None): (i) expectations and preferences on how an
p.(None): individual's protected health information is
p.(None): shared and used;
p.(None): (ii) issues related to specific subgroups of
p.(None): people, such as children, incarcerated
p.(None): individuals, and individuals with a cognitive or
p.(None): intellectual disability impacting capacity to
p.(None): consent;
p.(None): (iii) relevant Federal and State laws;
p.(None): (iv) models of facilitating data access and
p.(None): levels of data access, including data
p.(None): segmentation, where applicable;
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
p.(None): or part 164, as appropriate, of title 45, Code of Federal
p.(None): Regulations (or any successor regulation).
p.(None): (2) Part 164.--References to a specified section of ``part
...
p.(None): technology that provides accurate patient
p.(None): information for the correct patient, including
p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
...
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p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
...
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
p.(None): functional impairment and substantially interferes with or
p.(None): limits one or more major life activities.
p.(None): (3) In reporting on the incidence of serious mental illness,
p.(None): the Substance Abuse and Mental Health Services Administration
p.(None): includes major depression, schizophrenia, bipolar disorder, and
p.(None): other mental disorders that cause serious impairment.
p.(None): (4) Adults with a serious mental illness are at a higher
p.(None): risk for chronic physical illnesses and premature death.
p.(None): (5) According to the World Health Organization, adults with
p.(None): a serious mental illness have lifespans that are 10 to 25 years
p.(None): shorter than those without serious mental illness. The vast
p.(None): majority of these deaths are due to chronic physical medical
p.(None): conditions, such as cardiovascular, respiratory, and infectious
p.(None): diseases, as well as diabetes and hypertension.
p.(None): (6) According to the World Health Organization, the majority
p.(None): of deaths of adults with a serious mental illness that are due
p.(None): to physical medical conditions are preventable.
p.(None): (7) Supported decision making can facilitate care decisions
p.(None): in areas where serious mental illness may impact the capacity of
p.(None): an individual to determine a course of treatment while still
p.(None): allowing the individual to make decisions independently.
p.(None): (8) Help should be provided to adults with a serious mental
p.(None): illness to address their acute or chronic physical illnesses,
p.(None): make informed choices about treatment, and understand and follow
p.(None): through with appropriate treatment.
p.(None):
p.(None): [[Page 130 STAT. 1270]]
p.(None):
p.(None): (9) There is confusion in the health care community
p.(None): regarding permissible practices under the regulations
...
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
...
Health / Drug Dependence
Searching for indicator dependence:
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p.(None): amended by striking subsection (d).
p.(None): (X) Recognition of foreign government inspections.--
p.(None): Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by
p.(None): striking ``conduction'' and inserting ``conducting''.
p.(None):
p.(None): (b) FDASIA.--
p.(None): (1) Findings relating to drug approval.--Section
p.(None): 901(a)(1)(A) of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is
p.(None): amended by striking ``serious and life-threatening diseases''
p.(None): and inserting ``serious or life-threatening diseases''.
p.(None): (2) Reporting of inclusion of demographic subgroups.--
p.(None): Section 907 of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is
p.(None): amended--
p.(None): (A) in the section heading, by striking
p.(None): ``biologics'' in the heading and inserting ``biological
p.(None): products''; and
p.(None): (B) in subsection (a)(2)(B), by striking
p.(None): ``applications for new drug applications'' and inserting
p.(None): ``new drug applications''.
p.(None): (3) Combating prescription drug abuse.--Section 1122 of the
p.(None): Food and Drug Administration Safety and Innovation Act (Public
p.(None): Law 112-144; 126 Stat. 1112, 1113) is amended--
p.(None): (A) in subsection (a)(2), by striking ``dependance''
p.(None): and inserting ``dependence''; and
p.(None): (B) in subsection (c), by striking ``promulgate''
p.(None): and inserting ``issue''.
p.(None): SEC. 3102. COMPLETED STUDIES.
p.(None):
p.(None): The Federal Food, Drug, and Cosmetic Act is amended--
p.(None): (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
p.(None): (A) in subparagraph (A), by inserting ``and'' after
p.(None): the semicolon;
p.(None): (B) by striking subparagraph (B); and
p.(None): (C) by redesignating subparagraph (C) as
p.(None): subparagraph (B);
p.(None): (2) in section 505A (21 U.S.C. 355a), by striking subsection
p.(None): (p);
p.(None): (3) in section 505B (21 U.S.C. 355c)--
p.(None): (A) by striking subsection (l); and
p.(None): (B) by redesignating subsection (m) as subsection
p.(None): (l); and
p.(None): (4) in section 523 (21 U.S.C. 360m), by striking subsection
p.(None): (d).
p.(None):
p.(None): [[Page 130 STAT. 1157]]
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
p.(None):
p.(None): (a) In General.--The Health Information Technology for Economic and
p.(None): Clinical Health Act (title XIII of division A of Public Law 111-5) is
p.(None): amended--
p.(None): (1) by adding at the end of part 1 of subtitle A the
p.(None): following:
p.(None): ``SEC. 13103. <> ASSISTING DOCTORS
p.(None): AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
p.(None): ``(a) Reduction in Burdens Goal.--The Secretary of Health and Human
p.(None): Services (referred to in this section as the `Secretary'), in
p.(None): consultation with providers of health services, health care suppliers of
p.(None): services, health care payers, health professional societies, health
p.(None): information technology developers, health care quality organizations,
...
Searching for indicator dependency:
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p.(None): ROUTING SERVICE.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Treatment Referral Routing
p.(None): Service (referred to in this section as the `Routing Service') to assist
p.(None): individuals and families in locating mental and substance use disorders
p.(None): treatment providers.
p.(None): ``(b) Activities of the Secretary.--To maintain the Routing Service,
p.(None): the activities of the Assistant Secretary shall include administering--
p.(None): ``(1) a nationwide, telephone number providing year-round
p.(None): access to information that is updated on a regular basis
p.(None): regarding local behavioral health providers and community-based
p.(None): organizations in a manner that is confidential, without
p.(None): requiring individuals to identify themselves, is in languages
p.(None): that include at least English and Spanish, and is at no cost to
p.(None): the individual using the Routing Service; and
p.(None):
p.(None): [[Page 130 STAT. 1240]]
p.(None):
p.(None): ``(2) an Internet website to provide a searchable, online
p.(None): treatment services locator of behavioral health treatment
p.(None): providers and community-based organizations, which shall include
p.(None): information on the name, location, contact information, and
p.(None): basic services provided by such providers and organizations.
p.(None):
p.(None): ``(c) Removing Practitioner Contact Information.--In the event that
p.(None): the Internet website described in subsection (b)(2) contains information
p.(None): on any qualified practitioner that is certified to prescribe medication
p.(None): for opioid dependency under section 303(g)(2)(B) of the Controlled
p.(None): Substances Act, the Assistant Secretary--
p.(None): ``(1) shall provide an opportunity to such practitioner to
p.(None): have the contact information of the practitioner removed from
p.(None): the website at the request of the practitioner; and
p.(None): ``(2) may evaluate other methods to periodically update the
p.(None): information displayed on such website.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the Assistant Secretary from using any unobligated
p.(None): amounts otherwise made available to the Administration to maintain the
p.(None): Routing Service.''.
p.(None): SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall award competitive grants to--
p.(None): ``(1) State and local governments and Indian tribes and
p.(None): tribal organizations, to enhance community-based crisis response
p.(None): systems; or
p.(None): ``(2) States to develop, maintain, or enhance a database of
p.(None): beds at inpatient psychiatric facilities, crisis stabilization
p.(None): units, and residential community mental health and residential
p.(None): substance use disorder treatment facilities, for adults with a
p.(None): serious mental illness, children with a serious emotional
p.(None): disturbance, or individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Applications.--
...
p.(None): 1968 (42 U.S.C. 3797aa) is amended by--
p.(None): (1) redesignating subsection (j) as subsection (o); and
p.(None): (2) inserting after subsection (i) the following:
p.(None):
p.(None): ``(j) Forensic Assertive Community Treatment (FACT) Initiative
p.(None): Program.--
p.(None): ``(1) In general.--The Attorney General may make grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand Assertive Community Treatment initiatives
p.(None): to develop forensic assertive community treatment (referred to
p.(None): in this subsection as `FACT') programs that provide high
p.(None): intensity services in the community for individuals with mental
p.(None): illness with involvement in the criminal justice system to
p.(None): prevent future incarcerations.
p.(None): ``(2) Allowable uses.--Grant funds awarded under this
p.(None): subsection may be used for--
p.(None): ``(A) multidisciplinary team initiatives for
p.(None): individuals with mental illnesses with criminal justice
p.(None): involvement that address criminal justice involvement as
p.(None): part of treatment protocols;
p.(None): ``(B) FACT programs that involve mental health
p.(None): professionals, criminal justice agencies, chemical
p.(None): dependency specialists, nurses, psychiatrists,
p.(None): vocational specialists, forensic peer specialists,
p.(None): forensic specialists, and dedicated administrative
p.(None): support staff who work together to provide recovery
p.(None): oriented, 24/7 wraparound services;
p.(None): ``(C) services such as integrated evidence-based
p.(None): practices for the treatment of co-occurring mental
p.(None): health and substance-related disorders, assertive
p.(None): outreach and engagement, community-based service
p.(None): provision at participants' residence or in the
p.(None): community, psychiatric rehabilitation, recovery oriented
p.(None): services, services to address criminogenic risk factors,
p.(None): and community tenure;
p.(None): ``(D) payments for treatment providers that are
p.(None): approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide needed treatment to eligible
p.(None): offenders
p.(None):
p.(None): [[Page 130 STAT. 1296]]
p.(None):
p.(None): participating in the program, including behavioral
p.(None): health services and aftercare supervision; and
p.(None): ``(E) training for all FACT teams to promote high-
p.(None): fidelity practice principles and technical assistance to
p.(None): support effective and continuing integration with
p.(None): criminal justice agency partners.
p.(None): ``(3) Supplement and not supplant.--Grants made under this
p.(None): subsection shall be used to supplement, and not supplant, non-
p.(None): Federal funds that would otherwise be available for programs
p.(None): described in this subsection.
p.(None): ``(4) Applications.--To request a grant under this
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): Sec. 2039. Enhancing the rigor and reproducibility of scientific
p.(None): research.
p.(None): Sec. 2040. Improving medical rehabilitation research at the National
p.(None): Institutes of Health.
p.(None):
p.(None): [[Page 130 STAT. 1034]]
p.(None):
p.(None): Sec. 2041. Task force on research specific to pregnant women and
p.(None): lactating women.
p.(None): Sec. 2042. Streamlining National Institutes of Health reporting
p.(None): requirements.
p.(None): Sec. 2043. Reimbursement for research substances and living organisms.
p.(None): Sec. 2044. Sense of Congress on increased inclusion of underrepresented
p.(None): populations in clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): Sec. 2051. Technical updates to clinical trials database.
p.(None): Sec. 2052. Compliance activities reports.
p.(None): Sec. 2053. Updates to policies to improve data.
p.(None): Sec. 2054. Consultation.
p.(None):
p.(None): Subtitle F--Facilitating Collaborative Research
p.(None):
p.(None): Sec. 2061. National neurological conditions surveillance system.
p.(None): Sec. 2062. Tick-borne diseases.
p.(None): Sec. 2063. Accessing, sharing, and using health data for research
p.(None): purposes.
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): Sec. 2071. National pediatric research network.
p.(None): Sec. 2072. Global pediatric clinical study network.
p.(None):
p.(None): TITLE III--DEVELOPMENT
p.(None):
p.(None): Subtitle A--Patient-Focused Drug Development
p.(None):
p.(None): Sec. 3001. Patient experience data.
p.(None): Sec. 3002. Patient-focused drug development guidance.
p.(None): Sec. 3003. Streamlining patient input.
p.(None): Sec. 3004. Report on patient experience drug development.
p.(None):
p.(None): Subtitle B--Advancing New Drug Therapies
p.(None):
p.(None): Sec. 3011. Qualification of drug development tools.
p.(None): Sec. 3012. Targeted drugs for rare diseases.
p.(None): Sec. 3013. Reauthorization of program to encourage treatments for rare
p.(None): pediatric diseases.
p.(None): Sec. 3014. GAO study of priority review voucher programs.
p.(None): Sec. 3015. Amendments to the Orphan Drug grants.
p.(None): Sec. 3016. Grants for studying continuous drug manufacturing.
p.(None):
p.(None): Subtitle C--Modern Trial Design and Evidence Development
p.(None):
p.(None): Sec. 3021. Novel clinical trial designs.
p.(None): Sec. 3022. Real world evidence.
p.(None): Sec. 3023. Protection of human research subjects.
p.(None): Sec. 3024. Informed consent waiver or alteration for clinical
p.(None): investigations.
p.(None):
p.(None): Subtitle D--Patient Access to Therapies and Information
p.(None):
p.(None): Sec. 3031. Summary level review.
p.(None): Sec. 3032. Expanded access policy.
p.(None): Sec. 3033. Accelerated approval for regenerative advanced therapies.
p.(None): Sec. 3034. Guidance regarding devices used in the recovery, isolation,
p.(None): or delivery of regenerative advanced therapies.
p.(None): Sec. 3035. Report on regenerative advanced therapies.
p.(None): Sec. 3036. Standards for regenerative medicine and regenerative advanced
p.(None): therapies.
p.(None): Sec. 3037. Health care economic information.
p.(None): Sec. 3038. Combination product innovation.
p.(None): Subtitle E--Antimicrobial Innovation and Stewardship
p.(None):
p.(None): Sec. 3041. Antimicrobial resistance monitoring.
p.(None): Sec. 3042. Limited population pathway.
p.(None): Sec. 3043. Prescribing authority.
p.(None): Sec. 3044. Susceptibility test interpretive criteria for microorganisms;
p.(None): antimicrobial susceptibility testing devices.
p.(None):
p.(None): Subtitle F--Medical Device Innovations
p.(None):
p.(None): Sec. 3051. Breakthrough devices.
p.(None): Sec. 3052. Humanitarian device exemption.
p.(None): Sec. 3053. Recognition of standards.
p.(None): Sec. 3054. Certain class I and class II devices.
p.(None):
p.(None): [[Page 130 STAT. 1035]]
p.(None):
p.(None): Sec. 3055. Classification panels.
p.(None): Sec. 3056. Institutional review board flexibility.
p.(None): Sec. 3057. CLIA waiver improvements.
p.(None): Sec. 3058. Least burdensome device review.
p.(None): Sec. 3059. Cleaning instructions and validation data requirement.
p.(None): Sec. 3060. Clarifying medical software regulation.
p.(None):
p.(None): Subtitle G--Improving Scientific Expertise and Outreach at FDA
p.(None):
p.(None): Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical
p.(None): Product Assessment Service.
p.(None): Sec. 3072. Hiring authority for scientific, technical, and professional
p.(None): personnel.
p.(None): Sec. 3073. Establishment of Food and Drug Administration Intercenter
p.(None): Institutes.
p.(None): Sec. 3074. Scientific engagement.
p.(None): Sec. 3075. Drug surveillance.
p.(None): Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
p.(None):
p.(None): Subtitle H--Medical Countermeasures Innovation
p.(None):
p.(None): Sec. 3081. Medical countermeasure guidelines.
p.(None): Sec. 3082. Clarifying BARDA contracting authority.
p.(None): Sec. 3083. Countermeasure budget plan.
p.(None): Sec. 3084. Medical countermeasures innovation.
p.(None): Sec. 3085. Streamlining Project BioShield procurement.
p.(None): Sec. 3086. Encouraging treatments for agents that present a national
p.(None): security threat.
p.(None): Sec. 3087. Paperwork Reduction Act waiver during a public health
p.(None): emergency.
p.(None): Sec. 3088. Clarifying Food and Drug Administration emergency use
p.(None): authorization.
p.(None):
p.(None): Subtitle I--Vaccine Access, Certainty, and Innovation
p.(None):
p.(None): Sec. 3091. Predictable review timelines of vaccines by the Advisory
p.(None): Committee on Immunization Practices.
p.(None): Sec. 3092. Review of processes and consistency of Advisory Committee on
p.(None): Immunization Practices recommendations.
p.(None): Sec. 3093. Encouraging vaccine innovation.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): Sec. 3101. Technical corrections.
p.(None): Sec. 3102. Completed studies.
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): Sec. 4001. Assisting doctors and hospitals in improving quality of care
p.(None): for patients.
p.(None): Sec. 4002. Transparent reporting on usability, security, and
p.(None): functionality.
p.(None): Sec. 4003. Interoperability.
p.(None): Sec. 4004. Information blocking.
p.(None): Sec. 4005. Leveraging electronic health records to improve patient care.
p.(None): Sec. 4006. Empowering patients and improving patient access to their
p.(None): electronic health information.
p.(None): Sec. 4007. GAO study on patient matching.
p.(None): Sec. 4008. GAO study on patient access to health information.
p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
...
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
...
p.(None): (B) For the Brain Research through Advancing
p.(None): Innovative Neurotechnologies Initiative (known as the
p.(None): ``BRAIN Initiative''), not to exceed a total of
p.(None): $1,511,000,000, as follows:
p.(None): (i) For fiscal year 2017, $10,000,000.
p.(None): (ii) For fiscal year 2018, $86,000,000.
p.(None): (iii) For fiscal year 2019, $115,000,000.
p.(None): (iv) For fiscal year 2020, $140,000,000.
p.(None): (v) For fiscal year 2021, $100,000,000.
p.(None): (vi) For fiscal year 2022, $152,000,000.
p.(None): (vii) For fiscal year 2023, $450,000,000.
p.(None): (viii) For fiscal year 2024, $172,000,000.
p.(None): (ix) For fiscal year 2025, $91,000,000.
p.(None): (x) For fiscal year 2026, $195,000,000.
p.(None): (C) To support cancer research, such as the
p.(None): development of cancer vaccines, the development of more
p.(None): sensitive
p.(None):
p.(None): [[Page 130 STAT. 1041]]
p.(None):
p.(None): diagnostic tests for cancer, immunotherapy and the
p.(None): development of combination therapies, and research that
p.(None): has the potential to transform the scientific field,
p.(None): that has inherently higher risk, and that seeks to
p.(None): address major challenges related to cancer, not to
p.(None): exceed a total of $1,800,000,000, as follows:
p.(None): (i) For fiscal year 2017, $300,000,000.
p.(None): (ii) For fiscal year 2018, $300,000,000.
p.(None): (iii) For fiscal year 2019, $400,000,000.
p.(None): (iv) For fiscal year 2020, $195,000,000.
p.(None): (v) For fiscal year 2021, $195,000,000.
p.(None): (vi) For fiscal year 2022, $194,000,000.
p.(None): (vii) For fiscal year 2023, $216,000,000.
p.(None): (D) For the National Institutes of Health, in
p.(None): coordination with the Food and Drug Administration, to
p.(None): award grants and contracts for clinical research to
p.(None): further the field of regenerative medicine using adult
p.(None): stem cells, including autologous stem cells, for which
p.(None): grants and contracts shall be contingent upon the
p.(None): recipient making available non-Federal contributions
p.(None): toward the costs of such research in an amount not less
p.(None): than $1 for each $1 of Federal funds provided in the
p.(None): award, not to exceed a total of $30,000,000, as follows:
p.(None): (i) For fiscal year 2017, $2,000,000.
p.(None): (ii) For each of fiscal years 2018 and 2019,
p.(None): $10,000,000.
p.(None): (iii) For fiscal year 2020, $8,000,000.
p.(None): (iv) For each of fiscal years 2021 through
p.(None): 2026, $0.
p.(None):
p.(None): (c) Accountability and Oversight.--
p.(None): (1) Work plan.--
p.(None): (A) In general.--Not later than 180 days after the
p.(None): date of enactment of this Act, the Director of NIH shall
p.(None): submit to the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the
p.(None): Senate and the Committee on Energy and Commerce and the
p.(None): Committee on Appropriations of the House of
p.(None): Representatives, a work plan including the proposed
p.(None): allocation of funds authorized to be appropriated
p.(None): pursuant to subsection (b)(3) for each of fiscal years
p.(None): 2017 through 2026 for the NIH Innovation Projects and
p.(None): the contents described in subparagraph (B).
p.(None): (B) Contents.--The work plan submitted under
p.(None): subparagraph (A) shall include--
p.(None): (i) recommendations from the Advisory
p.(None): Committee described in subparagraph (C);
...
p.(None): paragraph (3).
p.(None): (3) Appropriations.--
p.(None): (A) Authorization of appropriations.--For each of
p.(None): the fiscal years 2017 through 2025, there is authorized
p.(None): to be appropriated from the Account to the Commissioner,
p.(None): for the purpose of carrying out the activities described
p.(None): in paragraph (5), an amount not to exceed the total
p.(None): amount transferred to the Account under paragraph
p.(None): (2)(A), to remain available until expended.
p.(None): (B) Offsetting future appropriations.--For any of
p.(None): fiscal years 2017 through 2025, for any discretionary
p.(None): appropriation under the heading ``FDA Innovation
p.(None): Account'' provided to the Commissioner pursuant to the
p.(None): authorization of appropriations under subparagraph (A)
p.(None): for the purpose of carrying out the projects activities
p.(None): described in paragraph (4), the total amount of such
p.(None): appropriations in the applicable fiscal year (not to
p.(None): exceed the total amount remaining in the Account) shall
p.(None): be subtracted from the estimate of discretionary budget
p.(None): authority and the resulting outlays for any estimate
p.(None): under the Congressional Budget and Impoundment Control
p.(None): Act of 1974 or the Balanced Budget and Emergency Deficit
p.(None): Control Act of 1985, and the amount transferred to the
p.(None): Account shall be reduced by the same amount.
p.(None): (4) FDA activities.--The activities authorized to be funded
p.(None): under this section are the activities under subtitles A through
p.(None): F (including the amendments made by such subtitles) of title III
p.(None): of this Act and section 1014 of the Federal Food, Drug, and
p.(None): Cosmetic Act, as added by section 3073 of this Act.
p.(None):
p.(None): (c) Accountability and Oversight.--
p.(None): (1) Work plan.--
p.(None): (A) In general.--Not later than 180 days after the
p.(None): date of enactment of this Act, the Commissioner shall
p.(None): submit to the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the
p.(None): Senate and the Committee on Energy and Commerce and the
p.(None): Committee on Appropriations of the House of
p.(None): Representatives, a work plan including the proposed
p.(None): allocation of funds appropriated pursuant to the
p.(None): authorization of appropriations under subsection (b)(3)
p.(None): for each of fiscal years 2017 through 2025 and the
p.(None): contents described in subparagraph (B).
p.(None):
p.(None): [[Page 130 STAT. 1044]]
p.(None):
p.(None): (B) Contents.--The work plan submitted under
p.(None): subparagraph (A) shall include--
p.(None): (i) recommendations from the Advisory
p.(None): Committee described in subparagraph (C);
p.(None): (ii) the amount of money to be obligated or
p.(None): expended in each fiscal year for each activity
p.(None): described in subsection (b)(4); and
p.(None): (iii) a description and justification of each
p.(None): such project activity.
p.(None): (C) Recommendations.--Prior to submitting the work
p.(None): plan under this paragraph, the Commissioner shall seek
p.(None): recommendations from the Science Board to the Food and
p.(None): Drug Administration, on the proposed allocation of funds
p.(None): appropriated pursuant to the authorization of
p.(None): appropriations under subsection (b)(3) for each of
p.(None): fiscal years 2017 through 2025 and on the contents of
p.(None): the proposed work plan.
p.(None): (2) Reports.--
p.(None): (A) Annual reports.--Not later than October 1 of
p.(None): each of fiscal years 2018 through 2026, the Commissioner
p.(None): shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate and the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives, a report including--
p.(None): (i) the amount of money obligated or expended
p.(None): in the prior fiscal year for each activity
p.(None): described in subsection (b)(4);
p.(None): (ii) a description of all such activities
p.(None): using funds provided pursuant to the authorization
p.(None): of appropriations under subsection (b)(3); and
p.(None): (iii) how the activities are advancing public
p.(None): health.
p.(None): (B) Additional reports.--At the request of the
p.(None): Committee on Health, Education, Labor, and Pensions or
p.(None): the Committee on Appropriations of the Senate, or the
p.(None): Committee on Energy and Commerce or the Committee on
p.(None): Appropriations of the House of Representatives, the
p.(None): Commissioner shall provide an update in the form of
p.(None): testimony and any additional reports to the respective
p.(None): congressional committee regarding the allocation of
p.(None): funding under this section or the description of the
p.(None): activities undertaken with such funding.
p.(None):
...
p.(None): budget authority and the resulting outlays for any
p.(None): estimate under the Congressional Budget and Impoundment
p.(None): Control Act of 1974 or the Balanced Budget and Emergency
p.(None): Deficit Control Act of 1985, and the amount transferred
p.(None): to the Account shall be reduced by the same amount.
p.(None):
p.(None): (c) Opioid Grant Program.--
p.(None): (1) State response to the opioid abuse crisis.--Subject to
p.(None): the availability of appropriations, the Secretary shall award
p.(None): grants to States for the purpose of addressing the opioid abuse
p.(None): crisis within such States, in accordance with subparagraph (B).
p.(None): In awarding such grants, the Secretary shall give preference to
p.(None): States with an incidence or prevalence of opioid use disorders
p.(None): that is substantially higher relative to other States.
p.(None): (2) Opioid grants.--Grants awarded to a State under this
p.(None): subsection shall be used for carrying out activities that
p.(None): supplement activities pertaining to opioids undertaken by the
p.(None): State agency responsible for administering the substance abuse
p.(None): prevention and treatment block grant under subpart II of part B
p.(None): of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
p.(None): et seq.), which may include public health-related activities
p.(None): such as the following:
p.(None): (A) Improving State prescription drug monitoring
p.(None): programs.
p.(None):
p.(None): [[Page 130 STAT. 1046]]
p.(None): (B) Implementing prevention activities, and
p.(None): evaluating such activities to identify effective
p.(None): strategies to prevent opioid abuse.
p.(None): (C) Training for health care practitioners, such as
p.(None): best practices for prescribing opioids, pain management,
p.(None): recognizing potential cases of substance abuse, referral
p.(None): of patients to treatment programs, and overdose
p.(None): prevention.
p.(None): (D) Supporting access to health care services,
p.(None): including those services provided by Federally certified
p.(None): opioid treatment programs or other appropriate health
p.(None): care providers to treat substance use disorders.
p.(None): (E) Other public health-related activities, as the
p.(None): State determines appropriate, related to addressing the
p.(None): opioid abuse crisis within the State.
p.(None):
p.(None): (d) Accountability and Oversight.--A State receiving a grant under
p.(None): subsection (c) shall include in a report related to substance abuse
p.(None): submitted to the Secretary pursuant to section 1942 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-52), a description of--
p.(None): (1) the purposes for which the grant funds received by the
...
p.(None): Initiative' (in this section referred to as the `Initiative'), to
p.(None): augment efforts to address disease prevention, diagnosis, and treatment.
p.(None): ``(b) Components.--The Initiative described under subsection (a) may
p.(None): include--
p.(None): ``(1) developing a network of scientists to assist in
p.(None): carrying out the purposes of the Initiative;
p.(None): ``(2) developing new approaches for addressing scientific,
p.(None): medical, public health, and regulatory science issues;
p.(None): ``(3) applying genomic technologies, such as whole genomic
p.(None): sequencing, to provide data on the molecular basis of disease;
p.(None): ``(4) collecting information voluntarily provided by a
p.(None): diverse cohort of individuals that can be used to better
p.(None): understand health and disease; and
p.(None): ``(5) other activities to advance the goals of the
p.(None): Initiative, as the Secretary determines appropriate.
p.(None):
p.(None): ``(c) Authority of the Secretary.--In carrying out this section, the
p.(None): Secretary may--
p.(None): ``(1) coordinate with the Secretary of Energy, private
p.(None): industry, and others, as the Secretary determines appropriate,
p.(None): to identify and address the advanced supercomputing and other
p.(None): advanced technology needs for the Initiative;
p.(None): ``(2) develop and utilize public-private partnerships; and
p.(None): ``(3) leverage existing data sources.
p.(None):
p.(None): ``(d) Requirements.--In the implementation of the Initiative under
p.(None): subsection (a), the Secretary shall--
p.(None): ``(1) ensure the collaboration of the National Institutes of
p.(None): Health, the Food and Drug Administration, the Office of the
p.(None): National Coordinator for Health Information Technology, and the
p.(None): Office for Civil Rights of the Department of Health and Human
p.(None): Services;
p.(None): ``(2) comply with existing laws and regulations for the
p.(None): protection of human subjects involved in research, including the
p.(None): protection of participant privacy;
p.(None): ``(3) implement policies and mechanisms for appropriate
p.(None): secure data sharing across systems that include protections for
p.(None): privacy and security of data;
p.(None): ``(4) consider the diversity of the cohort to ensure
p.(None): inclusion of a broad range of participants, including
p.(None): consideration of biological, social, and other determinants of
p.(None): health that contribute to health disparities;
p.(None): ``(5) ensure that only authorized individuals may access
p.(None): controlled or sensitive, identifiable biological material and
p.(None): associated information collected or stored in connection with
p.(None): the Initiative; and
p.(None): ``(6) on the appropriate Internet website of the Department
p.(None): of Health and Human Services, identify any entities with access
p.(None): to such information and provide information with respect to the
p.(None): purpose of such access, a summary of the research project for
p.(None): which such access is granted, as applicable, and a description
p.(None): of the biological material and associated information to which
...
p.(None): subparagraphs (D) through (M), respectively; and
p.(None): (2) by inserting after subparagraph (B), the following:
p.(None): ``(C) shall, as appropriate, conduct and support research
p.(None): that has the potential to transform the scientific field, has
p.(None): inherently higher risk, and that seeks to address major current
p.(None): challenges;''.
p.(None): SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.
p.(None):
p.(None): (a) In General.--Section 479(b) of the Public Health Service Act (42
p.(None): U.S.C. 287(b)) is amended--
p.(None): (1) in paragraph (1), by striking ``phase IIA'' and
p.(None): inserting ``phase IIB''; and
p.(None): (2) in paragraph (2)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``phase IIB'' and inserting ``phase III'';
p.(None): (B) in subparagraph (A), by striking ``phase IIB''
p.(None): and inserting ``phase III'';
p.(None): (C) in subparagraph (B), by striking ``phase IIA''
p.(None): and inserting ``phase IIB''; and
p.(None): (D) in subparagraph (C), by striking ``phase IIB''
p.(None): and inserting ``phase III''.
p.(None):
p.(None): (b) Increased Transparency.--Section 479 of the Public Health
p.(None): Service Act (42 U.S.C. 287) is amended--
p.(None): (1) in subsection (c)--
p.(None): (A) in paragraph (4)(D), by striking ``and'' at the
p.(None): end;
p.(None): (B) in paragraph (5), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (C) by adding at the end the following:
p.(None): ``(6) the methods and tools, if any, that have been
p.(None): developed since the last biennial report was prepared; and
p.(None): ``(7) the methods and tools, if any, that have been
p.(None): developed and are being utilized by the Food and Drug
p.(None): Administration to support medical product reviews.''; and
p.(None):
p.(None): [[Page 130 STAT. 1064]]
p.(None):
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(d) Inclusion of List.--The first biennial report submitted under
p.(None): this section after the date of enactment of the 21st Century Cures Act
p.(None): shall include a complete list of all of the methods and tools, if any,
p.(None): which have been developed by research supported by the Center.
p.(None): ``(e) Rule of Construction.--Nothing in this section shall be
p.(None): construed as authorizing the Secretary to disclose any information that
p.(None): is a trade secret, or other privileged or confidential information
p.(None): subject to section 552(b)(4) of title 5, United States Code, or section
p.(None): 1905 of title 18, United States Code.''.
p.(None): SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.
p.(None):
p.(None): (a) Research Priorities; Collaborative Research Projects.--Section
p.(None): 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
p.(None): (1) by amending paragraph (4) to read as follows:
p.(None): ``(4) shall assemble accurate data to be used to assess
p.(None): research priorities, including--
p.(None): ``(A) information to better evaluate scientific
p.(None): opportunity, public health burdens, and progress in
p.(None): reducing health disparities; and
p.(None): ``(B) data on study populations of clinical
p.(None): research, funded by or conducted at each national
p.(None): research institute and national center, which--
p.(None): ``(i) specifies the inclusion of--
p.(None): ``(I) women;
p.(None): ``(II) members of minority groups;
p.(None): ``(III) relevant age categories,
...
p.(None): TRIALS.
p.(None):
p.(None): It is the sense of Congress that the National Institute on Minority
p.(None): Health and Health Disparities should include within its strategic plan
p.(None): under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m))
p.(None): ways to increase representation of underrepresented populations in
p.(None): clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
p.(None):
p.(None): Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
p.(None): 282(j)(2)(D)) is amended--
p.(None): (1) in clause (ii)(I), by inserting before the semicolon ``,
p.(None): unless the responsible party affirmatively requests that the
p.(None): Director of the National Institutes of Health publicly post such
p.(None): clinical trial information for an applicable device clinical
p.(None): trial prior to such date of clearance or approval''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(iii) Option to make certain clinical trial
p.(None): information available earlier.--The Director of
p.(None): the National Institutes of Health shall inform
p.(None): responsible parties of the option to request that
p.(None): clinical trial information for an applicable
p.(None): device clinical trial be publicly posted prior to
p.(None): the date of clearance or approval, in accordance
p.(None): with clause (ii)(I).
p.(None): ``(iv) Combination products.--An applicable
p.(None): clinical trial for a product that is a combination
p.(None): of drug, device, or biological product shall be
p.(None): considered--
p.(None):
p.(None): [[Page 130 STAT. 1075]]
p.(None):
p.(None): ``(I) an applicable drug clinical
p.(None): trial, if the Secretary determines under
p.(None): section 503(g) of the Federal Food,
p.(None): Drug, and Cosmetic Act that the primary
p.(None): mode of action of such product is that
p.(None): of a drug or biological product; or
p.(None): ``(II) an applicable device clinical
p.(None): trial, if the Secretary determines under
p.(None): such section that the primary mode of
p.(None): action of such product is that of a
p.(None): device.''.
p.(None): SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
p.(None):
p.(None): (a) Definitions.--In this section:
p.(None): (1) Applicable clinical trial.--The term ``applicable
p.(None): clinical trial'' has the meaning given the term in section
p.(None): 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.(None): (2) Secretary.--The term ``Secretary'' means the Secretary
p.(None): of Health and Human Services.
p.(None):
p.(None): (b) Report on Activities To Encourage Compliance.--Not later than 2
p.(None): years after the date of enactment of this Act, the Secretary, acting
p.(None): through the Director of the National Institutes of Health and in
p.(None): collaboration with the Commissioner of Food and Drugs, shall submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate
p.(None): and the Committee on Energy and Commerce of the House of
p.(None): Representatives, a report that describes education and outreach,
p.(None): guidance, enforcement, and other activities undertaken to encourage
p.(None): compliance with section 402(j) of the Public Health Service Act (42
p.(None): U.S.C. 282(j)).
p.(None): (c) Reports on Clinical Trials.--
p.(None): (1) In general.--Not later than 2 years after the final
p.(None): compliance date under the final rule implementing section 402(j)
p.(None): of the Public Health Service Act, and every 2 years thereafter
p.(None): for the next 4 years, the Secretary, acting through the Director
p.(None): of the National Institutes of Health and in collaboration with
...
p.(None):
p.(None): Section 492B(c) of the Public Health Service Act (42 U.S.C. 289a-
p.(None): 2(c)) is amended--
p.(None): (1) by striking ``In the case'' and inserting the following:
p.(None): ``(1) In general.--In the case''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(2) Reporting requirements.--For any new and competing
p.(None): project of clinical research subject to the requirements under
p.(None): this section that receives a grant award 1 year after the date
p.(None): of enactment of the 21st Century Cures Act, or any date
p.(None): thereafter, for which a valid analysis is provided under
p.(None): paragraph (1)--
p.(None): ``(A) and which is an applicable clinical trial as
p.(None): defined in section 402(j), the entity conducting such
p.(None): clinical research shall submit the results of such valid
p.(None): analysis to the clinical trial registry data bank
p.(None): expanded under section 402(j)(3), and the Director of
p.(None): the National Institutes of Health shall, as appropriate,
p.(None): consider whether such entity has complied with the
p.(None): reporting requirement described in this subparagraph in
p.(None): awarding any future grant to such entity, including
p.(None): pursuant to section 402(j)(5)(A)(ii) when applicable;
p.(None): and
p.(None): ``(B) the Director of the National Institutes of
p.(None): Health shall encourage the reporting of the results of
p.(None): such valid analysis described in paragraph (1) through
p.(None): any additional means determined appropriate by the
p.(None): Director.''.
p.(None): SEC. 2054. CONSULTATION.
p.(None):
p.(None): Not later than 90 days after the date of enactment of this Act, the
p.(None): Secretary of Health and Human Services shall consult with relevant
p.(None): Federal agencies, including the Food and Drug Administration, the Office
p.(None): of the National Coordinator for Health Information Technology, and the
p.(None): National Institutes of Health, as well as other stakeholders (including
p.(None): patients, researchers, physicians, industry representatives, and
p.(None): developers of health information technology) to receive recommendations
p.(None): with respect to enhancements to the clinical trial registry data bank
p.(None): under section 402(j) of the Public Health Service Act (42 U.S.C.
p.(None): 282(j)), including with respect to usability, functionality, and search
p.(None): capability.
p.(None):
p.(None): Subtitle F--Facilitating Collaborative Research
p.(None):
p.(None): SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE SYSTEM.
p.(None):
p.(None): Part P of title III of the Public Health Service Act (42 U.S.C. 280g
p.(None): et seq.) is amended by inserting after section 399S the following:
p.(None):
p.(None): [[Page 130 STAT. 1077]]
p.(None):
p.(None): ``SEC. 399S-1. <> SURVEILLANCE OF
p.(None): NEUROLOGICAL DISEASES.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Director of the
p.(None): Centers for Disease Control and Prevention and in coordination with
p.(None): other agencies as the Secretary determines, shall, as appropriate--
p.(None): ``(1) enhance and expand infrastructure and activities to
p.(None): track the epidemiology of neurological diseases; and
p.(None): ``(2) incorporate information obtained through such
p.(None): activities into an integrated surveillance system, which may
p.(None): consist of or include a registry, to be known as the National
p.(None): Neurological Conditions Surveillance System.
p.(None):
p.(None): ``(b) Research.--The Secretary shall ensure that the National
p.(None): Neurological Conditions Surveillance System is designed in a manner that
...
p.(None): duration of illness, and intervention for
p.(None): individuals with tick-borne diseases;
p.(None): (ii) advances made pursuant to such research;
p.(None): (iii) Federal activities related to tick-borne
p.(None): diseases, including--
p.(None): (I) epidemiological activities
p.(None): related to tick-borne diseases; and
p.(None): (II) basic, clinical, and
p.(None): translational tick-borne disease
p.(None): research related to the pathogenesis,
p.(None): prevention, diagnosis, and treatment of
p.(None): tick-borne diseases;
p.(None): (iv) gaps in tick-borne disease research
p.(None): described in clause (iii)(II);
p.(None): (v) the Working Group's meetings required
p.(None): under paragraph (4); and
p.(None): (vi) the comments received by the Working
p.(None): Group;
p.(None): (B) make recommendations to the Secretary regarding
p.(None): any appropriate changes or improvements to such
p.(None): activities and research; and
p.(None): (C) solicit input from States, localities, and
p.(None): nongovernmental entities, including organizations
p.(None): representing patients, health care providers,
p.(None): researchers, and industry regarding scientific advances,
p.(None): research questions, surveillance activities, and
p.(None): emerging strains in species of pathogenic organisms.
p.(None):
p.(None): [[Page 130 STAT. 1080]]
p.(None):
p.(None): (3) Membership.--The members of the working group shall
p.(None): represent a diversity of scientific disciplines and views and
p.(None): shall be composed of the following members:
p.(None): (A) Federal members.--Seven Federal members,
p.(None): consisting of one or more representatives of each of the
p.(None): following:
p.(None): (i) The Office of the Assistant Secretary for
p.(None): Health.
p.(None): (ii) The Food and Drug Administration.
p.(None): (iii) The Centers for Disease Control and
p.(None): Prevention.
p.(None): (iv) The National Institutes of Health.
p.(None): (v) Such other agencies and offices of the
p.(None): Department of Health and Human Services as the
p.(None): Secretary determines appropriate.
p.(None): (B) Non-Federal public members.--Seven non-Federal
p.(None): public members, consisting of representatives of the
p.(None): following categories:
p.(None): (i) Physicians and other medical providers
p.(None): with experience in diagnosing and treating tick-
p.(None): borne diseases.
p.(None): (ii) Scientists or researchers with expertise.
p.(None): (iii) Patients and their family members.
p.(None): (iv) Nonprofit organizations that advocate for
p.(None): patients with respect to tick-borne diseases.
p.(None): (v) Other individuals whose expertise is
p.(None): determined by the Secretary to be beneficial to
p.(None): the functioning of the Working Group.
p.(None): (4) Meetings.--The Working Group shall meet not less than
p.(None): twice each year.
p.(None): (5) Reporting.--Not later than 2 years after the date of
p.(None): enactment of this Act, and every 2 years thereafter until
p.(None): termination of the Working Group pursuant to paragraph (7), the
p.(None): Working Group shall--
p.(None): (A) submit a report on its activities under
p.(None): paragraph (2)(A) and any recommendations under paragraph
p.(None): (2)(B) to the Secretary, the Committee on Energy and
p.(None): Commerce of the House of Representatives, and the
p.(None): Committee on Health, Education, Labor, and Pensions of
p.(None): the Senate; and
p.(None): (B) make such report publicly available on the
p.(None): Internet website of the Department of Health and Human
p.(None): Services.
...
p.(None): (A) sufficiently describes the purposes such that it
p.(None): would be reasonable for the individual to expect that
p.(None): the protected health information could be used or
p.(None): disclosed for such future research;
p.(None): (B) either--
p.(None): (i) states that the authorization will expire
p.(None): on a particular date or on the occurrence of a
p.(None): particular event; or
p.(None): (ii) states that the authorization will remain
p.(None): valid unless and until it is revoked by the
p.(None): individual; and
p.(None): (C) provides instruction to the individual on how to
p.(None): revoke such authorization at any time.
p.(None): (2) Reminder of the right to revoke.--Clarification of the
p.(None): circumstances under which it is appropriate to provide an
p.(None): individual with an annual notice or reminder that the individual
p.(None): has the right to revoke such authorization.
p.(None): (3) Revocation of authorization.--Clarification of
p.(None): appropriate mechanisms by which an individual may revoke an
p.(None): authorization for future research purposes, such as described in
p.(None): paragraph (1)(C).
p.(None):
p.(None): (c) Working Group on Protected Health Information for Research.--
p.(None): (1) Establishment.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Secretary shall convene a working
p.(None): group to study and report on the uses and disclosures of
p.(None): protected health information for research purposes, under the
p.(None): Health Insurance Portability and Accountability Act of 1996
p.(None): (Public Law 104-191).
p.(None): (2) Members.--The working group shall include
p.(None): representatives of--
p.(None): (A) relevant Federal agencies, including the
p.(None): National Institutes of Health, the Centers for Disease
p.(None): Control and Prevention, the Food and Drug
p.(None): Administration, and the Office for Civil Rights;
p.(None): (B) the research community;
p.(None): (C) patients;
p.(None): (D) experts in civil rights, such as privacy rights;
p.(None): (E) developers of health information technology;
p.(None): (F) experts in data privacy and security;
p.(None): (G) health care providers;
p.(None): (H) bioethicists; and
p.(None): (I) other experts and entities, as the Secretary
p.(None): determines appropriate.
p.(None):
p.(None): [[Page 130 STAT. 1082]]
p.(None):
p.(None): (3) Report.--Not later than 1 year after the date on which
p.(None): the working group is convened under paragraph (1), the working
p.(None): group shall conduct a review and submit a report to the
p.(None): Secretary containing recommendations on whether the uses and
p.(None): disclosures of protected health information for research
p.(None): purposes should be modified to allow protected health
p.(None): information to be available, as appropriate, for research
p.(None): purposes, including studies to obtain generalizable knowledge,
p.(None): while protecting individuals' privacy rights. In conducting the
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
...
p.(None): centers that carry out activities involving pediatric research,
p.(None): shall support''; and
p.(None): (2) in paragraph (2)(A) and the first sentence of paragraph
p.(None): (2)(E), by striking ``may'' each place such term appears and
p.(None): inserting ``shall''.
p.(None): SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
p.(None):
p.(None): It is the sense of Congress that--
p.(None): (1) the National Institutes of Health should encourage a
p.(None): global pediatric clinical study network by providing grants,
p.(None): contracts, or cooperative agreements to support new and early
p.(None): stage investigators who participate in the global pediatric
p.(None): clinical study network;
p.(None): (2) the Secretary of Health and Human Services (referred to
p.(None): in this section as the ``Secretary'') should engage with
p.(None): clinical investigators and appropriate authorities outside of
p.(None): the United States, including authorities in the European Union,
p.(None): during the formation of the global pediatric clinical study
p.(None): network to encourage the participation of such investigator and
p.(None): authorities; and
p.(None): (3) once a global pediatric clinical study network is
p.(None): established and becomes operational, the Secretary should
p.(None): continue to encourage and facilitate the participation of
p.(None): clinical investigators and appropriate authorities outside of
p.(None): the United States, including in the European Union, to
p.(None): participate in the network with the goal of enhancing the global
p.(None): reach of the network.
p.(None):
p.(None): TITLE III--DEVELOPMENT
p.(None):
p.(None): Subtitle A--Patient-Focused Drug Development
p.(None):
p.(None): SEC. 3001. PATIENT EXPERIENCE DATA.
p.(None):
p.(None): Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360bbb-8c) is amended--
p.(None): [[Page 130 STAT. 1084]]
p.(None):
p.(None): (1) in subsection (a)--
p.(None): (A) in the subsection heading, by striking ``In
p.(None): General'' and inserting ``Patient Engagement in Drugs
p.(None): and Devices'';
p.(None): (B) by redesignating paragraphs (1) and (2) as
p.(None): subparagraphs (A) and (B), respectively, and moving such
p.(None): subparagraphs 2 ems to the right; and
p.(None): (C) by striking ``The Secretary'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The Secretary'';
p.(None): (2) by redesignating subsections (b) through (e) as
p.(None): paragraphs (2) through (5), respectively, and moving such
p.(None): paragraphs 2 ems to the right; and
p.(None): (3) by adding at the end the following:
p.(None):
p.(None): ``(b) Statement of Patient Experience.--
p.(None): ``(1) In general.--Following the approval of an application
p.(None): that was submitted under section 505(b) of this Act or section
p.(None): 351(a) of the Public Health Service Act at least 180 days after
p.(None): the date of enactment of the 21st Century Cures Act, the
p.(None): Secretary shall make public a brief statement regarding the
p.(None): patient experience data and related information, if any,
p.(None): submitted and reviewed as part of such application.
p.(None): ``(2) Data and information.--The data and information
p.(None): referred to in paragraph (1) are--
p.(None): ``(A) patient experience data;
p.(None): ``(B) information on patient-focused drug
p.(None): development tools; and
p.(None): ``(C) other relevant information, as determined by
p.(None): the Secretary.
p.(None):
p.(None): ``(c) Patient Experience Data.--For purposes of this section, the
p.(None): term `patient experience data' includes data that--
p.(None): ``(1) are collected by any persons (including patients,
p.(None): family members and caregivers of patients, patient advocacy
p.(None): organizations, disease research foundations, researchers, and
p.(None): drug manufacturers); and
p.(None): ``(2) are intended to provide information about patients'
p.(None): experiences with a disease or condition, including--
p.(None): ``(A) the impact of such disease or condition, or a
p.(None): related therapy, on patients' lives; and
p.(None): ``(B) patient preferences with respect to treatment
p.(None): of such disease or condition.''.
p.(None): SEC. 3002. <> PATIENT-FOCUSED DRUG
p.(None): DEVELOPMENT GUIDANCE.
p.(None):
p.(None): (a) Publication of Guidance Documents.--Not later than 180 days
p.(None): after the date of enactment of this Act, the Secretary of Health and
p.(None): Human Services (referred to in this section as the ``Secretary''),
p.(None): acting through the Commissioner of Food and Drugs, shall develop a plan
p.(None): to issue draft and final versions of one or more guidance documents,
p.(None): over a period of 5 years, regarding the collection of patient experience
p.(None): data, and the use of such data and related information in drug
p.(None): development. Not later than 18 months after the date of enactment of
p.(None): this Act, the Secretary shall issue a draft version of at least one such
p.(None): guidance document. Not later than 18 months after the public comment
p.(None): period on the draft guidance ends, the Secretary shall issue a revised
p.(None): draft guidance or final guidance.
p.(None):
p.(None): [[Page 130 STAT. 1085]]
p.(None):
p.(None): (b) Patient Experience Data.--For purposes of this section, the term
p.(None): ``patient experience data'' has the meaning given such term in section
p.(None): 569C of the Federal Food, Drug, and Cosmetic Act (as added by section
p.(None): 3001).
p.(None): (c) Contents.--The guidance documents described in subsection (a)
p.(None): shall address--
p.(None): (1) methodological approaches that a person seeking to
p.(None): collect patient experience data for submission to, and proposed
p.(None): use by, the Secretary in regulatory decisionmaking may use, that
p.(None): are relevant and objective and ensure that such data are
p.(None): accurate and representative of the intended population,
p.(None): including methods to collect meaningful patient input throughout
p.(None): the drug development process and methodological considerations
p.(None): for data collection, reporting, management, and analysis;
p.(None): (2) methodological approaches that may be used to develop
p.(None): and identify what is most important to patients with respect to
p.(None): burden of disease, burden of treatment, and the benefits and
p.(None): risks in the management of the patient's disease;
p.(None): (3) approaches to identifying and developing methods to
p.(None): measure impacts to patients that will help facilitate collection
p.(None): of patient experience data in clinical trials;
p.(None): (4) methodologies, standards, and technologies to collect
p.(None): and analyze clinical outcome assessments for purposes of
p.(None): regulatory decisionmaking;
p.(None): (5) how a person seeking to develop and submit proposed
p.(None): draft guidance relating to patient experience data for
p.(None): consideration by the Secretary may submit such proposed draft
p.(None): guidance to the Secretary;
p.(None): (6) the format and content required for submissions under
p.(None): this section to the Secretary, including with respect to the
p.(None): information described in paragraph (1);
p.(None): (7) how the Secretary intends to respond to submissions of
p.(None): information described in paragraph (1), if applicable, including
p.(None): any timeframe for response when such submission is not part of a
p.(None): regulatory application or other submission that has an
p.(None): associated timeframe for response; and
p.(None): (8) how the Secretary, if appropriate, anticipates using
p.(None): relevant patient experience data and related information,
p.(None): including with respect to the structured risk-benefit assessment
p.(None): framework described in section 505(d) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory
p.(None): decisionmaking.
p.(None): SEC. 3003. <> STREAMLINING PATIENT
p.(None): INPUT.
p.(None):
p.(None): Chapter 35 of title 44, United States Code, shall not apply to the
p.(None): collection of information to which a response is voluntary, that is
p.(None): initiated by the Secretary under section 569C of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 360bbb-8c) (as amended by section 3001) or
p.(None): section 3002.
p.(None): SEC. 3004. <> REPORT ON PATIENT
p.(None): EXPERIENCE DRUG DEVELOPMENT.
p.(None):
p.(None): Not later than June 1 of 2021, 2026, and 2031, the Secretary of
p.(None): Health and Human Services, acting through the Commissioner of Food and
p.(None): Drugs, shall prepare and publish on the Internet website of the Food and
p.(None): Drug Administration a report assessing the use of patient experience
p.(None): data in regulatory decisionmaking, in particular with respect to the
p.(None): review of patient experience data and information on patient-focused
p.(None): drug development tools as part
p.(None):
p.(None): [[Page 130 STAT. 1086]]
p.(None):
p.(None): of applications approved under section 505(c) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public
p.(None): Health Service Act (42 U.S.C. 262(a)).
p.(None):
p.(None): Subtitle B--Advancing New Drug Therapies
p.(None):
p.(None): SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
p.(None):
p.(None): (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F
p.(None): the following new section:
p.(None): ``SEC. 507. <> QUALIFICATION OF DRUG
p.(None): DEVELOPMENT TOOLS.
p.(None):
p.(None): ``(a) Process for Qualification.--
p.(None): ``(1) In general.--The Secretary shall establish a process
p.(None): for the qualification of drug development tools for a proposed
p.(None): context of use under which--
p.(None): ``(A)(i) a requestor initiates such process by
p.(None): submitting a letter of intent to the Secretary; and
p.(None): ``(ii) the Secretary accepts or declines to accept
p.(None): such letter of intent;
p.(None): ``(B)(i) if the Secretary accepts the letter of
p.(None): intent, a requestor submits a qualification plan to the
p.(None): Secretary; and
p.(None): ``(ii) the Secretary accepts or declines to accept
p.(None): the qualification plan; and
p.(None): ``(C)(i) if the Secretary accepts the qualification
p.(None): plan, the requestor submits to the Secretary a full
p.(None): qualification package;
p.(None): ``(ii) the Secretary determines whether to accept
p.(None): such qualification package for review; and
p.(None): ``(iii) if the Secretary accepts such qualification
p.(None): package for review, the Secretary conducts such review
p.(None): in accordance with this section.
p.(None): ``(2) Acceptance and review of submissions.--
p.(None): ``(A) In general.--Subparagraphs (B), (C), and (D)
p.(None): shall apply with respect to the treatment of a letter of
p.(None): intent, a qualification plan, or a full qualification
p.(None): package submitted under paragraph (1) (referred to in
p.(None): this paragraph as `qualification submissions').
p.(None): ``(B) Acceptance factors; nonacceptance.--The
p.(None): Secretary shall determine whether to accept a
p.(None): qualification submission based on factors which may
p.(None): include the scientific merit of the qualification
p.(None): submission. A determination not to accept a submission
p.(None): under paragraph (1) shall not be construed as a final
p.(None): determination by the Secretary under this section
p.(None): regarding the qualification of a drug development tool
p.(None): for its proposed context of use.
p.(None): ``(C) Prioritization of qualification review.--The
p.(None): Secretary may prioritize the review of a full
p.(None): qualification package submitted under paragraph (1) with
p.(None): respect to a drug development tool, based on factors
p.(None): determined appropriate by the Secretary, including--
p.(None): ``(i) as applicable, the severity, rarity, or
p.(None): prevalence of the disease or condition targeted by
p.(None): the drug
p.(None):
p.(None): [[Page 130 STAT. 1087]]
p.(None):
p.(None): development tool and the availability or lack of
p.(None): alternative treatments for such disease or
p.(None): condition; and
p.(None): ``(ii) the identification, by the Secretary or
p.(None): by biomedical research consortia and other expert
p.(None): stakeholders, of such a drug development tool and
p.(None): its proposed context of use as a public health
p.(None): priority.
p.(None): ``(D) Engagement of external experts.--The Secretary
p.(None): may, for purposes of the review of qualification
p.(None): submissions, through the use of cooperative agreements,
p.(None): grants, or other appropriate mechanisms, consult with
p.(None): biomedical research consortia and may consider the
p.(None): recommendations of such consortia with respect to the
p.(None): review of any qualification plan submitted under
p.(None): paragraph (1) or the review of any full qualification
p.(None): package under paragraph (3).
p.(None): ``(3) Review of full qualification package.--The Secretary
p.(None): shall--
p.(None): ``(A) conduct a comprehensive review of a full
p.(None): qualification package accepted under paragraph (1)(C);
p.(None): and
p.(None): ``(B) determine whether the drug development tool at
p.(None): issue is qualified for its proposed context of use.
p.(None): ``(4) Qualification.--The Secretary shall determine whether
p.(None): a drug development tool is qualified for a proposed context of
p.(None): use based on the scientific merit of a full qualification
p.(None): package reviewed under paragraph (3).
p.(None):
p.(None): ``(b) Effect of Qualification.--
p.(None): ``(1) In general.--A drug development tool determined to be
p.(None): qualified under subsection (a)(4) for a proposed context of use
p.(None): specified by the requestor may be used by any person in such
p.(None): context of use for the purposes described in paragraph (2).
p.(None): ``(2) Use of a drug development tool.--Subject to paragraph
p.(None): (3), a drug development tool qualified under this section may be
p.(None): used for--
p.(None): ``(A) supporting or obtaining approval or licensure
p.(None): (as applicable) of a drug or biological product
p.(None): (including in accordance with section 506(c)) under
p.(None): section 505 of this Act or section 351 of the Public
p.(None): Health Service Act; or
p.(None): ``(B) supporting the investigational use of a drug
p.(None): or biological product under section 505(i) of this Act
p.(None): or section 351(a)(3) of the Public Health Service Act.
p.(None): ``(3) Rescission or modification.--
p.(None): ``(A) In general.--The Secretary may rescind or
p.(None): modify a determination under this section to qualify a
p.(None): drug development tool if the Secretary determines that
p.(None): the drug development tool is not appropriate for the
p.(None): proposed context of use specified by the requestor. Such
p.(None): a determination may be based on new information that
p.(None): calls into question the basis for such qualification.
p.(None): ``(B) Meeting for review.--If the Secretary rescinds
p.(None): or modifies under subparagraph (A) a determination to
p.(None): qualify a drug development tool, the requestor involved
p.(None): shall, on request, be granted a meeting with the
p.(None): Secretary to discuss the basis of the Secretary's
p.(None): decision to rescind or modify the determination before
p.(None): the effective date of the rescission or modification.
p.(None):
p.(None): ``(c) Transparency.--
p.(None):
p.(None): [[Page 130 STAT. 1088]]
p.(None):
p.(None): ``(1) In general.--Subject to paragraph (3), the Secretary
p.(None): shall make publicly available, and update on at least a biannual
p.(None): basis, on the Internet website of the Food and Drug
p.(None): Administration the following:
p.(None): ``(A) Information with respect to each qualification
p.(None): submission under the qualification process under
p.(None): subsection (a), including--
p.(None): ``(i) the stage of the review process
p.(None): applicable to the submission;
p.(None): ``(ii) the date of the most recent change in
p.(None): stage status;
p.(None): ``(iii) whether external scientific experts
p.(None): were utilized in the development of a
p.(None): qualification plan or the review of a full
p.(None): qualification package; and
p.(None): ``(iv) submissions from requestors under the
p.(None): qualification process under subsection (a),
p.(None): including any data and evidence contained in such
p.(None): submissions, and any updates to such submissions.
p.(None): ``(B) The Secretary's formal written determinations
p.(None): in response to such qualification submissions.
p.(None): ``(C) Any rescissions or modifications under
p.(None): subsection (b)(3) of a determination to qualify a drug
p.(None): development tool.
p.(None): ``(D) Summary reviews that document conclusions and
p.(None): recommendations for determinations to qualify drug
p.(None): development tools under subsection (a).
p.(None): ``(E) A comprehensive list of--
p.(None): ``(i) all drug development tools qualified
p.(None): under subsection (a); and
p.(None): ``(ii) all surrogate endpoints which were the
p.(None): basis of approval or licensure (as applicable) of
p.(None): a drug or biological product (including in
p.(None): accordance with section 506(c)) under section 505
p.(None): of this Act or section 351 of the Public Health
p.(None): Service Act.
p.(None): ``(2) Relation to trade secrets act.--Information made
p.(None): publicly available by the Secretary under paragraph (1) shall be
p.(None): considered a disclosure authorized by law for purposes of
p.(None): section 1905 of title 18, United States Code.
p.(None): ``(3) Applicability.--Nothing in this section shall be
p.(None): construed as authorizing the Secretary to disclose any
p.(None): information contained in an application submitted under section
p.(None): 505 of this Act or section 351 of the Public Health Service Act
p.(None): that is confidential commercial or trade secret information
p.(None): subject to section 552(b)(4) of title 5, United States Code, or
p.(None): section 1905 of title 18, United States Code.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed--
p.(None): ``(1) to alter the standards of evidence under subsection
p.(None): (c) or (d) of section 505, including the substantial evidence
p.(None): standard in such subsection (d), or under section 351 of the
p.(None): Public Health Service Act (as applicable); or
p.(None): ``(2) to limit the authority of the Secretary to approve or
p.(None): license products under this Act or the Public Health Service
p.(None): Act, as applicable (as in effect before the date of the
p.(None): enactment of the 21st Century Cures Act).
p.(None):
p.(None): ``(e) Definitions.--In this section:
p.(None): ``(1) Biomarker.--The term `biomarker'--
p.(None):
p.(None): [[Page 130 STAT. 1089]]
p.(None):
p.(None): ``(A) means a characteristic (such as a physiologic,
p.(None): pathologic, or anatomic characteristic or measurement)
p.(None): that is objectively measured and evaluated as an
p.(None): indicator of normal biologic processes, pathologic
p.(None): processes, or biological responses to a therapeutic
p.(None): intervention; and
p.(None): ``(B) includes a surrogate endpoint.
p.(None): ``(2) Biomedical research consortia.--The term `biomedical
p.(None): research consortia' means collaborative groups that may take the
p.(None): form of public-private partnerships and may include government
p.(None): agencies, institutions of higher education (as defined in
p.(None): section 101(a) of the Higher Education Act of 1965), patient
p.(None): advocacy groups, industry representatives, clinical and
p.(None): scientific experts, and other relevant entities and individuals.
p.(None): ``(3) Clinical outcome assessment.--The term `clinical
p.(None): outcome assessment' means--
p.(None): ``(A) a measurement of a patient's symptoms, overall
p.(None): mental state, or the effects of a disease or condition
p.(None): on how the patient functions; and
p.(None): ``(B) includes a patient-reported outcome.
p.(None): ``(4) Context of use.--The term `context of use' means, with
p.(None): respect to a drug development tool, the circumstances under
p.(None): which the drug development tool is to be used in drug
p.(None): development and regulatory review.
p.(None): ``(5) Drug development tool.--The term `drug development
p.(None): tool' includes--
p.(None): ``(A) a biomarker;
p.(None): ``(B) a clinical outcome assessment; and
p.(None): ``(C) any other method, material, or measure that
p.(None): the Secretary determines aids drug development and
p.(None): regulatory review for purposes of this section.
p.(None): ``(6) Patient-reported outcome.--The term `patient-reported
p.(None): outcome' means a measurement based on a report from a patient
p.(None): regarding the status of the patient's health condition without
p.(None): amendment or interpretation of the patient's report by a
p.(None): clinician or any other person.
p.(None): ``(7) Qualification.--The terms `qualification' and
p.(None): `qualified' mean a determination by the Secretary that a drug
p.(None): development tool and its proposed context of use can be relied
p.(None): upon to have a specific interpretation and application in drug
p.(None): development and regulatory review under this Act.
p.(None): ``(8) Requestor.--The term `requestor' means an entity or
p.(None): entities, including a drug sponsor or a biomedical research
p.(None): consortia, seeking to qualify a drug development tool for a
p.(None): proposed context of use under this section.
p.(None): ``(9) Surrogate endpoint.--The term `surrogate endpoint'
p.(None): means a marker, such as a laboratory measurement, radiographic
p.(None): image, physical sign, or other measure, that is not itself a
p.(None): direct measurement of clinical benefit, and--
p.(None): ``(A) is known to predict clinical benefit and could
p.(None): be used to support traditional approval of a drug or
p.(None): biological product; or
p.(None): ``(B) is reasonably likely to predict clinical
p.(None): benefit and could be used to support the accelerated
p.(None): approval of a drug or biological product in accordance
p.(None): with section 506(c).''.
p.(None):
p.(None): (b) <> Guidance.--
p.(None):
p.(None): [[Page 130 STAT. 1090]]
p.(None):
p.(None): (1) In general.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall, in
p.(None): consultation with biomedical research consortia (as defined in
p.(None): subsection (e) of section 507 of the Federal Food, Drug, and
p.(None): Cosmetic Act (as added by subsection (a)) and other interested
p.(None): parties through a collaborative public process, issue guidance
p.(None): to implement such section 507 that--
p.(None): (A) provides a conceptual framework describing
p.(None): appropriate standards and scientific approaches to
p.(None): support the development of biomarkers delineated under
p.(None): the taxonomy established under paragraph (3);
p.(None): (B) with respect to the qualification process under
p.(None): such section 507--
p.(None): (i) describes the requirements that entities
p.(None): seeking to qualify a drug development tool under
p.(None): such section shall observe when engaging in such
p.(None): process;
p.(None): (ii) outlines reasonable timeframes for the
p.(None): Secretary's review of letters, qualification
p.(None): plans, or full qualification packages submitted
p.(None): under such process; and
p.(None): (iii) establishes a process by which such
p.(None): entities or the Secretary may consult with
p.(None): biomedical research consortia and other
p.(None): individuals and entities with expert knowledge and
p.(None): insights that may assist the Secretary in the
p.(None): review of qualification plans and full
p.(None): qualification submissions under such section; and
p.(None): (C) includes such other information as the Secretary
p.(None): determines appropriate.
p.(None): (2) Timing.--Not later than 3 years after the date of the
p.(None): enactment of this Act, the Secretary shall issue draft guidance
p.(None): under paragraph (1) on the implementation of section 507 of the
p.(None): Federal Food, Drug, and Cosmetic Act (as added by subsection
p.(None): (a)). The Secretary shall issue final guidance on the
p.(None): implementation of such section not later than 6 months after the
p.(None): date on which the comment period for the draft guidance closes.
p.(None): (3) Taxonomy.--
p.(None): (A) In general.--For purposes of informing guidance
p.(None): under this subsection, the Secretary shall, in
p.(None): consultation with biomedical research consortia and
p.(None): other interested parties through a collaborative public
p.(None): process, establish a taxonomy for the classification of
p.(None): biomarkers (and related scientific concepts) for use in
p.(None): drug development.
p.(None): (B) Public availability.--Not later than 2 years
p.(None): after the date of the enactment of this Act, the
p.(None): Secretary shall make such taxonomy publicly available in
p.(None): draft form for public comment. The Secretary shall
p.(None): finalize the taxonomy not later than 1 year after the
p.(None): close of the public comment period.
p.(None):
p.(None): (c) Meeting and Report.--
p.(None): (1) Meeting.--Not later than 2 years after the date of the
p.(None): enactment of this Act, the Secretary shall convene a public
p.(None): meeting to describe and solicit public input regarding the
p.(None): qualification process under section 507 of the Federal Food,
p.(None): Drug, and Cosmetic Act, as added by subsection (a).
p.(None):
p.(None): [[Page 130 STAT. 1091]]
p.(None):
p.(None): (2) Report.--Not later than 5 years after the date of the
p.(None): enactment of this Act, the Secretary shall make publicly
p.(None): available on the Internet website of the Food and Drug
p.(None): Administration a report. Such report shall include, with respect
p.(None): to the qualification process under section 507 of the Federal
p.(None): Food, Drug, and Cosmetic Act, as added by subsection (a),
p.(None): information on--
p.(None): (A) the number of requests submitted, as a letter of
p.(None): intent, for qualification of a drug development tool (as
p.(None): defined in subsection (e) of such section 507);
p.(None): (B) the number of such requests accepted and
p.(None): determined to be eligible for submission of a
p.(None): qualification plan or full qualification package (as
p.(None): such terms are defined in subsection (e) of such section
p.(None): 507), respectively;
p.(None): (C) the number of such requests for which external
p.(None): scientific experts were utilized in the development of a
p.(None): qualification plan or review of a full qualification
p.(None): package;
p.(None): (D) the number of qualification plans and full
p.(None): qualification packages, respectively, submitted to the
p.(None): Secretary; and
p.(None): (E) the drug development tools qualified through
p.(None): such qualification process, specified by type of tool,
p.(None): such as a biomarker or clinical outcome assessment (as
p.(None): such terms are defined in subsection (e) of such section
p.(None): 507).
p.(None): SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.
p.(None):
p.(None): Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529
p.(None): the following:
p.(None): ``SEC. 529A. <> TARGETED DRUGS FOR RARE
p.(None): DISEASES.
p.(None):
p.(None): ``(a) Purpose.--The purpose of this section, through the approach
p.(None): provided for in subsection (b), is to--
p.(None): ``(1) facilitate the development, review, and approval of
p.(None): genetically targeted drugs and variant protein targeted drugs to
p.(None): address an unmet medical need in one or more patient subgroups,
p.(None): including subgroups of patients with different mutations of a
p.(None): gene, with respect to rare diseases or conditions that are
p.(None): serious or life-threatening; and
p.(None): ``(2) maximize the use of scientific tools or methods,
p.(None): including surrogate endpoints and other biomarkers, for such
p.(None): purposes.
p.(None):
p.(None): ``(b) Leveraging of Data From Previously Approved Drug Application
p.(None): or Applications.--The Secretary may, consistent with applicable
p.(None): standards for approval under this Act or section 351(a) of the Public
p.(None): Health Service Act, allow the sponsor of an application under section
p.(None): 505(b)(1) of this Act or section 351(a) of the Public Health Service Act
p.(None): for a genetically targeted drug or a variant protein targeted drug to
p.(None): rely upon data and information--
p.(None): ``(1) previously developed by the same sponsor (or another
p.(None): sponsor that has provided the sponsor with a contractual right
p.(None): of reference to such data and information); and
p.(None): ``(2) submitted by a sponsor described in paragraph (1) in
p.(None): support of one or more previously approved applications that
p.(None): were submitted under section 505(b)(1) of this Act or section
p.(None): 351(a) of the Public Health Service Act,
p.(None):
p.(None): for a drug that incorporates or utilizes the same or similar genetically
p.(None): targeted technology as the drug or drugs that are the subject
p.(None):
p.(None): [[Page 130 STAT. 1092]]
p.(None):
p.(None): of an application or applications described in paragraph (2) or for a
p.(None): variant protein targeted drug that is the same or incorporates or
p.(None): utilizes the same variant protein targeted drug, as the drug or drugs
p.(None): that are the subject of an application or applications described in
p.(None): paragraph (2).
p.(None): ``(c) Definitions.--For purposes of this section--
p.(None): ``(1) the term `genetically targeted drug' means a drug
p.(None): that--
p.(None): ``(A) is the subject of an application under section
p.(None): 505(b)(1) of this Act or section 351(a) of the Public
p.(None): Health Service Act for the treatment of a rare disease
p.(None): or condition (as such term is defined in section 526)
p.(None): that is serious or life-threatening;
p.(None): ``(B) may result in the modulation (including
p.(None): suppression, up-regulation, or activation) of the
p.(None): function of a gene or its associated gene product; and
p.(None): ``(C) incorporates or utilizes a genetically
p.(None): targeted technology;
p.(None): ``(2) the term `genetically targeted technology' means a
p.(None): technology comprising non-replicating nucleic acid or analogous
p.(None): compounds with a common or similar chemistry that is intended to
p.(None): treat one or more patient subgroups, including subgroups of
p.(None): patients with different mutations of a gene, with the same
p.(None): disease or condition, including a disease or condition due to
p.(None): other variants in the same gene; and
p.(None): ``(3) the term `variant protein targeted drug' means a drug
p.(None): that--
p.(None): ``(A) is the subject of an application under section
p.(None): 505(b)(1) of this Act or section 351(a) of the Public
p.(None): Health Service Act for the treatment of a rare disease
p.(None): or condition (as such term is defined in section 526)
p.(None): that is serious or life-threatening;
p.(None): ``(B) modulates the function of a product of a
p.(None): mutated gene where such mutation is responsible in whole
p.(None): or in part for a given disease or condition; and
p.(None): ``(C) is intended to treat one or more patient
p.(None): subgroups, including subgroups of patients with
p.(None): different mutations of a gene, with the same disease or
p.(None): condition.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to--
p.(None): ``(1) alter the authority of the Secretary to approve drugs
p.(None): pursuant to this Act or section 351 of the Public Health Service
p.(None): Act (as authorized prior to the date of enactment of the 21st
p.(None): Century Cures Act), including the standards of evidence, and
p.(None): applicable conditions, for approval under such applicable Act;
p.(None): or
p.(None): ``(2) confer any new rights, beyond those authorized under
p.(None): this Act or the Public Health Service Act prior to enactment of
p.(None): this section, with respect to the permissibility of a sponsor
p.(None): referencing information contained in another application
p.(None): submitted under section 505(b)(1) of this Act or section 351(a)
p.(None): of the Public Health Service Act.''.
p.(None):
p.(None): [[Page 130 STAT. 1093]]
p.(None):
p.(None): SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR
p.(None): RARE PEDIATRIC DISEASES.
p.(None):
p.(None): (a) In General.--Section 529(b) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5)
p.(None): and inserting the following:
p.(None): ``(5) Termination of authority.--The Secretary may not award
p.(None): any priority review vouchers under paragraph (1) after September
p.(None): 30, 2020, unless the rare pediatric disease product
p.(None): application--
p.(None): ``(A) is for a drug that, not later than September
p.(None): 30, 2020, is designated under subsection (d) as a drug
p.(None): for a rare pediatric disease; and
p.(None): ``(B) is, not later than September 30, 2022,
p.(None): approved under section 505(b)(1) of this Act or section
p.(None): 351(a) of the Public Health Service Act.''.
p.(None):
p.(None): (b) Report.--The Advancing Hope Act of 2016 (Public Law 114-229) is
p.(None): amended by striking section 3.
p.(None): SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.
p.(None):
p.(None): (a) Study.--The Comptroller General of the United States (referred
p.(None): to in this section as the ``Comptroller General'') shall conduct a study
p.(None): addressing the effectiveness and overall impact of the following
p.(None): priority review voucher programs, including any such programs amended or
p.(None): established by this Act:
p.(None): (1) The neglected tropical disease priority review voucher
p.(None): program under section 524 of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360n).
p.(None): (2) The rare pediatric disease priority review voucher
p.(None): program under section 529 of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360ff).
p.(None): (3) The medical countermeasure priority review voucher
p.(None): program under section 565A of the Federal Food, Drug, and
p.(None): Cosmetic Act, as added by section 3086.
p.(None):
p.(None): (b) Issuance of Report.--Not later than January 31, 2020, the
p.(None): Comptroller General shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives a report containing the results
p.(None): of the study under subsection (a).
p.(None): (c) Contents of Reports.--The report submitted under subsection (b)
p.(None): shall address--
p.(None): (1) for each drug for which a priority review voucher has
p.(None): been awarded as of initiation of the study--
p.(None): (A) the indications for which the drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262(a));
p.(None): (B) whether, and to what extent, the voucher
p.(None): impacted the sponsor's decision to develop the drug; and
p.(None): (C) whether, and to what extent, the approval or
p.(None): licensure of the drug, as applicable and appropriate--
p.(None): (i) addressed a global unmet need related to
p.(None): the treatment or prevention of a neglected
p.(None): tropical disease, including whether the sponsor of
p.(None): a drug coordinated with international development
p.(None): organizations;
p.(None):
p.(None): [[Page 130 STAT. 1094]]
p.(None):
p.(None): (ii) addressed an unmet need related to the
p.(None): treatment of a rare pediatric disease; or
p.(None): (iii) affected the Nation's preparedness
p.(None): against a chemical, biological, radiological, or
p.(None): nuclear threat, including naturally occurring
p.(None): threats;
p.(None): (2) for each drug for which a priority review voucher has
p.(None): been used--
p.(None): (A) the indications for which such drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262);
p.(None): (B) the value of the voucher, if transferred; and
p.(None): (C) the length of time between the date on which the
p.(None): voucher was awarded and the date on which the voucher
p.(None): was used; and
p.(None): (3) an analysis of the priority review voucher programs
p.(None): described in subsection (a), including--
p.(None): (A) the resources used by the Food and Drug
p.(None): Administration in reviewing drugs for which vouchers
p.(None): were used, including the effect of the programs on the
p.(None): Food and Drug Administration's review of drugs for which
p.(None): priority review vouchers were not awarded or used;
p.(None): (B) whether any improvements to such programs are
p.(None): necessary to appropriately target incentives for the
p.(None): development of drugs that would likely not otherwise be
p.(None): developed, or developed in as timely a manner, and, as
p.(None): applicable and appropriate--
p.(None): (i) address global unmet needs related to the
p.(None): treatment or prevention of neglected tropical
p.(None): diseases, including in countries in which
p.(None): neglected tropical diseases are endemic; or
p.(None): (ii) address unmet needs related to the
p.(None): treatment of rare pediatric diseases; and
p.(None): (C) whether the sunset of the rare pediatric disease
p.(None): program and medical countermeasure program has had an
p.(None): impact on the program, including any potential
p.(None): unintended consequences.
p.(None):
p.(None): (d) Protection of National Security.--The Comptroller General shall
p.(None): conduct the study and issue reports under this section in a manner that
p.(None): does not compromise national security.
p.(None): SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.
p.(None):
p.(None): Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
p.(None): (1) in subsection (a), by striking paragraph (1) and
p.(None): inserting the following: ``(1) defraying the costs of developing
p.(None): drugs for rare diseases or conditions, including qualified
p.(None): testing expenses,''; and
p.(None): (2) in subsection (b)(1)--
p.(None): (A) in subparagraph (A)(ii), by striking ``and''
p.(None): after the semicolon;
p.(None): (B) in subparagraph (B), by striking the period and
p.(None): inserting ``; and''; and
p.(None): (C) by adding at the end the following:
p.(None):
p.(None): [[Page 130 STAT. 1095]]
p.(None):
p.(None): ``(C) prospectively planned and designed
p.(None): observational studies and other analyses conducted to
p.(None): assist in the understanding of the natural history of a
p.(None): rare disease or condition and in the development of a
p.(None): therapy, including studies and analyses to--
p.(None): ``(i) develop or validate a drug development
p.(None): tool related to a rare disease or condition; or
p.(None): ``(ii) understand the full spectrum of the
p.(None): disease manifestations, including describing
p.(None): genotypic and phenotypic variability and
p.(None): identifying and defining distinct subpopulations
p.(None): affected by a rare disease or condition.''.
p.(None): SEC. 3016. <> GRANTS FOR STUDYING CONTINUOUS
p.(None): DRUG MANUFACTURING.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services may
p.(None): award grants to institutions of higher education and nonprofit
p.(None): organizations for the purpose of studying and recommending improvements
p.(None): to the process of continuous manufacturing of drugs and biological
p.(None): products and similar innovative monitoring and control techniques.
p.(None): (b) Definitions.--In this section--
p.(None): (1) the term ``drug'' has the meaning given such term in
p.(None): section 201 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 321);
p.(None): (2) the term ``biological product'' has the meaning given
p.(None): such term in section 351(i) of the Public Health Service Act (42
p.(None): U.S.C. 262(i)); and
p.(None): (3) the term ``institution of higher education'' has the
p.(None): meaning given such term in section 101(a) of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001(a)).
p.(None):
p.(None): Subtitle C--Modern Trial Design and Evidence Development
p.(None):
p.(None): SEC. 3021. <> NOVEL CLINICAL TRIAL
p.(None): DESIGNS.
p.(None):
p.(None): (a) Proposals for Use of Novel Clinical Trial Designs for Drugs and
p.(None): Biological Products.--For purposes of assisting sponsors in
p.(None): incorporating complex adaptive and other novel trial designs into
p.(None): proposed clinical protocols and applications for new drugs under section
p.(None): 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and
p.(None): biological products under section 351 of the Public Health Service Act
p.(None): (42 U.S.C. 262), the Secretary of Health and Human Services (referred to
p.(None): in this section as the ``Secretary'') shall conduct a public meeting and
p.(None): issue guidance in accordance with subsection (b).
p.(None): (b) Guidance Addressing Use of Novel Clinical Trial Designs.--
p.(None): (1) In general.--The Secretary, acting through the
p.(None): Commissioner of Food and Drugs, shall update or issue guidance
p.(None): addressing the use of complex adaptive and other novel trial
p.(None): design in the development and regulatory review and approval or
p.(None): licensure for drugs and biological products.
p.(None): (2) Contents.--The guidance under paragraph (1) shall
p.(None): address--
p.(None):
p.(None): [[Page 130 STAT. 1096]]
p.(None):
p.(None): (A) the use of complex adaptive and other novel
p.(None): trial designs, including how such clinical trials
p.(None): proposed or submitted help to satisfy the substantial
p.(None): evidence standard under section 505(d) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
p.(None): (B) how sponsors may obtain feedback from the
p.(None): Secretary on technical issues related to modeling and
p.(None): simulations prior to--
p.(None): (i) completion of such modeling or
p.(None): simulations; or
p.(None): (ii) the submission of resulting information
p.(None): to the Secretary;
p.(None): (C) the types of quantitative and qualitative
p.(None): information that should be submitted for review; and
p.(None): (D) recommended analysis methodologies.
p.(None): (3) Public meeting.--Prior to updating or issuing the
p.(None): guidance required by paragraph (1), the Secretary shall consult
p.(None): with stakeholders, including representatives of regulated
p.(None): industry, academia, patient advocacy organizations, consumer
p.(None): groups, and disease research foundations, through a public
p.(None): meeting to be held not later than 18 months after the date of
p.(None): enactment of this Act.
p.(None): (4) Timing.--The Secretary shall update or issue a draft
p.(None): version of the guidance required by paragraph (1) not later than
p.(None): 18 months after the date of the public meeting required by
p.(None): paragraph (3) and finalize such guidance not later than 1 year
p.(None): after the date on which the public comment period for the draft
p.(None): guidance closes.
p.(None): SEC. 3022. REAL WORLD EVIDENCE.
p.(None):
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
p.(None): inserting after section 505E (21 U.S.C. 355f) the following:
p.(None): ``SEC. 505F. <> UTILIZING REAL WORLD
p.(None): EVIDENCE.
p.(None):
p.(None): ``(a) In General.--The Secretary shall establish a program to
p.(None): evaluate the potential use of real world evidence--
p.(None): ``(1) to help to support the approval of a new indication
p.(None): for a drug approved under section 505(c); and
p.(None): ``(2) to help to support or satisfy postapproval study
p.(None): requirements.
p.(None):
p.(None): ``(b) Real World Evidence Defined.--In this section, the term `real
p.(None): world evidence' means data regarding the usage, or the potential
p.(None): benefits or risks, of a drug derived from sources other than randomized
p.(None): clinical trials.
p.(None): ``(c) Program Framework.--
p.(None): ``(1) In general.--Not later than 2 years after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary shall
p.(None): establish a draft framework for implementation of the program
p.(None): under this section.
p.(None): ``(2) Contents of framework.--The framework shall include
p.(None): information describing--
p.(None): ``(A) the sources of real world evidence, including
p.(None): ongoing safety surveillance, observational studies,
p.(None): registries, claims, and patient-centered outcomes
p.(None): research activities;
p.(None): ``(B) the gaps in data collection activities;
p.(None):
p.(None): [[Page 130 STAT. 1097]]
p.(None):
p.(None): ``(C) the standards and methodologies for collection
p.(None): and analysis of real world evidence; and
p.(None): ``(D) the priority areas, remaining challenges, and
p.(None): potential pilot opportunities that the program
p.(None): established under this section will address.
p.(None): ``(3) Consultation.--
p.(None): ``(A) In general.--In developing the program
p.(None): framework under this subsection, the Secretary shall
p.(None): consult with regulated industry, academia, medical
p.(None): professional organizations, representatives of patient
p.(None): advocacy organizations, consumer organizations, disease
p.(None): research foundations, and other interested parties.
p.(None): ``(B) Process.--The consultation under subparagraph
p.(None): (A) may be carried out through approaches such as--
p.(None): ``(i) a public-private partnership with the
p.(None): entities described in such subparagraph in which
p.(None): the Secretary may participate;
p.(None): ``(ii) a contract, grant, or other
p.(None): arrangement, as the Secretary determines
...
p.(None): (A) FDA human subject regulations.--The term ``FDA
p.(None): Human Subject Regulations'' means the provisions
p.(None):
p.(None): [[Page 130 STAT. 1099]]
p.(None):
p.(None): of parts 50, 56, 312, and 812 of title 21, Code of
p.(None): Federal Regulations (or any successor regulations).
p.(None): (B) HHS human subject regulations.--The term ``HHS
p.(None): Human Subject Regulations'' means the provisions of
p.(None): subpart A of part 46 of title 45, Code of Federal
p.(None): Regulations (or any successor regulations).
p.(None): (C) Vulnerable population rules.--The term
p.(None): ``vulnerable population rules'' means--
p.(None): (i) except in the case of research described
p.(None): in clause (ii), the provisions of subparts B
p.(None): through D of part 46, Code of Federal Regulations
p.(None): (or any successor regulations); and
p.(None): (ii) in the case of research that is subject
p.(None): to FDA Human Subject Regulations, the provisions
p.(None): applicable to vulnerable populations under part 56
p.(None): of title 21, Code of Federal Regulations (or any
p.(None): successor regulations) and subpart D of part 50 of
p.(None): such title 21 (or any successor regulations).
p.(None): (2) Institutional review board defined.--In this section,
p.(None): the term ``institutional review board'' has the meaning that
p.(None): applies to the term ``institutional review board'' under the HHS
p.(None): Human Subject Regulations.
p.(None): SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL
p.(None): INVESTIGATIONS.
p.(None):
p.(None): (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
p.(None): (1) in subparagraph (D), by striking ``except where subject
p.(None): to such conditions as the Secretary may prescribe, the
p.(None): investigator'' and inserting the following: ``except where,
p.(None): subject to such conditions as the Secretary may prescribe--
p.(None): ``(i) the proposed clinical testing poses no more
p.(None): than minimal risk to the human subject and includes
p.(None): appropriate safeguards to protect the rights, safety,
p.(None): and welfare of the human subject; or
p.(None): ``(ii) the investigator''; and
p.(None): (2) in the matter following subparagraph (D), by striking
p.(None): ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
p.(None):
p.(None): (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where
p.(None): it is not feasible or it is contrary to the best interests of such human
p.(None): beings'' and inserting ``except where it is not feasible, it is contrary
p.(None): to the best interests of such human beings, or the proposed clinical
p.(None): testing poses no more than minimal risk to such human beings and
p.(None): includes appropriate safeguards as prescribed to protect the rights,
p.(None): safety, and welfare of such human beings''.
p.(None):
p.(None): Subtitle D--Patient Access to Therapies and Information
p.(None):
p.(None): SEC. 3031. SUMMARY LEVEL REVIEW.
p.(None):
p.(None): (a) FFDCA.--Section 505(c) of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 355(c)) is amended by adding at the end the following:
p.(None): ``(5)(A) The Secretary may rely upon qualified data summaries to
p.(None): support the approval of a supplemental application, with respect
p.(None):
p.(None): [[Page 130 STAT. 1100]]
p.(None):
p.(None): to a qualified indication for a drug, submitted under subsection (b), if
p.(None): such supplemental application complies with subparagraph (B).
p.(None): ``(B) A supplemental application is eligible for review as described
p.(None): in subparagraph (A) only if--
p.(None): ``(i) there is existing data available and acceptable to the
p.(None): Secretary demonstrating the safety of the drug; and
p.(None): ``(ii) all data used to develop the qualified data summaries
p.(None): are submitted to the Secretary as part of the supplemental
p.(None): application.
p.(None):
p.(None): ``(C) The Secretary shall post on the Internet website of the Food
p.(None): and Drug Administration and update annually--
p.(None): ``(i) the number of applications reviewed solely under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act;
p.(None): ``(ii) the average time for completion of review under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act;
p.(None): ``(iii) the average time for review of supplemental
p.(None): applications where the Secretary did not use review flexibility
p.(None): under subparagraph (A) or section 351(a)(2)(E) of the Public
p.(None): Health Service Act; and
p.(None): ``(iv) the number of applications reviewed under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act for which the Secretary made use of full data sets
p.(None): in addition to the qualified data summary.
p.(None):
p.(None): ``(D) In this paragraph--
p.(None): ``(i) the term `qualified indication' means an indication
p.(None): for a drug that the Secretary determines to be appropriate for
p.(None): summary level review under this paragraph; and
p.(None): ``(ii) the term `qualified data summary' means a summary of
p.(None): clinical data that demonstrates the safety and effectiveness of
p.(None): a drug with respect to a qualified indication.''.
p.(None):
p.(None): (b) PHSA.--Section 351(a)(2) of the Public Health Service Act (42
p.(None): U.S.C. 262(a)(2)) is amended by adding at the end the following:
p.(None): ``(E)(i) The Secretary may rely upon qualified data summaries to
p.(None): support the approval of a supplemental application, with respect to a
p.(None): qualified indication for a drug, submitted under this subsection, if
p.(None): such supplemental application complies with the requirements of
p.(None): subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ``(ii) In this subparagraph, the terms `qualified indication' and
p.(None): `qualified data summary' have the meanings given such terms in section
p.(None): 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.''.
p.(None): SEC. 3032. EXPANDED ACCESS POLICY.
p.(None):
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
p.(None): inserting after section 561 (21 U.S.C. 360bbb) the following:
p.(None): ``SEC. 561A. <> EXPANDED ACCESS POLICY
p.(None): REQUIRED FOR INVESTIGATIONAL DRUGS.
p.(None):
p.(None): ``(a) In General.--The manufacturer or distributor of one or more
p.(None): investigational drugs for the diagnosis, monitoring, or treatment of one
p.(None): or more serious diseases or conditions shall make available the policy
p.(None): of the manufacturer or distributor on evaluating and responding to
p.(None): requests submitted under section 561(b) for provision of such a drug.
p.(None):
p.(None): [[Page 130 STAT. 1101]]
p.(None):
p.(None): ``(b) Public Availability of Expanded Access Policy.--The policies
p.(None): under subsection (a) shall be made public and readily available, such as
p.(None): by posting such policies on a publicly available Internet website. Such
p.(None): policies may be generally applicable to all investigational drugs of
p.(None): such manufacturer or distributor.
p.(None): ``(c) Content of Policy.--A policy described in subsection (a) shall
p.(None): include--
p.(None): ``(1) contact information for the manufacturer or
p.(None): distributor to facilitate communication about requests described
p.(None): in subsection (a);
p.(None): ``(2) procedures for making such requests;
p.(None): ``(3) the general criteria the manufacturer or distributor
p.(None): will use to evaluate such requests for individual patients, and
p.(None): for responses to such requests;
p.(None): ``(4) the length of time the manufacturer or distributor
p.(None): anticipates will be necessary to acknowledge receipt of such
p.(None): requests; and
p.(None): ``(5) a hyperlink or other reference to the clinical trial
p.(None): record containing information about the expanded access for such
p.(None): drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of
p.(None): the Public Health Service Act.
p.(None):
p.(None): ``(d) No Guarantee of Access.--The posting of policies by
p.(None): manufacturers and distributors under subsection (a) shall not serve as a
p.(None): guarantee of access to any specific investigational drug by any
p.(None): individual patient.
p.(None): ``(e) Revised Policy.--Nothing in this section shall prevent a
p.(None): manufacturer or distributor from revising a policy required under this
p.(None): section at any time.
p.(None): ``(f) Application.--This section shall apply to a manufacturer or
p.(None): distributor with respect to an investigational drug beginning on the
p.(None): later of--
p.(None): ``(1) the date that is 60 calendar days after the date of
p.(None): enactment of the 21st Century Cures Act; or
p.(None): ``(2) the first initiation of a phase 2 or phase 3 study (as
p.(None): such terms are defined in section 312.21(b) and (c) of title 21,
p.(None): Code of Federal Regulations (or any successor regulations)) with
p.(None): respect to such investigational drug.''.
p.(None): SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
p.(None): THERAPIES.
p.(None):
p.(None): (a) In General.--Section 506 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 356) is amended--
p.(None): (1) by transferring subsection (e) (relating to
p.(None): construction) so that it appears before subsection (f) (relating
p.(None): to awareness efforts); and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(g) Regenerative Advanced Therapy.--
p.(None): ``(1) In general.--The Secretary, at the request of the
p.(None): sponsor of a drug, shall facilitate an efficient development
p.(None): program for, and expedite review of, such drug if the drug
p.(None): qualifies as a regenerative advanced therapy under the criteria
p.(None): described in paragraph (2).
p.(None): ``(2) Criteria.--A drug is eligible for designation as a
p.(None): regenerative advanced therapy under this subsection if--
p.(None): ``(A) the drug is a regenerative medicine therapy
p.(None): (as defined in paragraph (8));
p.(None):
p.(None): [[Page 130 STAT. 1102]]
p.(None):
p.(None): ``(B) the drug is intended to treat, modify,
p.(None): reverse, or cure a serious or life-threatening disease
p.(None): or condition; and
p.(None): ``(C) preliminary clinical evidence indicates that
p.(None): the drug has the potential to address unmet medical
p.(None): needs for such a disease or condition.
p.(None): ``(3) Request for designation.--The sponsor of a drug may
p.(None): request the Secretary to designate the drug as a regenerative
p.(None): advanced therapy concurrently with, or at any time after,
p.(None): submission of an application for the investigation of the drug
p.(None): under section 505(i) of this Act or section 351(a)(3) of the
p.(None): Public Health Service Act.
p.(None): ``(4) Designation.--Not later than 60 calendar days after
p.(None): the receipt of a request under paragraph (3), the Secretary
p.(None): shall determine whether the drug that is the subject of the
p.(None): request meets the criteria described in paragraph (2). If the
p.(None): Secretary determines that the drug meets the criteria, the
p.(None): Secretary shall designate the drug as a regenerative advanced
p.(None): therapy and shall take such actions as are appropriate under
p.(None): paragraph (1). If the Secretary determines that a drug does not
p.(None): meet the criteria for such designation, the Secretary shall
p.(None): include with the determination a written description of the
p.(None): rationale for such determination.
p.(None): ``(5) Actions.--The sponsor of a regenerative advanced
p.(None): therapy shall be eligible for the actions to expedite
p.(None): development and review of such therapy under subsection
p.(None): (a)(3)(B), including early interactions to discuss any potential
p.(None): surrogate or intermediate endpoint to be used to support the
p.(None): accelerated approval of an application for the product under
p.(None): subsection (c).
p.(None): ``(6) Access to expedited approval pathways.--An application
p.(None): for a regenerative advanced therapy under section 505(b)(1) of
p.(None): this Act or section 351(a) of the Public Health Service Act may
p.(None): be--
p.(None): ``(A) eligible for priority review, as described in
p.(None): the Manual of Policies and Procedures of the Food and
p.(None): Drug Administration and goals identified in the letters
p.(None): described in section 101(b) of the Prescription Drug
p.(None): User Fee Amendments of 2012; and
p.(None): ``(B) eligible for accelerated approval under
p.(None): subsection (c), as agreed upon pursuant to subsection
p.(None): (a)(3)(B), through, as appropriate--
p.(None): ``(i) surrogate or intermediate endpoints
p.(None): reasonably likely to predict long-term clinical
p.(None): benefit; or
p.(None): ``(ii) reliance upon data obtained from a
p.(None): meaningful number of sites, including through
p.(None): expansion to additional sites, as appropriate.
p.(None): ``(7) Postapproval requirements.--The sponsor of a
p.(None): regenerative advanced therapy that is granted accelerated
p.(None): approval and is subject to the postapproval requirements under
p.(None): subsection (c) may, as appropriate, fulfill such requirements,
p.(None): as the Secretary may require, through--
p.(None): ``(A) the submission of clinical evidence, clinical
p.(None): studies, patient registries, or other sources of real
p.(None): world evidence, such as electronic health records;
p.(None): ``(B) the collection of larger confirmatory data
p.(None): sets, as agreed upon pursuant to subsection (a)(3)(B);
p.(None): or
p.(None):
p.(None): [[Page 130 STAT. 1103]]
p.(None):
p.(None): ``(C) postapproval monitoring of all patients
p.(None): treated with such therapy prior to approval of the
p.(None): therapy.
p.(None): ``(8) Definition.--For purposes of this section, the term
p.(None): `regenerative medicine therapy' includes cell therapy,
p.(None): therapeutic tissue engineering products, human cell and tissue
p.(None): products, and combination products using any such therapies or
p.(None): products, except for those regulated solely under section 361 of
p.(None): the Public Health Service Act and part 1271 of title 21, Code of
p.(None): Federal Regulations.''.
p.(None):
p.(None): (b) <> Rule of Construction.--Nothing in
p.(None): this section and the amendments made by this section shall be construed
p.(None): to alter the authority of the Secretary of Health and Human Services--
p.(None): (1) to approve drugs pursuant to the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the
p.(None): Public Health Service Act (42 U.S.C. 262) as authorized prior to
p.(None): the date of enactment of the 21st Century Cures Act, including
p.(None): the standards of evidence, and applicable conditions, for
p.(None): approval under such Acts; or
p.(None): (2) to alter the authority of the Secretary to require
p.(None): postapproval studies pursuant to such Acts, as authorized prior
p.(None): to the date of enactment of the 21st Century Cures Act.
p.(None):
p.(None): (c) Conforming Amendment.--Section 506(e)(1) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting
p.(None): ``and the 21st Century Cures Act'' after ``Food and Drug Administration
p.(None): Safety and Innovation Act''.
p.(None): SEC. 3034. <> GUIDANCE REGARDING DEVICES
p.(None): USED IN THE RECOVERY, ISOLATION, OR
p.(None): DELIVERY OF REGENERATIVE ADVANCED
p.(None): THERAPIES.
p.(None):
p.(None): (a) Draft Guidance.--Not later than 1 year after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary of Health and
p.(None): Human Services, acting through the Commissioner of Food and Drugs, shall
p.(None): issue draft guidance clarifying how, in the context of regenerative
p.(None): advanced therapies, the Secretary will evaluate devices used in the
p.(None): recovery, isolation, or delivery of regenerative advanced therapies. In
p.(None): doing so, the Secretary shall specifically address--
p.(None): (1) how the Food and Drug Administration intends to simplify
p.(None): and streamline regulatory requirements for combination device
p.(None): and cell or tissue products;
p.(None): (2) what, if any, intended uses or specific attributes would
p.(None): result in a device used with a regenerative therapy product to
p.(None): be classified as a class III device;
p.(None): (3) when the Food and Drug Administration considers it is
p.(None): necessary, if ever, for the intended use of a device to be
p.(None): limited to a specific intended use with only one particular type
p.(None): of cell; and
p.(None): (4) application of the least burdensome approach to
p.(None): demonstrate how a device may be used with more than one cell
p.(None): type.
p.(None):
p.(None): (b) Final Guidance.--Not later than 12 months after the close of the
p.(None): period for public comment on the draft guidance under subsection (a),
p.(None): the Secretary of Health and Human Services shall finalize such guidance.
p.(None): SEC. 3035. <> REPORT ON REGENERATIVE
p.(None): ADVANCED THERAPIES.
p.(None): (a) Report to Congress.--Before March 1 of each calendar year, the
p.(None): Secretary of Health and Human Services shall, with
p.(None):
p.(None): [[Page 130 STAT. 1104]]
p.(None):
p.(None): respect to the previous calendar year, submit a report to the Committee
p.(None): on Health, Education, Labor, and Pensions of the Senate and the
p.(None): Committee on Energy and Commerce of the House of Representatives on--
p.(None): (1) the number and type of applications for approval of
p.(None): regenerative advanced therapies filed, approved or licensed as
p.(None): applicable, withdrawn, or denied; and
p.(None): (2) how many of such applications or therapies, as
p.(None): applicable, were granted accelerated approval or priority
p.(None): review.
p.(None):
p.(None): (b) Regenerative Advanced Therapy.--In this section, the term
p.(None): ``regenerative advanced therapy'' has the meaning given such term in
p.(None): section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by
p.(None): section 3033 of this Act.
p.(None): SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE
p.(None): ADVANCED THERAPIES.
p.(None):
p.(None): Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F
p.(None): the following:
p.(None): ``SEC. 506G. <> STANDARDS FOR REGENERATIVE
p.(None): MEDICINE AND REGENERATIVE ADVANCED
p.(None): THERAPIES.
p.(None):
p.(None): ``(a) In General.--Not later than 2 years after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary, in consultation
p.(None): with the National Institute of Standards and Technology and stakeholders
p.(None): (including regenerative medicine and advanced therapies manufacturers
p.(None): and clinical trial sponsors, contract manufacturers, academic
p.(None): institutions, practicing clinicians, regenerative medicine and advanced
p.(None): therapies industry organizations, and standard setting organizations),
p.(None): shall facilitate an effort to coordinate and prioritize the development
p.(None): of standards and consensus definition of terms, through a public
p.(None): process, to support, through regulatory predictability, the development,
p.(None): evaluation, and review of regenerative medicine therapies and
p.(None): regenerative advanced therapies, including with respect to the
p.(None): manufacturing processes and controls of such products.
p.(None): ``(b) Activities.--
p.(None): ``(1) In general.--In carrying out this section, the
p.(None): Secretary shall continue to--
p.(None): ``(A) identity opportunities to help advance the
p.(None): development of regenerative medicine therapies and
p.(None): regenerative advanced therapies;
p.(None): ``(B) identify opportunities for the development of
p.(None): laboratory regulatory science research and documentary
p.(None): standards that the Secretary determines would help
p.(None): support the development, evaluation, and review of
p.(None): regenerative medicine therapies and regenerative
p.(None): advanced therapies through regulatory predictability;
p.(None): and
p.(None): ``(C) work with stakeholders, such as those
p.(None): described in subsection (a), as appropriate, in the
p.(None): development of such standards.
p.(None): ``(2) Regulations and guidance.--Not later than 1 year after
p.(None): the development of standards as described in subsection (a), the
p.(None): Secretary shall review relevant regulations and guidance and,
p.(None): through a public process, update such regulations and guidance
p.(None): as the Secretary determines appropriate.
p.(None):
p.(None): [[Page 130 STAT. 1105]]
p.(None):
p.(None): ``(c) Definitions.--For purposes of this section, the terms
p.(None): `regenerative medicine therapy' and `regenerative advanced therapy' have
p.(None): the meanings given such terms in section 506(g).''.
p.(None): SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.
p.(None):
p.(None): Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 352(a)) is amended--
p.(None): (1) by striking ``(a) If its'' and inserting ``(a)(1) If
p.(None): its'';
p.(None): (2) by striking ``a formulary committee, or other similar
p.(None): entity, in the course of the committee or the entity carrying
p.(None): out its responsibilities for the selection of drugs for managed
p.(None): care or other similar organizations'' and inserting ``a payor,
p.(None): formulary committee, or other similar entity with knowledge and
p.(None): expertise in the area of health care economic analysis, carrying
p.(None): out its responsibilities for the selection of drugs for coverage
p.(None): or reimbursement'';
p.(None): (3) by striking ``directly relates'' and inserting
p.(None): ``relates'';
p.(None): (4) by striking ``and is based on competent and reliable
p.(None): scientific evidence. The requirements set forth in section
p.(None): 505(a) or in section 351(a) of the Public Health Service Act
p.(None): shall not apply to health care economic information provided to
p.(None): such a committee or entity in accordance with this paragraph''
p.(None): and inserting ``, is based on competent and reliable scientific
p.(None): evidence, and includes, where applicable, a conspicuous and
p.(None): prominent statement describing any material differences between
p.(None): the health care economic information and the labeling approved
p.(None): for the drug under section 505 or under section 351 of the
p.(None): Public Health Service Act. The requirements set forth in section
p.(None): 505(a) or in subsections (a) and (k) of section 351 of the
p.(None): Public Health Service Act shall not apply to health care
p.(None): economic information provided to such a payor, committee, or
p.(None): entity in accordance with this paragraph''; and
p.(None): (5) by striking ``In this paragraph, the term'' and all that
p.(None): follows and inserting the following:
p.(None):
p.(None): ``(2)(A) For purposes of this paragraph, the term `health care
p.(None): economic information' means any analysis (including the clinical data,
p.(None): inputs, clinical or other assumptions, methods, results, and other
p.(None): components underlying or comprising the analysis) that identifies,
p.(None): measures, or describes the economic consequences, which may be based on
p.(None): the separate or aggregated clinical consequences of the represented
p.(None): health outcomes, of the use of a drug. Such analysis may be comparative
p.(None): to the use of another drug, to another health care intervention, or to
p.(None): no intervention.
p.(None): ``(B) Such term does not include any analysis that relates only to
p.(None): an indication that is not approved under section 505 or under section
p.(None): 351 of the Public Health Service Act for such drug.''.
p.(None): SEC. 3038. COMBINATION PRODUCT INNOVATION.
p.(None):
p.(None): (a) In General.--Section 503(g) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 353(g)) is amended--
p.(None): (1) by striking paragraph (3);
p.(None): (2) by redesignating paragraph (2) as paragraph (7);
p.(None): (3) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (8) and (9), respectively;
p.(None): (4) by striking ``(g)(1)'' and all that follows through the
p.(None): end of paragraph (1) and inserting the following:
p.(None):
p.(None): [[Page 130 STAT. 1106]]
p.(None):
p.(None): ``(g)(1)(A) The Secretary shall, in accordance with this subsection,
p.(None): assign a primary agency center to regulate products that constitute a
p.(None): combination of a drug, device, or biological product.
p.(None): ``(B) The Secretary shall conduct the premarket review of any
p.(None): combination product under a single application, whenever appropriate.
p.(None): ``(C) For purposes of this subsection, the term `primary mode of
p.(None): action' means the single mode of action of a combination product
p.(None): expected to make the greatest contribution to the overall intended
p.(None): therapeutic effects of the combination product.
p.(None): ``(D) The Secretary shall determine the primary mode of action of
p.(None): the combination product. If the Secretary determines that the primary
p.(None): mode of action is that of--
p.(None): ``(i) a drug (other than a biological product), the agency
p.(None): center charged with premarket review of drugs shall have primary
p.(None): jurisdiction;
p.(None): ``(ii) a device, the agency center charged with premarket
p.(None): review of devices shall have primary jurisdiction; or
p.(None): ``(iii) a biological product, the agency center charged with
p.(None): premarket review of biological products shall have primary
p.(None): jurisdiction.
p.(None):
p.(None): ``(E) In determining the primary mode of action of a combination
p.(None): product, the Secretary shall not determine that the primary mode of
p.(None): action is that of a drug or biological product solely because the
p.(None): combination product has any chemical action within or on the human body.
p.(None): ``(F) If a sponsor of a combination product disagrees with the
p.(None): determination under subparagraph (D)--
p.(None): ``(i) such sponsor may request, and the Secretary shall
p.(None): provide, a substantive rationale to such sponsor that references
p.(None): scientific evidence provided by the sponsor and any other
p.(None): scientific evidence relied upon by the Secretary to support such
p.(None): determination; and
p.(None): ``(ii)(I) the sponsor of the combination product may propose
p.(None): one or more studies (which may be nonclinical, clinical, or
p.(None): both) to establish the relevance, if any, of the chemical action
p.(None): in achieving the primary mode of action of such product;
p.(None): ``(II) if the sponsor proposes any such studies, the
p.(None): Secretary and the sponsor of such product shall collaborate and
p.(None): seek to reach agreement, within a reasonable time of such
p.(None): proposal, not to exceed 90 calendar days, on the design of such
p.(None): studies; and
p.(None): ``(III) if an agreement is reached under subclause (II) and
p.(None): the sponsor conducts one or more of such studies, the Secretary
p.(None): shall consider the data resulting from any such study when
p.(None): reevaluating the determination of the primary mode of action of
p.(None): such product, and unless and until such reevaluation has
p.(None): occurred and the Secretary issues a new determination, the
p.(None): determination of the Secretary under subparagraph (D) shall
p.(None): remain in effect.
p.(None):
p.(None): ``(2)(A)(i) To establish clarity and certainty for the sponsor, the
p.(None): sponsor of a combination product may request a meeting on such
p.(None): combination product. If the Secretary concludes that a determination of
...
p.(None): ``(iv) Any such agreement shall remain in effect, except--
p.(None): ``(I) upon the written agreement of the Secretary and the
p.(None): sponsor or applicant; or
p.(None): ``(II) pursuant to a decision by the director of the
p.(None): reviewing division of the primary agency center, or a person
p.(None): more senior than such director, in consultation with consulting
p.(None): centers and the Office, as appropriate, that an issue essential
p.(None): to determining whether the standard for market clearance or
p.(None): other applicable standard under this Act or the Public Health
p.(None): Service Act applicable to the combination product has been
p.(None): identified since the agreement was reached, or that deviating
p.(None): from the agreement is otherwise justifiable based on scientific
p.(None): evidence, for public health reasons.
p.(None):
p.(None): ``(3) For purposes of conducting the premarket review of a
p.(None): combination product that contains an approved constituent part described
p.(None): in paragraph (4), the Secretary may require that the sponsor of such
p.(None): combination product submit to the Secretary only data or information
p.(None): that the Secretary determines is necessary to meet the standard for
p.(None): clearance or approval, as applicable, under this Act or the Public
p.(None): Health Service Act, including any incremental risks and benefits posed
p.(None): by such combination product, using a risk-based approach and taking into
p.(None): account any prior finding of safety and effectiveness or substantial
p.(None): equivalence for the approved constituent part relied upon by the
p.(None): applicant in accordance with paragraph (5).
p.(None): ``(4) For purposes of paragraph (3), an approved constituent part
p.(None): is--
p.(None): ``(A) a drug constituent part of a combination product being
p.(None): reviewed in a single application or request under section 515,
p.(None): 510(k), or 513(f)(2) (submitted in accordance with paragraph
p.(None): (5)), that is an approved drug, provided such application or
p.(None): request complies with paragraph (5);
p.(None): ``(B) a device constituent part approved under section 515
p.(None): that is referenced by the sponsor and that is available for use
p.(None): by the Secretary under section 520(h)(4); or
p.(None): ``(C) any constituent part that was previously approved,
p.(None): cleared, or classified under section 505, 510(k), 513(f)(2), or
p.(None): 515 of this Act for which the sponsor has a right of reference
p.(None): or any constituent part that is a nonprescription drug, as
p.(None): defined in section 760(a)(2).
p.(None):
p.(None): [[Page 130 STAT. 1108]]
p.(None):
p.(None): ``(5)(A) If an application is submitted under section 515 or 510(k)
p.(None): or a request is submitted under section 513(f)(2), consistent with any
p.(None): determination made under paragraph (1)(D), for a combination product
p.(None): containing as a constituent part an approved drug--
p.(None): ``(i) the application or request shall include the
p.(None): certification or statement described in section 505(b)(2); and
p.(None): ``(ii) the applicant or requester shall provide notice as
p.(None): described in section 505(b)(3).
p.(None):
p.(None): ``(B) For purposes of this paragraph and paragraph (4), the term
p.(None): `approved drug' means an active ingredient--
p.(None): ``(i) that was in an application previously approved under
p.(None): section 505(c);
p.(None): ``(ii) where such application is relied upon by the
p.(None): applicant submitting the application or request described in
p.(None): subparagraph (A);
p.(None): ``(iii) for which full reports of investigations that have
p.(None): been made to show whether such drug is safe for use and whether
p.(None): such drug is effective in use were not conducted by or for the
p.(None): applicant submitting the application or request described in
p.(None): subparagraph (A); and
p.(None): ``(iv) for which the applicant submitting the application or
p.(None): request described in subparagraph (A) has not obtained a right
p.(None): of reference or use from the person by or for whom the
p.(None): investigations described in clause (iii) were conducted.
p.(None):
p.(None): ``(C) The following provisions shall apply with respect to an
p.(None): application or request described in subparagraph (A) to the same extent
p.(None): and in the same manner as if such application or request were an
p.(None): application described in section 505(b)(2) that referenced the approved
p.(None): drug:
p.(None): ``(i) Subparagraphs (A), (B), (C), and (D) of section
p.(None): 505(c)(3).
p.(None): ``(ii) Clauses (ii), (iii), and (iv) of section
p.(None): 505(c)(3)(E).
p.(None): ``(iii) Subsections (b) and (c) of section 505A.
p.(None): ``(iv) Section 505E(a).
p.(None): ``(v) Section 527(a).
p.(None):
p.(None): ``(D) Notwithstanding any other provision of this subsection, an
p.(None): application or request for classification for a combination product
p.(None): described in subparagraph (A) shall be considered an application
p.(None): submitted under section 505(b)(2) for purposes of section 271(e)(2)(A)
p.(None): of title 35, United States Code.
p.(None): ``(6) Nothing in this subsection shall be construed as prohibiting a
p.(None): sponsor from submitting separate applications for the constituent parts
p.(None): of a combination product, unless the Secretary determines that a single
p.(None): application is necessary.'';
p.(None): (5) in paragraph (8) (as redesignated by paragraph (3))--
p.(None): (A) in subparagraph (C)--
p.(None): (i) by amending clause (i) to read as follows:
p.(None):
p.(None): ``(i) In carrying out this subsection, the Office shall help to
p.(None): ensure timely and effective premarket review that involves more than one
p.(None): agency center by coordinating such reviews, overseeing the timeliness of
p.(None): such reviews, and overseeing the alignment of feedback regarding such
p.(None): reviews.'';
p.(None): (ii) in clause (ii), by inserting ``and
p.(None): alignment'' after ``the timeliness'' each place it
p.(None): appears; and
p.(None): (iii) by adding at the end the following new
p.(None): clauses:
p.(None):
p.(None): ``(iii) The Office shall ensure that, with respect to a combination
p.(None): product, a designated person or persons in the primary agency
p.(None):
p.(None): [[Page 130 STAT. 1109]]
...
p.(None): involved in the review, as appropriate;
p.(None): ``(II) ensure that each consulting agency center has
p.(None): completed its premarket review and provided the results of such
p.(None): review to the primary agency center in a timely manner; and
p.(None): ``(III) ensure that each consulting center follows the
p.(None): guidance described in clause (vi) and advises, as appropriate,
p.(None): on other relevant regulations, guidances, and policies.
p.(None):
p.(None): ``(v) In seeking agency action with respect to a combination
p.(None): product, the sponsor of such product--
p.(None): ``(I) shall identify the product as a combination product;
p.(None): and
p.(None): ``(II) may request in writing the participation of
p.(None): representatives of the Office in meetings related to such
p.(None): combination product, or to have the Office otherwise engage on
p.(None): such regulatory matters concerning the combination product.
p.(None):
p.(None): ``(vi) Not later than 4 years after the date of enactment of the
p.(None): 21st Century Cures Act, and after a public comment period of not less
p.(None): than 60 calendar days, the Secretary shall issue a final guidance that
p.(None): describes--
p.(None): ``(I) the structured process for managing pre-submission
p.(None): interactions with sponsors developing combination products;
p.(None): ``(II) the best practices for ensuring that the feedback in
p.(None): such pre-submission interactions represents the Agency's best
p.(None): advice based on the information provided during such pre-
p.(None): submission interactions;
p.(None): ``(III) the information that is required to be submitted
p.(None): with a meeting request under paragraph (2), how such meetings
p.(None): relate to other types of meetings in the Food and Drug
p.(None): Administration, and the form and content of any agreement
p.(None): reached through a meeting under such paragraph (2);''; and
p.(None): (B) in subparagraph (G)--
p.(None): (i) in the matter preceding clause (i), by
p.(None): inserting ``(except with respect to clause (iv),
p.(None): beginning not later than one year after the date
p.(None): of the enactment of the 21st Century Cures Act)''
p.(None): after ``enactment of this paragraph'';
p.(None): (ii) in clause (ii), by striking ``and'' at
p.(None): the end;
p.(None): (iii) in clause (iii), by striking the period
p.(None): at the end and inserting ``; and''; and
p.(None): (iv) by adding at the end the following new
p.(None): clause:
p.(None): ``(iv) identifying the percentage of combination products
p.(None): for which a dispute resolution, with respect to premarket
p.(None): review, was requested by the combination product's sponsor.'';
p.(None): and
p.(None):
p.(None): [[Page 130 STAT. 1110]]
p.(None):
p.(None): (6) in paragraph (9) (as redesignated by paragraph (3))--
p.(None): (A) in subparagraph (C)--
p.(None): (i) in clause (i), by striking the comma at
p.(None): the end and inserting a semicolon;
p.(None): (ii) in clause (ii), by striking ``, and'' at
p.(None): the end and inserting a semicolon;
p.(None): (iii) in clause (iii), by striking the period
p.(None): at the end and inserting ``; and''; and
p.(None): (iv) by adding at the end the following:
p.(None): ``(iv) de novo classification under section
p.(None): 513(a)(1).''; and
p.(None): (B) by adding at the end the following:
p.(None): ``(D) The terms `premarket review' and `reviews' include all
p.(None): activities of the Food and Drug Administration conducted prior
p.(None): to approval or clearance of an application, notification, or
p.(None): request for classification submitted under section 505, 510(k),
p.(None): 513(f)(2), 515, or 520 of this Act or under section 351 of the
p.(None): Public Health Service Act, including with respect to
p.(None): investigational use of the product.''.
p.(None):
p.(None): (b) Information for Approval of Combination Products.--Section
p.(None): 520(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360j(h)(4)) is amended--
p.(None): (1) in subparagraph (A), by striking ``Any information'' and
p.(None): inserting ``Subject to subparagraph (C), any information''; and
p.(None): (2) by adding at the end the following new subparagraph:
p.(None):
p.(None): ``(C) No information contained in an application for premarket
p.(None): approval filed with the Secretary pursuant to section 515(c) may be used
p.(None): to approve or clear any application submitted under section 515 or
p.(None): 510(k) or to classify a product under section 513(f)(2) for a
p.(None): combination product containing as a constituent part an approved drug
p.(None): (as defined in section 503(g)(5)(B)) unless--
p.(None): ``(i) the application includes the certification or
p.(None): statement referenced in section 503(g)(5)(A);
p.(None): ``(ii) the applicant provides notice as described in section
p.(None): 503(g)(5)(A); and
p.(None): ``(iii) the Secretary's approval of such application is
p.(None): subject to the provisions in section 503(g)(5)(C).''.
p.(None):
p.(None): (c) <> Variations From CGMP Streamlined
p.(None): Approach.--Not later than 18 months after the date of enactment of this
p.(None): Act, the Secretary of Health and Human Services (referred to in this
p.(None): subsection as the ``Secretary'') shall identify types of combination
p.(None): products and manufacturing processes with respect to which the Secretary
p.(None): proposes that good manufacturing processes may be adopted that vary from
p.(None): the requirements set forth in section 4.4 of title 21, Code of Federal
p.(None): Regulations (or any successor regulations) or that the Secretary
p.(None): proposes can satisfy the requirements in section 4.4 through alternative
p.(None): or streamlined mechanisms. The Secretary shall identify such types,
p.(None): variations from such requirements, and such mechanisms, in a proposed
p.(None): list published in the Federal Register. After a public comment period
p.(None): regarding the appropriate good manufacturing practices for such types,
p.(None): the Secretary shall publish a final list in the Federal Register,
p.(None): notwithstanding section 553 of title 5, United States Code. The
p.(None): Secretary shall evaluate such types, variations, and mechanisms using a
p.(None): risk-based approach. The Secretary shall periodically review such final
p.(None): list.
p.(None):
p.(None): [[Page 130 STAT. 1111]]
p.(None):
p.(None): Subtitle E--Antimicrobial Innovation and Stewardship
p.(None): SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.
p.(None):
p.(None): (a) In General.--Section 319E of the Public Health Service Act (42
p.(None): U.S.C. 247d-5) is amended--
p.(None): (1) by redesignating subsections (f) and (g) as subsections
p.(None): (l) and (m), respectively; and
p.(None): (2) by inserting after subsection (e), the following:
p.(None):
p.(None): ``(f) Monitoring at Federal Health Care Facilities.--The Secretary
p.(None): shall encourage reporting on aggregate antimicrobial drug use and
p.(None): antimicrobial resistance to antimicrobial drugs and the implementation
p.(None): of antimicrobial stewardship programs by health care facilities of the
p.(None): Department of Defense, the Department of Veterans Affairs, and the
p.(None): Indian Health Service and shall provide technical assistance to the
p.(None): Secretary of Defense and the Secretary of Veterans Affairs, as
p.(None): appropriate and upon request.
p.(None): ``(g) Report on Antimicrobial Resistance in Humans and Use of
p.(None): Antimicrobial Drugs.--Not later than 1 year after the date of enactment
p.(None): of the 21st Century Cures Act, and annually thereafter, the Secretary
p.(None): shall prepare and make publicly available data and information
p.(None): concerning--
p.(None): ``(1) aggregate national and regional trends of
p.(None): antimicrobial resistance in humans to antimicrobial drugs,
p.(None): including such drugs approved under section 506(h) of the
p.(None): Federal Food, Drug, and Cosmetic Act;
p.(None): ``(2) antimicrobial stewardship, which may include summaries
p.(None): of State efforts to address antimicrobial resistance in humans
p.(None): to antimicrobial drugs and antimicrobial stewardship; and
p.(None): ``(3) coordination between the Director of the Centers for
p.(None): Disease Control and Prevention and the Commissioner of Food and
p.(None): Drugs with respect to the monitoring of--
p.(None): ``(A) any applicable resistance under paragraph (1);
p.(None): and
p.(None): ``(B) drugs approved under section 506(h) of the
p.(None): Federal Food, Drug, and Cosmetic Act.
p.(None):
p.(None): ``(h) Information Related to Antimicrobial Stewardship Programs.--
p.(None): The Secretary shall, as appropriate, disseminate guidance, educational
p.(None): materials, or other appropriate materials related to the development and
p.(None): implementation of evidence-based antimicrobial stewardship programs or
p.(None): practices at health care facilities, such as nursing homes and other
p.(None): long-term care facilities, ambulatory surgical centers, dialysis
p.(None): centers, outpatient clinics, and hospitals, including community and
p.(None): rural hospitals.
p.(None): ``(i) Supporting State-Based Activities To Combat Antimicrobial
p.(None): Resistance.--The Secretary shall continue to work with State and local
p.(None): public health departments on statewide or regional programs related to
p.(None): antimicrobial resistance. Such efforts may include activities to related
p.(None): to--
p.(None): ``(1) identifying patterns of bacterial and fungal
p.(None): resistance in humans to antimicrobial drugs;
p.(None): ``(2) preventing the spread of bacterial and fungal
p.(None): infections that are resistant to antimicrobial drugs; and
p.(None): ``(3) promoting antimicrobial stewardship.
p.(None):
p.(None): [[Page 130 STAT. 1112]]
p.(None):
p.(None): ``(j) Antimicrobial Resistance and Stewardship Activities.--
p.(None): ``(1) In general.--For the purposes of supporting
p.(None): stewardship activities, examining changes in antimicrobial
p.(None): resistance, and evaluating the effectiveness of section 506(h)
p.(None): of the Federal Food, Drug, and Cosmetic Act, the Secretary
p.(None): shall--
p.(None): ``(A) provide a mechanism for facilities to report
p.(None): data related to their antimicrobial stewardship
p.(None): activities (including analyzing the outcomes of such
p.(None): activities); and
p.(None): ``(B) evaluate--
p.(None): ``(i) antimicrobial resistance data using a
p.(None): standardized approach; and
p.(None): ``(ii) trends in the utilization of drugs
p.(None): approved under such section 506(h) with respect to
p.(None): patient populations.
p.(None): ``(2) Use of systems.--The Secretary shall use available
p.(None): systems, including the National Healthcare Safety Network or
p.(None): other systems identified by the Secretary, to fulfill the
p.(None): requirements or conduct activities under this section.
p.(None):
p.(None): ``(k) Antimicrobial.--For purposes of subsections (f) through (j),
p.(None): the term `antimicrobial' includes any antibacterial or antifungal drugs,
p.(None): and may include drugs that eliminate or inhibit the growth of other
p.(None): microorganisms, as appropriate.''.
p.(None): (b) <> Availability of Data.--The
p.(None): Secretary shall make the data collected pursuant to this subsection
p.(None): public. Nothing in this subsection shall be construed as authorizing the
p.(None): Secretary to disclose any information that is a trade secret or
p.(None): confidential information subject to section 552(b)(4) of title 5, United
p.(None): States Code, or section 1905 of title 18, United States Code.
p.(None): SEC. 3042. LIMITED POPULATION PATHWAY.
p.(None):
p.(None): Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 356), as amended by section 3033, is further amended by adding at the
p.(None): end the following:
p.(None): ``(h) Limited Population Pathway for Antibacterial and Antifungal
p.(None): Drugs.--
p.(None): ``(1) In general.--The Secretary may approve an
p.(None): antibacterial or antifungal drug, alone or in combination with
p.(None): one or more other drugs, as a limited population drug pursuant
p.(None): to this subsection only if--
p.(None): ``(A) the drug is intended to treat a serious or
p.(None): life-threatening infection in a limited population of
p.(None): patients with unmet needs;
p.(None): ``(B) the standards for approval under section
p.(None): 505(c) and (d), or the standards for licensure under
p.(None): section 351 of the Public Health Service Act, as
p.(None): applicable, are met; and
p.(None): ``(C) the Secretary receives a written request from
p.(None): the sponsor to approve the drug as a limited population
p.(None): drug pursuant to this subsection.
p.(None): ``(2) Benefit-risk consideration.--The Secretary's
p.(None): determination of safety and effectiveness of an antibacterial or
p.(None): antifungal drug shall reflect the benefit-risk profile of such
p.(None): drug in the intended limited population, taking into account the
p.(None): severity, rarity, or prevalence of the infection the drug is
p.(None): intended to treat and the availability or lack of alternative
p.(None): treatment in such limited population. Such drug may be
p.(None):
p.(None): [[Page 130 STAT. 1113]]
p.(None):
p.(None): approved under this subsection notwithstanding a lack of
p.(None): evidence to fully establish a favorable benefit-risk profile in
p.(None): a population that is broader than the intended limited
p.(None): population.
p.(None): ``(3) Additional requirements.--A drug approved under this
p.(None): subsection shall be subject to the following requirements, in
p.(None): addition to any other applicable requirements of this Act:
p.(None): ``(A) Labeling.--To indicate that the safety and
p.(None): effectiveness of a drug approved under this subsection
p.(None): has been demonstrated only with respect to a limited
p.(None): population--
p.(None): ``(i) all labeling and advertising of an
p.(None): antibacterial or antifungal drug approved under
p.(None): this subsection shall contain the statement
p.(None): `Limited Population' in a prominent manner and
p.(None): adjacent to, and not more prominent than--
p.(None): ``(I) the proprietary name of such
p.(None): drug, if any; or
p.(None): ``(II) if there is no proprietary
p.(None): name, the established name of the drug,
p.(None): if any, as defined in section 503(e)(3),
p.(None): or, in the case of a drug that is a
p.(None): biological product, the proper name, as
p.(None): defined by regulation; and
p.(None): ``(ii) the prescribing information for the
p.(None): drug required by section 201.57 of title 21, Code
p.(None): of Federal Regulations (or any successor
p.(None): regulation) shall also include the following
p.(None): statement: `This drug is indicated for use in a
p.(None): limited and specific population of patients.'.
p.(None): ``(B) Promotional material.--The sponsor of an
p.(None): antibacterial or antifungal drug subject to this
p.(None): subsection shall submit to the Secretary copies of all
p.(None): promotional materials related to such drug at least 30
p.(None): calendar days prior to dissemination of the materials.
p.(None): ``(4) Other programs.--A sponsor of a drug that seeks
p.(None): approval of a drug under this subsection may also seek
p.(None): designation or approval, as applicable, of such drug under other
p.(None): applicable sections or subsections of this Act or the Public
p.(None): Health Service Act.
p.(None): ``(5) Guidance.--Not later than 18 months after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary shall
p.(None): issue draft guidance describing criteria, processes, and other
p.(None): general considerations for demonstrating the safety and
p.(None): effectiveness of limited population antibacterial and antifungal
p.(None): drugs. The Secretary shall publish final guidance within 18
p.(None): months of the close of the public comment period on such draft
p.(None): guidance. The Secretary may approve antibacterial and antifungal
p.(None): drugs under this subsection prior to issuing guidance under this
p.(None): paragraph.
p.(None): ``(6) Advice.--The Secretary shall provide prompt advice to
p.(None): the sponsor of a drug for which the sponsor seeks approval under
p.(None): this subsection to enable the sponsor to plan a development
p.(None): program to obtain the necessary data for such approval, and to
p.(None): conduct any additional studies that would be required to gain
p.(None): approval of such drug for use in a broader population.
p.(None): ``(7) Termination of limitations.--If, after approval of a
p.(None): drug under this subsection, the Secretary approves a broader
p.(None): indication for such drug under section 505(b) or section 351(a)
p.(None): of the Public Health Service Act, the Secretary may remove
p.(None):
p.(None): [[Page 130 STAT. 1114]]
p.(None):
p.(None): any postmarketing conditions, including requirements with
p.(None): respect to labeling and review of promotional materials under
p.(None): paragraph (3), applicable to the approval of the drug under this
p.(None): subsection.
p.(None): ``(8) Rules of construction.--Nothing in this subsection
p.(None): shall be construed to alter the authority of the Secretary to
p.(None): approve drugs pursuant to this Act or section 351 of the Public
p.(None): Health Service Act, including the standards of evidence and
p.(None): applicable conditions for approval under such Acts, the
p.(None): standards of approval of a drug under such Acts, or to alter the
p.(None): authority of the Secretary to monitor drugs pursuant to such
p.(None): Acts.
p.(None): ``(9) Reporting and accountability.--
p.(None): ``(A) Biennial reporting.--The Secretary shall
p.(None): report to Congress not less often than once every 2
p.(None): years on the number of requests for approval, and the
p.(None): number of approvals, of an antibacterial or antifungal
p.(None): drug under this subsection.
p.(None): ``(B) GAO report.--Not later than December 2021, the
p.(None): Comptroller General of the United States shall submit to
p.(None): the Committee on Energy and Commerce of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor and Pensions of the Senate a report on the
p.(None): coordination of activities required under section 319E
p.(None): of the Public Health Service Act. Such report shall
p.(None): include a review of such activities, and the extent to
p.(None): which the use of the pathway established under this
p.(None): subsection has streamlined premarket approval for
p.(None): antibacterial or antifungal drugs for limited
p.(None): populations, if such pathway has functioned as intended,
p.(None): if such pathway has helped provide for safe and
p.(None): effective treatment for patients, if such premarket
p.(None): approval would be appropriate for other categories of
p.(None): drugs, and if the authorities under this subsection have
p.(None): affected antibacterial or antifungal resistance.''.
p.(None): SEC. 3043. <> PRESCRIBING AUTHORITY.
p.(None):
p.(None): Nothing in this subtitle, or an amendment made by this subtitle,
p.(None): shall be construed to restrict the prescribing of antimicrobial drugs or
p.(None): other products, including drugs approved under subsection (h) of section
p.(None): 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as
p.(None): added by section 3042), by health care professionals, or to limit the
p.(None): practice of health care.
p.(None): SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
p.(None): MICROORGANISMS; ANTIMICROBIAL
p.(None): SUSCEPTIBILITY TESTING DEVICES.
p.(None):
p.(None): (a) In General.--Subchapter A of chapter V of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
p.(None): after section 511 the following:
p.(None): ``SEC. 511A. <> SUSCEPTIBILITY TEST
p.(None): INTERPRETIVE CRITERIA FOR
p.(None): MICROORGANISMS.
p.(None):
p.(None): ``(a) Purpose; Identification of Criteria.--
p.(None): ``(1) Purpose.--The purpose of this section is to clarify
p.(None): the Secretary's authority to--
p.(None): ``(A) efficiently update susceptibility test
p.(None): interpretive criteria for antimicrobial drugs when
p.(None): necessary for public
p.(None):
p.(None): [[Page 130 STAT. 1115]]
p.(None):
p.(None): health, due to, among other things, the constant
p.(None): evolution of microorganisms that leads to the
p.(None): development of resistance to drugs that have been
p.(None): effective in decreasing morbidity and mortality for
p.(None): patients, which warrants unique management of
p.(None): antimicrobial drugs that is inappropriate for most other
p.(None): drugs in order to delay or prevent the development of
p.(None): further resistance to existing therapies;
p.(None): ``(B) provide for public notice of the availability
p.(None): of recognized interpretive criteria and interpretive
p.(None): criteria standards; and
p.(None): ``(C) clear under section 510(k), classify under
p.(None): section 513(f)(2), or approve under section 515,
p.(None): antimicrobial susceptibility testing devices utilizing
p.(None): updated, recognized susceptibility test interpretive
p.(None): criteria to characterize the in vitro susceptibility of
p.(None): particular bacteria, fungi, or other microorganisms, as
p.(None): applicable, to antimicrobial drugs.
p.(None): ``(2) Identification of criteria.--The Secretary shall
p.(None): identify appropriate susceptibility test interpretive criteria
p.(None): with respect to antimicrobial drugs--
p.(None): ``(A) if such criteria are available on the date of
p.(None): approval of the drug under section 505 of this Act or
p.(None): licensure of the drug under section 351 of the Public
p.(None): Health Service Act (as applicable), upon such approval
p.(None): or licensure; or
p.(None): ``(B) if such criteria are unavailable on such date,
p.(None): on the date on which such criteria are available for
p.(None): such drug.
p.(None): ``(3) Bases for initial identification.--The Secretary shall
p.(None): identify appropriate susceptibility test interpretive criteria
p.(None): under paragraph (2), based on the Secretary's review of, to the
p.(None): extent available and relevant--
p.(None): ``(A) preclinical and clinical data, including
p.(None): pharmacokinetic, pharmacodynamic, and epidemiological
p.(None): data;
p.(None): ``(B) the relationship of susceptibility test
p.(None): interpretive criteria to morbidity and mortality
p.(None): associated with the disease or condition for which such
p.(None): drug is used; and
p.(None): ``(C) such other evidence and information as the
p.(None): Secretary considers appropriate.
p.(None):
p.(None): ``(b) Susceptibility Test Interpretive Criteria Website.--
p.(None): ``(1) In general.--Not later than 1 year after the date of
p.(None): the enactment of the 21st Century Cures Act, the Secretary shall
p.(None): establish, and maintain thereafter, on the website of the Food
p.(None): and Drug Administration, a dedicated website that contains a
p.(None): list of any appropriate new or updated susceptibility test
p.(None): interpretive criteria standards and interpretive criteria in
p.(None): accordance with paragraph (2) (referred to in this section as
p.(None): the `Interpretive Criteria Website').
p.(None): ``(2) Listing of susceptibility test interpretive criteria
p.(None): standards and interpretive criteria.--
p.(None): ``(A) In general.--The list described in paragraph
p.(None): (1) shall consist of any new or updated susceptibility
p.(None): test interpretive criteria standards that are--
p.(None): ``(i) established by a nationally or
p.(None): internationally recognized standard development
p.(None): organization that--
p.(None): ``(I) establishes and maintains
p.(None): procedures to address potential
p.(None): conflicts of interest and ensure
p.(None): transparent decisionmaking;
p.(None):
p.(None): [[Page 130 STAT. 1116]]
p.(None):
p.(None): ``(II) holds open meetings to ensure
p.(None): that there is an opportunity for public
p.(None): input by interested parties, and
p.(None): establishes and maintains processes to
p.(None): ensure that such input is considered in
p.(None): decisionmaking; and
p.(None): ``(III) permits its standards to be
p.(None): made publicly available, through the
p.(None): National Library of Medicine or another
p.(None): similar source acceptable to the
p.(None): Secretary; and
p.(None): ``(ii) recognized in whole, or in part, by the
p.(None): Secretary under subsection (c).
p.(None): ``(B) Other list.--The Interpretive Criteria Website
p.(None): shall, in addition to the list described in subparagraph
p.(None): (A), include a list of interpretive criteria, if any,
p.(None): that the Secretary has determined to be appropriate with
p.(None): respect to legally marketed antimicrobial drugs, where--
p.(None): ``(i) the Secretary does not recognize, in
p.(None): whole or in part, an interpretive criteria
p.(None): standard described under subparagraph (A)
p.(None): otherwise applicable to such a drug;
p.(None): ``(ii) the Secretary withdraws under
p.(None): subsection (c)(1)(A) recognition of a standard, in
p.(None): whole or in part, otherwise applicable to such a
p.(None): drug;
p.(None): ``(iii) the Secretary approves an application
p.(None): under section 505 of this Act or section 351 of
p.(None): the Public Health Service Act, as applicable, with
p.(None): respect to marketing of such a drug for which
p.(None): there are no relevant interpretive criteria
p.(None): included in a standard recognized by the Secretary
p.(None): under subsection (c); or
p.(None): ``(iv) because the characteristics of such a
p.(None): drug differ from other drugs with the same active
p.(None): ingredient, the interpretive criteria with respect
p.(None): to such drug--
p.(None): ``(I) differ from otherwise
p.(None): applicable interpretive criteria
p.(None): included in a standard listed under
p.(None): subparagraph (A) or interpretive
p.(None): criteria otherwise listed under this
p.(None): subparagraph; and
p.(None): ``(II) are determined by the
p.(None): Secretary to be appropriate for the
p.(None): drug.
p.(None): ``(C) Required statements.--The Interpretive
p.(None): Criteria Website shall include statements conveying--
p.(None): ``(i) that the website provides information
p.(None): about the in vitro susceptibility of bacteria,
p.(None): fungi, or other microorganisms, as applicable to a
p.(None): certain drug (or drugs);
p.(None): ``(ii) that--
p.(None): ``(I) the safety and efficacy of
p.(None): such drugs in treating clinical
p.(None): infections due to such bacteria, fungi,
p.(None): or other microorganisms, as applicable,
p.(None): may or may not have been established in
p.(None): adequate and well-controlled clinical
p.(None): trials in order for the susceptibility
p.(None): information described in clause (i) to
p.(None): be included on the website; and
p.(None): ``(II) the clinical significance of
p.(None): such susceptibility information in such
p.(None): instances is unknown;
p.(None): ``(iii) that the approved product labeling for
p.(None): specific drugs provides the uses for which the
p.(None): Secretary has approved the product; and
p.(None):
p.(None): [[Page 130 STAT. 1117]]
p.(None):
p.(None): ``(iv) any other information that the
p.(None): Secretary determines appropriate to adequately
p.(None): convey the meaning of the data supporting the
p.(None): recognition or listing of susceptibility test
p.(None): interpretive criteria standards or susceptibility
p.(None): test interpretive criteria included on the
p.(None): website.
p.(None): ``(3) Notice.--Not later than the date on which the
p.(None): Interpretive Criteria Website is established, the Secretary
p.(None): shall publish a notice of that establishment in the Federal
p.(None): Register.
p.(None): ``(4) Inapplicability of misbranding provision.--The
p.(None): inclusion in the approved labeling of an antimicrobial drug of a
p.(None): reference or hyperlink to the Interpretive Criteria Website, in
p.(None): and of itself, shall not cause the drug to be misbranded in
p.(None): violation of section 502.
p.(None): ``(5) Trade secrets and confidential information.--Nothing
p.(None): in this section shall be construed as authorizing the Secretary
p.(None): to disclose any information that is a trade secret or
p.(None): confidential information subject to section 552(b)(4) of title
p.(None): 5, United States Code.
p.(None):
p.(None): ``(c) Recognition of Susceptibility Test Interpretive Criteria.--
p.(None): ``(1) Evaluation and publication.--
p.(None): ``(A) In general.--Beginning on the date of the
p.(None): establishment of the Interpretive Criteria Website, and
p.(None): at least every 6 months thereafter, the Secretary
p.(None): shall--
p.(None): ``(i) evaluate any appropriate new or updated
p.(None): susceptibility test interpretive criteria
p.(None): standards established by a nationally or
p.(None): internationally recognized standard development
p.(None): organization described in subsection (b)(2)(A)(i);
p.(None): and
p.(None): ``(ii) publish on the public website of the
p.(None): Food and Drug Administration a notice--
p.(None): ``(I) withdrawing recognition of any
p.(None): different susceptibility test
p.(None): interpretive criteria standard, in whole
p.(None): or in part;
p.(None): ``(II) recognizing the new or
p.(None): updated standards;
p.(None): ``(III) recognizing one or more
p.(None): parts of the new or updated interpretive
p.(None): criteria specified in such a standard
p.(None): and declining to recognize the remainder
p.(None): of such standard; and
p.(None): ``(IV) making any necessary updates
p.(None): to the lists under subsection (b)(2).
p.(None): ``(B) Upon approval of a drug.--Upon the approval of
p.(None): an initial or supplemental application for an
p.(None): antimicrobial drug under section 505 of this Act or
p.(None): section 351 of the Public Health Service Act, as
p.(None): applicable, where such approval is based on
p.(None): susceptibility test interpretive criteria which differ
p.(None): from those contained in a standard recognized, or from
p.(None): those otherwise listed, by the Secretary pursuant to
p.(None): this subsection, or for which there are no relevant
p.(None): interpretive criteria standards recognized, or
p.(None): interpretive criteria otherwise listed, by the Secretary
p.(None): pursuant to this subsection, the Secretary shall update
p.(None): the lists under subparagraphs (A) and (B) of subsection
p.(None): (b)(2) to include the susceptibility test interpretive
p.(None): criteria upon which such approval was based.
p.(None):
p.(None): [[Page 130 STAT. 1118]]
p.(None):
p.(None): ``(2) Bases for updating interpretive criteria standards.--
p.(None): In evaluating new or updated susceptibility test interpretive
p.(None): criteria standards under paragraph (1)(A), the Secretary may
p.(None): consider--
p.(None): ``(A) the Secretary's determination that such a
p.(None): standard is not applicable to a particular drug because
p.(None): the characteristics of the drug differ from other drugs
p.(None): with the same active ingredient;
p.(None): ``(B) information provided by interested third
p.(None): parties, including public comment on the annual
p.(None): compilation of notices published under paragraph (3);
p.(None): ``(C) any bases used to identify susceptibility test
p.(None): interpretive criteria under subsection (a)(2); and
p.(None): ``(D) such other information or factors as the
p.(None): Secretary determines appropriate.
p.(None): ``(3) Annual compilation of notices.--Each year, the
p.(None): Secretary shall compile the notices published under paragraph
p.(None): (1)(A) and publish such compilation in the Federal Register and
p.(None): provide for public comment. If the Secretary receives comments,
p.(None): the Secretary shall review such comments and, if the Secretary
p.(None): determines appropriate, update pursuant to this subsection
p.(None): susceptibility test interpretive criteria standards or
p.(None): criteria--
p.(None): ``(A) recognized by the Secretary under this
p.(None): subsection; or
p.(None): ``(B) otherwise listed on the Interpretive Criteria
p.(None): Website under subsection (b)(2).
p.(None): ``(4) Relation to section 514(c).--Any susceptibility test
p.(None): interpretive standard recognized under this subsection or any
p.(None): criteria otherwise listed under subsection (b)(2)(B) shall be
p.(None): deemed to be recognized as a standard by the Secretary under
p.(None): section 514(c)(1).
p.(None): ``(5) Voluntary use of interpretive criteria.--Nothing in
p.(None): this section prohibits a person from seeking approval or
p.(None): clearance of a drug or device, or changes to the drug or the
p.(None): device, on the basis of susceptibility test interpretive
p.(None): criteria which differ from those contained in a standard
p.(None): recognized, or from those otherwise listed, by the Secretary
p.(None): pursuant to subsection (b)(2).
p.(None):
p.(None): ``(d) Antimicrobial Drug Labeling.--
p.(None): ``(1) Drugs marketed prior to establishment of interpretive
p.(None): criteria website.--
p.(None): ``(A) In general.--With respect to an antimicrobial
p.(None): drug lawfully introduced or delivered for introduction
p.(None): into interstate commerce for commercial distribution
p.(None): before the establishment of the Interpretive Criteria
p.(None): Website, a holder of an approved application under
p.(None): section 505 of this Act or section 351 of the Public
p.(None): Health Service Act, as applicable, for each such drug,
p.(None): not later than 1 year after establishment of the
p.(None): Interpretive Criteria Website described in subsection
p.(None): (b)(1), shall remove susceptibility test interpretive
p.(None): criteria, if any, and related information from the
p.(None): approved drug labeling and replace it with a reference
p.(None): to the Interpretive Criteria Website.
p.(None): ``(B) Labeling changes.--The labeling changes
p.(None): required by this section shall be considered a minor
p.(None): change
p.(None):
p.(None): [[Page 130 STAT. 1119]]
p.(None):
p.(None): under section 314.70 of title 21, Code of Federal
p.(None): Regulations (or any successor regulations) that may be
p.(None): implemented through documentation in the next applicable
p.(None): annual report.
p.(None): ``(2) Drugs marketed subsequent to establishment of
p.(None): interpretive criteria website.--With respect to antimicrobial
p.(None): drugs approved on or after the date of the establishment of the
p.(None): Interpretive Criteria Website described in subsection (b)(1),
p.(None): the labeling for such a drug shall include, in lieu of
p.(None): susceptibility test interpretive criteria and related
p.(None): information, a reference to such Website.
p.(None):
p.(None): ``(e) Special Condition for Marketing of Antimicrobial
p.(None): Susceptibility Testing Devices.--
p.(None): ``(1) In general.--Notwithstanding sections 501, 502, 505,
p.(None): 510, 513, and 515, if the conditions specified in paragraph (2)
p.(None): are met (in addition to other applicable provisions under this
p.(None): chapter) with respect to an antimicrobial susceptibility testing
p.(None): device described in subsection (f)(1), the Secretary may
p.(None): authorize the marketing of such device for a use described in
p.(None): such subsection.
p.(None): ``(2) Conditions applicable to antimicrobial susceptibility
p.(None): testing devices.--The conditions specified in this paragraph are
p.(None): the following:
p.(None): ``(A) The device is used to make a determination of
p.(None): susceptibility using susceptibility test interpretive
p.(None): criteria that are--
p.(None): ``(i) included in a standard recognized by the
p.(None): Secretary under subsection (c); or
p.(None): ``(ii) otherwise listed on the Interpretive
p.(None): Criteria Website under subsection (b)(2).
p.(None): ``(B) The labeling of such device includes
p.(None): statements conveying--
p.(None): ``(i) that the device provides information
p.(None): about the in vitro susceptibility of bacteria,
p.(None): fungi, or other microorganisms, as applicable to
p.(None): antimicrobial drugs;
p.(None): ``(ii) that--
p.(None): ``(I) the safety and efficacy of
p.(None): such drugs in treating clinical
p.(None): infections due to such bacteria, fungi,
p.(None): or other microorganisms, as applicable,
p.(None): may or may not have been established in
p.(None): adequate and well-controlled clinical
p.(None): trials in order for the device to report
p.(None): the susceptibility of such bacteria,
p.(None): fungi, or other microorganisms, as
p.(None): applicable, to such drugs; and
p.(None): ``(II) the clinical significance of
p.(None): such susceptibility information in those
p.(None): instances is unknown;
p.(None): ``(iii) that the approved labeling for drugs
p.(None): tested using such a device provides the uses for
p.(None): which the Secretary has approved such drugs; and
p.(None): ``(iv) any other information the Secretary
p.(None): determines appropriate to adequately convey the
p.(None): meaning of the data supporting the recognition or
p.(None): listing of susceptibility test interpretive
p.(None): criteria standards or susceptibility test
p.(None): interpretive criteria described in subparagraph
p.(None): (A).
p.(None): ``(C) The antimicrobial susceptibility testing
p.(None): device meets all other requirements to be cleared under
p.(None): section
p.(None):
p.(None): [[Page 130 STAT. 1120]]
p.(None):
p.(None): 510(k), classified under section 513(f)(2), or approved
p.(None): under section 515.
p.(None):
p.(None): ``(f) Definitions.--In this section:
p.(None): ``(1) The term `antimicrobial susceptibility testing device'
p.(None): means a device that utilizes susceptibility test interpretive
p.(None): criteria to determine and report the in vitro susceptibility of
p.(None): certain microorganisms to a drug (or drugs).
p.(None): ``(2) The term `qualified infectious disease product' means
p.(None): a qualified infectious disease product designated under section
p.(None): 505E(d).
p.(None): ``(3) The term `susceptibility test interpretive criteria'
p.(None): means--
p.(None): ``(A) one or more specific numerical values which
p.(None): characterize the susceptibility of bacteria or other
p.(None): microorganisms to the drug tested; and
p.(None): ``(B) related categorizations of such
p.(None): susceptibility, including categorization of the drug as
p.(None): susceptible, intermediate, resistant, or such other term
p.(None): as the Secretary determines appropriate.
p.(None): ``(4)(A) The term `antimicrobial drug' means, subject to
p.(None): subparagraph (B), a systemic antibacterial or antifungal drug
p.(None): that--
p.(None): ``(i) is intended for human use in the treatment of
p.(None): a disease or condition caused by a bacterium or fungus;
p.(None): ``(ii) may include a qualified infectious disease
p.(None): product designated under section 505E(d); and
p.(None): ``(iii) is subject to section 503(b)(1).
p.(None): ``(B) If provided by the Secretary through regulations, such
p.(None): term may include--
p.(None): ``(i) drugs other than systemic antibacterial and
p.(None): antifungal drugs; and
p.(None): ``(ii) biological products (as such term is defined
p.(None): in section 351 of the Public Health Service Act) to the
p.(None): extent such products exhibit antimicrobial activity.
p.(None): ``(5) The term `interpretive criteria standard' means a
p.(None): compilation of susceptibility test interpretive criteria
p.(None): developed by a standard development organization that meets the
p.(None): criteria set forth in subsection (b)(2)(A)(i).
p.(None):
p.(None): ``(g) Rule of Construction.--Nothing in this section shall be
p.(None): construed to--
p.(None): ``(1) alter the standards of evidence under subsection (c)
p.(None): or (d) of section 505 (including the substantial evidence
p.(None): standard under section 505(d)) or under section 351 of the
p.(None): Public Health Service Act (as applicable); or
p.(None): ``(2) with respect to clearing devices under section 510(k),
p.(None): classifying devices under section 513(f)(2), or approving
p.(None): devices under section 515--
p.(None): ``(A) apply with respect to any drug, device, or
p.(None): biological product, in any context other than an
p.(None): antimicrobial drug and an antimicrobial susceptibility
p.(None): testing device that uses susceptibility test
p.(None): interpretive criteria to characterize and report the
p.(None): susceptibility of certain bacteria, fungi, or other
p.(None): microorganisms, as applicable, to such drug to reflect
p.(None): patient morbidity and mortality in accordance with this
p.(None): section; or
p.(None):
p.(None): [[Page 130 STAT. 1121]]
p.(None):
p.(None): ``(B) unless specifically stated, have any effect on
p.(None): authorities provided under other sections of this Act,
p.(None): including any regulations issued under such sections.''.
p.(None):
p.(None): (b) Conforming Amendments.--
p.(None): (1) Repeal of prior related authority.--Section 1111 of the
p.(None): Food and Drug Administration Amendments Act of 2007 (42 U.S.C.
p.(None): 247d-5a), relating to identification of clinically susceptible
p.(None): concentrations of antimicrobials, is repealed.
p.(None): (2) Addition to categories of misbranded drugs.--Section 502
p.(None): of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None): ``(dd) If it is an antimicrobial drug, as defined in section
p.(None): 511A(f), and its labeling fails to conform with the requirements under
p.(None): section 511A(d).''.
p.(None): (3) Recognition of interpretive criteria standard as device
p.(None): standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting
p.(None): after ``the Secretary shall, by publication in the Federal
p.(None): Register'' the following: ``(or, with respect to a
p.(None): susceptibility test interpretive criteria standard under section
p.(None): 511A, by posting on the Interpretive Criteria Website in
p.(None): accordance with such section)''.
p.(None):
p.(None): (c) Report to Congress.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Secretary of Health and Human Services shall
p.(None): submit to the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of
p.(None): Representatives a report on the progress made in implementing section
p.(None): 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as
p.(None): added by subsection (a).
p.(None): (d) <> Requests for Updates to
p.(None): Interpretive Criteria Website.--Chapter 35 of title 44, United States
p.(None): Code, shall not apply to the collection of information from interested
p.(None): parties regarding updating the lists established under section 511A(b)
p.(None): of the Federal Food, Drug, and Cosmetic Act and posted on the
p.(None): Interpretive Criteria Website established under section 511A(c) of such
p.(None): Act.
p.(None):
p.(None): Subtitle F--Medical Device Innovations
p.(None):
p.(None): SEC. 3051. BREAKTHROUGH DEVICES.
p.(None):
p.(None): (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B,
p.(None): as added by section 3034(b), the following:
p.(None): ``SEC. 515C. <> BREAKTHROUGH DEVICES.
p.(None):
p.(None): ``(a) Purpose.--The purpose of this section is to encourage the
p.(None): Secretary, and provide the Secretary with sufficient authority, to apply
p.(None): efficient and flexible approaches to expedite the development of, and
p.(None): prioritize the Food and Drug Administration's review of, devices that
p.(None): represent breakthrough technologies.
p.(None): ``(b) Establishment of Program.--The Secretary shall establish a
p.(None): program to expedite the development of, and provide for the priority
p.(None): review for, devices, as determined by the Secretary--
p.(None):
p.(None): [[Page 130 STAT. 1122]]
p.(None):
p.(None): ``(1) that provide for more effective treatment or diagnosis
p.(None): of life-threatening or irreversibly debilitating human disease
p.(None): or conditions; and
p.(None): ``(2)(A) that represent breakthrough technologies;
p.(None): ``(B) for which no approved or cleared alternatives exist;
p.(None): ``(C) that offer significant advantages over existing
p.(None): approved or cleared alternatives, including the potential,
p.(None): compared to existing approved alternatives, to reduce or
p.(None): eliminate the need for hospitalization, improve patient quality
p.(None): of life, facilitate patients' ability to manage their own care
p.(None): (such as through self-directed personal assistance), or
p.(None): establish long-term clinical efficiencies; or
p.(None): ``(D) the availability of which is in the best interest of
p.(None): patients.
p.(None):
p.(None): ``(c) Request for Designation.--A sponsor of a device may request
p.(None): that the Secretary designate such device for expedited development and
p.(None): priority review under this section. Any such request for designation may
p.(None): be made at any time prior to the submission of an application under
p.(None): section 515(c), a notification under section 510(k), or a petition for
p.(None): classification under section 513(f)(2).
p.(None): ``(d) Designation Process.--
p.(None): ``(1) In general.--Not later than 60 calendar days after the
p.(None): receipt of a request under subsection (c), the Secretary shall
p.(None): determine whether the device that is the subject of the request
p.(None): meets the criteria described in subsection (b). If the Secretary
p.(None): determines that the device meets the criteria, the Secretary
p.(None): shall designate the device for expedited development and
p.(None): priority review.
p.(None): ``(2) Review.--Review of a request under subsection (c)
p.(None): shall be undertaken by a team that is composed of experienced
p.(None): staff and senior managers of the Food and Drug Administration.
p.(None): ``(3) Withdrawal.--The Secretary may not withdraw a
p.(None): designation granted under this section on the basis of the
p.(None): criteria under subsection (b) no longer applying because of the
p.(None): subsequent clearance or approval of another device that--
p.(None): ``(A) was designated under this section; or
p.(None): ``(B) was given priority review under section
p.(None): 515(d)(5), as in effect prior to the date of enactment
p.(None): of the 21st Century Cures Act.
p.(None):
p.(None): ``(e) Expedited Development and Priority Review.--
p.(None): ``(1) Actions.--For purposes of expediting the development
p.(None): and review of devices designated under subsection (d) the
p.(None): Secretary shall--
p.(None): ``(A) assign a team of staff, including a team
p.(None): leader with appropriate subject matter expertise and
p.(None): experience, for each device for which a request is
p.(None): submitted under subsection (c);
p.(None): ``(B) provide for oversight of the team by senior
p.(None): agency personnel to facilitate the efficient development
p.(None): of the device and the efficient review of any submission
p.(None): described in subsection (c) for the device;
p.(None): ``(C) adopt an efficient process for timely dispute
p.(None): resolution;
p.(None): ``(D) provide for interactive and timely
p.(None): communication with the sponsor of the device during the
p.(None): development program and review process;
p.(None):
p.(None): [[Page 130 STAT. 1123]]
p.(None):
p.(None): ``(E) expedite the Secretary's review of
p.(None): manufacturing and quality systems compliance, as
p.(None): applicable;
p.(None): ``(F) disclose to the sponsor, not less than 5
p.(None): business days in advance, the topics of any consultation
p.(None): the Secretary intends to undertake with external experts
p.(None): or an advisory committee concerning the sponsor's device
...
p.(None): team leaders, to review devices designated for expedited
p.(None): development and priority review, including any training
p.(None): required for such personnel to ensure effective and
p.(None): efficient review.
p.(None): ``(2) Process.--Prior to finalizing the guidance under
p.(None): paragraph (1), the Secretary shall seek public comment on a
p.(None): proposed guidance.
p.(None):
p.(None): ``(g) Rule of Construction.--Nothing in this section shall be
p.(None): construed to affect--
p.(None): ``(1) the criteria and standards for evaluating an
p.(None): application pursuant to section 515(c), a report and request for
p.(None): classification under section 513(f)(2), or a report under
p.(None): section 510(k), including the recognition of valid scientific
p.(None): evidence as described in section 513(a)(3)(B) and consideration
p.(None): and application of the least burdensome means of evaluating
p.(None): device effectiveness or demonstrating substantial equivalence
p.(None): between devices with differing technological characteristics, as
p.(None): applicable;
p.(None): ``(2) the authority of the Secretary with respect to
p.(None): clinical holds under section 520(g)(8)(A);
p.(None): ``(3) the authority of the Secretary to act on an
p.(None): application pursuant to section 515(d) before completion of an
p.(None): establishment inspection, as the Secretary determines
p.(None): appropriate; or
p.(None): ``(4) the authority of the Secretary with respect to
p.(None): postmarket surveillance under sections 519(h) and 522.''.
p.(None):
p.(None): (b) Documentation and Review of Significant Decisions.--Section
p.(None): 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
p.(None): 1(a)(1)) is amended by inserting ``a request for designation under
p.(None): section 515C,'' after ``application under section 515,''.
p.(None): (c) Termination of Previous Program.--
p.(None): (1) In general.--Section 515(d) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
p.(None): (A) by striking paragraph (5); and
p.(None): (B) by redesignating paragraph (6) as paragraph (5).
p.(None): (2) Conforming amendment.--Section 737(5) of the Federal
p.(None): Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by
p.(None): striking ``515(d)(6)'' and inserting ``515(d)(5)''.
p.(None):
p.(None): (d) Report.--On January 1, 2019, the Secretary of Health and Human
p.(None): Services shall issue a report to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives--
p.(None): (1) on the program under section 515C of the Federal Food,
p.(None): Drug, and Cosmetic Act, as added by subsection (a), in bringing
p.(None): safe and effective devices included in such program to patients
p.(None): as soon as possible; and
p.(None): (2) that includes recommendations, if any, to strengthen the
p.(None): program to better meet patient device needs in a manner as
p.(None): timely as possible.
p.(None): SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.
p.(None):
p.(None): (a) In General.--Section 520(m) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360j) is amended--
p.(None):
p.(None): [[Page 130 STAT. 1125]]
p.(None):
p.(None): (1) in paragraph (1) by striking ``fewer than 4,000'' and
p.(None): inserting ``not more than 8,000'';
p.(None): (2) in paragraph (2)(A) by striking ``fewer than 4,000'' and
p.(None): inserting ``not more than 8,000''; and
p.(None): (3) in paragraph (6)(A)(ii), by striking ``4,000'' and
p.(None): inserting ``8,000''.
p.(None):
p.(None): (b) <> Guidance Document on Probable
p.(None): Benefit.--Not later than 18 months after the date of enactment of this
p.(None): Act, the Secretary of Health and Human Services, acting through the
p.(None): Commissioner of Food and Drugs, shall publish a draft guidance that
p.(None): defines the criteria for establishing ``probable benefit'' as that term
p.(None): is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360j(m)(2)(C)).
p.(None): SEC. 3053. RECOGNITION OF STANDARDS.
p.(None):
p.(None): (a) In General.--Section 514(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360d(c)) is amended--
p.(None): (1) in paragraph (1), by inserting after subparagraph (B)
p.(None): the following new subparagraphs:
p.(None):
p.(None): ``(C)(i) Any person may submit a request for recognition under
p.(None): subparagraph (A) of all or part of an appropriate standard established
p.(None): by a nationally or internationally recognized standard organization.
p.(None): ``(ii) Not later than 60 calendar days after the Secretary receives
p.(None): such a request, the Secretary shall--
p.(None): ``(I) make a determination to recognize all, part, or none
p.(None): of the standard that is the subject of the request; and
p.(None): ``(II) issue to the person who submitted such request a
p.(None): response in writing that states the Secretary's rationale for
p.(None): that determination, including the scientific, technical,
p.(None): regulatory, or other basis for such determination.
p.(None):
p.(None): ``(iii) The Secretary shall make a response issued under clause
p.(None): (ii)(II) publicly available, in such a manner as the Secretary
p.(None): determines appropriate.
p.(None): ``(iv) The Secretary shall take such actions as may be necessary to
p.(None): implement all or part of a standard recognized under clause (ii)(I), in
p.(None): accordance with subparagraph (A).
p.(None): ``(D) The Secretary shall make publicly available, in such manner as
p.(None): the Secretary determines appropriate, the rationale for recognition
p.(None): under subparagraph (A) of all, part, or none of a standard, including
p.(None): the scientific, technical, regulatory, or other basis for the decision
p.(None): regarding such recognition.''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(4) The Secretary shall provide to all employees of the Food and
p.(None): Drug Administration who review premarket submissions for devices
p.(None): periodic training on the concept and use of recognized standards for
p.(None): purposes of meeting a premarket submission requirement or other
p.(None): applicable requirement under this Act, including standards relevant to
p.(None): an employee's area of device review.''.
p.(None): (b) <> Guidance.--The Secretary of Health
p.(None): and Human Services, acting through the Commissioner of Food and Drugs,
p.(None): shall review and update, if necessary, previously published guidance and
p.(None): standard operating procedures identifying the principles for recognizing
p.(None): standards, and for withdrawing the recognition of standards, under
p.(None): section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360d(c)), taking into account the experience with and reliance on a
p.(None): standard by foreign regulatory authorities and the
p.(None):
p.(None): [[Page 130 STAT. 1126]]
p.(None):
p.(None): device industry, and whether recognition of a standard will promote
p.(None): harmonization among regulatory authorities in the regulation of devices.
p.(None): SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.
p.(None):
p.(None): (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360(l)) is amended--
p.(None): (1) by striking ``A report under subsection (k)'' and
p.(None): inserting ``(1) A report under subsection (k)''; and
p.(None): (2) by adding at the end the following new paragraph:
p.(None):
p.(None): ``(2) Not later than 120 calendar days after the date of enactment
p.(None): of the 21st Century Cures Act and at least once every 5 years
p.(None): thereafter, as the Secretary determines appropriate, the Secretary shall
p.(None): identify, through publication in the Federal Register, any type of class
p.(None): I device that the Secretary determines no longer requires a report under
p.(None): subsection (k) to provide reasonable assurance of safety and
p.(None): effectiveness. Upon such publication--
p.(None): ``(A) each type of class I device so identified shall be
p.(None): exempt from the requirement for a report under subsection (k);
p.(None): and
p.(None): ``(B) the classification regulation applicable to each such
p.(None): type of device shall be deemed amended to incorporate such
p.(None): exemption.''.
p.(None):
p.(None): (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360(m)) is amended--
p.(None): (1) by striking ``(m)(1)'' and all that follows through ``by
p.(None): the Secretary.'' and inserting the following:
p.(None):
p.(None): ``(m)(1) The Secretary shall--
p.(None): ``(A) not later than 90 days after the date of enactment of
p.(None): the 21st Century Cures Act and at least once every 5 years
p.(None): thereafter, as the Secretary determines appropriate--
p.(None): ``(i) publish in the Federal Register a notice that
p.(None): contains a list of each type of class II device that the
p.(None): Secretary determines no longer requires a report under
p.(None): subsection (k) to provide reasonable assurance of safety
p.(None): and effectiveness; and
p.(None): ``(ii) provide for a period of not less than 60
p.(None): calendar days for public comment beginning on the date
p.(None): of the publication of such notice; and
p.(None): ``(B) not later than 210 calendar days after the date of
p.(None): enactment of the 21st Century Cures Act, publish in the Federal
p.(None): Register a list representing the Secretary's final determination
p.(None): with respect to the devices contained in the list published
p.(None): under subparagraph (A).''; and
p.(None): (2) in paragraph (2)--
p.(None): (A) by striking ``1 day after the date of
p.(None): publication of a list under this subsection,'' and
p.(None): inserting ``1 calendar day after the date of publication
p.(None): of the final list under paragraph (1)(B),''; and
p.(None): (B) by striking ``30-day period'' and inserting
p.(None): ``60-calendar-day period''; and
p.(None): (C) by adding at the end the following new
p.(None): paragraph:
p.(None):
p.(None): ``(3) Upon the publication of the final list under paragraph
p.(None): (1)(B)--
p.(None): ``(A) each type of class II device so listed shall be exempt
p.(None): from the requirement for a report under subsection (k); and
p.(None):
p.(None): [[Page 130 STAT. 1127]]
p.(None):
p.(None): ``(B) the classification regulation applicable to each such
p.(None): type of device shall be deemed amended to incorporate such
p.(None): exemption.''.
p.(None): SEC. 3055. CLASSIFICATION PANELS.
p.(None):
p.(None): (a) Classification Panels.--Paragraph (5) of section 513(b) of the
p.(None): Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
p.(None): (1) by striking ``(5)'' and inserting ``(5)(A)''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(B) When a device is specifically the subject of review by a
p.(None): classification panel, the Secretary shall--
p.(None): ``(i) ensure that adequate expertise is represented on the
p.(None): classification panel to assess--
p.(None): ``(I) the disease or condition which the device is
p.(None): intended to cure, treat, mitigate, prevent, or diagnose;
p.(None): and
p.(None): ``(II) the technology of the device; and
p.(None): ``(ii) provide an opportunity for the person whose device is
p.(None): specifically the subject of panel review to provide
p.(None): recommendations on the expertise needed among the voting members
p.(None): of the panel.
p.(None):
p.(None): ``(C) For purposes of subparagraph (B)(i), the term `adequate
p.(None): expertise' means that the membership of the classification panel
p.(None): includes--
p.(None): ``(i) two or more voting members, with a specialty or other
p.(None): expertise clinically relevant to the device under review; and
p.(None): ``(ii) at least one voting member who is knowledgeable about
p.(None): the technology of the device.
p.(None):
p.(None): ``(D) The Secretary shall provide an annual opportunity for
p.(None): patients, representatives of patients, and sponsors of medical device
p.(None): submissions to provide recommendations for individuals with appropriate
p.(None): expertise to fill voting member positions on classification panels.''.
p.(None): (b) Panel Review Process.--Section 513(b)(6) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
p.(None): (1) in subparagraph (A)(iii), by inserting before the period
p.(None): at the end ``, including, subject to the discretion of the panel
p.(None): chairperson, by designating a representative who will be
p.(None): provided a time during the panel meeting to address the panel
p.(None): for the purpose of correcting misstatements of fact or providing
p.(None): clarifying information, and permitting the person or
p.(None): representative to call on experts within the person's
p.(None): organization to address such specific issues in the time
p.(None): provided''; and
p.(None): (2) by striking subparagraph (B) and inserting the following
p.(None): new subparagraph:
p.(None):
p.(None): ``(B)(i) Any meeting of a classification panel with respect to the
p.(None): review of a device shall--
p.(None): ``(I) provide adequate time for initial presentations by the
p.(None): person whose device is specifically the subject of such review
p.(None): and by the Secretary; and
p.(None): ``(II) encourage free and open participation by all
p.(None): interested persons.
p.(None):
p.(None): ``(ii) Following the initial presentations described in clause (i),
p.(None): the panel may--
p.(None): ``(I) pose questions to a designated representative
p.(None): described in subparagraph (A)(iii); and
p.(None):
p.(None): [[Page 130 STAT. 1128]]
p.(None):
p.(None): ``(II) consider the responses to such questions in the
p.(None): panel's review of the device.''.
p.(None): SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
p.(None):
p.(None): Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360j) is amended--
p.(None): (1) in subsection (g)(3)--
p.(None): (A) in subparagraph (A)(i)--
p.(None): (i) by striking ``local''; and
p.(None): (ii) by striking ``which has been''; and
p.(None): (B) in subparagraph (B), by striking ``a local
p.(None): institutional'' and inserting ``an institutional''; and
p.(None): (2) in subsection (m)(4)--
p.(None): (A) by striking subparagraph (A) and inserting the
p.(None): following:
p.(None): ``(A) in facilities in which clinical testing of devices is
p.(None): supervised by an institutional review committee established in
p.(None): accordance with the regulations of the Secretary; and'';
p.(None): (B) in subparagraph (B), by striking ``a local
p.(None): institutional'' and inserting ``an institutional''; and
p.(None): (C) in the matter following subparagraph (B), by
p.(None): striking ``local''.
p.(None): SEC. 3057. <> CLIA WAIVER IMPROVEMENTS.
p.(None):
p.(None): (a) Draft Revised Guidance.--Not later than 1 year after the date of
p.(None): the enactment of this Act, the Secretary of Health and Human Services,
p.(None): acting through the Commissioner of Food and Drugs, shall publish a draft
p.(None): guidance that--
p.(None): (1) revises ``Section V. Demonstrating Insignificant Risk of
p.(None): an Erroneous Result - Accuracy'' of the guidance entitled
p.(None): ``Recommendations for Clinical Laboratory Improvement Amendments
p.(None): of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
p.(None): Diagnostic Devices'' and dated January 30, 2008; and
p.(None): (2) includes the appropriate use of comparable performance
p.(None): between a waived user and a moderately complex laboratory user
p.(None): to demonstrate accuracy.
p.(None): (b) Final Revised Guidance.--The Secretary of Health and Human
p.(None): Services, acting through the Commissioner of Food and Drugs, shall
p.(None): finalize the draft guidance published under subsection (a) not later
p.(None): than 1 year after the comment period for such draft guidance closes.
p.(None): SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.
p.(None):
p.(None): (a) In General.--Section 513 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360c) is amended by adding at the end the following:
p.(None): ``(j) Training and Oversight of Least Burdensome Requirements.--
p.(None): ``(1) The Secretary shall--
p.(None): ``(A) ensure that each employee of the Food and Drug
p.(None): Administration who is involved in the review of
p.(None): premarket submissions, including supervisors, receives
p.(None): training regarding the meaning and implementation of the
p.(None): least burdensome requirements under subsections
p.(None): (a)(3)(D) and (i)(1)(D) of this section and section
p.(None): 515(c)(5); and
p.(None): ``(B) periodically assess the implementation of the
p.(None): least burdensome requirements, including the employee
p.(None): training
p.(None):
p.(None): [[Page 130 STAT. 1129]]
p.(None):
p.(None): under subparagraph (A), to ensure that the least
p.(None): burdensome requirements are fully and consistently
p.(None): applied.
p.(None): ``(2) Not later than 18 months after the date of enactment
p.(None): of the 21st Century Cures Act, the ombudsman for any
p.(None): organizational unit of the Food and Drug Administration
p.(None): responsible for the premarket review of devices shall--
p.(None): ``(A) conduct an audit of the training described in
p.(None): paragraph (1)(A), including the effectiveness of such
p.(None): training in implementing the least burdensome
p.(None): requirements;
p.(None): ``(B) include in such audit interviews of persons
p.(None): who are representatives of the device industry regarding
p.(None): their experiences in the device premarket review
p.(None): process, including with respect to the application of
p.(None): least burdensome concepts to premarket review and
p.(None): decisionmaking;
p.(None): ``(C) include in such audit a list of the
p.(None): measurement tools the Secretary uses to assess the
p.(None): implementation of the least burdensome requirements,
p.(None): including under paragraph (1)(B) and section 517A(a)(3),
p.(None): and may also provide feedback on the effectiveness of
p.(None): such tools in the implementation of the least burdensome
p.(None): requirements;
p.(None): ``(D) summarize the findings of such audit in a
p.(None): final audit report; and
p.(None): ``(E) within 30 calendar days of completion of such
p.(None): final audit report, make such final audit report
p.(None): available--
p.(None): ``(i) to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the
p.(None): Committee on Energy and Commerce of the House of
p.(None): Representatives; and
p.(None): ``(ii) on the Internet website of the Food and
p.(None): Drug Administration.''.
p.(None):
p.(None): (b) Premarket Applications.--Section 515(c) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the
p.(None): end the following:
p.(None): ``(5)(A) In requesting additional information with respect to an
p.(None): application under this section, the Secretary shall consider the least
p.(None): burdensome appropriate means necessary to demonstrate a reasonable
p.(None): assurance of device safety and effectiveness.
p.(None): ``(B) For purposes of subparagraph (A), the term `necessary' means
p.(None): the minimum required information that would support a determination by
p.(None): the Secretary that an application provides a reasonable assurance of the
p.(None): safety and effectiveness of the device.
p.(None): ``(C) For purposes of this paragraph, the Secretary shall consider
p.(None): the role of postmarket information in determining the least burdensome
p.(None): means of demonstrating a reasonable assurance of device safety and
p.(None): effectiveness.
p.(None): ``(D) Nothing in this paragraph alters the standards for premarket
p.(None): approval of a device.''.
p.(None): (c) Rationale for Significant Decisions Regarding Devices.--Section
p.(None): 517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
p.(None): 1(a)) is amended by adding at the end the following:
p.(None): ``(3) Application of least burdensome requirements.--The
p.(None): substantive summary required under this subsection shall include
p.(None): a brief statement regarding how the least burdensome
p.(None): requirements were considered and applied consistent with section
p.(None): 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as
p.(None): applicable.''.
p.(None):
p.(None): [[Page 130 STAT. 1130]]
p.(None):
p.(None): SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT.
p.(None):
p.(None): (a) In General.--Section 510 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360) is amended by adding at the end the following:
p.(None): ``(q) Reusable Medical Devices.--
p.(None): ``(1) In general.--Not later than 180 days after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary shall
p.(None): identify and publish a list of reusable device types for which
p.(None): reports under subsection (k) are required to include--
p.(None): ``(A) instructions for use, which have been
p.(None): validated in a manner specified by the Secretary; and
p.(None): ``(B) validation data, the types of which shall be
p.(None): specified by the Secretary;
p.(None): regarding cleaning, disinfection, and sterilization, and for
p.(None): which a substantial equivalence determination may be based.
p.(None): ``(2) Revision of list.--The Secretary shall revise the list
p.(None): under paragraph (2), as the Secretary determines appropriate,
p.(None): with notice in the Federal Register.
p.(None): ``(3) Content of reports.--Reports under subsection (k) that
p.(None): are submitted after the publication of the list described in
p.(None): paragraph (1), for devices or types of devices included on such
p.(None): list, shall include such instructions for use and validation
p.(None): data.''.
p.(None): (b) <> Device Modifications.--The Secretary
p.(None): of Health and Human Services, acting through the Commissioner of Food
p.(None): and Drugs, shall issue final guidance regarding when a premarket
p.(None): notification under section 510(k) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a
p.(None): modification or change to a legally marketed device. Such final guidance
p.(None): shall be issued not later than 1 year after the date on which the
p.(None): comment period closes for the draft guidance on such subject.
p.(None): SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
p.(None):
p.(None): (a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360j) is amended by adding at the end the following:
p.(None): ``(o) Regulation of Medical and Certain Decisions Support
p.(None): Software.--
p.(None): ``(1) The term device, as defined in section 201(h), shall
p.(None): not include a software function that is intended--
p.(None): ``(A) for administrative support of a health care
p.(None): facility, including the processing and maintenance of
p.(None): financial records, claims or billing information,
p.(None): appointment schedules, business analytics, information
p.(None): about patient populations, admissions, practice and
p.(None): inventory management, analysis of historical claims data
p.(None): to predict future utilization or cost-effectiveness,
p.(None): determination of health benefit eligibility, population
p.(None): health management, and laboratory workflow;
p.(None): ``(B) for maintaining or encouraging a healthy
p.(None): lifestyle and is unrelated to the diagnosis, cure,
p.(None): mitigation, prevention, or treatment of a disease or
p.(None): condition;
p.(None): ``(C) to serve as electronic patient records,
p.(None): including patient-provided information, to the extent
p.(None): that such records are intended to transfer, store,
p.(None): convert formats,
p.(None):
p.(None): [[Page 130 STAT. 1131]]
p.(None):
p.(None): or display the equivalent of a paper medical chart, so
p.(None): long as--
p.(None): ``(i) such records were created, stored,
p.(None): transferred, or reviewed by health care
p.(None): professionals, or by individuals working under
p.(None): supervision of such professionals;
p.(None): ``(ii) such records are part of health
p.(None): information technology that is certified under
p.(None): section 3001(c)(5) of the Public Health Service
p.(None): Act; and
p.(None): ``(iii) such function is not intended to
p.(None): interpret or analyze patient records, including
...
p.(None): limiting the authority of the Secretary to--
p.(None): ``(A) exercise enforcement discretion as to any
p.(None): device subject to regulation under this Act;
p.(None): ``(B) regulate software used in the manufacture and
p.(None): transfusion of blood and blood components to assist in
p.(None): the prevention of disease in humans; or
p.(None): ``(C) regulate software as a device under this Act
p.(None): if such software meets the criteria under section
p.(None): 513(a)(1)(C).''.
p.(None):
p.(None): (b) <> Reports.--The Secretary of Health
p.(None): and Human Services (referred to in this subsection as the
p.(None): ``Secretary''), after consultation with agencies and offices of the
p.(None): Department of Health and Human Services involved in health information
p.(None): technology, shall publish a report, not later than 2 years after the
p.(None): date of enactment of this Act and every 2 years thereafter, that--
p.(None): (1) includes input from outside experts, such as
p.(None): representatives of patients, consumers, health care providers,
p.(None): startup companies, health plans or other third-party payers,
p.(None): venture capital investors, information technology vendors,
p.(None): health information technology vendors, small businesses,
p.(None): purchasers, employers, and other stakeholders with relevant
p.(None): expertise, as determined by the Secretary;
p.(None):
p.(None): [[Page 130 STAT. 1133]]
p.(None):
p.(None): (2) examines information available to the Secretary on any
p.(None): risks and benefits to health associated with software functions
p.(None): described in section 520(o)(1) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a));
p.(None): and
p.(None): (3) summarizes findings regarding the impact of such
p.(None): software functions on patient safety, including best practices
p.(None): to promote safety, education, and competency related to such
p.(None): functions.
p.(None):
p.(None): (c) Classification of Accessories.--Section 513(b) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding at
p.(None): the end the following:
p.(None): ``(9) The Secretary shall classify an accessory under this section
p.(None): based on the intended use of the accessory, notwithstanding the
p.(None): classification of any other device with which such accessory is intended
p.(None): to be used.''.
p.(None): (d) Conforming Amendment.--Section 201(h) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the
p.(None): following: ``The term `device' does not include software functions
p.(None): excluded pursuant to section 520(o).''.
p.(None):
p.(None): Subtitle G--Improving Scientific Expertise and Outreach at FDA
p.(None):
p.(None): SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND
p.(None): BIOMEDICAL PRODUCT ASSESSMENT SERVICE.
p.(None):
p.(None): (a) Hiring and Retention Authority.--Section 228 of the Public
p.(None): Health Service Act (42 U.S.C. 237) is amended--
p.(None): (1) in the section heading, by inserting ``and biomedical
p.(None): product assessment'' after ``research'';
p.(None): (2) in subsection (a)--
p.(None): (A) in paragraph (1), by striking ``Silvio O. Conte
p.(None): Senior Biomedical Research Service, not to exceed 500
p.(None): members'' and inserting ``Silvio O. Conte Senior
p.(None): Biomedical Research and Biomedical Product Assessment
p.(None): Service (in this section referred to as the `Service'),
p.(None): not to exceed 2,000 members, the purpose of which is to
p.(None): recruit and retain outstanding and qualified scientific
p.(None): and technical experts in the fields of biomedical
p.(None): research, clinical research evaluation, and biomedical
p.(None): product assessment'';
p.(None): (B) by amending paragraph (2) to read as follows:
p.(None):
p.(None): ``(2) The authority established in paragraph (1) may not be
p.(None): construed to require the Secretary to reduce the number of employees
p.(None): serving under any other employment system in order to offset the number
p.(None): of members serving in the Service.''; and
p.(None): (C) by adding at the end the following:
p.(None):
...
p.(None): paragraph (1) shall include an examination of the extent to
p.(None): which recruitment and retention of outstanding and qualified
p.(None): scientific, medical, or technical experts in the fields of
p.(None): biomedical research, clinical research evaluation, and
p.(None): biomedical product assessment have improved or otherwise have
p.(None): been affected by the amendments to section 228 of the Public
p.(None): Health Service Act (42 U.S.C. 237) made by subsection (a),
p.(None): including by determining, during the period between the date of
p.(None): enactment of this Act and the completion of the study--
p.(None): (A) the total number of members recruited and
p.(None): retained under the Senior Biomedical Research and
p.(None): Biomedical Product Assessment Service under such section
p.(None): 228, and the effect of increasing the number of members
p.(None): eligible for such Service;
p.(None): (B) the number of members of such Senior Biomedical
p.(None): Research and Biomedical Product Assessment Service hired
p.(None): with a doctoral level degree in biomedicine or a related
p.(None): field, and the number of such members hired with a
p.(None): doctoral or master's level degree in engineering,
p.(None): bioinformatics, or a related or emerging field; and
p.(None): (C) the number of Senior Biomedical Research and
p.(None): Biomedical Product Assessment Service members that have
p.(None): been hired by each agency or department of the
p.(None): Department of Health and Human Services, and how such
p.(None): Department assigns such members to each agency or
p.(None): department.
p.(None): SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
p.(None): PROFESSIONAL PERSONNEL.
p.(None):
p.(None): (a) In General.--The Federal Food, Drug, and Cosmetic Act is amended
p.(None): by inserting after section 714 (21 U.S.C. 379d-3) the following:
p.(None):
p.(None): [[Page 130 STAT. 1135]]
p.(None):
p.(None): ``SEC. 714A. <> HIRING AUTHORITY FOR
p.(None): SCIENTIFIC, TECHNICAL, AND PROFESSIONAL
p.(None): PERSONNEL.
p.(None):
p.(None): ``(a) In General.--The Secretary may, notwithstanding title 5,
p.(None): United States Code, governing appointments in the competitive service,
p.(None): appoint outstanding and qualified candidates to scientific, technical,
p.(None): or professional positions that support the development, review, and
p.(None): regulation of medical products. Such positions shall be within the
p.(None): competitive service.
p.(None): ``(b) Compensation.--
p.(None): ``(1) In general.--Notwithstanding any other provision of
p.(None): law, including any requirement with respect to General Schedule
p.(None): pay rates under subchapter III of chapter 53 of title 5, United
p.(None): States Code, and consistent with the requirements of paragraph
p.(None): (2), the Commissioner of Food and Drugs may determine and set--
p.(None): ``(A) the annual rate of pay of any individual
p.(None): appointed under subsection (a); and
p.(None): ``(B) for purposes of retaining qualified employees,
p.(None): the annual rate of pay for any qualified scientific,
p.(None): technical, or professional personnel appointed to a
p.(None): position described in subsection (a) before the date of
p.(None): enactment of the 21st Century Cures Act.
p.(None): ``(2) Limitation.--The annual rate of pay established
p.(None): pursuant to paragraph (1) may not exceed the amount of annual
p.(None): compensation (excluding expenses) specified in section 102 of
p.(None): title 3, United States Code.
p.(None): ``(3) Public availability.--The annual rate of pay provided
p.(None): to an individual in accordance with this section shall be
p.(None): publicly available information.
p.(None):
p.(None): ``(c) Rule of Construction.--The authorities under this section
p.(None): shall not be construed to affect the authority provided under section
p.(None): 714.
p.(None): ``(d) Report on Workforce Planning.--
p.(None): ``(1) In general.--Not later than 18 months after the date
p.(None): of enactment of the 21st Century Cures Act, the Secretary shall
p.(None): submit a report on workforce planning to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the
p.(None): Committee on Energy and Commerce of the House of Representatives
p.(None): that examines the extent to which the Food and Drug
p.(None): Administration has a critical need for qualified individuals for
p.(None): scientific, technical, or professional positions, including--
p.(None): ``(A) an analysis of the workforce needs at the Food
p.(None): and Drug Administration and the Secretary's strategic
p.(None): plan for addressing such needs, including through use of
p.(None): the authority under this section; and
p.(None): ``(B) a recruitment and retention plan for hiring
p.(None): qualified scientific, technical, and professional
p.(None): candidates, which may include the use of--
p.(None): ``(i) recruitment through nongovernmental
p.(None): recruitment or placement agencies;
p.(None): ``(ii) recruitment through academic
p.(None): institutions;
p.(None): ``(iii) recruitment or hiring bonuses, if
p.(None): applicable;
p.(None): ``(iv) recruitment using targeted direct
p.(None): hiring authorities; and
p.(None): ``(v) retention of qualified scientific,
p.(None): technical, and professional employees using the
p.(None): authority under this section, or other applicable
p.(None): authorities of the Secretary.
p.(None):
p.(None): [[Page 130 STAT. 1136]]
p.(None):
p.(None): ``(2) Recommendations.--The report under paragraph (1) may
p.(None): include the recommendations of the Commissioner of Food and
p.(None): Drugs that would help the Food and Drug Administration to better
p.(None): recruit and retain qualified individuals for scientific,
p.(None): technical, or professional positions at the agency.''.
p.(None):
p.(None): (b) GAO Study and Report.--
p.(None): (1) In general.--The Comptroller General of the United
p.(None): States shall conduct a study of the ability of the Food and Drug
p.(None): Administration to hire, train, and retain qualified scientific,
p.(None): technical, and professional staff, not including contractors,
p.(None): necessary to fulfill the mission of the Food and Drug
p.(None): Administration to protect and promote public health. Not later
p.(None): than January 1, 2022, the Comptroller General shall submit a
p.(None): report on such study to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives.
p.(None): (2) Contents of study.--The Comptroller General shall
p.(None): include in the study and report under paragraph (1)--
p.(None): (A) information about the progress of the Food and
p.(None): Drug Administration in recruiting and retaining
p.(None): qualified scientific, technical, and professional staff
p.(None): outstanding in the field of biomedical research,
p.(None): clinical research evaluation, and biomedical product
p.(None): assessment;
p.(None): (B) the extent to which critical staffing needs
p.(None): exist at the Food and Drug Administration, and barriers
p.(None): to hiring, training, and retaining qualified staff, if
p.(None): any;
p.(None): (C) an examination of the recruitment and retention
p.(None): strategies of the Food and Drug Administration,
p.(None): including examining any strategic workforce plan,
p.(None): focused on improving scientific, technical, and
p.(None): professional staff recruitment and retention; and
p.(None): (D) recommendations for potential improvements that
p.(None): would address staffing needs of the Food and Drug
p.(None): Administration.
p.(None): SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION
p.(None): INTERCENTER INSTITUTES.
p.(None):
p.(None): (a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 391 et seq.) is amended by adding at the end the
p.(None): following:
p.(None): ``SEC. 1014. <> FOOD AND DRUG ADMINISTRATION
p.(None): INTERCENTER INSTITUTES.
p.(None):
p.(None): ``(a) In General.--The Secretary shall establish one or more
p.(None): Intercenter Institutes within the Food and Drug Administration (referred
p.(None): to in this section as an `Institute') for a major disease area or areas.
p.(None): With respect to the major disease area of focus of an Institute, such
p.(None): Institute shall develop and implement processes for coordination of
p.(None): activities, as applicable to such major disease area or areas, among the
p.(None): Center for Drug Evaluation and Research, the Center for Biologics
p.(None): Evaluation and Research, and the Center for Devices and Radiological
p.(None): Health (for the purposes of this section, referred to as the `Centers').
p.(None): Such activities may include--
p.(None): ``(1) coordination of staff from the Centers with diverse
p.(None): product expertise in the diagnosis, cure, mitigation, treatment,
p.(None): or prevention of the specific diseases relevant to the major
p.(None): disease area of focus of the Institute;
p.(None):
p.(None): [[Page 130 STAT. 1137]]
p.(None):
p.(None): ``(2) streamlining, where appropriate, the review of medical
p.(None): products to diagnose, cure, mitigate, treat, or prevent the
p.(None): specific diseases relevant to the major disease area of focus of
p.(None): the Institute, applying relevant standards under sections 505,
p.(None): 510(k), 513(f)(2), and 515 of this Act and section 351 of the
p.(None): Public Health Service Act, and other applicable authorities;
p.(None): ``(3) promotion of scientific programs within the Centers
p.(None): related to the major disease area of focus of the Institute;
p.(None): ``(4) development of programs and enhancement of strategies
p.(None): to recruit, train, and provide continuing education
p.(None): opportunities for the personnel of the Centers with expertise
p.(None): related to the major disease area of focus of the Institute;
p.(None): ``(5) enhancement of the interactions of the Centers with
p.(None): patients, sponsors, and the external biomedical community
p.(None): regarding the major disease area of focus of the Institute; and
p.(None): ``(6) facilitation of the collaborative relationships of the
p.(None): Centers with other agencies within the Department of Health and
p.(None): Human Services regarding the major disease area of focus of the
p.(None): Institute.
p.(None):
p.(None): ``(b) Public Process.--The Secretary shall provide a period for
p.(None): public comment during the time that each Institute is being implemented.
p.(None): ``(c) Timing.--The Secretary shall establish at least one Institute
p.(None): under subsection (a) before the date that is 1 year after the date of
p.(None): enactment of the 21st Century Cures Act.
p.(None): ``(d) Termination of Institutes.--The Secretary may terminate any
p.(None): Institute established pursuant to this section if the Secretary
p.(None): determines such Institute is no longer benefitting the public health.
p.(None): Not less than 60 days prior to so terminating an Institute, the
p.(None): Secretary shall provide public notice, including the rationale for such
p.(None): termination.''.
p.(None): (b) Technical Amendments.--Chapter X of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
p.(None): (1) by redesignating section 1012 as section 1013; and
p.(None): (2) by redesignating the second section 1011 (with respect
p.(None): to improving the training of State, local, territorial, and
p.(None): tribal food safety officials), as added by section 209(a) of the
p.(None): FDA Food Safety Modernization Act (Public Law 111-353), as
p.(None): section 1012.
p.(None): SEC. 3074. <> SCIENTIFIC ENGAGEMENT.
p.(None):
p.(None): (a) In General.--Scientific meetings that are attended by scientific
p.(None): or medical personnel, or other professionals, of the Department of
p.(None): Health and Human Services for whom attendance at such meeting is
p.(None): directly related to their professional duties and the mission of the
p.(None): Department--
p.(None): (1) shall not be considered conferences for the purposes of
p.(None): complying with Federal reporting requirements contained in
p.(None): annual appropriations Acts or in this section; and
p.(None): (2) shall not be considered conferences for purposes of a
p.(None): restriction contained in an annual appropriations Act, based on
p.(None): Office of Management and Budget Memorandum M-12-12 or any other
p.(None): regulation restricting travel to such meeting.
p.(None):
p.(None): (b) Limitation.--Nothing in this section shall be construed to
p.(None): exempt travel for scientific meetings from Federal regulations relating
p.(None): to travel.
p.(None):
p.(None): [[Page 130 STAT. 1138]]
p.(None):
p.(None): (c) Reports.--Not later than 90 days after the end of the fiscal
p.(None): year, each operating division of the Department of Health and Human
p.(None): Services shall prepare, and post on an Internet website of the operating
p.(None): division, an annual report on scientific meeting attendance and related
p.(None): travel spending for each fiscal year. Such report shall include--
p.(None): (1) general information concerning the scientific meeting
p.(None): activities involved;
p.(None): (2) information concerning the total amount expended for
p.(None): such meetings;
p.(None): (3) a description of all such meetings that were attended by
p.(None): scientific or medical personnel, or other professionals, of each
p.(None): such operating division where the total amount expended by the
p.(None): operating division associated with each such meeting were in
p.(None): excess of $30,000, including--
p.(None): (A) the total amount of meeting expenses incurred by
p.(None): the operating division for such meeting;
p.(None): (B) the location of such meeting;
p.(None): (C) the date of such meeting;
p.(None): (D) a brief explanation on how such meeting advanced
p.(None): the mission of the operating division; and
p.(None): (E) the total number of individuals whose travel
p.(None): expenses or other scientific meeting expenses were paid
p.(None): by the operating division; and
p.(None): (4) with respect to any such meeting where the total
p.(None): expenses to the operating division exceeded $150,000, a
p.(None): description of the exceptional circumstances that necessitated
p.(None): the expenditure of such amounts.
p.(None): SEC. 3075. DRUG SURVEILLANCE.
p.(None):
p.(None): (a) New Drugs.--Section 505(k)(5) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 2074, is
p.(None): further amended--
p.(None): (1) in subparagraph (A), by striking ``, bi-weekly
p.(None): screening'' and inserting ``screenings'';
p.(None): (2) in subparagraph (B), as redesignated by section
p.(None): 2074(1)(C), by striking the period at the end and inserting ``;
p.(None): and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(C) make available on the Internet website of the Food and
p.(None): Drug Administration--
p.(None): ``(i) guidelines, developed with input from experts
p.(None): qualified by scientific training and experience to
p.(None): evaluate the safety and effectiveness of drugs, that
p.(None): detail best practices for drug safety surveillance using
p.(None): the Adverse Event Reporting System; and
p.(None): ``(ii) criteria for public posting of adverse event
p.(None): signals.''.
p.(None):
p.(None): (b) FAERS Revision.--Section 505(r)(2)(D) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking ``, by
p.(None): 18 months'' and all that follows through the semicolon at the end of the
p.(None): subparagraph and inserting ``and making publicly available on the
p.(None): Internet website established under paragraph (1) best practices for drug
p.(None): safety surveillance activities for drugs approved under this section or
p.(None): section 351 of the Public Health Service Act;''.
p.(None):
p.(None): [[Page 130 STAT. 1139]]
p.(None):
p.(None): (c) Risk Evaluation and Mitigation Strategies.--Section 505-1(f)(5)
p.(None): of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is
p.(None): amended--
p.(None): (1) in the matter preceding subparagraph (A), by inserting
p.(None): ``or other advisory committee'' after ``(or successor
p.(None): committee)''; and
p.(None): (2) in subparagraph (B), by striking ``at least annually,''
p.(None): and inserting ``periodically''.
p.(None): SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
p.(None): ADMINISTRATION.
p.(None):
p.(None): (a) Board of Directors.--
p.(None): (1) Composition and size.--Section 770(d)(1)(C) of the
p.(None): Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C))
p.(None): is amended--
p.(None): (A) by redesignating clause (ii) as clause (iii);
p.(None): (B) by inserting after clause (i) the following:
p.(None): ``(ii) Additional members.--The Board, through
p.(None): amendments to the bylaws of the Foundation, may
p.(None): provide that the number of voting members of the
p.(None): Board shall be a number (to be specified in such
p.(None): amendment) greater than 14. Any Board positions
p.(None): that are established by any such amendment shall
p.(None): be appointed (by majority vote) by the individuals
p.(None): who, as of the date of such amendment, are voting
p.(None): members of the Board and persons so appointed may
p.(None): represent any of the categories specified in
p.(None): subclauses (I) through (V) of clause (i), so long
p.(None): as no more than 30 percent of the total voting
p.(None): members of the Board (including members whose
p.(None): positions are established by such amendment) are
p.(None): representatives of the general pharmaceutical,
p.(None): device, food, cosmetic, and biotechnology
p.(None): industries.''; and
p.(None): (C) in clause (iii)(I), as redesignated by
p.(None): subparagraph (A), by striking ``The ex officio members
p.(None): shall ensure'' and inserting ``The ex officio members,
p.(None): acting pursuant to clause (i), and the Board, acting
p.(None): pursuant to clause (ii), shall ensure''.
p.(None): (2) Federal employees allowed to serve on board.--Clause
p.(None): (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by
p.(None): paragraph (1)(A), is amended by adding at the end the following:
p.(None): ``For purposes of this section, the term `employee of the
p.(None): Federal Government' does not include a special Government
p.(None): employee, as that term is defined in section 202(a) of title 18,
p.(None): United States Code.''.
p.(None): (3) Staggered terms.--Subparagraph (A) of section 770(d)(3)
p.(None): of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 379dd(d)(3)) is amended to read as follows:
p.(None): ``(A) Term.--The term of office of each member of
p.(None): the Board appointed under paragraph (1)(C)(i), and the
p.(None): term of office of any member of the Board whose position
p.(None): is established pursuant to paragraph (1)(C)(ii), shall
p.(None): be 4 years, except that--
p.(None): ``(i) the terms of offices for the members of
p.(None): the Board initially appointed under paragraph
p.(None): (1)(C)(i)
p.(None):
p.(None): [[Page 130 STAT. 1140]]
p.(None):
p.(None): shall expire on a staggered basis as determined by
p.(None): the ex officio members; and
p.(None): ``(ii) the terms of office for the persons
p.(None): initially appointed to positions established
p.(None): pursuant to paragraph (1)(C)(ii) may be made to
p.(None): expire on a staggered basis, as determined by the
p.(None): individuals who, as of the date of the amendment
p.(None): establishing such positions, are members of the
p.(None): Board.''.
p.(None):
p.(None): (b) Executive Director Compensation.--Section 770(g)(2) of the
p.(None): Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended
p.(None): by striking ``but shall not be greater than the compensation of the
p.(None): Commissioner''.
p.(None): (c) Separation of Funds.--Section 770(m) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ``are held
p.(None): in separate accounts from funds received from entities under subsection
p.(None): (i)'' and inserting ``are managed as individual programmatic funds under
p.(None): subsection (i), according to best accounting practices''.
p.(None):
p.(None): Subtitle H--Medical Countermeasures Innovation
p.(None):
p.(None): SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.
p.(None):
p.(None): Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
p.(None): is amended--
p.(None): (1) in subsection (a), by adding at the end the following:
p.(None): ``(3) Utilization guidelines.--The Secretary shall ensure
p.(None): timely and accurate recommended utilization guidelines for
p.(None): qualified countermeasures (as defined in section 319F-1),
p.(None): qualified pandemic and epidemic products (as defined in section
p.(None): 319F-3), and security countermeasures (as defined in subsection
p.(None): (c)), including for such products in the stockpile.''; and
p.(None): (2) in subsection (g)--
p.(None): (A) by amending paragraph (4) to read as follows:
p.(None): ``(4) Report on security countermeasure procurement.--Not
p.(None): later than March 1 of each year in which the Secretary
p.(None): determines that the amount of funds available for procurement of
p.(None): security countermeasures is less than $1,500,000,000, the
p.(None): Secretary shall submit to the Committee on Appropriations and
p.(None): the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Appropriations and the Committee on
p.(None): Energy and Commerce of the House of Representatives a report
p.(None): detailing the amount of such funds available for procurement and
p.(None): the impact such amount of funding will have--
...
p.(None): ``(A) Notice to appropriate congressional
p.(None): committees.--The Secretary shall notify the Committee on
p.(None): Appropriations and the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on
p.(None): Appropriations and the Committee on Energy and Commerce
p.(None): of the House of Representatives of each decision to make
p.(None): available the special reserve fund as defined in
p.(None): subsection (h) for procurement of a security
p.(None): countermeasure, including, where available, the number
p.(None): of, the nature of, and other information concerning
p.(None): potential suppliers of such countermeasure, and whether
p.(None): other potential suppliers of the same or similar
p.(None): countermeasures were considered and rejected for
p.(None): procurement under this section and the reasons for each
p.(None): such rejection.''; and
p.(None): (D) in the heading, by striking ``Recommendation for
p.(None): president's approval'' and inserting ``Recommendations
p.(None): for procurement''; and
p.(None): (3) in paragraph (7)--
p.(None): (A) by striking subparagraphs (A) and (B) and
p.(None): inserting the following:
p.(None): ``(A) Payments from special reserve fund.--The
p.(None): special reserve fund as defined in subsection (h) shall
p.(None): be available for payments made by the Secretary to a
p.(None): vendor for procurement of a security countermeasure in
p.(None): accordance with the provisions of this paragraph.''; and
p.(None): (B) by redesignating subparagraph (C) as
p.(None): subparagraph (B).
p.(None): SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A
p.(None): NATIONAL SECURITY THREAT.
p.(None):
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565
p.(None): the following:
p.(None):
p.(None): [[Page 130 STAT. 1145]]
p.(None):
p.(None): ``SEC. 565A. <> PRIORITY REVIEW TO
p.(None): ENCOURAGE TREATMENTS FOR AGENTS THAT
p.(None): PRESENT NATIONAL SECURITY THREATS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Human drug application.--The term `human drug
p.(None): application' has the meaning given such term in section 735(1).
p.(None): ``(2) Priority review.--The term `priority review', with
p.(None): respect to a human drug application, means review and action by
p.(None): the Secretary on such application not later than 6 months after
p.(None): receipt by the Secretary of such application, as described in
p.(None): the Manual of Policies and Procedures in the Food and Drug
p.(None): Administration and goals identified in the letters described in
p.(None): section 101(b) of the Food and Drug Administration Safety and
p.(None): Innovation Act.
p.(None): ``(3) Priority review voucher.--The term `priority review
p.(None): voucher' means a voucher issued by the Secretary to the sponsor
p.(None): of a material threat medical countermeasure application that
p.(None): entitles the holder of such voucher to priority review of a
p.(None): single human drug application submitted under section 505(b)(1)
p.(None): or section 351(a) of the Public Health Service Act after the
p.(None): date of approval of the material threat medical countermeasure
p.(None): application.
p.(None): ``(4) Material threat medical countermeasure application.--
p.(None): The term `material threat medical countermeasure application'
p.(None): means an application that--
p.(None): ``(A) is a human drug application for a drug
p.(None): intended for use--
p.(None): ``(i) to prevent, or treat harm from a
p.(None): biological, chemical, radiological, or nuclear
p.(None): agent identified as a material threat under
p.(None): section 319F-2(c)(2)(A)(ii) of the Public Health
p.(None): Service Act; or
p.(None): ``(ii) to mitigate, prevent, or treat harm
p.(None): from a condition that may result in adverse health
p.(None): consequences or death and may be caused by
p.(None): administering a drug, or biological product
p.(None): against such agent; and
p.(None): ``(B) the Secretary determines eligible for priority
p.(None): review;
p.(None): ``(C) is approved after the date of enactment of the
p.(None): 21st Century Cures Act; and
p.(None): ``(D) is for a human drug, no active ingredient
p.(None): (including any ester or salt of the active ingredient)
p.(None): of which has been approved in any other application
p.(None): under section 505(b)(1) or section 351(a) of the Public
p.(None): Health Service Act.
p.(None):
p.(None): ``(b) Priority Review Voucher.--
p.(None): ``(1) In general.--The Secretary shall award a priority
p.(None): review voucher to the sponsor of a material threat medical
p.(None): countermeasure application upon approval by the Secretary of
p.(None): such material threat medical countermeasure application.
p.(None): ``(2) Transferability.--The sponsor of a material threat
p.(None): medical countermeasure application that receives a priority
p.(None): review voucher under this section may transfer (including by
p.(None): sale) the entitlement to such voucher to a sponsor of a human
p.(None): drug for which an application under section 505(b)(1) or section
p.(None): 351(a) of the Public Health Service Act will be submitted after
p.(None): the date of the approval of the material threat medical
p.(None): countermeasure application. There is no limit on the number of
p.(None): times
p.(None):
p.(None): [[Page 130 STAT. 1146]]
p.(None):
p.(None): a priority review voucher may be transferred before such voucher
p.(None): is used.
p.(None): ``(3) Notification.--
p.(None): ``(A) In general.--The sponsor of a human drug
p.(None): application shall notify the Secretary not later than 90
p.(None): calendar days prior to submission of the human drug
p.(None): application that is the subject of a priority review
p.(None): voucher of an intent to submit the human drug
p.(None): application, including the date on which the sponsor
p.(None): intends to submit the application. Such notification
p.(None): shall be a legally binding commitment to pay for the
p.(None): user fee to be assessed in accordance with this section.
p.(None): ``(B) Transfer after notice.--The sponsor of a human
p.(None): drug application that provides notification of the
p.(None): intent of such sponsor to use the voucher for the human
p.(None): drug application under subparagraph (A) may transfer the
p.(None): voucher after such notification is provided, if such
p.(None): sponsor has not yet submitted the human drug application
p.(None): described in the notification.
p.(None): ``(c) Priority Review User Fee.--
p.(None): ``(1) In general.--The Secretary shall establish a user fee
p.(None): program under which a sponsor of a human drug application that
p.(None): is the subject of a priority review voucher shall pay to the
p.(None): Secretary a fee determined under paragraph (2). Such fee shall
p.(None): be in addition to any fee required to be submitted by the
p.(None): sponsor under chapter VII.
p.(None): ``(2) Fee amount.--The amount of the priority review user
p.(None): fee shall be determined each fiscal year by the Secretary and
p.(None): based on the average cost incurred by the agency in the review
p.(None): of a human drug application subject to priority review in the
p.(None): previous fiscal year.
p.(None): ``(3) Annual fee setting.--The Secretary shall establish,
p.(None): before the beginning of each fiscal year beginning after
p.(None): September 30, 2016, for that fiscal year, the amount of the
p.(None): priority review user fee.
p.(None): ``(4) Payment.--
p.(None): ``(A) In general.--The priority review user fee
p.(None): required by this subsection shall be due upon the
p.(None): submission of a human drug application under section
p.(None): 505(b)(1) or section 351(a) of the Public Health Service
p.(None): Act for which the priority review voucher is used.
p.(None): ``(B) Complete application.--An application
p.(None): described under subparagraph (A) for which the sponsor
p.(None): requests the use of a priority review voucher shall be
p.(None): considered incomplete if the fee required by this
p.(None): subsection and all other applicable user fees are not
p.(None): paid in accordance with the Secretary's procedures for
p.(None): paying such fees.
p.(None): ``(C) No waivers, exemptions, reductions, or
p.(None): refunds.--The Secretary may not grant a waiver,
p.(None): exemption, reduction, or refund of any fees due and
p.(None): payable under this section.
p.(None): ``(5) Offsetting collections.--Fees collected pursuant to
p.(None): this subsection for any fiscal year--
p.(None): ``(A) shall be deposited and credited as offsetting
p.(None): collections to the account providing appropriations to
p.(None): the Food and Drug Administration; and
p.(None):
p.(None): [[Page 130 STAT. 1147]]
p.(None):
p.(None): ``(6) shall not be collected for any fiscal year except to
p.(None): the extent provided in advance in appropriation Acts.
p.(None):
p.(None): ``(d) Notice of Issuance of Voucher and Approval of Products Under
p.(None): Voucher.--The Secretary shall publish a notice in the Federal Register
p.(None): and on the Internet website of the Food and Drug Administration not
p.(None): later than 30 calendar days after the occurrence of each of the
p.(None): following:
p.(None): ``(1) The Secretary issues a priority review voucher under
p.(None): this section.
p.(None): ``(2) The Secretary approves a drug pursuant to an
p.(None): application submitted under section 505(b) of this Act or
p.(None): section 351(a) of the Public Health Service Act for which the
p.(None): sponsor of the application used a priority review voucher issued
p.(None): under this section.
p.(None):
p.(None): ``(e) Eligibility for Other Programs.--Nothing in this section
p.(None): precludes a sponsor who seeks a priority review voucher under this
p.(None): section from participating in any other incentive program, including
p.(None): under this Act, except that no sponsor of a material threat medical
p.(None): countermeasure application may receive more than one priority review
p.(None): voucher issued under any section of this Act with respect to such drug.
p.(None): ``(f) Relation to Other Provisions.--The provisions of this section
p.(None): shall supplement, not supplant, any other provisions of this Act or the
p.(None): Public Health Service Act that encourage the development of medical
p.(None): countermeasures.
p.(None): ``(g) Sunset.--The Secretary may not award any priority review
p.(None): vouchers under subsection (b) after October 1, 2023.''.
p.(None): SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH
p.(None): EMERGENCY.
p.(None):
p.(None): Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
p.(None): amended by adding at the end the following:
p.(None): ``(f) Determination With Respect to Paperwork Reduction Act Waiver
p.(None): During a Public Health Emergency.--
p.(None): ``(1) Determination.--If the Secretary determines, after
p.(None): consultation with such public health officials as may be
p.(None): necessary, that--
p.(None): ``(A)(i) the criteria set forth for a public health
p.(None): emergency under paragraph (1) or (2) of subsection (a)
p.(None): has been met; or
p.(None): ``(ii) a disease or disorder, including a novel and
p.(None): emerging public health threat, is significantly likely
p.(None): to become a public health emergency; and
p.(None): ``(B) the circumstances of such public health
p.(None): emergency, or potential for such significantly likely
p.(None): public health emergency, including the specific
p.(None): preparation for and response to such public health
...
p.(None): Health and Human Services, as applicable.
p.(None): ``(3) Effectiveness of waiver.--Any waiver under this
p.(None): subsection shall take effect on the date on which the Secretary
p.(None): posts information on the Internet website as provided for in
p.(None): this subsection.
p.(None): ``(4) Termination of waiver.--Upon determining that the
p.(None): circumstances necessitating a waiver under paragraph (1) no
p.(None): longer exist, the Secretary shall promptly update the Internet
p.(None): website of the Department of Health and Human Services to
p.(None): reflect the termination of such waiver.
p.(None): ``(5) Limitations.--
p.(None): ``(A) Period of waiver.--The period of a waiver
p.(None): under paragraph (1) shall not exceed the period of time
p.(None): for the related public health emergency, including a
p.(None): public health emergency declared pursuant to subsection
p.(None): (a), and any immediate postresponse review regarding the
p.(None): public health emergency consistent with the requirements
p.(None): of this subsection.
p.(None): ``(B) Subsequent compliance.--An initiative subject
p.(None): to a waiver under paragraph (1) that is ongoing after
p.(None): the date on which the waiver expires, shall be subject
p.(None): to the requirements of subchapter I of chapter 35 of
p.(None): title 44, United States Code, and the Secretary shall
p.(None): ensure that compliance with such requirements occurs in
p.(None): as timely a manner as possible based on the applicable
p.(None): circumstances, but not to exceed 30 calendar days after
p.(None): the expiration of the applicable waiver.''.
p.(None): SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE
p.(None): AUTHORIZATION.
p.(None):
p.(None): (a) Authorization for Medical Products for Use in Emergencies.--
p.(None): Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360bbb-3) is amended--
p.(None): (1) in subsection (a)(2)--
p.(None): (A) in subparagraph (A)--
p.(None): (i) by striking ``or 515'' and inserting
p.(None): ``512, or 515''; and
p.(None): (ii) by inserting ``or conditionally approved
p.(None): under section 571 of this Act'' after ``Public
p.(None): Health Service Act''; and
p.(None):
p.(None): [[Page 130 STAT. 1149]]
p.(None):
p.(None): (B) in subparagraph (B), by inserting
p.(None): ``conditionally approved under section 571,'' after
p.(None): ``approved,'' each place the term appears;
p.(None): (2) in subsection (b)(4), by striking the second comma after
p.(None): ``determination'';
p.(None): (3) in subsection (e)(3)(B), by striking ``section 503(b)''
p.(None): and inserting ``subsection (b) or (f) of section 503 or under
p.(None): section 504'';
p.(None): (4) in subsection (f)(2)--
p.(None): (A) by inserting ``, or an animal to which,'' after
p.(None): ``to a patient to whom''; and
p.(None): (B) by inserting ``or by the veterinarian caring for
p.(None): such animal, as applicable'' after ``attending
p.(None): physician'';
p.(None): (5) in subsection (g)(1), by inserting ``conditional
p.(None): approval under section 571,'' after ``approval,'';
p.(None): (6) in subsection (h)(1), by striking ``or section
p.(None): 520(g)''and inserting ``512(j), or 520(g)''; and
p.(None): (7) in subsection (k), by striking ``section 520(g),''and
p.(None): inserting ``512(j), or 520(g)''.
p.(None):
p.(None): (b) New Animal Drugs.--Section 512(a)(1) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended--
p.(None): (1) in subparagraph (B), by striking ``or'' at the end;
p.(None): (2) in subparagraph (C), by striking the period and
p.(None): inserting ``; or''; and
p.(None): (3) by inserting after subparagraph (C) the following:
p.(None): ``(D) there is in effect an authorization pursuant to
p.(None): section 564 with respect to such use or intended use of such
p.(None): drug, and such drug, its labeling, and such use conform to any
p.(None): conditions of such authorization.''.
p.(None):
p.(None): (c) Emergency Use of Medical Products.--Section 564A of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
p.(None): (1) in subsection (a)(1)(A), by inserting ``, conditionally
p.(None): approved under section 571,'' after ``chapter''; and
p.(None): (2) in subsection (d), by striking ``sections 503(b) and
p.(None): 520(e)'' and inserting ``subsections (b) and (f) of section 503,
p.(None): section 504, and section 520(e)''.
p.(None):
p.(None): (d) Products Held for Emergency Use.--Section 564B(2) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is amended--
p.(None): (1) in subparagraph (A)--
p.(None): (A) by inserting ``or conditionally approved under
p.(None): section 571 of this Act'' after ``Public Health Service
p.(None): Act''; and
p.(None): (B) by striking ``or 515'' and inserting ``512, or
p.(None): 515''; and
p.(None): (2) in subparagraph (B), by striking ``or 520'' and
p.(None): inserting ``512, or 520''.
p.(None):
p.(None): Subtitle I--Vaccine Access, Certainty, and Innovation
p.(None):
p.(None): SEC. 3091. <> PREDICTABLE REVIEW
p.(None): TIMELINES OF VACCINES BY THE ADVISORY
p.(None): COMMITTEE ON IMMUNIZATION PRACTICES.
p.(None):
p.(None): (a) Consideration of New Vaccines.--Upon the licensure of any
p.(None): vaccine or any new indication for a vaccine, the Advisory
p.(None):
p.(None): [[Page 130 STAT. 1150]]
p.(None):
p.(None): Committee on Immunization Practices (in this section referred to as the
p.(None): ``Advisory Committee'') shall, as appropriate, consider the use of the
p.(None): vaccine at its next regularly scheduled meeting.
p.(None): (b) Additional Information.--If the Advisory Committee does not make
p.(None): a recommendation with respect to the use of a vaccine at the Advisory
p.(None): Committee's first regularly scheduled meeting after the licensure of the
p.(None): vaccine or any new indication for the vaccine, the Advisory Committee
p.(None): shall provide an update on the status of such committee's review.
p.(None): (c) Consideration for Breakthrough Therapies and for Potential Use
p.(None): During Public Health Emergency.--The Advisory Committee shall make
p.(None): recommendations with respect to the use of certain vaccines in a timely
p.(None): manner, as appropriate, including vaccines that--
p.(None): (1) are designated as a breakthrough therapy under section
p.(None): 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356)
p.(None): and licensed under section 351 of the Public Health Service Act
p.(None): (42 U.S.C. 262); or
p.(None): (2) could be used in a public health emergency.
p.(None):
p.(None): (d) Definition.--In this section, the terms ``Advisory Committee on
p.(None): Immunization Practices'' and ``Advisory Committee'' mean the Advisory
p.(None): Committee on Immunization Practices established by the Secretary
p.(None): pursuant to section 222 of the Public Health Service Act (42 U.S.C.
p.(None): 217a), acting through the Director of the Centers for Disease Control
p.(None): and Prevention.''.
p.(None): SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY
p.(None): COMMITTEE ON IMMUNIZATION PRACTICES
p.(None): RECOMMENDATIONS.
p.(None):
p.(None): (a) Review.--The Director of the Centers for Disease Control and
p.(None): Prevention shall conduct a review of the processes used by the Advisory
p.(None): Committee on Immunization Practices in formulating and issuing
p.(None): recommendations pertaining to vaccines, including with respect to
p.(None): consistency.
p.(None): (b) Considerations.--The review under subsection (a) shall include
p.(None): an assessment of--
p.(None): (1) the criteria used to evaluate new and existing vaccines,
p.(None): including the identification of any areas for which flexibility
p.(None): in evaluating such criteria is necessary and the reason for such
p.(None): flexibility;
p.(None): (2) the Grading of Recommendations, Assessment, Development,
p.(None): and Evaluation (GRADE) approach to the review and analysis of
p.(None): scientific and economic data, including the scientific basis for
p.(None): such approach; and
p.(None): (3) the extent to which the processes used by the work
p.(None): groups of the Advisory Committee on Immunization Practices are
...
p.(None): publicly available, a report on the results of the review under
p.(None): subsection (a), including any recommendations
p.(None):
p.(None): [[Page 130 STAT. 1151]]
p.(None):
p.(None): on improving the consistency of the processes described in such
p.(None): subsection.
p.(None): (e) Definition.--In this section, the term ``Advisory Committee on
p.(None): Immunization Practices'' means the Advisory Committee on Immunization
p.(None): Practices established by the Secretary of Health and Human Services
p.(None): pursuant to section 222 of the Public Health Service Act (42 U.S.C.
p.(None): 217a), acting through the Director of the Centers for Disease Control
p.(None): and Prevention.
p.(None): SEC. 3093. <> ENCOURAGING VACCINE
p.(None): INNOVATION.
p.(None):
p.(None): (a) Vaccine Meetings.--The Director of the Centers for Disease
p.(None): Control and Prevention shall ensure that appropriate staff within the
p.(None): relevant centers and divisions of the Office of Infectious Diseases, and
p.(None): others, as appropriate, coordinate with respect to the public health
p.(None): needs, epidemiology, and program planning and implementation
p.(None): considerations related to immunization, including with regard to
p.(None): meetings with stakeholders related to such topics.
p.(None): (b) Report on Vaccine Innovation.--
p.(None): (1) In general.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services (referred to in this section as the ``Secretary''), in
p.(None): collaboration with appropriate agencies or offices within the
p.(None): Department of Health and Human Services, including the National
p.(None): Institutes of Health, the Centers for Disease Control and
p.(None): Prevention, the Food and Drug Administration, and the Biomedical
p.(None): Advanced Research and Development Authority, shall submit to the
p.(None): Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of
p.(None): Representatives, and post publicly on the Internet website of
p.(None): the Department of Health and Human Services, a report on ways to
p.(None): promote innovation in the development of vaccines that minimize
p.(None): the burden of infectious disease.
p.(None): (2) Contents.--The report described in paragraph (1) shall
p.(None): review the current status of vaccine development and, as
p.(None): appropriate--
p.(None): (A) consider the optimal process to determine which
p.(None): vaccines would be beneficial to public health and how
p.(None): information on such vaccines is disseminated to key
p.(None): stakeholders;
p.(None): (B) examine and identify whether obstacles exist
p.(None): that inhibit the development of beneficial vaccines; and
p.(None): (C) make recommendations about how best to remove
p.(None): any obstacles identified under subparagraph (B) in order
p.(None): to promote and incentivize vaccine innovation and
p.(None): development.
p.(None): (3) Consultation.--In preparing the report under this
p.(None): subsection, the Secretary may consult with--
p.(None): (A) representatives of relevant Federal agencies and
p.(None): departments, including the Department of Defense and the
p.(None): Department of Veterans Affairs;
p.(None): (B) academic researchers;
p.(None): (C) developers and manufacturers of vaccines;
p.(None): (D) medical and public health practitioners;
p.(None): (E) representatives of patient, policy, and advocacy
p.(None): organizations; and
p.(None):
p.(None): [[Page 130 STAT. 1152]]
p.(None):
...
p.(None): covered vaccine while pregnant and any child who was in utero at
p.(None): the time such woman received the vaccine shall be considered
p.(None): persons to whom the covered vaccine was administered and persons
p.(None): who received the covered vaccine.
p.(None): ``(2) Definition.--As used in this subsection, the term
p.(None): `child' shall have the meaning given that term by subsections
p.(None): (a) and (b) of section 8 of title 1, United States Code, except
p.(None): that, for purposes of this subsection, such section 8 shall be
p.(None): applied as if the term `include' in subsection (a) of such
p.(None): section were replaced with the term `mean'.''.
p.(None): (3) Petitioners.--Section 2111(b)(2) of the Public Health
p.(None): Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A
p.(None): covered vaccine administered to a pregnant woman shall
p.(None): constitute more than one administration, one to the mother and
p.(None): one to each child (as such term is defined in subsection (f)(2))
p.(None): who was in utero at the time such woman was administered the
p.(None): vaccine.'' at the end.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): SEC. 3101. TECHNICAL CORRECTIONS.
p.(None):
p.(None): (a) FFDCA.--
p.(None): (1) References.--Except as otherwise expressly provided,
p.(None): whenever in this subsection an amendment is expressed in terms
p.(None): of an amendment to a section or other provision, the reference
p.(None): shall be considered to be made to that section or other
p.(None): provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 301 et seq.).
p.(None): (2) Amendments.--
p.(None): (A) Prohibited acts.--Section 301(r) (21 U.S.C.
p.(None): 331(r)) is amended by inserting ``, drug,'' after
p.(None): ``device'' each place the term appears.
p.(None): (B) New drugs.--Section 505 (21 U.S.C. 355) is
p.(None): amended--
p.(None):
p.(None): [[Page 130 STAT. 1153]]
p.(None):
p.(None): (i) in subsection (d), in the last sentence,
p.(None): by striking ``premarket approval'' and inserting
p.(None): ``marketing approval''; and
p.(None): (ii) in subsection (q)(5)(A), by striking
p.(None): ``subsection (b)(2) or (j) of the Act or 351(k)''
p.(None): and inserting ``subsection (b)(2) or (j) of this
p.(None): section or section 351(k)''.
p.(None): (C) Risk evaluation and mitigation strategies.--
p.(None): Section 505-1(h)(21 U.S.C. 355-1(h)) is amended--
p.(None): (i) in paragraph (2)(A)(iii)--
p.(None): (I) in the clause heading, by
p.(None): striking ``label'' and inserting
p.(None): ``labeling'';
p.(None): (II) by striking ``label'' each
p.(None): place the term appears and inserting
p.(None): ``labeling''; and
p.(None): (III) by striking ``sponsor'' and
p.(None): inserting ``responsible person''; and
p.(None): (ii) in paragraph (8), by striking ``and
p.(None): (7).'' and inserting ``and (7)''.
p.(None): (D) Pediatric study plans.--Section 505B (21 U.S.C.
p.(None): 355c) is amended--
p.(None): (i) in subsection (e)--
p.(None): (I) in paragraph (2)--
p.(None): (aa) in subparagraph (A), by
p.(None): inserting ``study'' after
p.(None): ``initial pediatric'' each place
p.(None): the term appears; and
p.(None): (bb) in subparagraph (B), in
p.(None): the subparagraph heading, by
p.(None): striking ``initial plan'' and
p.(None): inserting ``initial pediatric
p.(None): study plan'';
p.(None): (II) in paragraph (5), in the
p.(None): paragraph heading, by inserting ``agreed
p.(None): initial pediatric study'' before
p.(None): ``plan''; and
p.(None): (III) in paragraph (6), by striking
p.(None): ``agreed initial pediatric plan'' and
p.(None): inserting ``agreed initial pediatric
p.(None): study plan''; and
p.(None): (ii) in subsection (f)(1), by inserting ``and
p.(None): any significant amendments to such plans,'' after
p.(None): ``agreed initial pediatric study plans,''.
p.(None): (E) Discontinuance or interruption in the production
p.(None): of live-saving drugs.--Section 506C (21 U.S.C. 356c) is
p.(None): amended--
p.(None): (i) in subsection (c), by striking
p.(None): ``discontinuation'' and inserting
p.(None): ``discontinuance''; and
p.(None): (ii) in subsection (g)(1), by striking
p.(None): ``section 505(j) that could help'' and inserting
p.(None): ``section 505(j), that could help''.
p.(None): (F) Annual reporting on drug shortages.--Section
p.(None): 506C-1(a) (21 U.S.C. 331(a)) is amended, in the matter
p.(None): before paragraph (1)--
p.(None): (i) by striking ``Not later than the end of
p.(None): calendar year 2013, and not later than the end of
p.(None): each calendar year thereafter,'' and inserting
p.(None): ``Not later than March 31 of each calendar
p.(None): year,''; and
p.(None): (ii) by inserting ``, with respect to the
p.(None): preceding calendar year,'' after ``a report''.
p.(None): (G) Drug shortage list.--Section 506E(b)(3)(E) (21
p.(None): U.S.C. 356e(b)(3)(E)) is amended by striking
p.(None): ``discontinuation'' and inserting ``discontinuance''.
p.(None):
p.(None): [[Page 130 STAT. 1154]]
p.(None):
p.(None): (H) Inspections of establishments.--Section 510(h)
p.(None): (21 U.S.C. 360(h)) is amended--
p.(None): (i) in paragraph (4), in the matter preceding
p.(None): subparagraph (A), by striking ``establishing the
p.(None): risk-based scheduled'' and inserting
p.(None): ``establishing a risk-based schedule''; and
p.(None): (ii) in paragraph (6)--
p.(None): (I) in subparagraph (A), by striking
p.(None): ``fiscal'' and inserting ``calendar''
p.(None): each place the term appears; and
p.(None): (II) in subparagraph (B), by
p.(None): striking ``an active ingredient of a
p.(None): drug, a finished drug product, or an
p.(None): excipient of a drug'' and inserting ``an
p.(None): active ingredient of a drug or a
p.(None): finished drug product''.
p.(None): (I) Classification of devices intended for human
p.(None): use.--Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is
p.(None): amended--
p.(None): (i) in clause (i), by striking ``within 30
p.(None): days''; and
p.(None): (ii) in clause (iv), by striking ``low-
p.(None): moderate'' and inserting ``low to moderate''.
p.(None): (J) Premarket approval.--Section 515(a)(1) (21
p.(None): U.S.C. 360e(a)(1)) is amended by striking ``subject to a
p.(None): an order'' and inserting ``subject to an order''.
p.(None): (K) Program to improve the device recall system.--
p.(None): Section 518A (21 U.S.C. 360h-1) is amended--
p.(None): (i) by striking subsection (c); and
p.(None): (ii) by redesignating subsection (d) as
p.(None): subsection (c).
p.(None): (L) Unique device identifier.--Section 519(f) (21
p.(None): U.S.C. 360i(f)) is amended by striking ``and life
p.(None): sustaining'' and inserting ``or life sustaining''.
p.(None): (M) Priority review to encourage treatments for
p.(None): tropical diseases.--Section 524(c)(4)(A) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A))
p.(None): is amended by striking ``Services Act'' and inserting
p.(None): ``Service Act''.
p.(None): (N) Priority review for qualified infectious disease
p.(None): products.--Section 524A (21 U.S.C. 360n-1) is amended--
p.(None): (i) by striking ``If the Secretary'' and
p.(None): inserting the following:
p.(None):
p.(None): ``(a) In General.--If the Secretary'';
p.(None): (ii) by striking ``any'' and inserting ``the
p.(None): first''; and
p.(None): (iii) by adding at the end the following:
p.(None):
p.(None): ``(b) Construction.--Nothing in this section shall prohibit the
p.(None): Secretary from giving priority review to a human drug application or
p.(None): efficacy supplement submitted for approval under section 505(b) that
p.(None): otherwise meets the criteria for the Secretary to grant priority
p.(None): review.''.
p.(None): (O) Consultation with external experts on rare
p.(None): diseases, targeted therapies, and genetic targeting of
p.(None): treatments.--Section 569(a)(2)(A) (21 U.S.C. 360bbb-
p.(None): 8(a)(2)(A)) is amended, in the first sentence, by
p.(None): striking ``subsection (c)'' and inserting ``subsection
p.(None): (b)''.
p.(None): (P) Optimizing global clinical trials.--Section
p.(None): 569A(c) (21 U.S.C. 360bbb-8a(c)) is amended by inserting
p.(None): ``or under the Public Health Service Act'' after ``this
p.(None): Act''.
p.(None):
p.(None): [[Page 130 STAT. 1155]]
p.(None):
p.(None): (Q) Use of clinical investigation data from outside
p.(None): the united states.--Section 569B (21 U.S.C. 360bbb-8b)
p.(None): is amended by striking ``drug or device'' and inserting
p.(None): ``drug, biological product, or device'' each place the
p.(None): term appears.
p.(None): (R) Medical gases definitions.--Section 575(1)(H)
p.(None): (21 U.S.C. 360ddd(1)(H)) is amended--
p.(None): (i) by inserting ``for a new drug'' after
p.(None): ``any period of exclusivity''; and
p.(None): (ii) by inserting ``or any period of
p.(None): exclusivity for a new animal drug under section
p.(None): 512(c)(2)(F),'' after ``section 505A,''.
p.(None): (S) Regulation of medical gases.--Section 576(a) (21
p.(None): U.S.C. 360ddd-1(a)) is amended--
p.(None): (i) in the matter preceding subparagraph (A)
p.(None): of paragraph (1), by inserting ``who seeks to
p.(None): initially introduce or deliver for introduction a
p.(None): designated medical gas into interstate commerce''
p.(None): after ``any person''; and
p.(None): (ii) in paragraph (3)--
p.(None): (I) in subparagraph (A)--
p.(None): (aa) in clause (i)(VIII), by
p.(None): inserting ``for a new drug''
p.(None): after ``any period of
p.(None): exclusivity''; and
p.(None): (bb) in clause (ii), in the
p.(None): matter preceding subclause (I),
p.(None): by inserting ``the'' before
p.(None): ``final use''; and
p.(None): (II) in subparagraph (B)--
p.(None): (aa) in clause (i), by
p.(None): inserting ``for a new drug''
p.(None): after ``any period of
p.(None): exclusivity''; and
p.(None): (bb) in clause (ii), by
p.(None): inserting a comma after ``drug
p.(None): product''.
p.(None): (T) Inapplicability of drug fees to designated
p.(None): medical gases.--Section 577 (21 U.S.C. 360ddd-2) is
p.(None): amended by inserting ``or 740(a)'' after ``section
p.(None): 736(a)''.
p.(None): (U) Conflicts of interest.--Section 712(e)(1)(B) (21
p.(None): U.S.C. 379d-1(e)(1)(B)) is amended by striking
p.(None): ``services'' and inserting ``service''.
p.(None): (V) Authority to assess and use biosimilar
p.(None): biological product fees.--Section 744H(a) (21 U.S.C.
p.(None): 379j-52(a)) is amended--
p.(None): (i) in paragraph (1)(A)(v), by striking
p.(None): ``Biosimilars User Fee Act of 2012'' and inserting
p.(None): ``Biosimilar User Fee Act of 2012''; and
p.(None): (ii) in paragraph (2)(B), by striking
p.(None): ``Biosimilars User Fee Act of 2012'' and inserting
p.(None): ``Biosimilar User Fee Act of 2012''.
p.(None): (W) Registration of commercial importers.--
p.(None): (i) Amendment.--Section 801(s)(2) (21 U.S.C.
p.(None): 381(s)(2)) is amended by adding at the end the
p.(None): following:
p.(None): ``(D) Effective date.--In establishing the effective
p.(None): date of the regulations under subparagraph (A), the
p.(None): Secretary shall, in consultation with the Secretary of
p.(None): Homeland Security acting through U.S. Customs and Border
p.(None): Protection, as determined appropriate by the Secretary
p.(None): of Health and Human Services, provide a reasonable
p.(None): period of time for an importer of a drug to comply with
p.(None): good
p.(None):
p.(None): [[Page 130 STAT. 1156]]
p.(None):
p.(None): importer practices, taking into account differences
p.(None): among importers and types of imports, including based on
p.(None): the level of risk posed by the imported product.''.
p.(None): (ii) Conforming amendment.--Section 714 of the
p.(None): Food and Drug Administration Safety and Innovation
p.(None): Act (Public Law 112-144; 126 Stat. 1074) is
p.(None): amended by striking subsection (d).
p.(None): (X) Recognition of foreign government inspections.--
p.(None): Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by
p.(None): striking ``conduction'' and inserting ``conducting''.
p.(None):
p.(None): (b) FDASIA.--
p.(None): (1) Findings relating to drug approval.--Section
p.(None): 901(a)(1)(A) of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is
p.(None): amended by striking ``serious and life-threatening diseases''
p.(None): and inserting ``serious or life-threatening diseases''.
p.(None): (2) Reporting of inclusion of demographic subgroups.--
p.(None): Section 907 of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is
p.(None): amended--
p.(None): (A) in the section heading, by striking
p.(None): ``biologics'' in the heading and inserting ``biological
p.(None): products''; and
p.(None): (B) in subsection (a)(2)(B), by striking
p.(None): ``applications for new drug applications'' and inserting
p.(None): ``new drug applications''.
p.(None): (3) Combating prescription drug abuse.--Section 1122 of the
p.(None): Food and Drug Administration Safety and Innovation Act (Public
p.(None): Law 112-144; 126 Stat. 1112, 1113) is amended--
p.(None): (A) in subsection (a)(2), by striking ``dependance''
p.(None): and inserting ``dependence''; and
p.(None): (B) in subsection (c), by striking ``promulgate''
p.(None): and inserting ``issue''.
p.(None): SEC. 3102. COMPLETED STUDIES.
p.(None):
p.(None): The Federal Food, Drug, and Cosmetic Act is amended--
p.(None): (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
p.(None): (A) in subparagraph (A), by inserting ``and'' after
p.(None): the semicolon;
p.(None): (B) by striking subparagraph (B); and
p.(None): (C) by redesignating subparagraph (C) as
p.(None): subparagraph (B);
p.(None): (2) in section 505A (21 U.S.C. 355a), by striking subsection
p.(None): (p);
p.(None): (3) in section 505B (21 U.S.C. 355c)--
p.(None): (A) by striking subsection (l); and
p.(None): (B) by redesignating subsection (m) as subsection
p.(None): (l); and
p.(None): (4) in section 523 (21 U.S.C. 360m), by striking subsection
p.(None): (d).
p.(None):
p.(None): [[Page 130 STAT. 1157]]
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
p.(None):
p.(None): (a) In General.--The Health Information Technology for Economic and
p.(None): Clinical Health Act (title XIII of division A of Public Law 111-5) is
p.(None): amended--
p.(None): (1) by adding at the end of part 1 of subtitle A the
p.(None): following:
p.(None): ``SEC. 13103. <> ASSISTING DOCTORS
p.(None): AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
p.(None): ``(a) Reduction in Burdens Goal.--The Secretary of Health and Human
p.(None): Services (referred to in this section as the `Secretary'), in
p.(None): consultation with providers of health services, health care suppliers of
p.(None): services, health care payers, health professional societies, health
p.(None): information technology developers, health care quality organizations,
p.(None): health care accreditation organizations, public health entities, States,
p.(None): and other appropriate entities, shall, in accordance with subsection
p.(None): (b)--
p.(None): ``(1) establish a goal with respect to the reduction of
...
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
p.(None): subsection as a target area described in subparagraph
p.(None): (B) if--
p.(None): ``(i) the area is so identified for purposes
p.(None): of responding to new circumstances that have
p.(None): arisen in the health information technology
p.(None): community that affect the interoperability,
p.(None): privacy, or security of health information, or
p.(None): affect patient safety; and
p.(None): ``(ii) at least 30 days prior to treating such
p.(None): area as if it were a target area described in
p.(None): subparagraph (B), the National Coordinator
p.(None): provides adequate notice to Congress of the intent
p.(None): to treat such area as so described.
p.(None): ``(E) Focus of committee work.--It is the sense of
p.(None): Congress that the HIT Advisory Committee shall focus its
p.(None): work on the priority areas described in subparagraph (B)
p.(None): before proceeding to other work under subparagraph (C).
p.(None): ``(3) Rules relating to recommendations for standards,
...
p.(None): ``(B) will reimburse such contractor, grantee, or
p.(None): other recipient for any portion of the money or property
p.(None): which is requested or demanded.
p.(None):
p.(None): ``(s) For purposes of subsection (o), the term `obligation' means an
p.(None): established duty, whether or not fixed, arising from an express or
p.(None): implied contractual, grantor-grantee, or licensor-licensee relationship,
p.(None): for a fee-based or similar relationship, from statute or regulation, or
p.(None): from the retention of any overpayment.''.
p.(None): (b) Conforming Amendments.--Section 1128A of the Social Security Act
p.(None): (42 U.S.C. 1320a-7a) is amended--
p.(None): (1) in subsection (e), by inserting ``or specified claim''
p.(None): after ``claim'' in the first sentence; and
p.(None): (2) in subsection (f)--
p.(None): (A) in the matter preceding paragraph (1)--
p.(None): (i) by inserting ``or specified claim (as
p.(None): defined in subsection (r))'' after ``district
p.(None): where the claim''; and
p.(None): (ii) by inserting ``(or, with respect to a
p.(None): person described in subsection (o), the person)''
p.(None): after ``claimant''; and
p.(None): (B) in the matter following paragraph (4), by
p.(None): inserting ``(or, in the case of a penalty or assessment
p.(None): under subsection (o), by a specified State agency (as
p.(None): defined in subsection (q)(6)),'' after ``or a State
p.(None): agency''.
p.(None): SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
p.(None):
p.(None): (a) Treatment of Infusion Drugs Furnished Through Durable Medical
p.(None): Equipment.--Section 1842(o)(1) of the Social Security Act (42 U.S.C.
p.(None): 1395u(o)(1)) is amended--
p.(None): (1) in subparagraph (C), by inserting ``(and including a
p.(None): drug or biological described in subparagraph (D)(i) furnished on
p.(None): or after January 1, 2017)'' after ``2005''; and
p.(None): (2) in subparagraph (D)--
p.(None): (A) by striking ``infusion drugs'' and inserting
p.(None): ``infusion drugs or biologicals'' each place it appears;
p.(None): and
p.(None): (B) in clause (i)--
p.(None):
p.(None): [[Page 130 STAT. 1191]]
p.(None): (i) by striking ``2004'' and inserting ``2004,
p.(None): and before January 1, 2017''; and
p.(None): (ii) by striking ``for such drug''.
p.(None):
p.(None): (b) Noninclusion of DME Infusion Drugs Under DME Competitive
p.(None): Acquisition Programs.--
p.(None): (1) In general.--Section 1847(a)(2)(A) of the Social
p.(None): Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
p.(None): (A) by striking ``and excluding'' and inserting ``,
p.(None): excluding''; and
p.(None): (B) by inserting before the period at the end the
p.(None): following: ``, and excluding drugs and biologicals
p.(None): described in section 1842(o)(1)(D)''.
p.(None): (2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the
p.(None): Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by
p.(None): striking ``2007'' and inserting ``2007, and before the date of
p.(None): the enactment of the 21st Century Cures Act.''.
p.(None): SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID
p.(None): PROVIDERS.
p.(None):
p.(None): (a) Increased Oversight and Reporting.--
p.(None): (1) State reporting requirements.--Section 1902(kk) of the
p.(None): Social Security Act (42 U.S.C. 1396a(kk)) is amended--
p.(None): (A) by redesignating paragraph (8) as paragraph (9);
p.(None): and
p.(None): (B) by inserting after paragraph (7) the following
p.(None): new paragraph:
p.(None): ``(8) Provider terminations.--
p.(None): ``(A) In general.--Beginning on July 1, 2018, in the
p.(None): case of a notification under subsection (a)(41) with
p.(None): respect to a termination for a reason specified in
p.(None): section 455.101 of title 42, Code of Federal Regulations
p.(None): (as in effect on November 1, 2015) or for any other
p.(None): reason specified by the Secretary, of the participation
p.(None): of a provider of services or any other person under the
p.(None): State plan (or under a waiver of the plan), the State,
p.(None): not later than 30 days after the effective date of such
p.(None): termination, submits to the Secretary with respect to
...
p.(None): amount, and duration of infusion therapy services that are to be
p.(None): furnished such individual has been established by a physician
p.(None): (as defined in subsection (r)(1)) and is periodically reviewed
p.(None): by a physician (as so defined) in coordination with the
p.(None): furnishing of home infusion drugs (as defined in paragraph
p.(None): (3)(C)) under part B.
p.(None):
p.(None): ``(2) The items and services described in this paragraph are the
p.(None): following:
p.(None): ``(A) Professional services, including nursing services,
p.(None): furnished in accordance with the plan.
p.(None): ``(B) Training and education (not otherwise paid for as
p.(None): durable medical equipment (as defined in subsection (n)), remote
p.(None): monitoring, and monitoring services for the provision of home
p.(None): infusion therapy and home infusion drugs furnished by a
p.(None): qualified home infusion therapy supplier.
p.(None):
p.(None): ``(3) For purposes of this subsection:
p.(None): ``(A) The term `applicable provider' means--
p.(None): ``(i) a physician;
p.(None):
p.(None): [[Page 130 STAT. 1199]]
p.(None):
p.(None): ``(ii) a nurse practitioner; and
p.(None): ``(iii) a physician assistant.
p.(None): ``(B) The term `home' means a place of residence used as the
p.(None): home of an individual (as defined for purposes of subsection
p.(None): (n)).
p.(None): ``(C) The term `home infusion drug' means a parenteral drug
p.(None): or biological administered intravenously, or subcutaneously for
p.(None): an administration period of 15 minutes or more, in the home of
p.(None): an individual through a pump that is an item of durable medical
p.(None): equipment (as defined in subsection (n)). Such term does not
p.(None): include the following:
p.(None): ``(i) Insulin pump systems.
p.(None): ``(ii) A self-administered drug or biological on a
p.(None): self-administered drug exclusion list.
p.(None): ``(D)(i) The term `qualified home infusion therapy supplier'
p.(None): means a pharmacy, physician, or other provider of services or
p.(None): supplier licensed by the State in which the pharmacy, physician,
p.(None): or provider or services or supplier furnishes items or services
p.(None): and that--
p.(None): ``(I) furnishes infusion therapy to individuals with
p.(None): acute or chronic conditions requiring administration of
p.(None): home infusion drugs;
p.(None): ``(II) ensures the safe and effective provision and
p.(None): administration of home infusion therapy on a 7-day-a-
p.(None): week, 24-hour-a-day basis;
p.(None): ``(III) is accredited by an organization designated
p.(None): by the Secretary pursuant to section 1834(u)(5); and
p.(None): ``(IV) meets such other requirements as the
p.(None): Secretary determines appropriate, taking into account
p.(None): the standards of care for home infusion therapy
p.(None): established by Medicare Advantage plans under part C and
p.(None): in the private sector.
p.(None): ``(ii) A qualified home infusion therapy supplier may
p.(None): subcontract with a pharmacy, physician, provider of services, or
p.(None): supplier to meet the requirements of this subparagraph.''.
p.(None):
p.(None): (b) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by
p.(None): section 4011, is further amended by adding at the end the following new
p.(None): subsection:
p.(None): ``(u) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): ``(1) Payment.--
p.(None): ``(A) Single payment.--
p.(None): ``(i) In general.--Subject to clause (iii) and
p.(None): subparagraphs (B) and (C), the Secretary shall
p.(None): implement a payment system under which a single
p.(None): payment is made under this title to a qualified
p.(None): home infusion therapy supplier for items and
p.(None): services described in subparagraphs (A) and (B) of
p.(None): section 1861(iii)(2)) furnished by a qualified
p.(None): home infusion therapy supplier (as defined in
p.(None): section 1861(iii)(3)(D)) in coordination with the
p.(None): furnishing of home infusion drugs (as defined in
p.(None): section 1861(iii)(3)(C)) under this part.
p.(None): ``(ii) Unit of single payment.--A unit of
p.(None): single payment under the payment system
p.(None): implemented under this subparagraph is for each
p.(None): infusion drug administration calendar day in the
p.(None): individual's home. The Secretary shall, as
p.(None): appropriate, establish single
p.(None):
p.(None): [[Page 130 STAT. 1200]]
p.(None):
p.(None): payment amounts for types of infusion therapy,
p.(None): including to take into account variation in
p.(None): utilization of nursing services by therapy type.
p.(None): ``(iii) Limitation.--The single payment amount
p.(None): determined under this subparagraph after
p.(None): application of subparagraph (B) and paragraph (3)
p.(None): shall not exceed the amount determined under the
p.(None): fee schedule under section 1848 for infusion
p.(None): therapy services furnished in a calendar day if
p.(None): furnished in a physician office setting, except
p.(None): such single payment shall not reflect more than 5
p.(None): hours of infusion for a particular therapy in a
p.(None): calendar day.
p.(None): ``(B) Required adjustments.--The Secretary shall
p.(None): adjust the single payment amount determined under
p.(None): subparagraph (A) for home infusion therapy services
p.(None): under section 1861(iii)(1) to reflect other factors such
p.(None): as--
p.(None): ``(i) a geographic wage index and other costs
p.(None): that may vary by region; and
p.(None): ``(ii) patient acuity and complexity of drug
p.(None): administration.
p.(None): ``(C) Discretionary adjustments.--
p.(None): ``(i) In general.--Subject to clause (ii), the
p.(None): Secretary may adjust the single payment amount
p.(None): determined under subparagraph (A) (after
p.(None): application of subparagraph (B)) to reflect
p.(None): outlier situations and other factors as the
p.(None): Secretary determines appropriate.
p.(None): ``(ii) Requirement of budget neutrality.--Any
p.(None): adjustment under this subparagraph shall be made
p.(None): in a budget neutral manner.
p.(None): ``(2) Considerations.--In developing the payment system
p.(None): under this subsection, the Secretary may consider the costs of
p.(None): furnishing infusion therapy in the home, consult with home
p.(None): infusion therapy suppliers, consider payment amounts for similar
p.(None): items and services under this part and part A, and consider
p.(None): payment amounts established by Medicare Advantage plans under
p.(None): part C and in the private insurance market for home infusion
p.(None): therapy (including average per treatment day payment amounts by
p.(None): type of home infusion therapy).
p.(None): ``(3) Annual updates.--
p.(None): ``(A) In general.--Subject to subparagraph (B), the
p.(None): Secretary shall update the single payment amount under
p.(None): this subsection from year to year beginning in 2022 by
p.(None): increasing the single payment amount from the prior year
...
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (I) by striking paragraph (11) and inserting the
p.(None): following:
p.(None): ``(11) work with relevant agencies of the Department of
p.(None): Health and Human Services on integrating mental health promotion
p.(None): and substance use disorder prevention with general health
p.(None): promotion and disease prevention and integrating mental and
p.(None): substance use disorders treatment services with physical health
p.(None): treatment services;'';
p.(None): (J) in paragraph (13)--
p.(None): (i) in the matter preceding subparagraph (A),
...
p.(None): assure the widespread dissemination of such information'' and
p.(None): inserting ``disseminate mental health information, including
p.(None): evidence-based practices,'';
p.(None): (9) in paragraph (15), as so redesignated, by striking
p.(None): ``and'' at the end;
p.(None): (10) in paragraph (16), as so redesignated, by striking the
p.(None): period and inserting ``; and''; and
p.(None): (11) by adding at the end the following:
p.(None): ``(17) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded.''.
p.(None):
p.(None): (b) Director of the Center for Substance Abuse Prevention.--Section
p.(None): 515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
p.(None): (1) in the section heading, by striking ``office'' and
p.(None): inserting ``center'';
p.(None):
p.(None): [[Page 130 STAT. 1213]]
p.(None):
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``an Office'' and inserting ``a
p.(None): Center''; and
p.(None): (B) by striking ``The Office'' and inserting ``The
p.(None): Prevention Center''; and
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by inserting ``through the
p.(None): reduction of risk and the promotion of resiliency''
p.(None): before the semicolon;
p.(None): (B) by redesignating paragraphs (3) through (11) as
p.(None): paragraphs (4) through (12), respectively;
p.(None): (C) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute on Drug Abuse, the Director of the National Institute
p.(None): on Alcohol Abuse and Alcoholism, and States to promote the study
p.(None): of substance abuse prevention and the dissemination and
p.(None): implementation of research findings that will improve the
p.(None): delivery and effectiveness of substance abuse prevention
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
p.(None): Disease Control and Prevention, develop and disseminate
p.(None): educational materials to increase awareness for individuals at
p.(None): greatest risk for substance use disorders to prevent the
p.(None): transmission of communicable diseases, such as HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases;'';
p.(None): (G) in paragraph (9), as so redesignated--
p.(None): (i) by striking ``to discourage'' and
p.(None): inserting ``that reduce the risk of''; and
p.(None): (ii) by inserting before the semicolon ``and
p.(None): promote resiliency'';
p.(None): (H) in paragraph (11), as so redesignated, by
p.(None): striking ``and'' after the semicolon;
p.(None): (I) in paragraph (12), as so redesignated, by
p.(None): striking the period and inserting a semicolon; and
p.(None): (J) by adding at the end the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) assist and support States in preventing illicit drug
p.(None): use, including emerging illicit drug use issues.''.
p.(None):
p.(None): [[Page 130 STAT. 1214]]
p.(None):
p.(None): (c) Director of the Center for Substance Abuse Treatment.--Section
p.(None): 507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``treatment of substance abuse'' and
p.(None): inserting ``treatment of substance use disorders''; and
p.(None): (B) by striking ``abuse treatment systems'' and
p.(None): inserting ``use disorder treatment systems''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (B) in paragraph (3), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (C) in paragraph (4), by striking ``individuals who
p.(None): abuse drugs'' and inserting ``individuals who illicitly
p.(None): use drugs'';
p.(None): (D) in paragraph (9), by striking ``carried out by
p.(None): the Director'';
p.(None): (E) by striking paragraph (10);
p.(None): (F) by redesignating paragraphs (11) through (14) as
p.(None): paragraphs (10) through (13), respectively;
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 1(b)) is amended--
p.(None): (1) in paragraph (2)--
p.(None): (A) in subparagraph (E), by striking ``and'' after
p.(None): the semicolon;
p.(None): (B) by redesignating subparagraph (F) as
p.(None): subparagraph (J); and
p.(None): (C) by inserting after subparagraph (E), the
p.(None): following:
p.(None): ``(F) the Chief Medical Officer, appointed under
p.(None): section 501(g);
p.(None): ``(G) the Director of the National Institute of
p.(None): Mental Health for the advisory councils appointed under
p.(None): subsections (a)(1)(A) and (a)(1)(D);
p.(None): ``(H) the Director of the National Institute on Drug
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
...
p.(None):
p.(None): [[Page 130 STAT. 1221]]
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
...
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
p.(None): mental illness, serious emotional disturbances,
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
...
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (3) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (4) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$333,806,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``, including such programs that focus on emerging drug
p.(None): abuse issues''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health
p.(None): Service,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1225]]
p.(None):
p.(None): (i) in subparagraph (A), by striking ``; and''
p.(None): at the end and inserting ``;'';
p.(None): (ii) in subparagraph (B)--
p.(None): (I) by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and''; and
p.(None): (iii) by adding at the end the following:
p.(None): ``(C) substance use disorder prevention among high-
p.(None): risk groups.'';
p.(None): (4) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (5) in subsection (f), by striking ``$300,000,000'' and all
...
p.(None): ``1942(a)''; and
p.(None): (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and
p.(None): inserting ``1915(b)''.
p.(None):
p.(None): (f) Funding.--Section 1920 of the Public Health Service Act (42
p.(None): U.S.C. 300x-9) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(c)''; and
p.(None): (B) by striking ``$450,000,000'' and all that
p.(None): follows through the period and inserting ``$532,571,000
p.(None): for each of fiscal years 2018 through 2022.''; and
p.(None): (2) in subsection (b)(2) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(c) and''.
p.(None): SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1921(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x-21(b)) is amended--
p.(None): (1) by inserting ``carrying out the plan developed in
p.(None): accordance with section 1932(b) and for'' after ``for the
p.(None): purpose of''; and
p.(None): (2) by striking ``abuse'' and inserting ``use disorders''.
p.(None):
p.(None): (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the
p.(None): Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
p.(None): (1) in the subsection heading, by striking ``Regarding
p.(None): Intravenous Substance Abuse'' and inserting ``to Persons Who
p.(None): Inject Drugs''; and
p.(None): (2) by striking ``for intravenous drug abuse'' and inserting
p.(None): ``for persons who inject drugs''.
p.(None):
p.(None): (c) Requirements Regarding Tuberculosis and Human Immunodeficiency
p.(None): Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
p.(None): 24) is amended--
p.(None): (1) in subsection (a)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``substance abuse'' and inserting ``substance
p.(None): use disorders''; and
p.(None): (B) in subparagraph (A), by striking ``such abuse''
p.(None): and inserting ``such disorders'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1)(A), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (B) in paragraph (2), by inserting ``and
p.(None): Prevention'' after ``Disease Control'';
p.(None): (C) in paragraph (3)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``abuse'' and inserting ``use disorders''; and
p.(None): (ii) by striking ``substance abuse'' and
...
p.(None): (B) in paragraph (2), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (5) by striking subsection (g) and redesignating subsections
p.(None): (h) and (i) as (g) and (h), accordingly; and
p.(None): (6) in subsection (g), as redesignated by paragraph (5), by
p.(None): striking ``substance abuse'' each place such term appears and
p.(None): inserting ``substance use disorder''.
p.(None):
p.(None): (c) Description of Intended Expenditures of Grant.--Section 527 of
p.(None): the Public Health Service Act (42 U.S.C. 290cc-27) is amended by
p.(None): striking ``substance abuse'' each place such term appears and inserting
p.(None): ``substance use disorder''.
p.(None): (d) Technical Assistance.--Section 530 of the Public Health Service
p.(None): Act (42 U.S.C. 290cc-30) is amended by striking ``through the National
p.(None): Institute of Mental Health, the National Institute of Alcohol Abuse and
p.(None): Alcoholism, and the National Institute on Drug Abuse'' and inserting
p.(None): ``acting through the Assistant Secretary''.
p.(None): (e) Definitions.--Section 534(4) of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-34(4)) is amended to read as follows:
p.(None): ``(4) Substance use disorder services.--The term `substance
p.(None): use disorder services' has the meaning given the term `substance
p.(None): abuse services' in section 330(h)(5)(C).''.
p.(None):
p.(None): (f) Funding.--Section 535(a) of the Public Health Service Act (42
p.(None): U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the
p.(None): fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of
p.(None): fiscal years 2018 through 2022''.
p.(None): (g) Study Concerning Formula.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Assistant Secretary for Mental Health
p.(None): and Substance Use (referred to in this section as the
p.(None): ``Assistant Secretary'') shall conduct a study concerning the
p.(None): formula used under section 524 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-24) for making allotments to States under
p.(None): section 521 of such Act (42 U.S.C. 290cc-21). Such study shall
p.(None): include an evaluation of quality indicators of need for purposes
p.(None):
p.(None): [[Page 130 STAT. 1239]]
p.(None):
p.(None): of revising the formula for determining the amount of each
...
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
p.(None): functional impairment and substantially interferes with or
p.(None): limits one or more major life activities.
p.(None): (3) In reporting on the incidence of serious mental illness,
p.(None): the Substance Abuse and Mental Health Services Administration
p.(None): includes major depression, schizophrenia, bipolar disorder, and
p.(None): other mental disorders that cause serious impairment.
p.(None): (4) Adults with a serious mental illness are at a higher
p.(None): risk for chronic physical illnesses and premature death.
p.(None): (5) According to the World Health Organization, adults with
...
p.(None): an individual to determine a course of treatment while still
p.(None): allowing the individual to make decisions independently.
p.(None): (8) Help should be provided to adults with a serious mental
p.(None): illness to address their acute or chronic physical illnesses,
p.(None): make informed choices about treatment, and understand and follow
p.(None): through with appropriate treatment.
p.(None):
p.(None): [[Page 130 STAT. 1270]]
p.(None):
p.(None): (9) There is confusion in the health care community
p.(None): regarding permissible practices under the regulations
p.(None): promulgated under the Health Insurance Portability and
p.(None): Accountability Act of 1996 (commonly known as ``HIPAA''). This
p.(None): confusion may hinder appropriate communication of health care
p.(None): information or treatment preferences with appropriate
p.(None): caregivers.
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that
p.(None): clarification is needed regarding the privacy rule promulgated under
p.(None): section 264(c) of the Health Insurance Portability and Accountability
p.(None): Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses
p.(None): and disclosures of health information by health care professionals to
p.(None): communicate with caregivers of adults with a serious mental illness to
p.(None): facilitate treatment.
p.(None): SEC. 11002. CONFIDENTIALITY OF RECORDS.
p.(None): Not later than 1 year after the date on which the Secretary of
p.(None): Health and Human Services (in this title referred to as the
p.(None): ``Secretary'') first finalizes regulations updating part 2 of title 42,
p.(None): Code of Federal Regulations, relating to confidentiality of alcohol and
p.(None): drug abuse patient records, after the date of enactment of this Act, the
p.(None): Secretary shall convene relevant stakeholders to determine the effect of
p.(None): such regulations on patient care, health outcomes, and patient privacy.
p.(None): SEC. 11003. <> CLARIFICATION ON
p.(None): PERMITTED USES AND DISCLOSURES OF
p.(None): PROTECTED HEALTH INFORMATION.
p.(None):
p.(None): (a) In General.--The Secretary, acting through the Director of the
p.(None): Office for Civil Rights, shall ensure that health care providers,
p.(None): professionals, patients and their families, and others involved in
p.(None): mental or substance use disorder treatment have adequate, accessible,
p.(None): and easily comprehensible resources relating to appropriate uses and
p.(None): disclosures of protected health information under the regulations
p.(None): promulgated under section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
p.(None): (b) Guidance.--
p.(None): (1) Issuance.--In carrying out subsection (a), not later
p.(None): than 1 year after the date of enactment of this section, the
p.(None): Secretary shall issue guidance clarifying the circumstances
p.(None): under which, consistent with regulations promulgated under
p.(None): section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996, a health care provider or covered
p.(None): entity may use or disclose protected health information.
p.(None): (2) Circumstances addressed.--The guidance issued under this
p.(None): section shall address circumstances including those that--
p.(None): (A) require the consent of the patient;
p.(None): (B) require providing the patient with an
...
p.(None): ``(III) the application of the
p.(None): limitations described in subclause (I)
p.(None): to ensure that such limitations are
p.(None): applied in parity with respect to both
p.(None): medical and surgical benefits and mental
p.(None): health and substance use disorder
p.(None): benefits.
p.(None): ``(C) Nonquantitative treatment limitations.--The
p.(None): guidance issued under this paragraph shall include
p.(None): clarifying information and illustrative examples of
p.(None): methods, processes, strategies, evidentiary standards,
p.(None): and other factors that group health plans and health
p.(None): insurance issuers offering group or individual health
p.(None): insurance coverage may use regarding the development and
p.(None): application of nonquantitative treatment limitations to
p.(None): ensure compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, or
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable, (and any regulations promulgated pursuant to
p.(None): such respective section), including--
p.(None): ``(i) examples of methods of determining
p.(None): appropriate types of nonquantitative treatment
p.(None): limitations with respect to both medical and
p.(None): surgical benefits and mental health and substance
p.(None): use disorder benefits, including nonquantitative
p.(None): treatment limitations pertaining to--
p.(None): ``(I) medical management standards
p.(None): based on medical necessity or
p.(None): appropriateness, or whether a treatment
p.(None): is experimental or investigative;
p.(None): ``(II) limitations with respect to
p.(None): prescription drug formulary design; and
p.(None): ``(III) use of fail-first or step
p.(None): therapy protocols;
p.(None): ``(ii) examples of methods of determining--
p.(None): ``(I) network admission standards
p.(None): (such as credentialing); and
p.(None): ``(II) factors used in provider
p.(None): reimbursement methodologies (such as
p.(None): service type, geographic market, demand
p.(None): for services, and provider supply,
p.(None): practice size, training, experience, and
p.(None): licensure) as such factors apply to
p.(None): network adequacy;
p.(None): ``(iii) examples of sources of information
p.(None): that may serve as evidentiary standards for the
p.(None): purposes of making determinations regarding the
p.(None): development and application of nonquantitative
p.(None): treatment limitations;
p.(None): ``(iv) examples of specific factors, and the
p.(None): evidentiary standards used to evaluate such
p.(None): factors, used
p.(None):
p.(None): [[Page 130 STAT. 1282]]
p.(None):
p.(None): by such plans or issuers in performing a
p.(None): nonquantitative treatment limitation analysis;
p.(None): ``(v) examples of how specific evidentiary
p.(None): standards may be used to determine whether
p.(None): treatments are considered experimental or
p.(None): investigative;
p.(None): ``(vi) examples of how specific evidentiary
p.(None): standards may be applied to each service category
p.(None): or classification of benefits;
p.(None): ``(vii) examples of methods of reaching
p.(None): appropriate coverage determinations for new mental
p.(None): health or substance use disorder treatments, such
p.(None): as evidence-based early intervention programs for
p.(None): individuals with a serious mental illness and
p.(None): types of medical management techniques;
...
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
...
p.(None): extent practicable, continuity of psychiatric care at
p.(None): the end of the supervised period.
p.(None):
p.(None): (d) Implementation; Duration.--The pilot program established under
p.(None): subsection (b) shall be conducted--
p.(None): (1) in not less than 1 United States judicial district,
p.(None): designated by the Attorney General in consultation with the
p.(None): Director of the Administrative Office of the United States
p.(None): Courts, as appropriate for the pilot program; and
p.(None): (2) during fiscal year 2017 through fiscal year 2021.
p.(None):
p.(None): (e) Criteria for Designation.--Before making a designation under
p.(None): subsection (d)(1), the Attorney General shall--
p.(None):
p.(None): [[Page 130 STAT. 1291]]
p.(None):
p.(None): (1) obtain the approval, in writing, of the United States
p.(None): Attorney for the United States judicial district being
p.(None): designated;
p.(None): (2) obtain the approval, in writing, of the chief judge for
p.(None): the United States judicial district being designated; and
p.(None): (3) determine that the United States judicial district being
p.(None): designated has adequate behavioral health systems for treatment,
p.(None): including substance abuse and mental health treatment.
p.(None):
p.(None): (f) Assistance From Other Federal Entities.--The Administrative
p.(None): Office of the United States Courts and the United States Probation
p.(None): Offices shall provide such assistance and carry out such functions as
p.(None): the Attorney General may request in monitoring, supervising, providing
p.(None): services to, and evaluating eligible offenders placed in a drug or
p.(None): mental health court under this section.
p.(None): (g) Reports.--The Attorney General, in consultation with the
p.(None): Director of the Administrative Office of the United States Courts, shall
p.(None): monitor the drug and mental health courts under this section, and shall
p.(None): submit a report to Congress on the outcomes of the program at the end of
p.(None): the period described in subsection (d)(2).
p.(None): SEC. 14004. <> MENTAL HEALTH IN THE
p.(None): JUDICIAL SYSTEM.
p.(None):
p.(None): Part V of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
p.(None): the following:
p.(None): ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
p.(None):
p.(None): ``(a) Pretrial Screening and Supervision.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand pretrial services programs to improve the
p.(None): identification and outcomes of individuals with mental illness.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be may be used for--
p.(None): ``(A) behavioral health needs and risk screening of
p.(None): defendants, including verification of interview
p.(None): information, mental health evaluation, and criminal
p.(None): history screening;
p.(None): ``(B) assessment of risk of pretrial misconduct
p.(None): through objective, statistically validated means, and
p.(None): presentation to the court of recommendations based on
p.(None): such assessment, including services that will reduce the
p.(None): risk of pre-trial misconduct;
...
p.(None): of criminal justice agencies, mental health systems,
p.(None): judicial systems, substance abuse systems, and other
p.(None): relevant systems or agencies for determining how
p.(None): treatment and intensive supervision services should be
p.(None): allocated in order to maximize benefits, and developing
p.(None): and utilizing capacity accordingly.
p.(None):
p.(None): ``(c) Use of Grant Funds.--A State, unit of local government,
p.(None): territory, Indian Tribe, or nonprofit agency that receives a grant under
p.(None): this section shall, in accordance with subsection (b)(2), use grant
p.(None): funds for the expenses of a treatment program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including costs relating to enforcement;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the State or Indian Tribe and licensed, if necessary, to provide
p.(None): needed treatment to program participants, including aftercare
p.(None): supervision, vocational training, education, and job placement;
p.(None): and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide alcohol and drug addiction treatment to
p.(None): offenders participating in the program.
p.(None):
p.(None): ``(d) Supplement of Non-Federal Funds.--
p.(None): ``(1) In general.--Grants awarded under this section shall
p.(None): be used to supplement, and not supplant, non-Federal funds that
p.(None): would otherwise be available for programs described in this
p.(None): section.
p.(None): ``(2) Federal share.--The Federal share of a grant made
p.(None): under this section may not exceed 50 percent of the total costs
p.(None): of the program described in an application under subsection (e).
p.(None):
p.(None): ``(e) Applications.--To request a grant under this section, a State,
p.(None): unit of local government, territory, Indian Tribe, or nonprofit agency
p.(None): shall submit an application to the Attorney General in such form and
p.(None): containing such information as the Attorney General may reasonably
p.(None): require.
p.(None): ``(f) Geographic Distribution.--The Attorney General shall ensure
p.(None): that, to the extent practicable, the distribution of grants under this
p.(None): section is equitable and includes--
p.(None): ``(1) each State; and
p.(None):
p.(None): [[Page 130 STAT. 1293]]
p.(None):
p.(None): ``(2) a unit of local government, territory, Indian Tribe,
p.(None): or nonprofit agency--
p.(None): ``(A) in each State; and
p.(None): ``(B) in rural, suburban, Tribal, and urban
p.(None): jurisdictions.
p.(None):
p.(None): ``(g) Reports and Evaluations.--For each fiscal year, each grantee
p.(None): under this section during that fiscal year shall submit to the Attorney
p.(None): General a report on the effectiveness of activities carried out using
p.(None): such grant. Each report shall include an evaluation in such form and
p.(None): containing such information as the Attorney General may reasonably
p.(None): require. The Attorney General shall specify the dates on which such
...
p.(None): fidelity practice principles and technical assistance to
p.(None): support effective and continuing integration with
p.(None): criminal justice agency partners.
p.(None): ``(3) Supplement and not supplant.--Grants made under this
p.(None): subsection shall be used to supplement, and not supplant, non-
p.(None): Federal funds that would otherwise be available for programs
p.(None): described in this subsection.
p.(None): ``(4) Applications.--To request a grant under this
p.(None): subsection, a State, unit of local government, territory, Indian
p.(None): Tribe, or nonprofit agency shall submit an application to the
p.(None): Attorney General in such form and containing such information as
p.(None): the Attorney General may reasonably require.''.
p.(None): SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
p.(None): SYSTEMS.
p.(None):
p.(None): Section 2976(f) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
p.(None): (1) in paragraph (5), by striking ``and'' at the end;
p.(None): (2) in paragraph (6), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(7) provide mental health treatment and transitional
p.(None): services for those with mental illnesses or with co-occurring
p.(None): disorders, including housing placement or assistance; and''.
p.(None): SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN DRUG COURTS.
p.(None):
p.(None): Part EE of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797u et seq.) is amended--
p.(None): (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
p.(None): inserting ``, including co-occurring substance abuse and mental
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
...
p.(None): technical assistance to local law enforcement agencies, including
p.(None): active-shooter response training.
p.(None): SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN RESIDENTIAL SUBSTANCE
p.(None): ABUSE TREATMENT PROGRAMS.
p.(None):
p.(None): Section 1901(a) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(B) receiving centers as alternatives to
p.(None): incarceration of eligible participants;
p.(None): ``(C) specialized response units for calls related
p.(None): to substance use disorders, mental illness, or co-
p.(None): occurring mental illness and substance use disorders;
p.(None): and
p.(None): ``(D) other arrest and pre-booking treatment
p.(None): alternatives to incarceration models; or
p.(None): ``(2) post-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) specialized clinical case management;
p.(None):
p.(None): [[Page 130 STAT. 1299]]
p.(None):
p.(None): ``(B) pre-trial services related to substances use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(C) prosecutor and defender based programs;
p.(None): ``(D) specialized probation;
p.(None): ``(E) treatment and rehabilitation programs; and
p.(None): ``(F) problem-solving courts, including mental
p.(None): health courts, drug courts, co-occurring mental health
p.(None): and substance abuse courts, DWI courts, and veterans
p.(None): treatment courts.
p.(None):
p.(None): ``(c) Application.--
p.(None): ``(1) In general.--An eligible entity desiring a grant under
p.(None): this section shall submit an application to the Attorney
p.(None): General--
p.(None): ``(A) that meets the criteria under paragraph (2);
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
p.(None): 2007);
p.(None): ``(C) demonstrate that evidence-based treatment
p.(None): practices will be utilized; and
...
p.(None): an enforcement unit comprised of appropriately trained law
p.(None): enforcement professionals under the supervision of the State,
p.(None): Tribal, or local criminal justice agency involved, the duties of
p.(None): which shall include--
p.(None): ``(A) the verification of addresses and other
p.(None): contact information of each eligible participant who
p.(None): participates or desires to participate in the program;
p.(None): and
p.(None): ``(B) if necessary, the location, apprehension,
p.(None): arrest, and return to custody of an eligible participant
p.(None): in the program who has absconded from the facility of a
p.(None): treatment provider or has otherwise significantly
p.(None): violated the terms and conditions of the program,
p.(None): consistent with Federal and State confidentiality
p.(None): requirements;
p.(None):
p.(None): [[Page 130 STAT. 1300]]
p.(None):
p.(None): ``(4) notify the relevant criminal justice entity if any
p.(None): eligible participant in the program absconds from the facility
p.(None): of the treatment provider or otherwise violates the terms and
p.(None): conditions of the program, consistent with Federal and State
p.(None): confidentiality requirements;
p.(None): ``(5) submit periodic reports on the progress of treatment
p.(None): or other measured outcomes from participation in the program of
p.(None): each eligible participant in the program to the relevant State,
p.(None): Tribal, or local criminal justice agency, including mental
p.(None): health courts, drug courts, co-occurring mental health and
p.(None): substance abuse courts, DWI courts, and veterans treatment
p.(None): courts;
p.(None): ``(6) describe the evidence-based methodology and outcome
p.(None): measurements that will be used to evaluate the program, and
p.(None): specifically explain how such measurements will provide valid
p.(None): measures of the impact of the program; and
p.(None): ``(7) describe how the program could be broadly replicated
p.(None): if demonstrated to be effective.
p.(None):
p.(None): ``(e) Use of Funds.--An eligible entity shall use a grant received
p.(None): under this section for expenses of a treatment alternative to
p.(None): incarceration program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including the enforcement unit;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the relevant State or Tribal jurisdiction and licensed, if
p.(None): necessary, to provide needed treatment to eligible offenders
p.(None): participating in the program, including aftercare supervision,
p.(None): vocational training, education, and job placement; and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Tribal jurisdiction and licensed,
p.(None): if necessary, to provide alcohol and drug addiction treatment to
p.(None): eligible offenders participating in the program.
p.(None):
p.(None): ``(f) Supplement Not Supplant.--An eligible entity shall use Federal
p.(None): funds received under this section only to supplement the funds that
p.(None): would, in the absence of those Federal funds, be made available from
p.(None): other Federal and non-Federal sources for the activities described in
p.(None): this section, and not to supplant those funds. The Federal share of a
p.(None): grant made under this section may not exceed 50 percent of the total
p.(None): costs of the program described in an application under subsection (d).
p.(None): ``(g) Geographic Distribution.--The Attorney General shall ensure
p.(None): that, to the extent practicable, the geographical distribution of grants
p.(None): under this section is equitable and includes a grant to an eligible
p.(None): entity in--
p.(None): ``(1) each State;
p.(None): ``(2) rural, suburban, and urban areas; and
p.(None): ``(3) Tribal jurisdictions.
p.(None):
p.(None): ``(h) Reports and Evaluations.--Each fiscal year, each recipient of
p.(None): a grant under this section during that fiscal year shall submit to the
p.(None): Attorney General a report on the outcomes of activities carried out
p.(None): using that grant in such form, containing such information, and on such
p.(None): dates as the Attorney General shall specify.
p.(None): ``(i) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None):
p.(None): [[Page 130 STAT. 1301]]
p.(None):
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
...
p.(None): consider modifying measures under this subsection
p.(None): to incorporate V or other ICD-related codes at the
p.(None): same time as other changes are being made under
p.(None): this subparagraph.
p.(None): ``(iii) Removal of certain readmissions.--In
p.(None): promulgating regulations to carry out this
p.(None): subsection, with respect to discharges occurring
p.(None): after fiscal year 2018, the Secretary may consider
p.(None): removal as a readmission of an admission that is
p.(None): classified within one or more of the following:
p.(None): transplants, end-stage renal disease, burns,
p.(None): trauma, psychosis, or substance abuse. The
p.(None): Secretary may consider modifying measures under
p.(None): this subsection to remove readmissions at the same
p.(None): time as other changes are being made under this
p.(None): subparagraph.''.
p.(None):
p.(None): (c) MedPAC Study on Readmissions Program.--The Medicare Payment
p.(None): Advisory Commission shall conduct a study to review overall hospital
p.(None): readmissions described in section 1886(q)(5)(E) of the Social Security
p.(None): Act (42 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions are
p.(None): related to any changes in outpatient and emergency services furnished.
p.(None): The Commission shall submit to Congress a report on such study in its
p.(None): report to Congress in June 2018.
p.(None): SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL
p.(None): DEMONSTRATION PROGRAM.
p.(None):
p.(None): (a) Extension.--Section 410A of the Medicare Prescription Drug,
p.(None): Improvement, and Modernization Act of 2003 (Public Law 108-173; 42
p.(None): U.S.C. 1395ww note) is amended--
p.(None):
p.(None): [[Page 130 STAT. 1318]]
p.(None):
p.(None): (1) in subsection (a)(5), by striking ``5-year extension
p.(None): period'' and inserting ``10-year extension period''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in the subsection heading, by striking ``Five-
p.(None): Year'' and inserting ``Ten-Year'';
p.(None): (B) in paragraph (1), by striking ``additional 5-
p.(None): year'' and inserting ``additional 10-year'';
p.(None): (C) by striking ``5-year extension period'' and
p.(None): inserting ``10-year extension period'' each place it
p.(None): appears;
p.(None): (D) in paragraph (4)(B)--
p.(None): (i) in the matter preceding clause (i), by
p.(None): inserting ``each 5-year period in'' after
p.(None): ``hospital during''; and
p.(None): (ii) in clause (i), by inserting ``each
p.(None): applicable 5-year period in'' after ``the first
p.(None): day of''; and
p.(None): (E) by adding at the end the following new
p.(None): paragraphs:
p.(None): ``(5) Other hospitals in demonstration program.--During the
p.(None): second 5 years of the 10-year extension period, the Secretary
p.(None): shall apply the provisions of paragraph (4) to rural community
p.(None): hospitals that are not described in paragraph (4) but are
p.(None): participating in the demonstration program under this section as
p.(None): of December 30, 2014, in a similar manner as such provisions
p.(None): apply to rural community hospitals described in paragraph (4).
p.(None): ``(6) Expansion of demonstration program to rural areas in
p.(None): any state.--
p.(None): ``(A) In general.--The Secretary shall,
p.(None): notwithstanding subsection (a)(2) or paragraph (2) of
p.(None): this subsection, not later than 120 days after the date
p.(None): of the enactment of this paragraph, issue a solicitation
...
p.(None): ``(B) in a manner that provides for such data based
p.(None): on--
p.(None): ``(i) fee-for-service enrollment (as defined
p.(None): in paragraph (2));
p.(None): ``(ii) enrollment under part C (including
p.(None): separate for aggregate enrollment in MA-PD plans
p.(None): and aggregate enrollment in MA plans that are not
p.(None): MA-PD plans); and
p.(None): ``(iii) enrollment under part D.
p.(None):
p.(None): [[Page 130 STAT. 1331]]
p.(None):
p.(None): ``(2) Fee-for-service enrollment defined.--For purpose of
p.(None): paragraph (1)(B)(i), the term `fee-for-service enrollment' means
p.(None): aggregate enrollment (including receipt of benefits other than
p.(None): through enrollment) under--
p.(None): ``(A) part A only;
p.(None): ``(B) part B only; and
p.(None): ``(C) both part A and part B.''.
p.(None): SEC. 17003. <> UPDATING THE WELCOME TO
p.(None): MEDICARE PACKAGE.
p.(None):
p.(None): (a) In General.--Not later than 12 months after the last day of the
p.(None): period for the request of information described in subsection (b), the
p.(None): Secretary of Health and Human Services shall, taking into consideration
p.(None): information collected pursuant to subsection (b), update the information
p.(None): included in the Welcome to Medicare package to include information,
p.(None): presented in a clear and simple manner, about options for receiving
p.(None): benefits under the Medicare program under title XVIII of the Social
p.(None): Security Act (42 U.S.C. 1395 et seq.), including through the original
p.(None): medicare fee-for-service program under parts A and B of such title (42
p.(None): U.S.C. 1395c et seq., 42 U.S.C. 1395j et seq.), Medicare Advantage plans
p.(None): under part C of such title (42 U.S.C. 1395w-21 et seq.), and
p.(None): prescription drug plans under part D of such title (42 U.S.C. 1395w-101
p.(None): et seq.)). The Secretary shall make subsequent updates to the
p.(None): information included in the Welcome to Medicare package as appropriate.
p.(None): (b) Request for Information.--Not later than 6 months after the date
p.(None): of the enactment of this Act, the Secretary of Health and Human Services
p.(None): shall request information, including recommendations, from stakeholders
p.(None): (including patient advocates, issuers, and employers) on information
p.(None): included in the Welcome to Medicare package, including pertinent data
p.(None): and information regarding enrollment and coverage for Medicare eligible
p.(None): individuals.
p.(None): SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY NEWLY
p.(None): ENROLLED PROVIDERS OR SUPPLIERS WITHIN
p.(None): A TEMPORARY MORATORIUM AREA.
p.(None):
p.(None): (a) Medicare.--Section 1866(j)(7) of the Social Security Act (42
p.(None): U.S.C. 1395cc(j)(7)) is amended--
p.(None): (1) in the paragraph heading, by inserting ``; nonpayment''
p.(None): before the period; and
p.(None): (2) by adding at the end the following new subparagraph:
p.(None): ``(C) Nonpayment.--
p.(None): ``(i) In general.--No payment may be made
p.(None): under this title or under a program described in
p.(None): subparagraph (A) with respect to an item or
p.(None): service described in clause (ii) furnished on or
p.(None): after October 1, 2017.
p.(None): ``(ii) Item or service described.--An item or
p.(None): service described in this clause is an item or
p.(None): service furnished--
p.(None): ``(I) within a geographic area with
p.(None): respect to which a temporary moratorium
p.(None): imposed under subparagraph (A) is in
p.(None): effect; and
p.(None): ``(II) by a provider of services or
p.(None): supplier that meets the requirements of
p.(None): clause (iii).
...
p.(None): (A) in the heading, by inserting ``from 2011 through
p.(None): 2018'' after ``45-day period''; and
p.(None): (B) by inserting ``and ending with 2018'' after
p.(None): ``beginning with 2011''; and
p.(None): (2) by adding at the end the following new subparagraph:
p.(None): ``(G) Continuous open enrollment and disenrollment
p.(None): for first 3 months in 2016 and subsequent years.--
p.(None): ``(i) In general.--Subject to clause (ii) and
p.(None): subparagraph (D)--
p.(None): ``(I) in the case of an MA eligible
p.(None): individual who is enrolled in an MA
p.(None): plan, at any time during the first 3
p.(None): months of a year (beginning with 2019);
p.(None): or
p.(None): ``(II) in the case of an individual
p.(None): who first becomes an MA eligible
p.(None): individual during a year (beginning with
p.(None): 2019) and enrolls in an MA plan, during
p.(None): the first 3 months during such year in
p.(None): which the individual is an MA eligible
p.(None): individual;
p.(None):
p.(None): [[Page 130 STAT. 1334]]
p.(None): such MA eligible individual may change the
p.(None): election under subsection (a)(1).
p.(None): ``(ii) Limitation of one change during open
p.(None): enrollment period each year.--An individual may
p.(None): change the election pursuant to clause (i) only
p.(None): once during the applicable 3-month period
p.(None): described in such clause in each year. The
p.(None): limitation under this clause shall not apply to
p.(None): changes in elections effected during an annual,
p.(None): coordinated election period under paragraph (3) or
p.(None): during a special enrollment period under paragraph
p.(None): (4).
p.(None): ``(iii) Limited application to part d.--
p.(None): Clauses (i) and (ii) of this subparagraph shall
p.(None): only apply with respect to changes in enrollment
p.(None): in a prescription drug plan under part D in the
p.(None): case of an individual who, previous to such change
p.(None): in enrollment, is enrolled in a Medicare Advantage
p.(None): plan.
p.(None): ``(iv) Limitations on marketing.-- Pursuant to
p.(None): subsection (j), no unsolicited marketing or
p.(None): marketing materials may be sent to an individual
p.(None): described in clause (i) during the continuous open
p.(None): enrollment and disenrollment period established
p.(None): for the individual under such clause,
p.(None): notwithstanding marketing guidelines established
p.(None): by the Centers for Medicare & Medicaid
p.(None): Services.''.
p.(None): SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES TO
p.(None): CHOOSE A MEDICARE ADVANTAGE PLAN.
p.(None):
p.(None): (a) Removing Prohibition.--
p.(None): (1) In general.--Section 1851(a)(3) of the Social Security
p.(None): Act (42 U.S.C. 1395w-21(a)(3)) is amended--
p.(None): (A) by striking subparagraph (B); and
p.(None): (B) by striking ``eligible individual'' and all that
p.(None): follows through ``In this title, subject to subparagraph
p.(None): (B),'' and inserting ``eligible individual.--In this
p.(None): title,''.
p.(None): (2) Conforming amendments.--
p.(None): (A) Section 1852(b)(1) of the Social Security Act
p.(None): (42 U.S.C. 1395w-22(b)(1)) is amended--
p.(None): (i) by striking subparagraph (B); and
p.(None): (ii) by striking ``Beneficiaries'' and all
p.(None): that follows through ``A Medicare+Choice
p.(None): organization'' and inserting ``Beneficiaries.--A
p.(None): Medicare Advantage organization''.
p.(None): (B) Section 1859(b)(6) of the Social Security Act
p.(None): (42 U.S.C. 1395w-28(b)(6)) is amended, in the last
p.(None): sentence, by striking ``may waive'' and all that follows
p.(None): through ``subparagraph and''.
p.(None): (3) <> Effective date.--The
...
Searching for indicator influence:
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p.(None): and health disparities.''.
p.(None):
p.(None): (g) <> Basic Research.--
p.(None): (1) Developing policies.--Not later than 2 years after the
p.(None): date of enactment of this Act, the Director of the National
p.(None): Institutes of Health (referred to in this section as the
p.(None): ``Director of the National Institutes of Health''), taking into
p.(None): consideration the recommendations developed under section 2039,
p.(None): shall develop policies for projects of basic research funded by
p.(None): National Institutes of Health to assess--
p.(None): (A) relevant biological variables including sex, as
p.(None): appropriate; and
p.(None): (B) how differences between male and female cells,
p.(None): tissues, or animals may be examined and analyzed.
p.(None): (2) Revising policies.--The Director of the National
p.(None): Institutes of Health may update or revise the policies developed
p.(None): under paragraph (1) as appropriate.
p.(None): (3) Consultation and outreach.--In developing, updating, or
p.(None): revising the policies under this section, the Director of the
p.(None): National Institutes of Health shall--
p.(None): (A) consult with--
p.(None): (i) the Office of Research on Women's Health;
p.(None): (ii) the Office of Laboratory Animal Welfare;
p.(None): and
p.(None): (iii) appropriate members of the scientific
p.(None): and academic communities; and
p.(None): (B) conduct outreach to solicit feedback from
p.(None): members of the scientific and academic communities on
p.(None): the influence of sex as a variable in basic research,
p.(None): including feedback
p.(None):
p.(None): [[Page 130 STAT. 1067]]
p.(None):
p.(None): on when it is appropriate for projects of basic research
p.(None): involving cells, tissues, or animals to include both
p.(None): male and female cells, tissues, or animals.
p.(None): (4) Additional requirements.--The Director of the National
p.(None): Institutes of Health shall--
p.(None): (A) ensure that projects of basic research funded by
p.(None): the National Institutes of Health are conducted in
p.(None): accordance with the policies developed, updated, or
p.(None): revised under this section, as applicable; and
p.(None): (B) encourage that the results of such research,
p.(None): when published or reported, be disaggregated as
p.(None): appropriate with respect to the analysis of any sex
p.(None): differences.
p.(None):
p.(None): (h) <> Clinical Research.--
p.(None): (1) In general.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Director of the National Institutes
p.(None): of Health, in consultation with the Director of the Office of
p.(None): Research on Women's Health and the Director of the National
p.(None): Institute on Minority Health and Health Disparities, shall
p.(None): update the guidelines established under section 492B(d) of
p.(None): Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance
p.(None): with paragraph (2).
p.(None): (2) Requirements.--The updated guidelines described in
p.(None): paragraph (1) shall--
p.(None): (A) reflect the science regarding sex differences;
p.(None): (B) improve adherence to the requirements under
p.(None): section 492B of the Public Health Service Act (42 U.S.C.
p.(None): 289a-2), including the reporting requirements under
...
p.(None): paragraph in lieu of damages sustained by the United States or a
p.(None): specified State agency because of such specified claim, and in cases
p.(None): under paragraphs (2) and (4), such a person shall be subject to an
p.(None): assessment of not more than 3 times the total amount of the funds
p.(None): described in paragraph (2) or (4), respectively (or, in the case of an
p.(None): obligation to transmit property to the Secretary described in paragraph
p.(None): (4), of the value of the property described in such paragraph) in lieu
p.(None): of damages sustained by the United States or a specified State agency
p.(None): because of such case. In addition, the Secretary may make a
p.(None): determination in the same proceeding to exclude the person from
p.(None): participation in the Federal health care programs (as defined in section
p.(None): 1128B(f)(1)) and to direct the appropriate State agency to exclude the
p.(None): person from participation in any State health care program.
p.(None): ``(p) The provisions of subsections (c), (d), (g), and (h) shall
p.(None): apply to a civil money penalty or assessment under subsection (o) in the
p.(None): same manner as such provisions apply to a penalty, assessment, or
p.(None): proceeding under subsection (a). In applying subsection (d), each
p.(None): reference to a claim under such subsection shall be treated as including
p.(None): a reference to a specified claim (as defined in subsection (r)).
p.(None): ``(q) For purposes of this subsection and subsections (o) and (p):
p.(None): ``(1) The term `Department' means the Department of Health
p.(None): and Human Services.
p.(None): ``(2) The term `material' means having a natural tendency to
p.(None): influence, or be capable of influencing, the payment or receipt
p.(None): of money or property.
p.(None): ``(3) The term `other agreement' includes a cooperative
p.(None): agreement, scholarship, fellowship, loan, subsidy, payment for a
p.(None): specified use, donation agreement, award, or subaward
p.(None): (regardless of whether one or more of the persons entering into
p.(None): the agreement is a contractor or subcontractor).
p.(None): ``(4) The term `program beneficiary' means, in the case of a
p.(None): grant, contract, or other agreement designed to accomplish the
p.(None): objective of awarding or otherwise furnishing benefits or
p.(None): assistance to individuals and for which the Secretary provides
p.(None): funding, an individual who applies for, or who receives, such
p.(None): benefits or assistance from such grant, contract, or other
p.(None): agreement. Such term does not include, with respect to such
p.(None): grant, contract, or other agreement, an officer, employee, or
p.(None): agent of a person or entity that receives such grant or that
p.(None): enters into such contract or other agreement.
p.(None):
p.(None): [[Page 130 STAT. 1190]]
p.(None):
p.(None): ``(5) The term `recipient' includes a subrecipient or
p.(None): subcontractor.
p.(None): ``(6) The term `specified State agency' means an agency of a
p.(None): State government established or designated to administer or
p.(None): supervise the administration of a grant, contract, or other
p.(None): agreement funded in whole or in part by the Secretary.
p.(None):
p.(None): ``(r) For purposes of this section, the term `specified claim' means
p.(None): any application, request, or demand under a grant, contract, or other
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p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
...
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
...
p.(None): fiscal years 2017 and 2018, for any discretionary
p.(None): appropriation under the heading ``Account For the State
p.(None): Response to the Opioid Abuse Crisis'' for the grant
p.(None): program described in subsection (c), the total amount of
p.(None): such appropriations in the applicable fiscal year (not
p.(None): to exceed the total amount remaining in the Account)
p.(None): shall be subtracted from the estimate of discretionary
p.(None): budget authority and the resulting outlays for any
p.(None): estimate under the Congressional Budget and Impoundment
p.(None): Control Act of 1974 or the Balanced Budget and Emergency
p.(None): Deficit Control Act of 1985, and the amount transferred
p.(None): to the Account shall be reduced by the same amount.
p.(None):
p.(None): (c) Opioid Grant Program.--
p.(None): (1) State response to the opioid abuse crisis.--Subject to
p.(None): the availability of appropriations, the Secretary shall award
p.(None): grants to States for the purpose of addressing the opioid abuse
p.(None): crisis within such States, in accordance with subparagraph (B).
p.(None): In awarding such grants, the Secretary shall give preference to
p.(None): States with an incidence or prevalence of opioid use disorders
p.(None): that is substantially higher relative to other States.
p.(None): (2) Opioid grants.--Grants awarded to a State under this
p.(None): subsection shall be used for carrying out activities that
p.(None): supplement activities pertaining to opioids undertaken by the
p.(None): State agency responsible for administering the substance abuse
p.(None): prevention and treatment block grant under subpart II of part B
p.(None): of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
p.(None): et seq.), which may include public health-related activities
p.(None): such as the following:
p.(None): (A) Improving State prescription drug monitoring
p.(None): programs.
p.(None):
p.(None): [[Page 130 STAT. 1046]]
p.(None): (B) Implementing prevention activities, and
p.(None): evaluating such activities to identify effective
p.(None): strategies to prevent opioid abuse.
p.(None): (C) Training for health care practitioners, such as
p.(None): best practices for prescribing opioids, pain management,
p.(None): recognizing potential cases of substance abuse, referral
p.(None): of patients to treatment programs, and overdose
p.(None): prevention.
p.(None): (D) Supporting access to health care services,
p.(None): including those services provided by Federally certified
p.(None): opioid treatment programs or other appropriate health
p.(None): care providers to treat substance use disorders.
p.(None): (E) Other public health-related activities, as the
p.(None): State determines appropriate, related to addressing the
p.(None): opioid abuse crisis within the State.
p.(None):
p.(None): (d) Accountability and Oversight.--A State receiving a grant under
p.(None): subsection (c) shall include in a report related to substance abuse
p.(None): submitted to the Secretary pursuant to section 1942 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-52), a description of--
p.(None): (1) the purposes for which the grant funds received by the
p.(None): State under such subsection for the preceding fiscal year were
p.(None): expended and a description of the activities of the State under
p.(None): the program; and
p.(None): (2) the ultimate recipients of amounts provided to the State
p.(None): in the grant.
p.(None):
p.(None): (e) Limitations.--Any funds made available pursuant to the
p.(None): authorization of appropriations under subsection (b)--
p.(None): (1) notwithstanding any transfer authority in any
p.(None): appropriations Act, shall not be used for any purpose other than
p.(None): the grant program in subsection (c); and
p.(None): (2) shall be subject to the same requirements as substance
p.(None): abuse prevention and treatment programs under titles V and XIX
p.(None): of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w
p.(None): et seq.).
p.(None):
p.(None): (f) Sunset.--This section shall expire on September 30, 2026.
p.(None): SEC. 1004. BUDGETARY TREATMENT.
p.(None):
p.(None): (a) Statutory Paygo Scorecards.--The budgetary effects of division A
p.(None): of this Act shall not be entered on either PAYGO scorecard maintained
p.(None): pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
p.(None): (b) Senate Paygo Scorecards.--The budgetary effects of division A of
p.(None): this Act shall not be entered on any PAYGO scorecard maintained for
p.(None): purposes of section 201 of S. Con. Res. 21 (110th Congress).
p.(None): (c) Reservation of Savings.--None of the funds in the NIH Innovation
p.(None): Account, the FDA Innovation Account, or the Account For the State
p.(None): Response to the Opioid Abuse Crisis established by this title shall be
p.(None): made available except to the extent provided in advance in
p.(None): appropriations Acts, and legislation or an Act that rescinds or reduces
p.(None): amounts in such accounts shall not be estimated as a reduction in direct
p.(None): spending under the Congressional Budget and Impoundment Control Act of
p.(None): 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985.
p.(None):
p.(None): [[Page 130 STAT. 1047]]
p.(None):
p.(None): TITLE II--DISCOVERY
p.(None):
p.(None): Subtitle A--National Institutes of Health Reauthorization
p.(None):
p.(None): SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
p.(None):
p.(None): Section 402A(a)(1) of the Public Health Service Act (42 U.S.C.
p.(None): 282a(a)(1)) is amended--
...
p.(None): percent of the lesser of the actual charge for the
p.(None): services or the amount determined under section
p.(None): 1834(u)''.
p.(None): (2) Direct payment.--The first sentence of section
p.(None): 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is
p.(None): amended--
p.(None): (A) by striking ``and'' before ``(H)''; and
p.(None): (B) by inserting before the period at the end the
p.(None): following: ``, and (I) in the case of home infusion
p.(None): therapy, payment shall be made to the qualified home
p.(None): infusion therapy supplier''.
p.(None): (3) Exclusion from home health services.--Section 1861(m) of
p.(None): the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the
p.(None): first sentence, by inserting the following before the period at
p.(None): the end: ``and home infusion therapy (as defined in subsection
p.(None): (iii)(i))''.
p.(None):
p.(None): (d) <> Effective Date.--The amendments
p.(None): made by this section shall apply to items and services furnished on or
p.(None): after January 1, 2021.
p.(None):
p.(None): DIVISION <p.(None): 2016.>> B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None): SEC. 6000. <> SHORT TITLE.
p.(None):
p.(None): This division may be cited as the ``Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016''.
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE
p.(None): USE.
p.(None):
p.(None): (a) Assistant Secretary.--Section 501(c) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
p.(None): ``(c) Assistant Secretary and Deputy Assistant Secretary.--
p.(None):
p.(None): [[Page 130 STAT. 1203]]
p.(None):
p.(None): ``(1) Assistant secretary.--The Administration shall be
p.(None): headed by an official to be known as the Assistant Secretary for
p.(None): Mental Health and Substance Use (hereinafter in this title
p.(None): referred to as the `Assistant Secretary') who shall be appointed
p.(None): by the President, by and with the advice and consent of the
p.(None): Senate.
p.(None): ``(2) Deputy assistant secretary.--The Assistant Secretary,
p.(None): with the approval of the Secretary, may appoint a Deputy
p.(None): Assistant Secretary and may employ and prescribe the functions
p.(None): of such officers and employees, including attorneys, as are
p.(None): necessary to administer the activities to be carried out through
p.(None): the Administration.''.
p.(None):
p.(None): (b) <> Transfer of Authorities.--The
p.(None): Secretary of Health and Human Services shall delegate to the Assistant
p.(None): Secretary for Mental Health and Substance Use all duties and authorities
p.(None): that--
p.(None): (1) as of the day before the date of enactment of this Act,
p.(None): were vested in the Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration; and
p.(None): (2) are not terminated by this Act.
p.(None):
p.(None): (c) Conforming Amendments.--Title V of the Public Health Service Act
p.(None): (42 U.S.C. 290aa et seq.), as amended by the previous provisions of this
p.(None): section, is further amended--
p.(None): (1) by striking ``Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration'' each place it appears
p.(None): and inserting ``Assistant Secretary for Mental Health and
p.(None): Substance Use''; and
p.(None): (2) by striking ``Administrator'' or ``Administrator'' each
p.(None): place it appears (including in any headings) and inserting
p.(None): ``Assistant Secretary'' or ``Assistant Secretary'',
p.(None): respectively, except where the term ``Administrator'' appears--
p.(None): (A) in each of subsections (e) and (f) of section
p.(None): 501 of such Act (42 U.S.C. 290aa), including the
p.(None): headings of such subsections, within the term
p.(None): ``Associate Administrator'';
p.(None): (B) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Health Resources and Services Administration'';
p.(None): (C) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Centers for Medicare & Medicaid Services'';
p.(None): (D) in section 519B(c)(1)(B) of such Act (42 U.S.C.
p.(None): 290bb-25b(c)(1)(B)), within the term ``Administrator of
p.(None): the National Highway Traffic Safety Administration''; or
p.(None): (E) in each of sections 519B(c)(1)(B), 520C(a), and
p.(None): 520D(a) of such Act (42 U.S.C. 290bb-25b(c)(1)(B),
p.(None): 290bb-34(a), 290bb-35(a)), within the term
p.(None): ``Administrator of the Office of Juvenile Justice and
p.(None): Delinquency Prevention''.
p.(None):
p.(None): (d) <> References.--After executing
p.(None): subsections (a), (b), and (c), any reference in statute, regulation, or
p.(None): guidance to the Administrator of the Substance Abuse and Mental Health
p.(None): Services Administration shall be construed to be a reference to the
p.(None): Assistant Secretary for Mental Health and Substance Use.
p.(None):
p.(None): [[Page 130 STAT. 1204]]
p.(None):
p.(None): SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND
p.(None): MENTAL HEALTH SERVICES ADMINISTRATION.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by section 6001, is further amended--
p.(None): (1) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Agencies'' and inserting ``Centers''; and
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``entities'' and inserting ``Centers'';
p.(None): (2) in subsection (d)--
p.(None): (A) in paragraph (1)--
p.(None): (i) by striking ``agencies'' each place the
p.(None): term appears and inserting ``Centers''; and
p.(None): (ii) by striking ``such agency'' and inserting
p.(None): ``such Center'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``agencies'' and inserting
p.(None): ``Centers'';
p.(None): (ii) by striking ``with respect to substance
p.(None): abuse'' and inserting ``with respect to substance
p.(None): use disorders''; and
p.(None): (iii) by striking ``and individuals who are
p.(None): substance abusers'' and inserting ``and
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (I) by striking paragraph (11) and inserting the
p.(None): following:
p.(None): ``(11) work with relevant agencies of the Department of
p.(None): Health and Human Services on integrating mental health promotion
p.(None): and substance use disorder prevention with general health
p.(None): promotion and disease prevention and integrating mental and
p.(None): substance use disorders treatment services with physical health
p.(None): treatment services;'';
p.(None): (J) in paragraph (13)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``this title, assure that'' and
p.(None): inserting ``this title or part B of title XIX, or
p.(None): grant programs otherwise funded by the
p.(None): Administration'';
p.(None): (ii) in subparagraph (A)--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) by striking ``and'' at the end;
p.(None): (iii) by redesignating subparagraph (B) as
p.(None): subparagraph (C);
p.(None): (iv) by inserting after subparagraph (A) the
p.(None): following:
p.(None): ``(B) ensure that the director of each Center of the
p.(None): Administration consistently documents the application of
p.(None): criteria when awarding grants and the ongoing oversight
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
...
p.(None): (B) by striking ``The Secretary, acting'' and all
p.(None): that follows through ``year on--'' and inserting ``The
p.(None): Director shall--
p.(None): ``(1) coordinate the Administration's integrated data
p.(None): strategy, including by collecting data each year on--'';
p.(None): (C) in the subparagraph (B), as redesignated by
p.(None): subparagraph (A), by striking ``Assistant Secretary''
p.(None): and inserting ``Director''; and
p.(None): (D) by adding at the end the following new
p.(None): paragraphs:
p.(None): ``(2) provide statistical and analytical support for
p.(None): activities of the Administration;
p.(None): ``(3) recommend a core set of performance metrics to
p.(None): evaluate activities supported by the Administration; and
p.(None): ``(4) coordinate with the Assistant Secretary, the Assistant
p.(None): Secretary for Planning and Evaluation, and the Chief Medical
p.(None): Officer appointed under section 501(g), as appropriate, to
p.(None): improve the quality of services provided by programs of the
p.(None): Administration and the evaluation of activities carried out by
p.(None): the Administration.''.
p.(None): (5) in subsection (c), as so redesignated--
p.(None): (A) by striking ``With respect to the activities''
p.(None): and inserting ``Mental Health.--With respect to the
p.(None): activities'';
p.(None): (B) by striking ``Assistant Secretary'' each place
p.(None): it appears and inserting ``Director''; and
p.(None): (C) by striking ``subsection (a)'' and inserting
p.(None): ``subsection (b)(1)'';
p.(None): (6) in subsection (d), as so redesignated--
p.(None): (A) by striking the subsection designation and all
p.(None): that follows through ``With respect to the activities''
p.(None): and inserting the following:
p.(None):
p.(None): ``(d) Substance Abuse.--
p.(None): ``(1) In general.--With respect to the activities'';
p.(None): (B) in paragraph (1)--
p.(None): (i) in the matter before subparagraph (A)--
p.(None): (I) by striking ``subsection (a)''
p.(None): and inserting ``subsection (b)(1)''; and
p.(None): (II) by striking ``Assistant
p.(None): Secretary'' each place it appears and
p.(None): inserting ``Director''; and
p.(None):
p.(None): [[Page 130 STAT. 1209]]
p.(None):
p.(None): (ii) in subparagraph (B), by inserting ``in
p.(None): coordination with the Centers for Disease Control
p.(None): and Prevention'' before the semicolon at the end;
p.(None): and
p.(None): (C) in paragraph (2), by striking ``Annual surveys''
p.(None): and inserting ``Annual surveys; public availability of
p.(None): data.--Annual surveys''; and
p.(None): (7) in subsection (e), as so redesignated--
p.(None): (A) by striking ``After consultation'' and inserting
p.(None): ``Consultation.--After consultation''; and
p.(None): (B) by striking ``Assistant Secretary shall
p.(None): develop'' and inserting ``Assistant Secretary shall use
p.(None): existing standards and best practices to develop''.
p.(None): SEC. 6005. STRATEGIC PLAN.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 through 6003, is further amended by inserting
p.(None): after subsection (k), as redesignated by section 6003, the following:
p.(None): ``(l) Strategic Plan.--
p.(None): ``(1) In general.--Not later than September 30, 2018, and
p.(None): every 4 years thereafter, the Assistant Secretary shall develop
p.(None): and carry out a strategic plan in accordance with this
p.(None): subsection for the planning and operation of activities carried
p.(None): out by the Administration, including evidence-based programs.
...
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
p.(None): collaboration with States, local governments,
p.(None): communities, and Indian tribes and tribal organizations
p.(None): (as such terms are defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act); and
p.(None): ``(F) specify a strategy to disseminate evidence-
p.(None): based and promising best practices related to
p.(None): prevention, diagnosis, early intervention, treatment,
p.(None): and recovery services related to mental illness,
p.(None): particularly for adults with a serious mental illness
p.(None): and children with a serious emotional disturbance, and
p.(None): for individuals with a substance use disorder.''.
p.(None): SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
p.(None):
p.(None): (a) In General.--Section 501 of the Public Health Service Act (42
p.(None): U.S.C. 290aa), as so amended, is further amended by amending subsection
p.(None): (m), as redesignated by section 6003, to read as follows:
p.(None): ``(m) Biennial Report Concerning Activities and Progress.--Not later
p.(None): than September 30, 2020, and every 2 years thereafter, the Assistant
p.(None): Secretary shall prepare and submit to the Committee on Energy and
p.(None): Commerce and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
...
p.(None): disorders, including activities related to--
p.(None): ``(A) the implementation and dissemination of
p.(None): research findings into improved programs, including with
p.(None): respect to how advances in serious mental illness and
p.(None): serious emotional disturbance research have been
p.(None): incorporated into programs;
p.(None): ``(B) the recruitment, training, and retention of a
p.(None): mental and substance use disorders workforce;
p.(None): ``(C) the integration of mental disorder services,
p.(None): substance use disorder services, and physical health
p.(None): services;
p.(None): ``(D) homelessness; and
p.(None): ``(E) veterans;
p.(None): ``(5) a description of the manner in which the
p.(None): Administration promotes coordination by grantees under this
p.(None): title, and part B of title XIX, with State or local agencies;
p.(None): and
p.(None): ``(6) a description of the activities carried out under
p.(None): section 501A(e), with respect to mental and substance use
p.(None): disorders, including--
p.(None): ``(A) the number and a description of grants
p.(None): awarded;
p.(None): ``(B) the total amount of funding for grants
p.(None): awarded;
p.(None): ``(C) a description of the activities supported
p.(None): through such grants, including outcomes of programs
p.(None): supported; and
p.(None): ``(D) information on how the National Mental Health
p.(None): and Substance Use Policy Laboratory is consulting with
p.(None): the Assistant Secretary for Planning and Evaluation and
p.(None): collaborating with the Center for Substance Abuse
p.(None): Treatment, the Center for Substance Abuse Prevention,
p.(None): the Center for Behavioral Health Statistics and Quality,
p.(None): and the Center for Mental Health Services to carry out
p.(None): such activities; and
p.(None): ``(7) recommendations made by the Assistant Secretary for
p.(None): Planning and Evaluation under section 6021 of the Helping
p.(None): Families in Mental Health Crisis Reform Act of 2016 to improve
p.(None): programs within the Administration, and actions taken in
p.(None): response to such recommendations to improve programs within the
p.(None): Administration.
p.(None):
p.(None): The Assistant Secretary may meet reporting requirements established
p.(None): under this title by providing the contents of such reports as an
p.(None): addendum to the biennial report established under this subsection,
p.(None): notwithstanding the timeline of other reporting requirements in this
p.(None): title. Nothing in this subsection shall be construed to alter the
p.(None): content requirements of such reports or authorize the Assistant
p.(None): Secretary to alter the timeline of any such reports
p.(None):
p.(None): [[Page 130 STAT. 1212]]
p.(None):
p.(None): to be less frequent than biennially, unless as specified in this
p.(None): title.''.
p.(None): (b) Conforming Amendment.--Section 508(p) of the Public Health
p.(None): Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
p.(None): 501(k)'' and inserting ``section 501(m)''.
p.(None): SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
p.(None): SUBSTANCE ABUSE PREVENTION, AND
p.(None): SUBSTANCE ABUSE TREATMENT.
p.(None):
p.(None): (a) Center for Mental Health Services.--Section 520(b) of the Public
p.(None): Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
p.(None): (1) by redesignating paragraphs (3) through (15) as
p.(None): paragraphs (4) through (16), respectively;
p.(None): (2) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute of Mental Health and the Chief Medical Officer,
p.(None): appointed under section 501(g), to ensure that, as appropriate,
p.(None): programs related to the prevention and treatment of mental
p.(None): illness and the promotion of mental health and recovery support
p.(None): are carried out in a manner that reflects the best available
p.(None): science and evidence-based practices, including culturally and
p.(None): linguistically appropriate services, as appropriate;'';
p.(None): (3) in paragraph (5), as so redesignated, by inserting ``,
p.(None): including through programs that reduce risk and promote
p.(None): resiliency'' before the semicolon;
p.(None): (4) in paragraph (6), as so redesignated, by inserting ``in
p.(None): collaboration with the Director of the National Institute of
p.(None): Mental Health,'' before ``develop'';
p.(None): (5) in paragraph (8), as so redesignated, by inserting ``,
p.(None): increase meaningful participation of individuals with mental
p.(None): illness in programs and activities of the Administration,''
p.(None): before ``and protect the legal'';
p.(None): (6) in paragraph (10), as so redesignated, by striking
p.(None): ``professional and paraprofessional personnel pursuant to
p.(None): section 303'' and inserting ``health paraprofessional personnel
p.(None): and health professionals'';
p.(None): (7) in paragraph (11), as so redesignated, by inserting
p.(None): ``and tele-mental health'' after ``rural mental health'';
p.(None): (8) in paragraph (12), as so redesignated, by striking
p.(None): ``establish a clearinghouse for mental health information to
p.(None): assure the widespread dissemination of such information'' and
p.(None): inserting ``disseminate mental health information, including
p.(None): evidence-based practices,'';
p.(None): (9) in paragraph (15), as so redesignated, by striking
p.(None): ``and'' at the end;
p.(None): (10) in paragraph (16), as so redesignated, by striking the
p.(None): period and inserting ``; and''; and
p.(None): (11) by adding at the end the following:
p.(None): ``(17) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded.''.
p.(None):
p.(None): (b) Director of the Center for Substance Abuse Prevention.--Section
p.(None): 515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
p.(None): (1) in the section heading, by striking ``office'' and
p.(None): inserting ``center'';
p.(None):
p.(None): [[Page 130 STAT. 1213]]
p.(None):
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``an Office'' and inserting ``a
p.(None): Center''; and
p.(None): (B) by striking ``The Office'' and inserting ``The
p.(None): Prevention Center''; and
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by inserting ``through the
p.(None): reduction of risk and the promotion of resiliency''
p.(None): before the semicolon;
p.(None): (B) by redesignating paragraphs (3) through (11) as
p.(None): paragraphs (4) through (12), respectively;
p.(None): (C) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute on Drug Abuse, the Director of the National Institute
p.(None): on Alcohol Abuse and Alcoholism, and States to promote the study
p.(None): of substance abuse prevention and the dissemination and
p.(None): implementation of research findings that will improve the
p.(None): delivery and effectiveness of substance abuse prevention
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
p.(None): Disease Control and Prevention, develop and disseminate
p.(None): educational materials to increase awareness for individuals at
p.(None): greatest risk for substance use disorders to prevent the
p.(None): transmission of communicable diseases, such as HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases;'';
p.(None): (G) in paragraph (9), as so redesignated--
p.(None): (i) by striking ``to discourage'' and
p.(None): inserting ``that reduce the risk of''; and
p.(None): (ii) by inserting before the semicolon ``and
p.(None): promote resiliency'';
p.(None): (H) in paragraph (11), as so redesignated, by
p.(None): striking ``and'' after the semicolon;
p.(None): (I) in paragraph (12), as so redesignated, by
p.(None): striking the period and inserting a semicolon; and
p.(None): (J) by adding at the end the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) assist and support States in preventing illicit drug
p.(None): use, including emerging illicit drug use issues.''.
p.(None):
p.(None): [[Page 130 STAT. 1214]]
p.(None):
p.(None): (c) Director of the Center for Substance Abuse Treatment.--Section
p.(None): 507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``treatment of substance abuse'' and
p.(None): inserting ``treatment of substance use disorders''; and
p.(None): (B) by striking ``abuse treatment systems'' and
p.(None): inserting ``use disorder treatment systems''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (B) in paragraph (3), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (C) in paragraph (4), by striking ``individuals who
p.(None): abuse drugs'' and inserting ``individuals who illicitly
p.(None): use drugs'';
p.(None): (D) in paragraph (9), by striking ``carried out by
p.(None): the Director'';
p.(None): (E) by striking paragraph (10);
p.(None): (F) by redesignating paragraphs (11) through (14) as
p.(None): paragraphs (10) through (13), respectively;
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
...
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
p.(None): prevent substance misuse.''.
p.(None): SEC. 6009. PEER REVIEW.
p.(None):
p.(None): Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 3(b)) is amended by adding at the end the following: ``In the case of
p.(None): any such peer review group that is reviewing a grant, cooperative
p.(None): agreement, or contract related to mental illness treatment, not less
p.(None): than half of the members of such peer review group shall be licensed and
p.(None): experienced professionals in the prevention, diagnosis, or treatment of,
p.(None): or recovery from, mental illness or co-occurring mental illness and
p.(None): substance use disorders and have a medical degree, a doctoral degree in
p.(None): psychology, or an advanced degree in nursing or social work from an
p.(None): accredited program, and the Secretary, in consultation with the
p.(None): Assistant Secretary, shall, to the extent possible, ensure such peer
p.(None): review groups include broad geographic representation, including both
p.(None): urban and rural representatives.''.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): SEC. 6021. <> IMPROVING OVERSIGHT OF
p.(None): MENTAL AND SUBSTANCE USE DISORDERS
p.(None): PROGRAMS THROUGH THE ASSISTANT SECRETARY
p.(None): FOR PLANNING AND EVALUATION.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Planning and Evaluation, shall
p.(None): ensure efficient and effective planning and evaluation of mental and
...
p.(None): within the Department of Health and Human Services. The strategy shall--
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
p.(None): the Secretary of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, and the Congress on improving the
p.(None): quality of prevention and treatment programs and activities related to
p.(None): mental and substance use disorders, including recommendations for the
p.(None): use of performance metrics. The Assistant Secretary for Mental Health
p.(None): and Substance Use shall include such recommendations in the biennial
p.(None): report required by subsection 501(m) of the Public Health Service Act,
p.(None): as redesignated by section 6003 of this Act.
p.(None): SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
p.(None):
p.(None): (a) Public Availability of Reports.--Section 105(a)(7) of the
p.(None): Protection and Advocacy for Individuals with Mental Illness Act (42
p.(None): U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and
...
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
p.(None): the Assistant Secretary may establish a period for the
p.(None): submission of applications for evidence-based programs and
p.(None): practices to be posted publicly in accordance with subsection
p.(None): (a).
p.(None): ``(2) Notice.--In establishing the application period under
p.(None): paragraph (1), the Assistant Secretary shall provide for the
p.(None): public notice of such application period in the Federal
p.(None): Register.
p.(None):
p.(None): [[Page 130 STAT. 1223]]
p.(None):
p.(None): Such notice may solicit applications for evidence-based programs
p.(None): and practices to address gaps in information identified by the
p.(None): Assistant Secretary, the National Mental Health and Substance
p.(None): Use Policy Laboratory established under section 501A, or the
p.(None): Assistant Secretary for Planning and Evaluation, including
p.(None): pursuant to the evaluation and recommendations under section
p.(None): 6021 of the Helping Families in Mental Health Crisis Reform Act
p.(None): of 2016 or priorities identified in the strategic plan under
p.(None): section 501(l).
p.(None):
p.(None): ``(c) Requirements.--The Assistant Secretary may establish minimum
p.(None): requirements for the applications submitted under subsection (b),
p.(None): including applications related to the submission of research and
p.(None): evaluation.
p.(None): ``(d) Review and Rating.--
p.(None): ``(1) In general.--The Assistant Secretary shall review
p.(None): applications prior to public posting in accordance with
p.(None): subsection (a), and may prioritize the review of applications
p.(None): for evidence-based programs and practices that are related to
p.(None): topics included in the notice provided under subsection (b)(2).
p.(None): ``(2) System.--In carrying out paragraph (1), the Assistant
p.(None): Secretary may utilize a rating and review system, which may
p.(None): include information on the strength of evidence associated with
p.(None): the evidence-based programs and practices and a rating of the
p.(None): methodological rigor of the research supporting the
p.(None): applications.
p.(None): ``(3) Public access to metrics and rating.--The Assistant
p.(None): Secretary shall make the metrics used to evaluate applications
p.(None): under this section, and any resulting ratings of such
p.(None): applications, publicly available.''.
p.(None): SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
p.(None): SIGNIFICANCE.
p.(None):
p.(None): Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32)
p.(None): is amended--
...
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or''; and
p.(None): (2) by amending subsection (f) to read as follows:
p.(None):
p.(None): ``(f) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $394,550,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None):
p.(None): [[Page 130 STAT. 1224]]
p.(None):
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``that permit States, local governments, communities,
p.(None): and Indian tribes and tribal organizations (as the terms
p.(None): `Indian tribes' and `tribal organizations' are defined
p.(None): in section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act) to focus on emerging trends in
p.(None): substance abuse and co-occurrence of substance use
p.(None): disorders with mental illness or other conditions''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (3) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (4) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$333,806,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
...
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
p.(None): based system of care for individuals with mental
p.(None): illness, and describe available services and
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
p.(None): ``(iv) include a description of how the State
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
...
p.(None): of suicide using the block grant funds;
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
p.(None): (8) in subparagraph (D) (as so redesignated), by striking
p.(None): ``plan describes'' and inserting ``plan shall describe'';
p.(None): (9) in subparagraph (E) (as so redesignated)--
p.(None): (A) in the subparagraph heading by striking
p.(None): ``systems'' and inserting ``services'';
p.(None): (B) in the first sentence, by striking ``plan
p.(None): describes'' and all that follows through ``and provides
p.(None): for'' and inserting ``plan shall describe the financial
p.(None): resources available, the existing mental health
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
...
p.(None): under section 1911 may, upon request by the State,
p.(None): in lieu of having the amount of the allotment
p.(None): under section 1911 for the State reduced for the
p.(None): fiscal year of the grant, agree to comply with a
p.(None): negotiated agreement that is approved by the
p.(None): Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State
p.(None): fails to enter into or comply with a negotiated
p.(None): agreement, the Secretary may take action under
p.(None): this paragraph or the terms of the negotiated
p.(None): agreement.''; and
p.(None): (B) in subparagraph (B)--
p.(None):
p.(None): [[Page 130 STAT. 1229]]
p.(None):
p.(None): (i) by inserting after the subparagraph
p.(None): designation the following: ``Submission of
p.(None): information to the secretary.--''; and
p.(None): (ii) by striking ``subparagraph (A)'' and
p.(None): inserting ``subparagraph (A)(i)''.
p.(None):
p.(None): (e) Application for Grant.--Section 1917(a) of the Public Health
p.(None): Service Act (42 U.S.C. 300x-6(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``1941'' and inserting
p.(None): ``1942(a)''; and
p.(None): (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and
p.(None): inserting ``1915(b)''.
p.(None):
p.(None): (f) Funding.--Section 1920 of the Public Health Service Act (42
p.(None): U.S.C. 300x-9) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(c)''; and
p.(None): (B) by striking ``$450,000,000'' and all that
p.(None): follows through the period and inserting ``$532,571,000
p.(None): for each of fiscal years 2018 through 2022.''; and
p.(None): (2) in subsection (b)(2) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(c) and''.
p.(None): SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1921(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x-21(b)) is amended--
p.(None): (1) by inserting ``carrying out the plan developed in
p.(None): accordance with section 1932(b) and for'' after ``for the
p.(None): purpose of''; and
p.(None): (2) by striking ``abuse'' and inserting ``use disorders''.
p.(None):
p.(None): (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the
p.(None): Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
p.(None): (1) in the subsection heading, by striking ``Regarding
p.(None): Intravenous Substance Abuse'' and inserting ``to Persons Who
p.(None): Inject Drugs''; and
p.(None): (2) by striking ``for intravenous drug abuse'' and inserting
p.(None): ``for persons who inject drugs''.
p.(None):
p.(None): (c) Requirements Regarding Tuberculosis and Human Immunodeficiency
p.(None): Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
p.(None): 24) is amended--
p.(None): (1) in subsection (a)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``substance abuse'' and inserting ``substance
p.(None): use disorders''; and
p.(None): (B) in subparagraph (A), by striking ``such abuse''
p.(None): and inserting ``such disorders'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1)(A), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (B) in paragraph (2), by inserting ``and
p.(None): Prevention'' after ``Disease Control'';
p.(None): (C) in paragraph (3)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``abuse'' and inserting ``use disorders''; and
p.(None): (ii) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None):
p.(None): [[Page 130 STAT. 1230]]
p.(None):
p.(None): (D) in paragraph (6)(B), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (3) by striking subsection (d); and
p.(None): (4) by redesignating subsection (e) as subsection (d).
p.(None):
p.(None): (d) Group Homes.--Section 1925 of the Public Health Service Act (42
p.(None): U.S.C. 300x-25) is amended--
p.(None): (1) in the section heading, by striking ``recovering
p.(None): substance abusers'' and inserting ``persons in recovery from
p.(None): substance use disorders''; and
p.(None): (2) in subsection (a), in the matter preceding paragraph
p.(None): (1), by striking ``recovering substance abusers'' and inserting
p.(None): ``persons in recovery from substance use disorders''.
p.(None):
p.(None): (e) Additional Agreements.--Section 1928 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-28) is amended--
p.(None): (1) in subsection (a), by striking ``(relative to fiscal
p.(None): year 1992)'';
p.(None): (2) by striking subsection (b) and inserting the following:
p.(None):
p.(None): ``(b) Professional Development.--A funding agreement for a grant
p.(None): under section 1921 is that the State involved will ensure that
p.(None): prevention, treatment, and recovery personnel operating in the State's
p.(None): substance use disorder prevention, treatment, and recovery systems have
p.(None): an opportunity to receive training, on an ongoing basis, concerning--
p.(None): ``(1) recent trends in substance use disorders in the State;
p.(None): ``(2) improved methods and evidence-based practices for
p.(None): providing substance use disorder prevention and treatment
p.(None): services;
p.(None): ``(3) performance-based accountability;
p.(None): ``(4) data collection and reporting requirements; and
p.(None): ``(5) any other matters that would serve to further improve
p.(None): the delivery of substance use disorder prevention and treatment
p.(None): services within the State.''; and
p.(None): (3) in subsection (d)(1), by striking ``substance abuse''
p.(None): and inserting ``substance use disorders''.
p.(None):
p.(None): (f) Repeal.--Section 1929 of the Public Health Service Act (42
p.(None): U.S.C. 300x-29) is repealed.
p.(None): (g) Maintenance of Effort.--Section 1930 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-30) is amended--
p.(None): (1) in subsection (c)(1), by striking ``in the State justify
p.(None): the waiver'' and inserting ``exist in the State, or any part of
p.(None): the State, to justify the waiver''; and
p.(None): (2) in subsection (d), by inserting at the end the
p.(None): following:
p.(None): ``(3) Alternative.--A State that has failed to comply with
p.(None): this section and would otherwise be subject to a reduction in
p.(None): the State's allotment under section 1921, may, upon request by
p.(None): the State, in lieu of having the State's allotment under section
p.(None): 1921 reduced, agree to comply with a negotiated agreement that
p.(None): is approved by the Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State fails to enter
p.(None): into or comply with a negotiated agreement, the Secretary may
p.(None): take action under this paragraph or the terms of the negotiated
p.(None): agreement.''.
p.(None):
p.(None): (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
p.(None): Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
p.(None): ``substance abuse'' and inserting ``substance use disorders''.
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
...
p.(None): disorder service settings.
p.(None): ``(B) The establishment of goals and objectives for
p.(None): the period of the plan, including targets and milestones
p.(None): that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.
p.(None): ``(C) A description of how the State will comply
p.(None): with each funding agreement for a grant under section
p.(None): 1921 that is applicable to the State, including a
p.(None): description of the manner in which the State intends to
p.(None): expend grant funds.''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``authority of secretary regarding modifications''
p.(None): and inserting ``modifications'';
p.(None): (ii) by striking ``As a condition'' and
p.(None): inserting the following:
p.(None): ``(A) Authority of secretary.--As a condition;'';
p.(None): and
p.(None): (iii) by adding at the end the following:
p.(None): ``(B) State request for modification.--If the State
p.(None): determines that a modification to such plan is
p.(None): necessary, the State may request the Secretary to
p.(None): approve the modification. Any such modification shall be
p.(None): in accordance with paragraph (1) and section 1941.'';
p.(None): and
p.(None): (C) in paragraph (3), by inserting, ``, including
p.(None): any modification under paragraph (2)'' after
p.(None): ``subsection (a)(6)''; and
p.(None): (3) in subsection (e)(2), by striking ``section 1922(c)''
p.(None): and inserting ``section 1922(b)''.
p.(None):
p.(None): (j) Definitions.--Section 1934 of the Public Health Service Act (42
p.(None): U.S.C. 300x-34) is amended--
p.(None): (1) in paragraph (3), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None): (2) in paragraph (7), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''.
p.(None): (k) Funding.--Section 1935 of the Public Health Service Act (42
p.(None): U.S.C. 300x-35) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(d)''; and
p.(None): (B) by striking ``$2,000,000,000 for fiscal year
p.(None): 2001, and such sums as may be necessary for each of the
p.(None): fiscal years 2002 and 2003'' and inserting
p.(None): ``$1,858,079,000 for each of fiscal years 2018 through
p.(None): 2022.''; and
p.(None): (2) in subsection (b)(1)(B) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(d) and''.
p.(None): SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
p.(None):
p.(None): Subpart III of part B of title XIX of the Public Health Service Act
p.(None): (42 U.S.C. 300x-51 et seq.) is amended--
p.(None): (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
p.(None): striking ``section 505'' and inserting ``subsections (c) and (d)
p.(None): of section 505'';
p.(None):
p.(None): [[Page 130 STAT. 1233]]
p.(None):
p.(None): (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
p.(None): ``substance abuse'' and inserting ``substance use disorder'';
p.(None): and
p.(None): (3) by adding at the end the following:
p.(None): ``SEC. 1957. <> PUBLIC HEALTH EMERGENCIES.
p.(None):
p.(None): ``In the case of a public health emergency (as determined under
p.(None): section 319), the Secretary, on a State by State basis, may, as the
p.(None): circumstances of the emergency reasonably require and for the period of
p.(None): the emergency, grant an extension, or waive application deadlines or
p.(None): compliance with any other requirement, of a grant authorized under
p.(None): section 521, 1911, or 1921 or an allotment authorized under Public Law
p.(None): 99-319 (42 U.S.C. 10801 et seq.).
p.(None): ``SEC. 1958. <> JOINT APPLICATIONS.
p.(None):
p.(None): ``The Secretary, acting through the Assistant Secretary for Mental
p.(None): Health and Substance Use, shall permit a joint application to be
p.(None): submitted for grants under subpart I and subpart II upon the request of
p.(None): a State. Such application may be jointly reviewed and approved by the
p.(None): Secretary with respect to such subparts, consistent with the purposes
p.(None): and authorized activities of each such grant program. A State submitting
p.(None): such a joint application shall otherwise meet the requirements with
p.(None): respect to each such subpart.''.
p.(None): SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
p.(None): ABUSE PREVENTION AND TREATMENT BLOCK
p.(None): GRANT AND THE COMMUNITY MENTAL HEALTH
p.(None): SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Mental Health and Substance Use,
p.(None): shall through a grant or contract, or through an agreement with a third
p.(None): party, conduct a study on the formulas for distribution of funds under
p.(None): the substance abuse prevention and treatment block grant, and the
p.(None): community mental health services block grant, under part B of title XIX
p.(None): of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend
p.(None): changes if necessary. Such study shall include--
p.(None): (1) an analysis of whether the distributions under such
p.(None): block grants accurately reflect the need for the services under
p.(None): the grants in the States;
p.(None): (2) an examination of whether the indices used under the
p.(None): formulas for distribution of funds under such block grants are
p.(None): appropriate, and if not, alternatives recommended by the
p.(None): Secretary;
p.(None): (3) where recommendations are included under paragraph (2)
p.(None): for the use of different indices, a description of the variables
p.(None): and data sources that should be used to determine the indices;
p.(None): (4) an evaluation of the variables and data sources that are
p.(None): being used for each of the indices involved, and whether such
p.(None): variables and data sources accurately represent the need for
p.(None): services, the cost of providing services, and the ability of the
p.(None): States to pay for such services;
p.(None): (5) the effect that the minimum allotment requirements for
p.(None): each such block grant have on each State's final allotment and
p.(None): the effect of such requirements, if any, on each State's
p.(None): formula-based allotment;
p.(None):
p.(None): [[Page 130 STAT. 1234]]
p.(None):
p.(None): (6) recommendations for modifications to the minimum
p.(None): allotment provisions to ensure an appropriate distribution of
p.(None): funds; and
p.(None): (7) any other information that the Secretary determines
p.(None): appropriate.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of enactment of
p.(None): this Act, the Secretary of Health and Human Services shall submit to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and
p.(None): the Committee on Energy and Commerce of the House of Representatives, a
p.(None): report containing the findings and recommendations of the study
p.(None): conducted under subsection (a) and the study conducted under section
p.(None): 9004(g).
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
p.(None): INDIVIDUALS.
p.(None):
p.(None): Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is
p.(None): amended--
p.(None): (1) in subsection (a), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraphs (1) and (3), by striking
p.(None): ``substance abuse'' each place the term appears and
p.(None): inserting ``substance use disorder''; and
p.(None): (B) in paragraph (4), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder'';
p.(None): (3) in subsection (c)--
p.(None): (A) in paragraph (1), by striking ``substance abuse
p.(None): disorder'' and inserting ``substance use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in subparagraph (A), by striking
p.(None): ``substance abuse'' and inserting ``a substance
p.(None): use disorder''; and
p.(None): (ii) in subparagraph (B), by striking
p.(None): ``substance abuse'' and inserting ``substance use
p.(None): disorder''; and
p.(None): (4) in subsection (e), by striking ``, $50,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$41,304,000 for
p.(None): each of fiscal years 2018 through 2022''.
p.(None): SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
p.(None):
p.(None): Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38)
p.(None): is amended--
p.(None): (1) by striking ``substance abuse'' each place such term
p.(None): appears and inserting ``substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Indian tribes, and tribal
p.(None): organizations'' and inserting ``and Indian tribes and
p.(None): tribal organizations (as the terms `Indian tribes' and
p.(None): `tribal organizations' are
p.(None):
p.(None): [[Page 130 STAT. 1235]]
p.(None):
p.(None): defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act)''; and
p.(None): (B) by inserting ``or a health facility or program
p.(None): operated by or in accordance with a contract or grant
p.(None): with the Indian Health Service,'' after ``entities,'';
p.(None): (3) in subsection (c)(2)(A)(i), by striking ``the best
p.(None): known'' and inserting ``evidence-based'';
p.(None): (4) by redesignating subsections (d) through (i) as
p.(None): subsections (e) through (j), respectively;
p.(None): (5) by inserting after subsection (c) the following:
p.(None):
p.(None): ``(d) Special Consideration Regarding Veterans.--In awarding grants
p.(None): under subsection (a), the Secretary shall, as appropriate, give special
p.(None): consideration to entities proposing to use grant funding to support jail
p.(None): diversion services for veterans.'';
p.(None): (6) in subsection (e), as so redesignated--
p.(None): (A) in paragraph (3), by striking ``; and'' and
p.(None): inserting a semicolon;
p.(None): (B) in paragraph (4), by striking the period and
p.(None): inserting ``; and''; and
p.(None): (C) by adding at the end the following:
p.(None): ``(5) develop programs to divert individuals prior to
...
p.(None): paragraph (1) shall, as appropriate, be made available to
p.(None): States, political subdivisions of States, Indian tribes or
p.(None): tribal organizations (as defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act), outpatient
p.(None): mental health and addiction treatment centers, community mental
p.(None): health centers that meet the criteria under section 1913(c),
p.(None): certified community behavioral health clinics described in
p.(None): section 223 of the Protecting Access to Medicare Act of 2014,
p.(None): primary care organizations such as Federally qualified health
p.(None): centers or rural health clinics as defined in section 1861(aa)
p.(None):
p.(None): [[Page 130 STAT. 1238]]
p.(None):
p.(None): of the Social Security Act, other community-based organizations,
p.(None): or other entities engaging in integrated care activities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): ``(h) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $51,878,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
p.(None): HOMELESSNESS.
p.(None):
p.(None): (a) Formula Grants to States.--Section 521 of the Public Health
p.(None): Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through
p.(None): 1994'' and inserting ``2018 through 2022''.
p.(None): (b) Purpose of Grants.--Section 522 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-22) is amended--
p.(None): (1) in subsection (a)(1)(B), by striking ``substance abuse''
p.(None): and inserting ``a substance use disorder'';
p.(None): (2) in subsection (b)(6), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (3) in subsection (c), by striking ``substance abuse'' and
p.(None): inserting ``a substance use disorder'';
p.(None): (4) in subsection (e)--
p.(None): (A) in paragraph (1), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder''; and
p.(None): (B) in paragraph (2), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (5) by striking subsection (g) and redesignating subsections
p.(None): (h) and (i) as (g) and (h), accordingly; and
p.(None): (6) in subsection (g), as redesignated by paragraph (5), by
p.(None): striking ``substance abuse'' each place such term appears and
p.(None): inserting ``substance use disorder''.
p.(None):
p.(None): (c) Description of Intended Expenditures of Grant.--Section 527 of
p.(None): the Public Health Service Act (42 U.S.C. 290cc-27) is amended by
p.(None): striking ``substance abuse'' each place such term appears and inserting
p.(None): ``substance use disorder''.
p.(None): (d) Technical Assistance.--Section 530 of the Public Health Service
p.(None): Act (42 U.S.C. 290cc-30) is amended by striking ``through the National
p.(None): Institute of Mental Health, the National Institute of Alcohol Abuse and
p.(None): Alcoholism, and the National Institute on Drug Abuse'' and inserting
p.(None): ``acting through the Assistant Secretary''.
p.(None): (e) Definitions.--Section 534(4) of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-34(4)) is amended to read as follows:
p.(None): ``(4) Substance use disorder services.--The term `substance
p.(None): use disorder services' has the meaning given the term `substance
p.(None): abuse services' in section 330(h)(5)(C).''.
p.(None):
p.(None): (f) Funding.--Section 535(a) of the Public Health Service Act (42
p.(None): U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the
p.(None): fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of
p.(None): fiscal years 2018 through 2022''.
p.(None): (g) Study Concerning Formula.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Assistant Secretary for Mental Health
p.(None): and Substance Use (referred to in this section as the
p.(None): ``Assistant Secretary'') shall conduct a study concerning the
p.(None): formula used under section 524 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-24) for making allotments to States under
p.(None): section 521 of such Act (42 U.S.C. 290cc-21). Such study shall
p.(None): include an evaluation of quality indicators of need for purposes
p.(None):
p.(None): [[Page 130 STAT. 1239]]
p.(None):
p.(None): of revising the formula for determining the amount of each
p.(None): allotment for the fiscal years following the submission of the
p.(None): study.
p.(None): (2) Report.--In accordance with section 8004(b), the
p.(None): Assistant Secretary shall submit to the committees of Congress
p.(None): described in such section a report concerning the results of the
p.(None): study conducted under paragraph (1).
p.(None): SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2
p.(None): (42 U.S.C. 290bb-36b) the following:
p.(None): ``SEC. 520E-3. <> NATIONAL SUICIDE
...
p.(None): ``(2) Community-based crisis response plan.--An application
p.(None): for a grant under subsection (a)(1) shall include a plan for--
p.(None): ``(A) promoting integration and coordination between
p.(None): local public and private entities engaged in crisis
p.(None): response, including first responders, emergency health
p.(None): care providers, primary care providers, law enforcement,
p.(None): court systems, health care payers, social service
p.(None): providers, and behavioral health providers;
p.(None): ``(B) developing memoranda of understanding with
p.(None): public and private entities to implement crisis response
p.(None): services;
p.(None): ``(C) addressing gaps in community resources for
p.(None): crisis intervention and prevention; and
p.(None):
p.(None): [[Page 130 STAT. 1241]]
p.(None):
p.(None): ``(D) developing models for minimizing hospital
p.(None): readmissions, including through appropriate discharge
p.(None): planning.
p.(None): ``(3) Beds database plan.--An application for a grant under
p.(None): subsection (a)(2) shall include a plan for developing,
p.(None): maintaining, or enhancing a real-time, Internet-based bed
p.(None): database to collect, aggregate, and display information about
p.(None): beds in inpatient psychiatric facilities and crisis
p.(None): stabilization units, and residential community mental health and
p.(None): residential substance use disorder treatment facilities to
p.(None): facilitate the identification and designation of facilities for
p.(None): the temporary treatment of individuals in mental or substance
p.(None): use disorder crisis.
p.(None):
p.(None): ``(c) Database Requirements.--A bed database described in this
p.(None): section is a database that--
p.(None): ``(1) includes information on inpatient psychiatric
p.(None): facilities, crisis stabilization units, and residential
p.(None): community mental health and residential substance use disorder
p.(None): facilities in the State involved, including contact information
p.(None): for the facility or unit;
p.(None): ``(2) provides real-time information about the number of
p.(None): beds available at each facility or unit and, for each available
p.(None): bed, the type of patient that may be admitted, the level of
p.(None): security provided, and any other information that may be
p.(None): necessary to allow for the proper identification of appropriate
p.(None): facilities for treatment of individuals in mental or substance
p.(None): use disorder crisis; and
p.(None): ``(3) enables searches of the database to identify available
p.(None): beds that are appropriate for the treatment of individuals in
p.(None): mental or substance use disorder crisis.
p.(None):
p.(None): ``(d) Evaluation.--An entity receiving a grant under subsection
p.(None): (a)(1) shall submit to the Secretary, at such time, in such manner, and
p.(None): containing such information as the Secretary may reasonably require, a
p.(None): report, including an evaluation of the effect of such grant on--
p.(None): ``(1) local crisis response services and measures for
p.(None): individuals receiving crisis planning and early intervention
p.(None): supports;
p.(None): ``(2) individuals reporting improved functional outcomes;
p.(None): and
p.(None): ``(3) individuals receiving regular followup care following
p.(None): a crisis.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section, $12,500,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
p.(None):
p.(None): (a) Suicide Prevention Technical Assistance Center.--Section 520C of
p.(None): the Public Health Service Act (42 U.S.C. 290bb-34), as amended by
p.(None): section 6001, is further amended--
p.(None): (1) in the section heading, by striking ``youth interagency
p.(None): research, training, and technical assistance centers'' and
p.(None): inserting ``suicide prevention technical assistance center'';
p.(None): (2) in subsection (a), by striking ``acting through the
p.(None): Assistant Secretary for Mental Health and Substance Use'' and
...
p.(None): particularly among groups that are at a high risk for
p.(None): suicide'' before the semicolon at the end;
p.(None): (F) in paragraph (3), by inserting ``and tribal''
p.(None): after ``statewide'';
p.(None): (G) in paragraph (5), by inserting ``and
p.(None): prevention'' after ``intervention'';
p.(None): (H) in paragraph (8), by striking ``in youth'';
p.(None): (I) in paragraph (9), by striking ``and behavioral
p.(None): health'' and inserting ``health and substance use
p.(None): disorder''; and
p.(None): (J) in paragraph (10), by inserting ``conducting''
p.(None): before ``other''; and
p.(None): (6) by striking subsection (e) and inserting the following:
p.(None):
p.(None): ``(c) Authorization of Appropriations.--For the purpose of carrying
p.(None): out this section, there are authorized to be appropriated $5,988,000 for
p.(None): each of fiscal years 2018 through 2022.
p.(None): ``(d) Annual Report.--Not later than 2 years after the date of
p.(None): enactment of this subsection, the Secretary shall submit to Congress a
p.(None): report on the activities carried out by the center established under
p.(None): subsection (a) during the year involved, including the potential effects
p.(None): of such activities, and the States, organizations, and institutions that
p.(None): have worked with the center.''.
p.(None): (b) Youth Suicide Early Intervention and Prevention Strategies.--
p.(None): Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is
p.(None): amended--
p.(None): (1) in paragraph (1) of subsection (a) and in subsection
p.(None): (c), by striking ``substance abuse'' each place such term
p.(None): appears and inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1243]]
p.(None):
p.(None): (i) by striking ``ensure that each State is
p.(None): awarded only 1 grant or cooperative agreement
p.(None): under this section'' and inserting ``ensure that a
p.(None): State does not receive more than 1 grant or
p.(None): cooperative agreement under this section at any 1
p.(None): time''; and
p.(None): (ii) by striking ``been awarded'' and
p.(None): inserting ``received''; and
p.(None): (B) by adding after paragraph (2) the following:
p.(None): ``(3) Consideration.--In awarding grants under this section,
p.(None): the Secretary shall take into consideration the extent of the
p.(None): need of the applicant, including the incidence and prevalence of
p.(None): suicide in the State and among the populations of focus,
p.(None): including rates of suicide determined by the Centers for Disease
p.(None): Control and Prevention for the State or population of focus.'';
p.(None): (3) in subsection (g)(2), by striking ``2 years after the
p.(None): date of enactment of this section,'' and insert ``2 years after
p.(None): the date of enactment of Helping Families in Mental Health
p.(None): Crisis Reform Act of 2016,''; and
p.(None): (4) by striking subsection (m) and inserting the following:
p.(None):
p.(None): ``(m) Authorization of Appropriations.--For the purpose of carrying
p.(None): out this section, there are authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2018 through 2022.''.
p.(None): SEC. 9009. <> ADULT SUICIDE PREVENTION.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
...
p.(None): ``(2) training for nurse practitioners, physician
p.(None): assistants, health service psychologists, and social workers to
p.(None): provide mental and substance use disorders services in
p.(None): underserved community-based settings that integrate primary care
p.(None): and mental and substance use disorders services; and
p.(None): ``(3) establishing, maintaining, or improving academic units
p.(None): or programs that--
p.(None): ``(A) provide training for students or faculty,
p.(None): including through clinical experiences and research, to
p.(None): improve the ability to be able to recognize, diagnose,
p.(None): and treat mental and substance use disorders, with a
p.(None): special focus on addiction; or
p.(None): ``(B) develop evidence-based practices or
p.(None): recommendations for the design of the units or programs
p.(None): described in subparagraph (A), including curriculum
p.(None): content standards.
p.(None):
p.(None): ``(b) Activities.--
p.(None): ``(1) Training for residents and fellows.--A recipient of a
p.(None): grant under subsection (a)(1)--
p.(None): ``(A) shall use the grant funds--
p.(None): ``(i)(I) to plan, develop, and operate a
p.(None): training program for medical psychiatry residents
p.(None): and fellows in addiction medicine practicing in
p.(None): eligible entities described in subsection (c)(1);
p.(None): or
p.(None): ``(II) to train new psychiatric residents and
p.(None): fellows in addiction medicine to provide and
p.(None): expand access to integrated mental and substance
p.(None): use disorders services; and
p.(None): ``(ii) to provide at least 1 training track
p.(None): that is--
p.(None): ``(I) a virtual training track that
p.(None): includes an in-person rotation at a
p.(None): teaching health center or in a
p.(None): community-based setting, followed by a
p.(None): virtual rotation in which the resident
p.(None): or fellow continues to support the care
p.(None): of patients at the teaching health
p.(None): center or in the community-based setting
p.(None): through the use of health information
p.(None): technology and, as appropriate,
p.(None): telehealth services;
p.(None): ``(II) an in-person training track
p.(None): that includes a rotation, during which
p.(None): the resident or fellow practices at a
p.(None): teaching health center or in a
p.(None): community-based setting; or
p.(None): ``(III) an in-person training track
p.(None): that includes a rotation during which
p.(None): the resident practices in a community-
p.(None): based setting that specializes in the
p.(None):
p.(None): [[Page 130 STAT. 1251]]
p.(None):
p.(None): treatment of infants, children,
p.(None): adolescents, or pregnant or postpartum
p.(None): women; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such training.
p.(None): ``(2) Training for other providers.--A recipient of a grant
p.(None): under subsection (a)(2)--
p.(None): ``(A) shall use the grant funds to plan, develop, or
p.(None): operate a training program to provide mental and
...
p.(None): ``(5)(A) This subsection shall take effect on October 1, 2017,
p.(None): except as provided in subparagraph (B) and paragraph (6).
p.(None): ``(B) Effective on the date of the enactment of this subsection--
p.(None): ``(i) the Secretary may issue regulations for carrying out
p.(None): this subsection, and the Secretary may accept and consider
p.(None): applications submitted pursuant to paragraph (3)(B); and
p.(None): ``(ii) reports under paragraph (4)(B) may be submitted to
p.(None): Congress.
p.(None):
p.(None): ``(6) Beginning on October 1, 2022, this subsection shall cease to
p.(None): have any force or effect.''.
p.(None): SEC. 9026. REPORTS.
p.(None):
p.(None): (a) Workforce Development Report.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Administrator of the Health Resources
p.(None): and Services Administration, in consultation with the Assistant
p.(None): Secretary for Mental Health and Substance Use, shall conduct a
p.(None): study and publicly post on the appropriate Internet website of
p.(None): the Department of Health and Human Services a report on the
p.(None): adult and pediatric mental health and substance use disorder
p.(None): workforce in order to inform Federal, State, and local efforts
p.(None): related to workforce enhancement.
p.(None): (2) Contents.--The report under this subsection shall
p.(None): contain--
p.(None): (A) national and State-level projections of the
p.(None): supply and demand of the mental health and substance use
p.(None): disorder health workforce, disaggregated by profession;
p.(None): (B) an assessment of the mental health and substance
p.(None): use disorder workforce capacity, strengths, and
p.(None): weaknesses as of the date of the report, including the
p.(None): extent to which primary care providers are preventing,
p.(None): screening, or referring for mental and substance use
p.(None): disorder services;
p.(None): (C) information on trends within the mental health
p.(None): and substance use disorder provider workforce, including
p.(None): the number of individuals expected to enter the mental
p.(None): health workforce over the next 5 years; and
p.(None): (D) any additional information determined by the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, in consultation with the Assistant
p.(None): Secretary for Mental Health and Substance Use, to be
p.(None): relevant to the mental health and substance use disorder
p.(None): provider workforce.
p.(None):
p.(None): (b) Peer-Support Specialist Programs.--
p.(None): (1) In general.--The Comptroller General of the United
p.(None): States shall conduct a study on peer-support specialist programs
p.(None): in up to 10 States that receive funding from the Substance Abuse
p.(None): and Mental Health Services Administration.
p.(None):
p.(None): [[Page 130 STAT. 1257]]
p.(None):
p.(None): (2) Contents of study.--In conducting the study under
p.(None): paragraph (1), the Comptroller General of the United States
p.(None): shall examine and identify best practices, in the States
p.(None): selected pursuant to such paragraph, related to training and
p.(None): credential requirements for peer-support specialist programs,
p.(None): such as--
p.(None): (A) hours of formal work or volunteer experience
p.(None): related to mental and substance use disorders conducted
p.(None): through such programs;
p.(None): (B) types of peer-support specialist exams required
p.(None): for such programs in the selected States;
p.(None): (C) codes of ethics used by such programs in the
p.(None): selected States;
p.(None): (D) required or recommended skill sets for such
p.(None): programs in the selected States; and
p.(None): (E) requirements for continuing education.
p.(None): (3) Report.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Comptroller General of the United
p.(None): States shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives a report on the
p.(None): study conducted under paragraph (1).
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON
p.(None): CAMPUS.
p.(None):
p.(None): Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 36b) is amended--
p.(None): (1) in the section heading, by striking ``and behavioral
p.(None): health'' and inserting ``health and substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Services,'' and inserting
p.(None): ``Services and'';
p.(None): (B) by striking ``and behavioral health problems''
p.(None): and inserting ``health or substance use disorders'';
p.(None): (C) by striking ``substance abuse'' and inserting
p.(None): ``substance use disorders''; and
p.(None): (D) by adding after, ``suicide attempts,'' the
p.(None): following: ``prevent mental and substance use disorders,
p.(None): reduce stigma, and improve the identification and
p.(None): treatment for students at risk,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``for--'' and inserting ``for one or more of
p.(None): the following:''; and
p.(None): (B) by striking paragraphs (1) through (6) and
p.(None): inserting the following:
p.(None): ``(1) Educating students, families, faculty, and staff to
p.(None): increase awareness of mental and substance use disorders.
p.(None): ``(2) The operation of hotlines.
p.(None): ``(3) Preparing informational material.
p.(None): ``(4) Providing outreach services to notify students about
p.(None): available mental and substance use disorder services.
p.(None): ``(5) Administering voluntary mental and substance use
p.(None): disorder screenings and assessments.
p.(None):
p.(None): [[Page 130 STAT. 1258]]
p.(None):
p.(None): ``(6) Supporting the training of students, faculty, and
p.(None): staff to respond effectively to students with mental and
p.(None): substance use disorders.
p.(None): ``(7) Creating a network infrastructure to link institutions
p.(None): of higher education with health care providers who treat mental
p.(None): and substance use disorders.
p.(None): ``(8) Providing mental and substance use disorders
p.(None): prevention and treatment services to students, which may include
p.(None): recovery support services and programming and early
p.(None): intervention, treatment, and management, including through the
p.(None): use of telehealth services.
p.(None): ``(9) Conducting research through a counseling or health
p.(None): center at the institution of higher education involved regarding
p.(None): improving the behavioral health of students through clinical
p.(None): services, outreach, prevention, or academic success, in a manner
p.(None): that is in compliance with all applicable personal privacy laws.
p.(None): ``(10) Supporting student groups on campus, including
p.(None): athletic teams, that engage in activities to educate students,
p.(None): including activities to reduce stigma surrounding mental and
p.(None): behavioral disorders, and promote mental health.
p.(None): ``(11) Employing appropriately trained staff.
p.(None): ``(12) Developing and supporting evidence-based and emerging
p.(None): best practices, including a focus on culturally and
p.(None): linguistically appropriate best practices.'';
p.(None): (4) in subsection (c)(5), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (5) in subsection (d)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``An institution of higher education desiring a
p.(None): grant under this section'' and inserting ``To be
p.(None): eligible to receive a grant under this section, an
p.(None): institution of higher education'';
p.(None): (B) by striking paragraph (1) and inserting--
p.(None): ``(1) A description of the population to be targeted by the
p.(None): program carried out under the grant, including veterans whenever
p.(None): possible and appropriate, and of identified mental and substance
p.(None): use disorder needs of students at the institution of higher
p.(None): education.'';
p.(None): (C) in paragraph (2), by inserting ``, which may
p.(None): include, as appropriate and in accordance with
p.(None): subsection (b)(7), a plan to seek input from relevant
p.(None): stakeholders in the community, including appropriate
p.(None): public and private entities, in order to carry out the
p.(None): program under the grant'' before the period at the end;
p.(None): and
p.(None): (D) by adding after paragraph (5) the following new
p.(None): paragraphs:
p.(None): ``(6) An outline of the objectives of the program carried
p.(None): out under the grant.
p.(None): ``(7) For an institution of higher education proposing to
p.(None): use the grant for an activity described in paragraph (8) or (9)
p.(None): of subsection (b), a description of the policies and procedures
p.(None): of the institution of higher education that are related to
p.(None): applicable laws regarding access to, and sharing of, treatment
p.(None): records of students at any campus-based mental health center or
p.(None): partner organization, including the policies and State laws
p.(None): governing when such records can be accessed and shared for non-
p.(None): treatment purposes and a description of the process used
p.(None):
p.(None): [[Page 130 STAT. 1259]]
p.(None):
p.(None): by the institution of higher education to notify students of
p.(None): these policies and procedures, including the extent to which
p.(None): written consent is required.
p.(None): ``(8) An assurance that grant funds will be used to
p.(None): supplement and not supplant any other Federal, State, or local
p.(None): funds available to carry out activities of the type carried out
p.(None): under the grant.'';
p.(None): (6) in subsection (e)(1), by striking ``and behavioral
p.(None): health problems'' and inserting ``health and substance use
p.(None): disorders'';
p.(None): (7) in subsection (f)(2)--
p.(None): (A) by striking ``and behavioral health'' and
p.(None): inserting ``health and substance use disorder''; and
p.(None): (B) by striking ``suicide and substance abuse'' and
p.(None): inserting ``suicide and substance use disorders'';
p.(None): (8) by redesignating subsection (h) as subsection (i);
p.(None): (9) by inserting after subsection (g) the following new
p.(None): subsection:
p.(None):
p.(None): ``(h) Technical Assistance.--The Secretary may provide technical
p.(None): assistance to grantees in carrying out this section.''; and
p.(None): (10) in subsection (i), as redesignated by paragraph (8), by
p.(None): striking ``$5,000,000 for fiscal year 2005'' and all that
p.(None): follows through the period at the end and inserting ``$7,000,000
p.(None): for each of fiscal years 2018 through 2022.''.
p.(None): SEC. 9032. <> INTERAGENCY WORKING
p.(None): GROUP ON COLLEGE MENTAL HEALTH.
p.(None):
p.(None): (a) Purpose.--It is the purpose of this section to provide for the
p.(None): establishment of a College Campus Task Force to discuss mental and
p.(None): behavioral health concerns on campuses of institutions of higher
p.(None): education.
p.(None): (b) Establishment.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall establish a
p.(None): College Campus Task Force (referred to in this section as the ``Task
p.(None): Force'') to discuss mental and behavioral health concerns on campuses of
p.(None): institutions of higher education.
p.(None): (c) Membership.--The Task Force shall be composed of a
p.(None): representative from each Federal agency (as appointed by the head of the
p.(None): agency) that has jurisdiction over, or is affected by, mental health and
...
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
p.(None): under this section unless the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization involved agrees, with respect to
p.(None): the costs to be incurred by the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization in carrying out the purpose
p.(None): described in this section, to make available non-Federal contributions
p.(None): (in cash or in kind) toward such costs in an amount that is not less
p.(None): than 20 percent of Federal funds provided in the grant.
p.(None): ``(g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated, $9,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
p.(None): INTERVENTION SERVICES FOR CHILDREN AND
p.(None): ADOLESCENTS.
p.(None):
p.(None): The first section 514 of the Public Health Service Act (42 U.S.C.
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
p.(None): of the long-term consequences of child trauma, and early
p.(None): intervention services and treatment to address the long-term
...
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
p.(None): functional impairment and substantially interferes with or
p.(None): limits one or more major life activities.
p.(None): (3) In reporting on the incidence of serious mental illness,
p.(None): the Substance Abuse and Mental Health Services Administration
p.(None): includes major depression, schizophrenia, bipolar disorder, and
p.(None): other mental disorders that cause serious impairment.
p.(None): (4) Adults with a serious mental illness are at a higher
p.(None): risk for chronic physical illnesses and premature death.
p.(None): (5) According to the World Health Organization, adults with
p.(None): a serious mental illness have lifespans that are 10 to 25 years
p.(None): shorter than those without serious mental illness. The vast
p.(None): majority of these deaths are due to chronic physical medical
p.(None): conditions, such as cardiovascular, respiratory, and infectious
p.(None): diseases, as well as diabetes and hypertension.
p.(None): (6) According to the World Health Organization, the majority
p.(None): of deaths of adults with a serious mental illness that are due
p.(None): to physical medical conditions are preventable.
p.(None): (7) Supported decision making can facilitate care decisions
p.(None): in areas where serious mental illness may impact the capacity of
p.(None): an individual to determine a course of treatment while still
p.(None): allowing the individual to make decisions independently.
p.(None): (8) Help should be provided to adults with a serious mental
p.(None): illness to address their acute or chronic physical illnesses,
...
p.(None): (2) No particular or uniform electronic visit verification
p.(None): system required.--Nothing in the amendment made by this section
p.(None): shall be construed to require the use of a particular or uniform
p.(None): electronic visit verification system (as defined in subsection
p.(None): (l)(5) of section 1903 of the Social Security Act (42 U.S.C.
p.(None): 1396b), as inserted by subsection (a)) by all agencies or
p.(None): entities that provide personal care services or home health care
p.(None): under a State plan under title XIX of the Social Security Act
p.(None): (or under a waiver of the plan) (42 U.S.C. 1396 et seq.).
p.(None): (3) No limits on provision of care.--Nothing in the
p.(None): amendment made by this section may be construed to limit, with
p.(None): respect to personal care services or home health care services
p.(None): provided under a State plan under title XIX of the Social
p.(None): Security Act (or under a waiver of the plan) (42 U.S.C. 1396 et
p.(None): seq.), provider selection, constrain beneficiaries' selection of
p.(None): a caregiver, or impede the manner in which care is delivered.
p.(None): (4) No prohibition on state quality measures requirements.--
p.(None): Nothing in the amendment made by this section shall be construed
p.(None): as prohibiting a State, in implementing an electronic visit
p.(None): verification system (as defined in subsection (l)(5) of section
p.(None): 1903 of the Social Security Act (42 U.S.C. 1396b), as inserted
p.(None): by subsection (a)), from establishing requirements related to
p.(None): quality measures for such system.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE
p.(None): USE DISORDER COVERAGE REQUIREMENTS.
p.(None):
p.(None): (a) Compliance Program Guidance Document.--Section 2726(a) of the
p.(None): Public Health Service Act (42 U.S.C. 300gg-26(a)) is amended by adding
p.(None): at the end the following:
p.(None): ``(6) Compliance program guidance document.--
p.(None): ``(A) In general.--Not later than 12 months after
p.(None): the date of enactment of the Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016, the Secretary, the
p.(None): Secretary of Labor, and the Secretary of the Treasury,
p.(None): in consultation with the Inspector General of the
p.(None): Department of Health and Human Services, the Inspector
p.(None): General of the Department of Labor, and the Inspector
p.(None): General of the Department of the Treasury, shall issue a
p.(None): compliance program guidance document to help improve
p.(None): compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, and
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable. In carrying out this paragraph, the
p.(None): Secretaries may take into consideration the 2016
p.(None): publication of the Department of Health and Human
p.(None): Services and the Department of Labor, entitled `Warning
p.(None): Signs - Plan or Policy Non-Quantitative Treatment
p.(None): Limitations (NQTLs) that Require Additional Analysis to
p.(None): Determine Mental Health Parity Compliance'.
p.(None): ``(B) Examples illustrating compliance and
p.(None): noncompliance.--
p.(None):
p.(None): [[Page 130 STAT. 1279]]
p.(None):
p.(None): ``(i) In general.--The compliance program
p.(None): guidance document required under this paragraph
p.(None): shall provide illustrative, de-identified examples
p.(None): (that do not disclose any protected health
p.(None): information or individually identifiable
...
p.(None): nature with respect to--
p.(None): ``(I) nonquantitative treatment
p.(None): limitations for both medical and
p.(None): surgical benefits and mental health and
p.(None): substance use disorder benefits;
p.(None): ``(II) the processes, strategies,
p.(None): evidentiary standards, and other factors
p.(None): used to apply the limitations described
p.(None): in subclause (I); and
p.(None): ``(III) the application of the
p.(None): limitations described in subclause (I)
p.(None): to ensure that such limitations are
p.(None): applied in parity with respect to both
p.(None): medical and surgical benefits and mental
p.(None): health and substance use disorder
p.(None): benefits.
p.(None): ``(C) Nonquantitative treatment limitations.--The
p.(None): guidance issued under this paragraph shall include
p.(None): clarifying information and illustrative examples of
p.(None): methods, processes, strategies, evidentiary standards,
p.(None): and other factors that group health plans and health
p.(None): insurance issuers offering group or individual health
p.(None): insurance coverage may use regarding the development and
p.(None): application of nonquantitative treatment limitations to
p.(None): ensure compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, or
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable, (and any regulations promulgated pursuant to
p.(None): such respective section), including--
p.(None): ``(i) examples of methods of determining
p.(None): appropriate types of nonquantitative treatment
p.(None): limitations with respect to both medical and
p.(None): surgical benefits and mental health and substance
p.(None): use disorder benefits, including nonquantitative
p.(None): treatment limitations pertaining to--
p.(None): ``(I) medical management standards
p.(None): based on medical necessity or
p.(None): appropriateness, or whether a treatment
p.(None): is experimental or investigative;
p.(None): ``(II) limitations with respect to
p.(None): prescription drug formulary design; and
p.(None): ``(III) use of fail-first or step
p.(None): therapy protocols;
p.(None): ``(ii) examples of methods of determining--
p.(None): ``(I) network admission standards
p.(None): (such as credentialing); and
p.(None): ``(II) factors used in provider
p.(None): reimbursement methodologies (such as
p.(None): service type, geographic market, demand
p.(None): for services, and provider supply,
p.(None): practice size, training, experience, and
p.(None): licensure) as such factors apply to
p.(None): network adequacy;
p.(None): ``(iii) examples of sources of information
p.(None): that may serve as evidentiary standards for the
p.(None): purposes of making determinations regarding the
p.(None): development and application of nonquantitative
p.(None): treatment limitations;
p.(None): ``(iv) examples of specific factors, and the
p.(None): evidentiary standards used to evaluate such
p.(None): factors, used
p.(None):
p.(None): [[Page 130 STAT. 1282]]
p.(None):
p.(None): by such plans or issuers in performing a
p.(None): nonquantitative treatment limitation analysis;
p.(None): ``(v) examples of how specific evidentiary
p.(None): standards may be used to determine whether
p.(None): treatments are considered experimental or
p.(None): investigative;
p.(None): ``(vi) examples of how specific evidentiary
p.(None): standards may be applied to each service category
p.(None): or classification of benefits;
...
p.(None): Services shall convene a public meeting of stakeholders
p.(None): described in paragraph (2) to produce an action plan for
p.(None): improved Federal and State coordination related to the
p.(None): enforcement of section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the
p.(None): Internal Revenue Code of 1986, and any comparable provisions of
p.(None): State law (in this section such sections and provisions are
p.(None): collectively referred to as ``mental health parity and addiction
p.(None): equity requirements'').
p.(None): (2) Stakeholders.--The stakeholders described in this
p.(None): paragraph shall include each of the following:
p.(None): (A) The Federal Government, including
p.(None): representatives from--
p.(None): (i) the Department of Health and Human
p.(None): Services;
p.(None): (ii) the Department of the Treasury;
p.(None): (iii) the Department of Labor; and
p.(None): (iv) the Department of Justice.
p.(None): (B) State governments, including--
p.(None): (i) State health insurance commissioners;
p.(None): (ii) appropriate State agencies, including
p.(None): agencies on public health or mental health; and
p.(None): (iii) State attorneys general or other
p.(None): representatives of State entities involved in the
p.(None): enforcement of mental health parity and addiction
p.(None): equity requirements.
p.(None):
p.(None): [[Page 130 STAT. 1284]]
p.(None):
p.(None): (C) Representatives from key stakeholder groups,
p.(None): including--
p.(None): (i) the National Association of Insurance
p.(None): Commissioners;
p.(None): (ii) health insurance issuers;
p.(None): (iii) providers of mental health and substance
p.(None): use disorder treatment;
p.(None): (iv) employers; and
p.(None): (v) patients or their advocates.
p.(None):
p.(None): (b) Action Plan.--Not later than 6 months after the conclusion of
p.(None): the public meeting under subsection (a), the Secretary of Health and
p.(None): Human Services shall finalize the action plan described in such
p.(None): subsection and make it plainly available on the Internet website of the
p.(None): Department of Health and Human Services.
p.(None): (c) Content.--The action plan under this section shall--
p.(None): (1) take into consideration the recommendations of the
p.(None): Mental Health and Substance Use Disorder Parity Task Force in
p.(None): its final report issued in October of 2016, and any subsequent
p.(None): Federal and State actions in relation to such recommendations;
p.(None): (2) reflect the input of the stakeholders participating in
p.(None): the public meeting under subsection (a);
p.(None): (3) identify specific strategic objectives regarding how the
p.(None): various Federal and State agencies charged with enforcement of
p.(None): mental health parity and addiction equity requirements will
p.(None): collaborate to improve enforcement of such requirements;
p.(None): (4) provide a timeline for implementing the action plan; and
p.(None): (5) provide specific examples of how such objectives may be
p.(None): met, which may include--
p.(None): (A) providing common educational information and
p.(None): documents, such as the Consumer Guide to Disclosure
p.(None): Rights, to patients about their rights under mental
p.(None): health parity and addiction equity requirements;
p.(None): (B) facilitating the centralized collection of,
p.(None): monitoring of, and response to patient complaints or
...
p.(None): public comment, by the Department of
p.(None): Health and Human Services as of the date
p.(None): of the enactment of this Act;
p.(None): (C) Federal and State law enforcement agencies
p.(None): entering into memoranda of understanding to better
p.(None): coordinate enforcement responsibilities and information
p.(None): sharing--
p.(None): (i) including whether such agencies should
p.(None): make the results of enforcement actions related to
p.(None): mental health parity and addiction equity
p.(None): requirements publicly available; and
p.(None):
p.(None): [[Page 130 STAT. 1285]]
p.(None):
p.(None): (ii) which may include State Policy Academies
p.(None): on Parity Implementation for State Officials and
p.(None): other forums to bring together national experts to
p.(None): provide technical assistance to teams of State
p.(None): officials on strategies to advance compliance with
p.(None): mental health parity and addiction equity
p.(None): requirements in both the commercial market, and in
p.(None): the Medicaid program under title XIX of the Social
p.(None): Security Act and the State Children's Health
p.(None): Insurance Program under title XXI of such Act; and
p.(None): (D) recommendations to the Congress regarding the
p.(None): need for additional legal authority to improve
p.(None): enforcement of mental health parity and addiction equity
p.(None): requirements, including the need for additional legal
p.(None): authority to ensure that nonquantitative treatment
p.(None): limitations are applied, and the extent and frequency of
p.(None): the applications of such limitations, both to medical
p.(None): and surgical benefits and to mental health and substance
p.(None): use disorder benefits in a comparable manner.
p.(None): SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL
p.(None): HEALTH AND SUBSTANCE USE DISORDER
p.(None): BENEFITS.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, and annually thereafter for the subsequent 5 years, the
p.(None): Assistant Secretary of Labor of the Employee Benefits Security
p.(None): Administration, in collaboration with the Administrator of the Centers
p.(None): for Medicare & Medicaid Services and the Secretary of the Treasury,
p.(None): shall submit to the Committee on Energy and Commerce of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report summarizing the results of all closed
p.(None): Federal investigations completed during the preceding 12-month period
p.(None): with findings of any serious violation regarding compliance with mental
p.(None): health and substance use disorder coverage requirements under section
p.(None): 2726 of the Public Health Service Act (42 U.S.C. 300gg-26), section 712
p.(None): of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
p.(None): 1185a), and section 9812 of the Internal Revenue Code of 1986.
p.(None): (b) Contents.--Subject to subsection (c), a report under subsection
p.(None): (a) shall, with respect to investigations described in such subsection,
p.(None): include each of the following:
p.(None): (1) The number of closed Federal investigations conducted
p.(None): during the covered reporting period.
p.(None): (2) Each benefit classification examined by any such
p.(None): investigation conducted during the covered reporting period.
...
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS,
p.(None): MENTAL HEALTH PURPOSES.
p.(None):
p.(None): (a) Edward Byrne Memorial Justice Assistance Grant Program.--Section
p.(None): 501(a)(1) of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the end the
p.(None): following:
p.(None): ``(H) Mental health programs and related law
p.(None): enforcement and corrections programs, including
p.(None): behavioral programs and crisis intervention teams.''.
p.(None):
p.(None): [[Page 130 STAT. 1288]]
p.(None):
p.(None): (b) Community Oriented Policing Services Program.--Section 1701(b)
p.(None): of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42
p.(None): U.S.C. 3796dd(b)) is amended--
p.(None): (1) in paragraph (17), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (18) as paragraph (22);
p.(None): (3) by inserting after paragraph (17) the following:
p.(None): ``(18) to provide specialized training to law enforcement
p.(None): officers to--
p.(None): ``(A) recognize individuals who have a mental
p.(None): illness; and
p.(None): ``(B) properly interact with individuals who have a
p.(None): mental illness, including strategies for verbal de-
p.(None): escalation of crises;
p.(None): ``(19) to establish collaborative programs that enhance the
p.(None): ability of law enforcement agencies to address the mental
p.(None): health, behavioral, and substance abuse problems of individuals
p.(None): encountered by law enforcement officers in the line of duty;
p.(None): ``(20) to provide specialized training to corrections
p.(None): officers to recognize individuals who have a mental illness;
p.(None): ``(21) to enhance the ability of corrections officers to
p.(None): address the mental health of individuals under the care and
p.(None): custody of jails and prisons, including specialized training and
p.(None): strategies for verbal de-escalation of crises; and''; and
p.(None): (4) in paragraph (22), as redesignated, by striking
p.(None): ``through (17)'' and inserting ``through (21)''.
p.(None):
p.(None): (c) Modifications to the Staffing for Adequate Fire and Emergency
p.(None): Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention and
p.(None): Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting
p.(None): before the period at the end the following: ``and to provide specialized
p.(None): training to paramedics, emergency medical services workers, and other
p.(None): first responders to recognize individuals who have mental illness and
p.(None): how to properly intervene with individuals with mental illness,
p.(None): including strategies for verbal de-escalation of crises''.
p.(None): SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
p.(None):
p.(None): (a) In General.--Section 2201 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
...
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
p.(None): other family support services for each program
p.(None): participant who requires such services;
p.(None): (E) outpatient or inpatient mental health treatment,
p.(None): as ordered by the court, that carries with it the
p.(None): possibility of dismissal of charges or reduced
p.(None): sentencing upon successful completion of such treatment;
p.(None): (F) centralized case management, including--
p.(None): (i) the consolidation of all cases, including
p.(None): violations of probations, of the program
p.(None): participant; and
p.(None): (ii) coordination of all mental health
p.(None): treatment plans and social services, including
p.(None): life skills and vocational training, housing and
p.(None): job placement, education, health care, and relapse
p.(None): prevention for each program participant who
p.(None): requires such services; and
p.(None): (G) continuing supervision of treatment plan
p.(None): compliance by the program participant for a term not to
p.(None): exceed the maximum allowable sentence or probation
p.(None): period for the charged or relevant offense and, to the
p.(None): extent practicable, continuity of psychiatric care at
p.(None): the end of the supervised period.
p.(None):
p.(None): (d) Implementation; Duration.--The pilot program established under
p.(None): subsection (b) shall be conducted--
p.(None): (1) in not less than 1 United States judicial district,
p.(None): designated by the Attorney General in consultation with the
p.(None): Director of the Administrative Office of the United States
p.(None): Courts, as appropriate for the pilot program; and
p.(None): (2) during fiscal year 2017 through fiscal year 2021.
p.(None):
p.(None): (e) Criteria for Designation.--Before making a designation under
p.(None): subsection (d)(1), the Attorney General shall--
p.(None):
p.(None): [[Page 130 STAT. 1291]]
p.(None):
p.(None): (1) obtain the approval, in writing, of the United States
p.(None): Attorney for the United States judicial district being
p.(None): designated;
p.(None): (2) obtain the approval, in writing, of the chief judge for
p.(None): the United States judicial district being designated; and
p.(None): (3) determine that the United States judicial district being
p.(None): designated has adequate behavioral health systems for treatment,
p.(None): including substance abuse and mental health treatment.
p.(None):
p.(None): (f) Assistance From Other Federal Entities.--The Administrative
p.(None): Office of the United States Courts and the United States Probation
p.(None): Offices shall provide such assistance and carry out such functions as
p.(None): the Attorney General may request in monitoring, supervising, providing
p.(None): services to, and evaluating eligible offenders placed in a drug or
p.(None): mental health court under this section.
p.(None): (g) Reports.--The Attorney General, in consultation with the
p.(None): Director of the Administrative Office of the United States Courts, shall
p.(None): monitor the drug and mental health courts under this section, and shall
p.(None): submit a report to Congress on the outcomes of the program at the end of
p.(None): the period described in subsection (d)(2).
p.(None): SEC. 14004. <> MENTAL HEALTH IN THE
p.(None): JUDICIAL SYSTEM.
p.(None):
p.(None): Part V of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
p.(None): the following:
p.(None): ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
p.(None):
p.(None): ``(a) Pretrial Screening and Supervision.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand pretrial services programs to improve the
...
p.(None): through objective, statistically validated means, and
p.(None): presentation to the court of recommendations based on
p.(None): such assessment, including services that will reduce the
p.(None): risk of pre-trial misconduct;
p.(None): ``(C) followup review of defendants unable to meet
p.(None): the conditions of pretrial release;
p.(None): ``(D) evaluation of process and results of pre-trial
p.(None): service programs;
p.(None): ``(E) supervision of defendants who are on pretrial
p.(None): release, including reminders to defendants of scheduled
p.(None): court dates;
p.(None): ``(F) reporting on process and results of pretrial
p.(None): services programs to relevant public and private mental
p.(None): health stakeholders; and
p.(None): ``(G) data collection and analysis necessary to make
p.(None): available information required for assessment of risk.
p.(None):
p.(None): ``(b) Behavioral Health Assessments and Intervention.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None):
p.(None): [[Page 130 STAT. 1292]]
p.(None):
p.(None): implement, or expand a behavioral health screening and
p.(None): assessment program framework for State or local criminal justice
p.(None): systems.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be used for--
p.(None): ``(A) promotion of the use of validated assessment
p.(None): tools to gauge the criminogenic risk, substance abuse
p.(None): needs, and mental health needs of individuals;
p.(None): ``(B) initiatives to match the risk factors and
p.(None): needs of individuals to programs and practices
p.(None): associated with research-based, positive outcomes;
p.(None): ``(C) implementing methods for identifying and
p.(None): treating individuals who are most likely to benefit from
p.(None): coordinated supervision and treatment strategies, and
p.(None): identifying individuals who can do well with fewer
p.(None): interventions; and
p.(None): ``(D) collaborative decision-making among the heads
p.(None): of criminal justice agencies, mental health systems,
p.(None): judicial systems, substance abuse systems, and other
p.(None): relevant systems or agencies for determining how
p.(None): treatment and intensive supervision services should be
p.(None): allocated in order to maximize benefits, and developing
p.(None): and utilizing capacity accordingly.
p.(None):
p.(None): ``(c) Use of Grant Funds.--A State, unit of local government,
p.(None): territory, Indian Tribe, or nonprofit agency that receives a grant under
p.(None): this section shall, in accordance with subsection (b)(2), use grant
p.(None): funds for the expenses of a treatment program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including costs relating to enforcement;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the State or Indian Tribe and licensed, if necessary, to provide
p.(None): needed treatment to program participants, including aftercare
p.(None): supervision, vocational training, education, and job placement;
p.(None): and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide alcohol and drug addiction treatment to
p.(None): offenders participating in the program.
p.(None):
p.(None): ``(d) Supplement of Non-Federal Funds.--
p.(None): ``(1) In general.--Grants awarded under this section shall
p.(None): be used to supplement, and not supplant, non-Federal funds that
...
p.(None): implement, or expand Assertive Community Treatment initiatives
p.(None): to develop forensic assertive community treatment (referred to
p.(None): in this subsection as `FACT') programs that provide high
p.(None): intensity services in the community for individuals with mental
p.(None): illness with involvement in the criminal justice system to
p.(None): prevent future incarcerations.
p.(None): ``(2) Allowable uses.--Grant funds awarded under this
p.(None): subsection may be used for--
p.(None): ``(A) multidisciplinary team initiatives for
p.(None): individuals with mental illnesses with criminal justice
p.(None): involvement that address criminal justice involvement as
p.(None): part of treatment protocols;
p.(None): ``(B) FACT programs that involve mental health
p.(None): professionals, criminal justice agencies, chemical
p.(None): dependency specialists, nurses, psychiatrists,
p.(None): vocational specialists, forensic peer specialists,
p.(None): forensic specialists, and dedicated administrative
p.(None): support staff who work together to provide recovery
p.(None): oriented, 24/7 wraparound services;
p.(None): ``(C) services such as integrated evidence-based
p.(None): practices for the treatment of co-occurring mental
p.(None): health and substance-related disorders, assertive
p.(None): outreach and engagement, community-based service
p.(None): provision at participants' residence or in the
p.(None): community, psychiatric rehabilitation, recovery oriented
p.(None): services, services to address criminogenic risk factors,
p.(None): and community tenure;
p.(None): ``(D) payments for treatment providers that are
p.(None): approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide needed treatment to eligible
p.(None): offenders
p.(None):
p.(None): [[Page 130 STAT. 1296]]
p.(None):
p.(None): participating in the program, including behavioral
p.(None): health services and aftercare supervision; and
p.(None): ``(E) training for all FACT teams to promote high-
p.(None): fidelity practice principles and technical assistance to
p.(None): support effective and continuing integration with
p.(None): criminal justice agency partners.
p.(None): ``(3) Supplement and not supplant.--Grants made under this
p.(None): subsection shall be used to supplement, and not supplant, non-
p.(None): Federal funds that would otherwise be available for programs
p.(None): described in this subsection.
p.(None): ``(4) Applications.--To request a grant under this
p.(None): subsection, a State, unit of local government, territory, Indian
p.(None): Tribe, or nonprofit agency shall submit an application to the
p.(None): Attorney General in such form and containing such information as
p.(None): the Attorney General may reasonably require.''.
p.(None): SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
p.(None): SYSTEMS.
p.(None):
p.(None): Section 2976(f) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
p.(None): (1) in paragraph (5), by striking ``and'' at the end;
p.(None): (2) in paragraph (6), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(7) provide mental health treatment and transitional
p.(None): services for those with mental illnesses or with co-occurring
p.(None): disorders, including housing placement or assistance; and''.
p.(None): SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN DRUG COURTS.
p.(None):
p.(None): Part EE of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797u et seq.) is amended--
p.(None): (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
p.(None): inserting ``, including co-occurring substance abuse and mental
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
p.(None):
p.(None): The Attorney General, as part of the Preventing Violence Against Law
p.(None): Enforcement and Ensuring Officer Resilience and Survivability Initiative
p.(None): (VALOR) of the Department of Justice, may provide safety training and
p.(None): technical assistance to local law enforcement agencies, including
p.(None): active-shooter response training.
p.(None): SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN RESIDENTIAL SUBSTANCE
p.(None): ABUSE TREATMENT PROGRAMS.
p.(None):
p.(None): Section 1901(a) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(B) receiving centers as alternatives to
p.(None): incarceration of eligible participants;
p.(None): ``(C) specialized response units for calls related
p.(None): to substance use disorders, mental illness, or co-
p.(None): occurring mental illness and substance use disorders;
p.(None): and
p.(None): ``(D) other arrest and pre-booking treatment
p.(None): alternatives to incarceration models; or
p.(None): ``(2) post-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) specialized clinical case management;
p.(None):
p.(None): [[Page 130 STAT. 1299]]
p.(None):
p.(None): ``(B) pre-trial services related to substances use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(C) prosecutor and defender based programs;
p.(None): ``(D) specialized probation;
p.(None): ``(E) treatment and rehabilitation programs; and
p.(None): ``(F) problem-solving courts, including mental
p.(None): health courts, drug courts, co-occurring mental health
p.(None): and substance abuse courts, DWI courts, and veterans
p.(None): treatment courts.
p.(None):
p.(None): ``(c) Application.--
p.(None): ``(1) In general.--An eligible entity desiring a grant under
p.(None): this section shall submit an application to the Attorney
p.(None): General--
p.(None): ``(A) that meets the criteria under paragraph (2);
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
p.(None): 2007);
p.(None): ``(C) demonstrate that evidence-based treatment
p.(None): practices will be utilized; and
p.(None): ``(D) demonstrate that evidence-based screening and
p.(None): assessment tools will be used to place participants in
p.(None): the treatment alternative to incarceration program.
p.(None):
p.(None): ``(d) Requirements.--Each eligible entity awarded a grant for a
p.(None): treatment alternative to incarceration program under this section
p.(None): shall--
p.(None): ``(1) determine the terms and conditions of participation in
p.(None): the program by eligible participants, taking into consideration
p.(None): the collateral consequences of an arrest, prosecution or
p.(None): criminal conviction;
p.(None): ``(2) ensure that each substance abuse and mental health
p.(None): treatment component is licensed and qualified by the relevant
p.(None): jurisdiction;
p.(None): ``(3) for programs described in subsection (b)(2), organize
p.(None): an enforcement unit comprised of appropriately trained law
p.(None): enforcement professionals under the supervision of the State,
p.(None): Tribal, or local criminal justice agency involved, the duties of
p.(None): which shall include--
p.(None): ``(A) the verification of addresses and other
p.(None): contact information of each eligible participant who
p.(None): participates or desires to participate in the program;
p.(None): and
p.(None): ``(B) if necessary, the location, apprehension,
p.(None): arrest, and return to custody of an eligible participant
p.(None): in the program who has absconded from the facility of a
p.(None): treatment provider or has otherwise significantly
p.(None): violated the terms and conditions of the program,
p.(None): consistent with Federal and State confidentiality
p.(None): requirements;
p.(None):
p.(None): [[Page 130 STAT. 1300]]
p.(None):
p.(None): ``(4) notify the relevant criminal justice entity if any
p.(None): eligible participant in the program absconds from the facility
p.(None): of the treatment provider or otherwise violates the terms and
p.(None): conditions of the program, consistent with Federal and State
p.(None): confidentiality requirements;
p.(None): ``(5) submit periodic reports on the progress of treatment
p.(None): or other measured outcomes from participation in the program of
p.(None): each eligible participant in the program to the relevant State,
p.(None): Tribal, or local criminal justice agency, including mental
p.(None): health courts, drug courts, co-occurring mental health and
p.(None): substance abuse courts, DWI courts, and veterans treatment
p.(None): courts;
p.(None): ``(6) describe the evidence-based methodology and outcome
p.(None): measurements that will be used to evaluate the program, and
p.(None): specifically explain how such measurements will provide valid
p.(None): measures of the impact of the program; and
p.(None): ``(7) describe how the program could be broadly replicated
p.(None): if demonstrated to be effective.
p.(None):
p.(None): ``(e) Use of Funds.--An eligible entity shall use a grant received
p.(None): under this section for expenses of a treatment alternative to
p.(None): incarceration program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including the enforcement unit;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the relevant State or Tribal jurisdiction and licensed, if
p.(None): necessary, to provide needed treatment to eligible offenders
p.(None): participating in the program, including aftercare supervision,
p.(None): vocational training, education, and job placement; and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Tribal jurisdiction and licensed,
p.(None): if necessary, to provide alcohol and drug addiction treatment to
p.(None): eligible offenders participating in the program.
p.(None):
p.(None): ``(f) Supplement Not Supplant.--An eligible entity shall use Federal
p.(None): funds received under this section only to supplement the funds that
...
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
p.(None): training and technical assistance for criminal justice agencies;
p.(None): ``(5) develop a receiving center system and pilot strategy
p.(None): that provides, for a jurisdiction, a single point of entry into
p.(None): the mental health and substance abuse system for assessments and
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
p.(None): criminal justice agencies evaluation tools, mechanisms, and
p.(None): measures to better assess and document performance measures and
p.(None): outcomes relating to the provision of mental health services;
p.(None): ``(8) disseminate information to States, units of local
p.(None): government, criminal justice agencies, law enforcement agencies,
p.(None): and other relevant entities about best practices, policy
p.(None): standards, and research findings relating to the provision of
p.(None): mental health services; and
p.(None): ``(9) provide education and support to individuals with
...
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
p.(None): services and substance abuse treatment services;
p.(None): and
p.(None): ``(iii) alternatives to solitary confinement
p.(None): and segregated housing and mental health screening
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
p.(None): incidents involving inmates with mental health or co-
p.(None): occurring mental health and substance abuse
p.(None): disorders.''.
p.(None): SEC. 14023. ALLOWABLE USES.
p.(None):
p.(None): Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and
p.(None): Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by
p.(None): adding at the end the following:
p.(None): ``(v) Teams addressing frequent users of
p.(None): crisis services.--Multidisciplinary teams that--
p.(None): ``(I) coordinate, implement, and
p.(None): administer community-based crisis
p.(None): responses and long-term plans for
p.(None): frequent users of crisis services;
p.(None): ``(II) provide training on how to
p.(None): respond appropriately to the unique
p.(None): issues involving frequent users of
p.(None): crisis services for public service
p.(None): personnel,
p.(None):
p.(None): [[Page 130 STAT. 1310]]
p.(None):
p.(None): including criminal justice, mental
p.(None): health, substance abuse, emergency room,
p.(None): healthcare, law enforcement,
p.(None): corrections, and housing personnel;
p.(None): ``(III) develop or support
p.(None): alternatives to hospital and jail
p.(None): admissions for frequent users of crisis
p.(None): services that provide treatment,
p.(None): stabilization, and other appropriate
p.(None): supports in the least restrictive, yet
p.(None): appropriate, environment; and
p.(None): ``(IV) develop protocols and systems
p.(None): among law enforcement, mental health,
p.(None): substance abuse, housing, corrections,
p.(None): and emergency medical service operations
p.(None): to provide coordinated assistance to
p.(None): frequent users of crisis services.''.
p.(None): SEC. 14024. LAW ENFORCEMENT TRAINING.
p.(None):
p.(None): Section 2991(h) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
p.(None): mental health and substance abuse professions develop and
p.(None): administer cooperatively.''.
p.(None): SEC. 14025. <> FEDERAL LAW
p.(None): ENFORCEMENT TRAINING.
p.(None):
p.(None): Not later than 1 year after the date of enactment of this Act, the
p.(None): Attorney General shall provide direction and guidance for the following:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training, in procedures to identify and
p.(None): appropriately respond to incidents in which the unique needs of
p.(None): individuals who have a mental illness are involved, to first
p.(None): responders and tactical units of--
p.(None): (A) Federal law enforcement agencies; and
p.(None): (B) other Federal criminal justice agencies such as
p.(None): the Bureau of Prisons, the Administrative Office of the
p.(None): United States Courts, and other agencies that the
p.(None): Attorney General determines appropriate.
p.(None): (2) Improved technology.--The establishment of, or
p.(None): improvement of existing, computerized information systems to
p.(None): provide timely information to employees of Federal law
p.(None): enforcement agencies, and Federal criminal justice agencies to
p.(None): improve the response of such employees to situations involving
p.(None): individuals who have a mental illness.
p.(None): SEC. 14026. GAO REPORT.
p.(None):
...
p.(None): empirical evidence to reduce recidivism;
p.(None): ``(5) when appropriate, use validated assessment tools to
p.(None): target preliminarily qualified offenders with a moderate or high
p.(None): risk of recidivism and a need for treatment and services; or''.
p.(None): SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT
p.(None): OF LOCAL AUTHORITY.
p.(None):
p.(None): (a) In General.--Section 2991(a) of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
p.(None): (1) in paragraph (7)--
p.(None): (A) in the heading, by striking ``Mental illness''
p.(None): and inserting ``Mental illness; mental health
p.(None): disorder''; and
p.(None): (B) by striking ``term `mental illness' means'' and
p.(None): inserting ``terms `mental illness' and `mental health
p.(None): disorder' mean''; and
p.(None): (2) by striking paragraph (9) and inserting the following:
p.(None): ``(9) Preliminarily qualified offender.--
p.(None): ``(A) In general.--The term `preliminarily qualified
p.(None): offender' means an adult or juvenile accused of an
p.(None): offense who--
p.(None): ``(i)(I) previously or currently has been
p.(None): diagnosed by a qualified mental health
p.(None): professional as having a mental illness or co-
p.(None): occurring mental illness and substance abuse
p.(None): disorders;
p.(None): ``(II) manifests obvious signs of mental
p.(None): illness or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or
p.(None): confinement or before any court; or
p.(None): ``(III) in the case of a veterans treatment
p.(None): court provided under subsection (i), has been
p.(None): diagnosed with, or manifests obvious signs of,
p.(None): mental illness or a substance abuse disorder or
p.(None): co-occurring mental illness and substance abuse
p.(None): disorder;
p.(None):
p.(None): [[Page 130 STAT. 1312]]
p.(None):
p.(None): ``(ii) has been unanimously approved for
p.(None): participation in a program funded under this
p.(None): section by, when appropriate--
p.(None): ``(I) the relevant--
p.(None): ``(aa) prosecuting attorney;
p.(None): ``(bb) defense attorney;
p.(None): ``(cc) probation or
p.(None): corrections official; and
p.(None): ``(dd) judge; and
p.(None): ``(II) a representative from the
p.(None): relevant mental health agency described
p.(None): in subsection (b)(5)(B)(i);
p.(None): ``(iii) has been determined, by each person
p.(None): described in clause (ii) who is involved in
p.(None): approving the adult or juvenile for participation
p.(None): in a program funded under this section, to not
p.(None): pose a risk of violence to any person in the
p.(None): program, or the public, if selected to participate
p.(None): in the program; and
p.(None): ``(iv) has not been charged with or convicted
p.(None): of--
p.(None): ``(I) any sex offense (as defined in
p.(None): section 111 of the Sex Offender
p.(None): Registration and Notification Act (42
p.(None): U.S.C. 16911)) or any offense relating
p.(None): to the sexual exploitation of children;
p.(None): or
p.(None): ``(II) murder or assault with intent
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
p.(None): mental health or substance abuse agency representative
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
p.(None): or property of another may be used in the course of
p.(None): committing the offense.''.
p.(None): SEC. 14029. GRANT ACCOUNTABILITY.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (l), as added by section 14022, the following:
p.(None): ``(m) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
...
p.(None): further amended by adding at the end the following new subparagraph:
p.(None): ``(E) Changes in risk adjustment.--
p.(None): ``(i) Consideration of recommendations in
p.(None): impact reports.--The Secretary may take into
p.(None): account the studies conducted and the
p.(None): recommendations made by the Secretary under
p.(None): section 2(d)(1) of the IMPACT Act of 2014 (Public
p.(None): Law 113-185; 42 U.S.C. 1395lll note) with respect
p.(None): to the application under this subsection of risk
p.(None): adjustment methodologies. Nothing in this clause
p.(None): shall be construed as precluding consideration of
p.(None): the use of groupings of hospitals.
p.(None): ``(ii) Consideration of exclusion of patient
p.(None): cases based on v or other appropriate codes.--In
p.(None): promulgating regulations to carry out this
p.(None): subsection with respect to discharges occurring
p.(None): after fiscal year 2018, the Secretary may consider
p.(None): the use of V or other ICD-related codes for
p.(None): removal of a readmission. The Secretary may
p.(None): consider modifying measures under this subsection
p.(None): to incorporate V or other ICD-related codes at the
p.(None): same time as other changes are being made under
p.(None): this subparagraph.
p.(None): ``(iii) Removal of certain readmissions.--In
p.(None): promulgating regulations to carry out this
p.(None): subsection, with respect to discharges occurring
p.(None): after fiscal year 2018, the Secretary may consider
p.(None): removal as a readmission of an admission that is
p.(None): classified within one or more of the following:
p.(None): transplants, end-stage renal disease, burns,
p.(None): trauma, psychosis, or substance abuse. The
p.(None): Secretary may consider modifying measures under
p.(None): this subsection to remove readmissions at the same
p.(None): time as other changes are being made under this
p.(None): subparagraph.''.
p.(None):
p.(None): (c) MedPAC Study on Readmissions Program.--The Medicare Payment
p.(None): Advisory Commission shall conduct a study to review overall hospital
p.(None): readmissions described in section 1886(q)(5)(E) of the Social Security
p.(None): Act (42 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions are
p.(None): related to any changes in outpatient and emergency services furnished.
p.(None): The Commission shall submit to Congress a report on such study in its
p.(None): report to Congress in June 2018.
p.(None): SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL
p.(None): DEMONSTRATION PROGRAM.
p.(None):
p.(None): (a) Extension.--Section 410A of the Medicare Prescription Drug,
p.(None): Improvement, and Modernization Act of 2003 (Public Law 108-173; 42
p.(None): U.S.C. 1395ww note) is amended--
p.(None):
p.(None): [[Page 130 STAT. 1318]]
p.(None):
p.(None): (1) in subsection (a)(5), by striking ``5-year extension
p.(None): period'' and inserting ``10-year extension period''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in the subsection heading, by striking ``Five-
p.(None): Year'' and inserting ``Ten-Year'';
p.(None): (B) in paragraph (1), by striking ``additional 5-
p.(None): year'' and inserting ``additional 10-year'';
p.(None): (C) by striking ``5-year extension period'' and
p.(None): inserting ``10-year extension period'' each place it
p.(None): appears;
p.(None): (D) in paragraph (4)(B)--
...
p.(None): the Secretary''; and
p.(None): (B) by adding at the end the following new
p.(None): subparagraph:
p.(None): ``(I) Improvements to risk adjustment for 2019 and
p.(None): subsequent years.--
p.(None): ``(i) In general.--In order to determine the
p.(None): appropriate adjustment for health status under
p.(None): subparagraph (C)(i), the following shall apply:
p.(None): ``(I) Taking into account total
p.(None): number of diseases or conditions.--The
p.(None): Secretary shall take into account the
p.(None): total number of diseases or conditions
p.(None): of an individual enrolled in an MA plan.
p.(None): The Secretary shall make an additional
p.(None): adjustment under such subparagraph as
p.(None): the number of diseases or conditions of
p.(None): an individual increases.
p.(None): ``(II) Using at least 2 years of
p.(None): diagnostic data.--The Secretary may use
p.(None): at least 2 years of diagnosis data.
p.(None): ``(III) Providing separate
p.(None): adjustments for dual eligible
p.(None): individuals.--With respect to
p.(None): individuals who are dually eligible for
p.(None): benefits under this title and title XIX,
p.(None): the Secretary shall
p.(None):
p.(None): [[Page 130 STAT. 1337]]
p.(None):
p.(None): make separate adjustments for each of
p.(None): the following:
p.(None): ``(aa) Full-benefit dual
p.(None): eligible individuals (as defined
p.(None): in section 1935(c)(6)).
p.(None): ``(bb) Such individuals not
p.(None): described in item (aa).
p.(None): ``(IV) Evaluation of mental health
p.(None): and substance use disorders.--The
p.(None): Secretary shall evaluate the impact of
p.(None): including additional diagnosis codes
p.(None): related to mental health and substance
p.(None): use disorders in the risk adjustment
p.(None): model.
p.(None): ``(V) Evaluation of chronic kidney
p.(None): disease.--The Secretary shall evaluate
p.(None): the impact of including the severity of
p.(None): chronic kidney disease in the risk
p.(None): adjustment model.
p.(None): ``(VI) Evaluation of payment rates
p.(None): for end-stage renal disease.--The
p.(None): Secretary shall evaluate whether other
p.(None): factors (in addition to those described
p.(None): in subparagraph (H)) should be taken
p.(None): into consideration when computing
p.(None): payment rates under such subparagraph.
p.(None): ``(ii) Phased-in implementation.--The
p.(None): Secretary shall phase-in any changes to risk
p.(None): adjustment payment amounts under subparagraph
p.(None): (C)(i) under this subparagraph over a 3-year
p.(None): period, beginning with 2019, with such changes
p.(None): being fully implemented for 2022 and subsequent
p.(None): years.
p.(None): ``(iii) Opportunity for review and public
p.(None): comment.--The Secretary shall provide an
p.(None): opportunity for review of the proposed changes to
p.(None): such risk adjustment payment amounts under this
p.(None): subparagraph and a public comment period of not
p.(None): less than 60 days before implementing such
p.(None): changes.''.
p.(None): (2) Studies and reports.--
p.(None): (A) Reports on the risk adjustment system.--
p.(None): (i) Medpac evaluation and report.--
p.(None): (I) Evaluation.--The Medicare
p.(None): Payment Advisory Commission shall
p.(None): conduct an evaluation of the impact of
p.(None): the provisions of, and amendments made
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p.(None): (3) Public meeting.--Prior to updating or issuing the
p.(None): guidance required by paragraph (1), the Secretary shall consult
p.(None): with stakeholders, including representatives of regulated
p.(None): industry, academia, patient advocacy organizations, consumer
p.(None): groups, and disease research foundations, through a public
p.(None): meeting to be held not later than 18 months after the date of
p.(None): enactment of this Act.
p.(None): (4) Timing.--The Secretary shall update or issue a draft
p.(None): version of the guidance required by paragraph (1) not later than
p.(None): 18 months after the date of the public meeting required by
p.(None): paragraph (3) and finalize such guidance not later than 1 year
p.(None): after the date on which the public comment period for the draft
p.(None): guidance closes.
p.(None): SEC. 3022. REAL WORLD EVIDENCE.
p.(None):
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
p.(None): inserting after section 505E (21 U.S.C. 355f) the following:
p.(None): ``SEC. 505F. <> UTILIZING REAL WORLD
p.(None): EVIDENCE.
p.(None):
p.(None): ``(a) In General.--The Secretary shall establish a program to
p.(None): evaluate the potential use of real world evidence--
p.(None): ``(1) to help to support the approval of a new indication
p.(None): for a drug approved under section 505(c); and
p.(None): ``(2) to help to support or satisfy postapproval study
p.(None): requirements.
p.(None):
p.(None): ``(b) Real World Evidence Defined.--In this section, the term `real
p.(None): world evidence' means data regarding the usage, or the potential
p.(None): benefits or risks, of a drug derived from sources other than randomized
p.(None): clinical trials.
p.(None): ``(c) Program Framework.--
p.(None): ``(1) In general.--Not later than 2 years after the date of
p.(None): enactment of the 21st Century Cures Act, the Secretary shall
p.(None): establish a draft framework for implementation of the program
p.(None): under this section.
p.(None): ``(2) Contents of framework.--The framework shall include
p.(None): information describing--
p.(None): ``(A) the sources of real world evidence, including
p.(None): ongoing safety surveillance, observational studies,
p.(None): registries, claims, and patient-centered outcomes
p.(None): research activities;
p.(None): ``(B) the gaps in data collection activities;
p.(None):
p.(None): [[Page 130 STAT. 1097]]
p.(None):
p.(None): ``(C) the standards and methodologies for collection
p.(None): and analysis of real world evidence; and
p.(None): ``(D) the priority areas, remaining challenges, and
p.(None): potential pilot opportunities that the program
p.(None): established under this section will address.
p.(None): ``(3) Consultation.--
p.(None): ``(A) In general.--In developing the program
p.(None): framework under this subsection, the Secretary shall
p.(None): consult with regulated industry, academia, medical
p.(None): professional organizations, representatives of patient
p.(None): advocacy organizations, consumer organizations, disease
p.(None): research foundations, and other interested parties.
p.(None): ``(B) Process.--The consultation under subparagraph
p.(None): (A) may be carried out through approaches such as--
p.(None): ``(i) a public-private partnership with the
p.(None): entities described in such subparagraph in which
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p.(None): place it appears and inserting ``(B)''.
p.(None):
p.(None): (b) Fraud and Abuse Reporting.--Section 403B of the Public Health
p.(None): Service Act (42 U.S.C. 283a-1) is amended--
p.(None): (1) by striking subsection (b);
p.(None): (2) by redesignating subsection (c) as subsection (b); and
p.(None): (3) in subsection (b) (as so redesignated), by striking
p.(None): ``subsections (a) and (b)'' and inserting ``subsection (a)''.
p.(None):
p.(None): (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public
p.(None): Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking
p.(None): ``(not including any leaves of absence)''.
p.(None): (d) Vaccine Reporting.--Section 404B of the Public Health Service
p.(None): Act (42 U.S.C. 283d) is amended--
p.(None): (1) by striking subsection (b); and
p.(None): (2) by striking ``(a) Development of New Vaccines.--The
p.(None): Secretary'' and inserting ``The Secretary''.
p.(None):
p.(None): (e) National Center for Advancing Translational Sciences.--Section
p.(None): 479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
p.(None): (1) in the subsection heading, by striking ``Annual'' and
p.(None): inserting ``Biennial''; and
p.(None): (2) in the matter preceding paragraph (1), by striking ``an
p.(None): annual report'' and inserting ``a report on a biennial basis''.
p.(None):
p.(None): (f) Review of Centers of Excellence.--
p.(None): (1) Repeal.--Section 404H of the Public Health Service Act
p.(None): (42 U.S.C. 283j) is repealed.
p.(None): (2) Conforming amendment.--Section 399EE(c) of the Public
p.(None): Health Service Act (42 U.S.C. 280-4(c)) is amended by striking
p.(None): ``399CC, 404H,'' and inserting ``399CC''.
p.(None):
p.(None): (g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE
p.(None): Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
p.(None): (1) by striking paragraph (2); and
p.(None): (2) by redesignating paragraph (3) as paragraph (2).
p.(None):
p.(None): (h) National Institute of Nursing Research.--
p.(None): (1) Repeal.--Section 464Y of the Public Health Service Act
p.(None): (42 U.S.C. 285q-3) is repealed.
p.(None): (2) Conforming amendment.--Section 464X(g) of the Public
p.(None): Health Service Act (42 U.S.C. 285q-2(g)) is amended by striking
p.(None): ``biennial report made under section 464Y,'' and inserting
p.(None): ``triennial report made under section 403''.
p.(None):
p.(None): [[Page 130 STAT. 1074]]
p.(None):
p.(None): SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING
p.(None): ORGANISMS.
p.(None):
p.(None): Section 301 of the Public Health Service Act (42 U.S.C. 241), as
p.(None): amended by section 2035, is further amended--
p.(None): (1) in the flush matter at the end of subsection (a)--
p.(None): (A) by redesignating such matter as subsection
p.(None): (h)(1); and
p.(None): (B) by moving such matter so as to appear at the end
p.(None): of such section; and
p.(None): (2) in subsection (h) (as so redesignated), by adding at the
p.(None): end the following:
p.(None):
p.(None): ``(2) Where research substances and living organisms are made
p.(None): available under paragraph (1) through contractors, the Secretary may
p.(None): direct such contractors to collect payments on behalf of the Secretary
p.(None): for the costs incurred to make available such substances and organisms
p.(None): and to forward amounts so collected to the Secretary, in the time and
p.(None): manner specified by the Secretary.
p.(None): ``(3) Amounts collected under paragraph (2) shall be credited to the
p.(None): appropriations accounts that incurred the costs to make available the
...
p.(None): amended by section 6001, is further amended--
p.(None): (1) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Agencies'' and inserting ``Centers''; and
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``entities'' and inserting ``Centers'';
p.(None): (2) in subsection (d)--
p.(None): (A) in paragraph (1)--
p.(None): (i) by striking ``agencies'' each place the
p.(None): term appears and inserting ``Centers''; and
p.(None): (ii) by striking ``such agency'' and inserting
p.(None): ``such Center'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``agencies'' and inserting
p.(None): ``Centers'';
p.(None): (ii) by striking ``with respect to substance
p.(None): abuse'' and inserting ``with respect to substance
p.(None): use disorders''; and
p.(None): (iii) by striking ``and individuals who are
p.(None): substance abusers'' and inserting ``and
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (I) by striking paragraph (11) and inserting the
...
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
p.(None): Disease Control and Prevention, develop and disseminate
p.(None): educational materials to increase awareness for individuals at
p.(None): greatest risk for substance use disorders to prevent the
p.(None): transmission of communicable diseases, such as HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases;'';
p.(None): (G) in paragraph (9), as so redesignated--
p.(None): (i) by striking ``to discourage'' and
p.(None): inserting ``that reduce the risk of''; and
p.(None): (ii) by inserting before the semicolon ``and
p.(None): promote resiliency'';
p.(None): (H) in paragraph (11), as so redesignated, by
p.(None): striking ``and'' after the semicolon;
p.(None): (I) in paragraph (12), as so redesignated, by
p.(None): striking the period and inserting a semicolon; and
p.(None): (J) by adding at the end the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) assist and support States in preventing illicit drug
p.(None): use, including emerging illicit drug use issues.''.
p.(None):
p.(None): [[Page 130 STAT. 1214]]
p.(None):
p.(None): (c) Director of the Center for Substance Abuse Treatment.--Section
p.(None): 507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``treatment of substance abuse'' and
p.(None): inserting ``treatment of substance use disorders''; and
p.(None): (B) by striking ``abuse treatment systems'' and
p.(None): inserting ``use disorder treatment systems''; and
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p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
...
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
p.(None): practitioner shall for purposes of this subsection be considered to be a
p.(None): health professional volunteer at an entity described in subsection
p.(None): (g)(4) if the following conditions are met:
p.(None): ``(A) The service is provided to the individual at the
p.(None): facilities of an entity described in subsection (g)(4), or
p.(None): through offsite programs or events carried out by the entity.
p.(None): ``(B) The entity is sponsoring the health care practitioner
p.(None): pursuant to paragraph (3)(B).
p.(None): ``(C) The health care practitioner does not receive any
p.(None): compensation for the service from the individual, the entity
p.(None): described in subsection (g)(4), or any third-party payer
p.(None): (including reimbursement under any insurance policy or health
p.(None): plan, or under any Federal or State health benefits program),
p.(None): except that the health care practitioner may receive repayment
...
p.(None): the entity submits to the Secretary an application
p.(None): meeting the requirements of subsection (g)(1)(D); and
p.(None): ``(ii) the Secretary, pursuant to subsection
p.(None): (g)(1)(E), determines that the health care practitioner
p.(None): is deemed to be an employee of the Public Health
p.(None): Service.
p.(None): ``(C) In the case of a health care practitioner who is
p.(None): determined by the Secretary pursuant to subsection (g)(1)(E) to
p.(None): be a health professional volunteer at such entity, this
p.(None): subsection applies to the health care practitioner (with respect
p.(None): to services performed on behalf of the entity sponsoring the
p.(None): health care practitioner pursuant to subparagraph (B)) for any
p.(None): cause of action arising from an act or omission of the health
p.(None): care practitioner occurring on or after the date on which the
p.(None): Secretary makes such determination.
p.(None): ``(D) Subsection (g)(1)(F) applies to a health care
p.(None): practitioner for purposes of this subsection only to the extent
p.(None): that, in providing health services to an individual, each of the
p.(None): conditions specified in paragraph (2) is met.
p.(None):
p.(None): ``(4)(A) Amounts in the fund established under subsection (k)(2)
p.(None): shall be available for transfer under subparagraph (C) for purposes of
p.(None): carrying out this subsection.
p.(None): ``(B)(i) Not later than May 1 of each fiscal year, the Attorney
p.(None): General, in consultation with the Secretary, shall submit to the
p.(None): Congress a report providing an estimate of the amount of claims
p.(None): (together with related fees and expenses of witnesses) that, by reason
p.(None): of the acts or omissions of health professional volunteers, will be paid
p.(None): pursuant to this section during the calendar year that begins in the
p.(None): following fiscal year.
p.(None): ``(ii) Subsection (k)(1)(B) applies to the estimate under clause (i)
p.(None): regarding health professional volunteers to the same extent and in the
p.(None): same manner as such subsection applies to the estimate
p.(None):
p.(None): [[Page 130 STAT. 1256]]
p.(None):
p.(None): under such subsection regarding officers, governing board members,
p.(None): employees, and contractors of entities described in subsection (g)(4).
p.(None): ``(iii) The report shall include a summary of the data relied upon
p.(None): for the estimate in clause (i), including the number of claims filed and
p.(None): paid from the previous calendar year.
p.(None): ``(C) Not later than December 31 of each fiscal year, the Secretary
p.(None): shall transfer from the fund under subsection (k)(2) to the appropriate
p.(None): accounts in the Treasury an amount equal to the estimate made under
p.(None): subparagraph (B) for the calendar year beginning in such fiscal year,
p.(None): subject to the extent of amounts in the fund.
p.(None): ``(5)(A) This subsection shall take effect on October 1, 2017,
p.(None): except as provided in subparagraph (B) and paragraph (6).
p.(None): ``(B) Effective on the date of the enactment of this subsection--
p.(None): ``(i) the Secretary may issue regulations for carrying out
p.(None): this subsection, and the Secretary may accept and consider
p.(None): applications submitted pursuant to paragraph (3)(B); and
p.(None): ``(ii) reports under paragraph (4)(B) may be submitted to
p.(None): Congress.
p.(None):
p.(None): ``(6) Beginning on October 1, 2022, this subsection shall cease to
p.(None): have any force or effect.''.
p.(None): SEC. 9026. REPORTS.
p.(None):
p.(None): (a) Workforce Development Report.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Administrator of the Health Resources
p.(None): and Services Administration, in consultation with the Assistant
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
p.(None): Sec. 15004. Regulatory relief for LTCHs.
p.(None): Sec. 15005. Savings from IPPS MACRA pay-for through not applying
p.(None): documentation and coding adjustments.
...
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
...
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
...
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
p.(None): VETERANS AFFAIRS OF MENTAL CAPACITY OF
p.(None): BENEFICIARIES.
p.(None):
...
Searching for indicator disability:
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p.(None): purposes should be modified to allow protected health
p.(None): information to be available, as appropriate, for research
p.(None): purposes, including studies to obtain generalizable knowledge,
p.(None): while protecting individuals' privacy rights. In conducting the
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
p.(None): policy related to protecting the privacy of
p.(None): individuals, and
p.(None): (vi) existing barriers to research related to
p.(None): the current restrictions on the uses and
p.(None): disclosures of protected health information; and
p.(None): (B) consider, at a minimum--
p.(None): (i) expectations and preferences on how an
p.(None): individual's protected health information is
p.(None): shared and used;
p.(None): (ii) issues related to specific subgroups of
p.(None): people, such as children, incarcerated
p.(None): individuals, and individuals with a cognitive or
p.(None): intellectual disability impacting capacity to
p.(None): consent;
p.(None): (iii) relevant Federal and State laws;
p.(None): (iv) models of facilitating data access and
p.(None): levels of data access, including data
p.(None): segmentation, where applicable;
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
p.(None): or part 164, as appropriate, of title 45, Code of Federal
p.(None): Regulations (or any successor regulation).
p.(None): (2) Part 164.--References to a specified section of ``part
p.(None): 164'', refer to such specified section of part 164 of title 45,
p.(None): Code of Federal Regulations (or any successor section).
...
p.(None): and use of health information, including through
p.(None): technology that provides accurate patient
p.(None): information for the correct patient, including
p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None):
p.(None): [[Page 130 STAT. 1077]]
p.(None):
p.(None): ``SEC. 399S-1. <> SURVEILLANCE OF
p.(None): NEUROLOGICAL DISEASES.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Director of the
p.(None): Centers for Disease Control and Prevention and in coordination with
p.(None): other agencies as the Secretary determines, shall, as appropriate--
p.(None): ``(1) enhance and expand infrastructure and activities to
p.(None): track the epidemiology of neurological diseases; and
p.(None): ``(2) incorporate information obtained through such
p.(None): activities into an integrated surveillance system, which may
p.(None): consist of or include a registry, to be known as the National
p.(None): Neurological Conditions Surveillance System.
p.(None):
p.(None): ``(b) Research.--The Secretary shall ensure that the National
p.(None): Neurological Conditions Surveillance System is designed in a manner that
p.(None): facilitates further research on neurological diseases.
p.(None): ``(c) Content.--In carrying out subsection (a), the Secretary--
p.(None): ``(1) shall provide for the collection and storage of
p.(None): information on the incidence and prevalence of neurological
p.(None): diseases in the United States;
p.(None): ``(2) to the extent practicable, shall provide for the
p.(None): collection and storage of other available information on
p.(None): neurological diseases, including information related to persons
p.(None): living with neurological diseases who choose to participate,
p.(None): such as--
p.(None): ``(A) demographics, such as age, race, ethnicity,
p.(None): sex, geographic location, family history, and other
p.(None): information, as appropriate;
p.(None): ``(B) risk factors that may be associated with
p.(None): neurological diseases, such as genetic and environmental
p.(None): risk factors and other information, as appropriate; and
p.(None): ``(C) diagnosis and progression markers;
p.(None): ``(3) may provide for the collection and storage of
p.(None): information relevant to analysis on neurological diseases, such
p.(None): as information concerning--
p.(None): ``(A) the natural history of the diseases;
p.(None): ``(B) the prevention of the diseases;
p.(None): ``(C) the detection, management, and treatment
p.(None): approaches for the diseases; and
p.(None): ``(D) the development of outcomes measures;
p.(None): ``(4) may address issues identified during the consultation
p.(None): process under subsection (d); and
p.(None): ``(5) initially may address a limited number of neurological
p.(None): diseases.
p.(None):
p.(None): ``(d) Consultation.--In carrying out this section, the Secretary
p.(None): shall consult with individuals with appropriate expertise, which may
p.(None): include--
p.(None): ``(1) epidemiologists with experience in disease
p.(None): surveillance or registries;
p.(None): ``(2) representatives of national voluntary health
p.(None): associations that--
p.(None): ``(A) focus on neurological diseases; and
p.(None): ``(B) have demonstrated experience in research,
p.(None): care, or patient services;
p.(None): ``(3) health information technology experts or other
p.(None): information management specialists;
p.(None): ``(4) clinicians with expertise in neurological diseases;
p.(None): and
p.(None): ``(5) research scientists with experience conducting
p.(None): translational research or utilizing surveillance systems for
p.(None): scientific research purposes.
...
p.(None): under paragraph (4); and
p.(None): (vi) the comments received by the Working
p.(None): Group;
p.(None): (B) make recommendations to the Secretary regarding
p.(None): any appropriate changes or improvements to such
p.(None): activities and research; and
p.(None): (C) solicit input from States, localities, and
p.(None): nongovernmental entities, including organizations
p.(None): representing patients, health care providers,
p.(None): researchers, and industry regarding scientific advances,
p.(None): research questions, surveillance activities, and
p.(None): emerging strains in species of pathogenic organisms.
p.(None):
p.(None): [[Page 130 STAT. 1080]]
p.(None):
p.(None): (3) Membership.--The members of the working group shall
p.(None): represent a diversity of scientific disciplines and views and
p.(None): shall be composed of the following members:
p.(None): (A) Federal members.--Seven Federal members,
p.(None): consisting of one or more representatives of each of the
p.(None): following:
p.(None): (i) The Office of the Assistant Secretary for
p.(None): Health.
p.(None): (ii) The Food and Drug Administration.
p.(None): (iii) The Centers for Disease Control and
p.(None): Prevention.
p.(None): (iv) The National Institutes of Health.
p.(None): (v) Such other agencies and offices of the
p.(None): Department of Health and Human Services as the
p.(None): Secretary determines appropriate.
p.(None): (B) Non-Federal public members.--Seven non-Federal
p.(None): public members, consisting of representatives of the
p.(None): following categories:
p.(None): (i) Physicians and other medical providers
p.(None): with experience in diagnosing and treating tick-
p.(None): borne diseases.
p.(None): (ii) Scientists or researchers with expertise.
p.(None): (iii) Patients and their family members.
p.(None): (iv) Nonprofit organizations that advocate for
p.(None): patients with respect to tick-borne diseases.
p.(None): (v) Other individuals whose expertise is
p.(None): determined by the Secretary to be beneficial to
p.(None): the functioning of the Working Group.
p.(None): (4) Meetings.--The Working Group shall meet not less than
p.(None): twice each year.
p.(None): (5) Reporting.--Not later than 2 years after the date of
p.(None): enactment of this Act, and every 2 years thereafter until
p.(None): termination of the Working Group pursuant to paragraph (7), the
p.(None): Working Group shall--
p.(None): (A) submit a report on its activities under
p.(None): paragraph (2)(A) and any recommendations under paragraph
p.(None): (2)(B) to the Secretary, the Committee on Energy and
p.(None): Commerce of the House of Representatives, and the
p.(None): Committee on Health, Education, Labor, and Pensions of
p.(None): the Senate; and
p.(None): (B) make such report publicly available on the
p.(None): Internet website of the Department of Health and Human
p.(None): Services.
p.(None): (6) Applicability of faca.--The Working Group shall be
p.(None): treated as an advisory committee subject to the Federal Advisory
p.(None): Committee Act (5 U.S.C. App.).
p.(None): (7) Sunset.--The Working Group under this section shall
p.(None): terminate 6 years after the date of enactment of this Act.
p.(None): SEC. 2063. <> ACCESSING, SHARING, AND
p.(None): USING HEALTH DATA FOR RESEARCH PURPOSES.
p.(None):
p.(None): (a) Guidance Related to Remote Access.--Not later than 1 year after
p.(None): the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services (referred to in this section as the ``Secretary'') shall issue
...
p.(None):
p.(None): (1) in subsection (a)--
p.(None): (A) in the subsection heading, by striking ``In
p.(None): General'' and inserting ``Patient Engagement in Drugs
p.(None): and Devices'';
p.(None): (B) by redesignating paragraphs (1) and (2) as
p.(None): subparagraphs (A) and (B), respectively, and moving such
p.(None): subparagraphs 2 ems to the right; and
p.(None): (C) by striking ``The Secretary'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The Secretary'';
p.(None): (2) by redesignating subsections (b) through (e) as
p.(None): paragraphs (2) through (5), respectively, and moving such
p.(None): paragraphs 2 ems to the right; and
p.(None): (3) by adding at the end the following:
p.(None):
p.(None): ``(b) Statement of Patient Experience.--
p.(None): ``(1) In general.--Following the approval of an application
p.(None): that was submitted under section 505(b) of this Act or section
p.(None): 351(a) of the Public Health Service Act at least 180 days after
p.(None): the date of enactment of the 21st Century Cures Act, the
p.(None): Secretary shall make public a brief statement regarding the
p.(None): patient experience data and related information, if any,
p.(None): submitted and reviewed as part of such application.
p.(None): ``(2) Data and information.--The data and information
p.(None): referred to in paragraph (1) are--
p.(None): ``(A) patient experience data;
p.(None): ``(B) information on patient-focused drug
p.(None): development tools; and
p.(None): ``(C) other relevant information, as determined by
p.(None): the Secretary.
p.(None):
p.(None): ``(c) Patient Experience Data.--For purposes of this section, the
p.(None): term `patient experience data' includes data that--
p.(None): ``(1) are collected by any persons (including patients,
p.(None): family members and caregivers of patients, patient advocacy
p.(None): organizations, disease research foundations, researchers, and
p.(None): drug manufacturers); and
p.(None): ``(2) are intended to provide information about patients'
p.(None): experiences with a disease or condition, including--
p.(None): ``(A) the impact of such disease or condition, or a
p.(None): related therapy, on patients' lives; and
p.(None): ``(B) patient preferences with respect to treatment
p.(None): of such disease or condition.''.
p.(None): SEC. 3002. <> PATIENT-FOCUSED DRUG
p.(None): DEVELOPMENT GUIDANCE.
p.(None):
p.(None): (a) Publication of Guidance Documents.--Not later than 180 days
p.(None): after the date of enactment of this Act, the Secretary of Health and
p.(None): Human Services (referred to in this section as the ``Secretary''),
p.(None): acting through the Commissioner of Food and Drugs, shall develop a plan
p.(None): to issue draft and final versions of one or more guidance documents,
p.(None): over a period of 5 years, regarding the collection of patient experience
p.(None): data, and the use of such data and related information in drug
p.(None): development. Not later than 18 months after the date of enactment of
p.(None): this Act, the Secretary shall issue a draft version of at least one such
p.(None): guidance document. Not later than 18 months after the public comment
p.(None): period on the draft guidance ends, the Secretary shall issue a revised
p.(None): draft guidance or final guidance.
p.(None):
p.(None): [[Page 130 STAT. 1085]]
p.(None):
p.(None): (b) Patient Experience Data.--For purposes of this section, the term
p.(None): ``patient experience data'' has the meaning given such term in section
...
p.(None): at least each of the following target areas:
p.(None): ``(i) Achieving a health information
p.(None): technology infrastructure, nationally and locally,
p.(None): that allows for the electronic access, exchange,
p.(None): and use of health information, including through
p.(None): technology that provides accurate patient
p.(None): information for the correct patient, including
p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
...
p.(None): the Health Information Portability and Accountability
p.(None): Act, Privacy Rule (subpart E of part 164 of title 45,
p.(None): Code of Federal Regulations), the Director of the Office
p.(None): for Civil Rights, in consultation with the National
p.(None): Coordinator, shall assist individuals and health care
p.(None): providers in understanding a patient's rights to access
p.(None): and protect personal health information under the Health
p.(None): Insurance Portability and Accountability Act of 1996
p.(None): (Public Law 104-191), including providing best practices
p.(None):
p.(None): [[Page 130 STAT. 1183]]
p.(None):
p.(None): for requesting personal health information in a
p.(None): computable format, including using patient portals or
p.(None): third-party applications and common cases when a
p.(None): provider is permitted to exchange and provide access to
p.(None): health information.''.
p.(None): ``(2) Certifying usability for patients.--In carrying out
p.(None): certification programs under section 3001(c)(5), the National
p.(None): Coordinator may require that--
p.(None): ``(A) the certification criteria support--
p.(None): ``(i) patient access to their electronic
p.(None): health information, including in a single
p.(None): longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically;
p.(None): ``(ii) the patient's ability to electronically
p.(None): communicate patient-reported information (such as
p.(None): family history and medical history); and
p.(None): ``(iii) patient access to their personal
p.(None): electronic health information for research at the
p.(None): option of the patient; and
p.(None): ``(B) the HIT Advisory Committee develop and
p.(None): prioritize standards, implementation specifications, and
p.(None): certification criteria required to help support patient
p.(None): access to electronic health information, patient
p.(None): usability, and support for technologies that offer
p.(None): patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to
p.(None): understand, secure, and may be updated automatically.''.
p.(None):
p.(None): (b) Access to Information in an Electronic Format.--Section 13405(e)
p.(None): of the Health Information Technology for Economic and Clinical Health
p.(None): Act (42 U.S.C. 17935) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (2) as paragraph (3); and
p.(None): (3) by inserting after paragraph (1), the following:
p.(None): ``(2) if the individual makes a request to a business
p.(None): associate for access to, or a copy of, protected health
p.(None): information about the individual, or if an individual makes a
p.(None): request to a business associate to grant such access to, or
p.(None): transmit such copy directly to, a person or entity designated by
p.(None): the individual, a business associate may provide the individual
...
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
...
p.(None): title, a detailed accounting for each such system of how funds
p.(None): are spent, disaggregated according to whether the funds were
p.(None):
p.(None): [[Page 130 STAT. 1217]]
p.(None):
p.(None): received from the Federal Government, the State government, a
p.(None): local government, or a private entity.''.
p.(None): SEC. 6023. GAO STUDY.
p.(None):
p.(None): (a) In General.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States, in
p.(None): consultation with the Secretary of Health and Human Services and the
p.(None): Assistant Secretary for Mental Health and Substance Use, shall conduct
p.(None): an independent evaluation, and submit a report, to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, on programs
p.(None): funded by allotments made under title I of the Protection and Advocacy
p.(None): for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
p.(None): (b) Contents.--The report and evaluation required under subsection
p.(None): (a) shall include--
p.(None): (1) a review of the programs described in such subsection
p.(None): that are carried out by State agencies and such programs that
p.(None): are carried out by private, nonprofit organizations; and
p.(None): (2) a review of the compliance of the programs described in
p.(None): subsection (a) with statutory and regulatory responsibilities,
p.(None): such as--
p.(None): (A) responsibilities relating to family engagement;
p.(None): (B) responsibilities relating to the grievance
p.(None): procedure for clients or prospective clients of the
p.(None): system to assure that individuals with mental illness
p.(None): have full access to the services of the system, for
p.(None): individuals who have received or are receiving mental
p.(None): health services, and for family members of such
p.(None): individuals with mental illness, or representatives of
p.(None): such individuals or family members, to assure that the
p.(None): eligible system is operating in compliance with the
p.(None): provisions of the Protection and Advocacy for
p.(None): Individuals with Mental Illness Act, as required to be
p.(None): established by section 105(a)(9) of such Act (42 U.S.C.
p.(None): 10805(a)(9));
p.(None): (C) investigation of alleged abuse and neglect of
p.(None): persons with mental illness;
p.(None): (D) availability of adequate medical and behavioral
p.(None): health treatment;
p.(None): (E) denial of rights for persons with mental
p.(None): illness; and
p.(None): (F) compliance with the Federal prohibition on
p.(None): lobbying.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
p.(None): COMMITTEE.
p.(None):
p.(None): (a) Establishment.--
p.(None): (1) In general.--Not later than 3 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services, or the designee of the Secretary, shall establish a
p.(None): committee to be known as the Interdepartmental Serious Mental
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
...
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act), mental health system, health care facility, or any other entity
p.(None): the Assistant Secretary deems appropriate.
p.(None): ``(c) Special Consideration.--In selecting among applicants for a
p.(None): grant under this section, the Assistant Secretary may give special
p.(None): consideration to the potential of the applicant's program to reduce
p.(None): hospitalization, homelessness, and involvement with the criminal justice
p.(None): system while improving the health and social outcomes of the patient.
p.(None): ``(d) Additional Activities.--The Assistant Secretary shall--
p.(None): ``(1) not later than the end of fiscal year 2021, submit a
p.(None): report to the appropriate congressional committees on the grant
p.(None): program under this section, including an evaluation of--
p.(None): ``(A) any cost savings and public health outcomes
p.(None): such as mortality, suicide, substance use disorders,
p.(None): hospitalization, and use of services;
p.(None): ``(B) rates of involvement with the criminal justice
p.(None): system of patients;
p.(None): ``(C) rates of homelessness among patients; and
p.(None): ``(D) patient and family satisfaction with program
p.(None): participation; and
p.(None): ``(2) provide appropriate information, training, and
p.(None): technical assistance to grant recipients under this section to
p.(None): help such recipients to establish, maintain, or expand their
p.(None): assertive community treatment programs.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--
p.(None): ``(1) In general.--To carry out this section, there is
p.(None): authorized to be appropriated $5,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None): ``(2) Use of certain funds.--Of the funds appropriated to
p.(None): carry out this section in any fiscal year, not more than 5
p.(None): percent shall be available to the Assistant Secretary for
p.(None): carrying out subsection (d).''.
p.(None): SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
p.(None): REAUTHORIZATION.
p.(None):
p.(None): Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
p.(None): is amended--
p.(None): (1) in subsection (c)(3), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (2) in subsection (d)(4), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (3) in subsection (e)(1)(I), by striking ``fiscal year
p.(None): 2007'' and all that follows through the period at the end and
p.(None): inserting ``each of the fiscal years 2018 through 2022.'';
p.(None): (4) in subsection (f)(2), by striking ``$6,000,000 for
p.(None): fiscal year 2007'' and all that follows through the period at
p.(None): the end and inserting ``$3,000,000 for each of the fiscal years
p.(None): 2018 through 2022''; and
p.(None): (5) by adding at the end the following new subsection:
...
p.(None): patient.''.
p.(None):
p.(None): [[Page 130 STAT. 1248]]
p.(None):
p.(None): SEC. 9017. CENTER AND PROGRAM REPEALS.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
p.(None): second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
p.(None): amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
p.(None): 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
p.(None): 25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
p.(None): GRANTS.
p.(None):
p.(None): Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``of higher education''; and
p.(None): (B) by striking paragraphs (1) through (4) and
p.(None): inserting the following:
p.(None): ``(1) accredited institutions of higher education or
p.(None): accredited professional training programs that are establishing
p.(None): or expanding internships or other field placement programs in
p.(None): mental health in psychiatry, psychology, school psychology,
p.(None): behavioral pediatrics, psychiatric nursing (which may include
p.(None): master's and doctoral level programs), social work, school
p.(None): social work, substance use disorder prevention and treatment,
p.(None): marriage and family therapy, occupational therapy, school
p.(None): counseling, or professional counseling, including such programs
p.(None): with a focus on child and adolescent mental health and
p.(None): transitional-age youth;
p.(None): ``(2) accredited doctoral, internship, and post-doctoral
p.(None): residency programs of health service psychology (including
p.(None): clinical psychology, counseling, and school psychology) for the
p.(None): development and implementation of interdisciplinary training of
p.(None): psychology graduate students for providing behavioral health
p.(None): services, including substance use disorder prevention and
p.(None): treatment services, as well as the development of faculty in
p.(None): health service psychology;
p.(None): ``(3) accredited master's and doctoral degree programs of
p.(None): social work for the development and implementation of
p.(None): interdisciplinary training of social work graduate students for
p.(None): providing behavioral health services, including substance use
p.(None): disorder prevention and treatment services, and the development
p.(None): of faculty in social work; and
p.(None): ``(4) State-licensed mental health nonprofit and for-profit
p.(None): organizations to enable such organizations to pay for programs
p.(None): for preservice or in-service training in a behavioral health-
p.(None): related paraprofessional field with preference for preservice or
p.(None): in-service training of paraprofessional child and adolescent
p.(None): mental health workers.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (5);
p.(None): [[Page 130 STAT. 1249]]
p.(None):
p.(None): (B) by redesignating paragraphs (1) through (4) as
p.(None): paragraphs (2) through (5), respectively;
p.(None): (C) by inserting before paragraph (2), as so
p.(None): redesignated, the following:
p.(None): ``(1) an ability to recruit and place the students described
p.(None): in subsection (a) in areas with a high need and high demand
p.(None): population;'';
p.(None): (D) in paragraph (3), as so redesignated, by
p.(None): striking ``subsection (a)'' and inserting ``paragraph
p.(None): (2), especially individuals with mental disorder
p.(None): symptoms or diagnoses, particularly children and
p.(None): adolescents, and transitional-age youth'';
p.(None): (E) in paragraph (4), as so redesignated, by
p.(None): striking ``;'' and inserting ``; and''; and
p.(None): (F) in paragraph (5), as so redesignated, by
p.(None): striking ``; and'' and inserting a period;
p.(None): (3) in subsection (c), by striking ``authorized under
p.(None): subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
p.(None): and (3) of subsection (a)'';
p.(None): (4) by amending subsection (d) to read as follows:
p.(None):
p.(None): ``(d) Priority.--In selecting grant recipients under this section,
p.(None): the Secretary shall give priority to--
p.(None): ``(1) programs that have demonstrated the ability to train
p.(None): psychology, psychiatry, and social work professionals to work in
p.(None): integrated care settings for purposes of recipients under
p.(None): paragraphs (1), (2), and (3) of subsection (a); and
p.(None): ``(2) programs for paraprofessionals that emphasize the role
p.(None): of the family and the lived experience of the consumer and
p.(None): family-paraprofessional partnerships for purposes of recipients
p.(None): under subsection (a)(4).''; and
p.(None): (5) by striking subsection (e) and inserting the following:
p.(None):
p.(None): ``(e) Report to Congress.--Not later than 4 years after the date of
p.(None): enactment of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016, the Secretary shall include in the biennial report submitted to
p.(None): Congress under section 501(m) an assessment on the effectiveness of the
p.(None): grants under this section in--
p.(None): ``(1) providing graduate students support for experiential
p.(None): training (internship or field placement);
p.(None): ``(2) recruiting students interested in behavioral health
p.(None): practice;
p.(None): ``(3) recruiting students in accordance with subsection
p.(None): (b)(1);
p.(None): ``(4) developing and implementing interprofessional training
p.(None): and integration within primary care;
p.(None): ``(5) developing and implementing accredited field
p.(None): placements and internships; and
p.(None): ``(6) collecting data on the number of students trained in
p.(None): behavioral health care and the number of available accredited
p.(None): internships and field placements.
p.(None):
p.(None): ``(f) Authorization of Appropriations.--For each of fiscal years
p.(None): 2018 through 2022, there are authorized to be appropriated to carry out
p.(None): this section $50,000,000, to be allocated as follows:
p.(None): ``(1) For grants described in subsection (a)(1),
p.(None): $15,000,000.
p.(None): ``(2) For grants described in subsection (a)(2),
p.(None): $15,000,000.
p.(None): ``(3) For grants described in subsection (a)(3),
p.(None): $10,000,000.
p.(None): ``(4) For grants described in subsection (a)(4),
p.(None): $10,000,000.''.
p.(None):
...
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
p.(None): practitioner shall for purposes of this subsection be considered to be a
p.(None): health professional volunteer at an entity described in subsection
p.(None): (g)(4) if the following conditions are met:
p.(None): ``(A) The service is provided to the individual at the
p.(None): facilities of an entity described in subsection (g)(4), or
p.(None): through offsite programs or events carried out by the entity.
p.(None): ``(B) The entity is sponsoring the health care practitioner
p.(None): pursuant to paragraph (3)(B).
...
p.(None): ensure that students at institutions of higher education have the
p.(None): support necessary to successfully complete their studies.
p.(None): ``(b) National Public Education Campaign.--The Secretary, acting
p.(None): through the Assistant Secretary and in collaboration with the Director
p.(None): of the Centers for Disease Control and Prevention, shall convene an
p.(None): interagency, public-private sector working group to plan, establish, and
p.(None): begin coordinating and evaluating a targeted public education campaign
p.(None): that is designed to focus on mental and behavioral health on the
p.(None): campuses of institutions of higher education. Such campaign shall be
p.(None): designed to--
p.(None): ``(1) improve the general understanding of mental health and
p.(None): mental disorders;
p.(None): ``(2) encourage help-seeking behaviors relating to the
p.(None): promotion of mental health, prevention of mental disorders, and
p.(None): treatment of such disorders;
p.(None): ``(3) make the connection between mental and behavioral
p.(None): health and academic success; and
p.(None): ``(4) assist the general public in identifying the early
p.(None): warning signs and reducing the stigma of mental illness.
p.(None):
p.(None): ``(c) Composition.--The working group convened under subsection (b)
p.(None): shall include--
p.(None): ``(1) mental health consumers, including students and family
p.(None): members;
p.(None): ``(2) representatives of institutions of higher education;
p.(None): ``(3) representatives of national mental and behavioral
p.(None): health associations and associations of institutions of higher
p.(None): education;
p.(None): ``(4) representatives of health promotion and prevention
p.(None): organizations at institutions of higher education;
p.(None): ``(5) representatives of mental health providers, including
p.(None): community mental health centers; and
p.(None): ``(6) representatives of private-sector and public-sector
p.(None): groups with experience in the development of effective public
p.(None): health education campaigns.
p.(None):
p.(None): ``(d) Plan.--The working group under subsection (b) shall develop a
p.(None): plan that--
p.(None): ``(1) targets promotional and educational efforts to the age
p.(None): population of students at institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
p.(None): ``(3) provides support for local efforts to reduce stigma by
p.(None): using the National Health Information Center as a primary point
p.(None): of contact for information, publications, and service program
...
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
...
p.(None): disclosures of protected health information under the regulations
p.(None): promulgated under section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
p.(None): (b) Guidance.--
p.(None): (1) Issuance.--In carrying out subsection (a), not later
p.(None): than 1 year after the date of enactment of this section, the
p.(None): Secretary shall issue guidance clarifying the circumstances
p.(None): under which, consistent with regulations promulgated under
p.(None): section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996, a health care provider or covered
p.(None): entity may use or disclose protected health information.
p.(None): (2) Circumstances addressed.--The guidance issued under this
p.(None): section shall address circumstances including those that--
p.(None): (A) require the consent of the patient;
p.(None): (B) require providing the patient with an
p.(None): opportunity to object;
p.(None): (C) are based on the exercise of professional
p.(None): judgment regarding whether the patient would object when
p.(None): the opportunity to object cannot practicably be provided
p.(None): because of the incapacity of the patient or an emergency
p.(None): treatment circumstance; and
p.(None): (D) are determined, based on the exercise of
p.(None): professional judgment, to be in the best interest of the
p.(None): patient when the patient is not present or otherwise
p.(None): incapacitated.
p.(None):
p.(None): [[Page 130 STAT. 1271]]
p.(None):
p.(None): (3) Communication with family members and caregivers.--In
p.(None): addressing the circumstances described in paragraph (2), the
p.(None): guidance issued under this section shall clarify permitted uses
p.(None): or disclosures of protected health information for purposes of--
p.(None): (A) communicating with a family member of the
p.(None): patient, caregiver of the patient, or other individual,
p.(None): to the extent that such family member, caregiver, or
p.(None): individual is involved in the care of the patient;
p.(None): (B) in the case that the patient is an adult,
p.(None): communicating with a family member of the patient,
p.(None): caregiver of the patient, or other individual involved
p.(None): in the care of the patient;
p.(None): (C) in the case that the patient is a minor,
p.(None): communicating with the parent or caregiver of the
p.(None): patient;
p.(None): (D) involving the family members or caregivers of
p.(None): the patient, or others involved in the patient's care or
p.(None): care plan, including facilitating treatment and
p.(None): medication adherence;
p.(None): (E) listening to the patient, or receiving
p.(None): information with respect to the patient from the family
p.(None): or caregiver of the patient;
p.(None): (F) communicating with family members of the
p.(None): patient, caregivers of the patient, law enforcement, or
p.(None): others when the patient presents a serious and imminent
p.(None): threat of harm to self or others; and
p.(None): (G) communicating to law enforcement and family
p.(None): members or caregivers of the patient about the admission
p.(None): of the patient to receive care at, or the release of a
p.(None): patient from, a facility for an emergency psychiatric
p.(None): hold or involuntary treatment.
p.(None): SEC. 11004. <> DEVELOPMENT AND
p.(None): DISSEMINATION OF MODEL TRAINING
p.(None): PROGRAMS.
p.(None):
p.(None): (a) Initial Programs and Materials.--Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary, in consultation with
p.(None): appropriate experts, shall identify the following model programs and
p.(None): materials, or (in the case that no such programs or materials exist)
p.(None): recognize private or public entities to develop and disseminate each of
p.(None): the following:
p.(None): (1) Model programs and materials for training health care
p.(None): providers (including physicians, emergency medical personnel,
p.(None): psychiatrists, including child and adolescent psychiatrists,
p.(None): psychologists, counselors, therapists, nurse practitioners,
p.(None): physician assistants, behavioral health facilities and clinics,
p.(None): care managers, and hospitals, including individuals such as
p.(None): general counsels or regulatory compliance staff who are
p.(None): responsible for establishing provider privacy policies)
p.(None): regarding the permitted uses and disclosures, consistent with
p.(None): the standards governing the privacy and security of individually
p.(None): identifiable health information promulgated by the Secretary
p.(None): under part C of title XI of the Social Security Act (42 U.S.C.
p.(None): 1320d et seq.) and regulations promulgated under section 264(c)
...
p.(None): percentage points;
p.(None): ``(ii) for calendar quarters in 2021, by .5
p.(None): percentage points;
p.(None): ``(iii) for calendar quarters in 2022, by .75
p.(None): percentage points; and
p.(None):
p.(None): [[Page 130 STAT. 1276]]
p.(None):
p.(None): ``(iv) for calendar quarters in 2023 and each year
p.(None): thereafter, by 1 percentage point; and
p.(None): ``(B) in the case of home health care services--
p.(None): ``(i) for calendar quarters in 2023 and 2024, by .25
p.(None): percentage points;
p.(None): ``(ii) for calendar quarters in 2025, by .5
p.(None): percentage points;
p.(None): ``(iii) for calendar quarters in 2026, by .75
p.(None): percentage points; and
p.(None): ``(iv) for calendar quarters in 2027 and each year
p.(None): thereafter, by 1 percentage point.
p.(None):
p.(None): ``(2) Subject to paragraphs (3) and (4), in implementing the
p.(None): requirement for the use of an electronic visit verification system under
p.(None): paragraph (1), a State shall--
p.(None): ``(A) consult with agencies and entities that provide
p.(None): personal care services, home health care services, or both under
p.(None): the State plan (or under a waiver of the plan) to ensure that
p.(None): such system--
p.(None): ``(i) is minimally burdensome;
p.(None): ``(ii) takes into account existing best practices
p.(None): and electronic visit verification systems in use in the
p.(None): State; and
p.(None): ``(iii) is conducted in accordance with the
p.(None): requirements of HIPAA privacy and security law (as
p.(None): defined in section 3009 of the Public Health Service
p.(None): Act);
p.(None): ``(B) take into account a stakeholder process that includes
p.(None): input from beneficiaries, family caregivers, individuals who
p.(None): furnish personal care services or home health care services, and
p.(None): other stakeholders, as determined by the State in accordance
p.(None): with guidance from the Secretary; and
p.(None): ``(C) ensure that individuals who furnish personal care
p.(None): services, home health care services, or both under the State
p.(None): plan (or under a waiver of the plan) are provided the
p.(None): opportunity for training on the use of such system.
p.(None):
p.(None): ``(3) Paragraphs (1) and (2) shall not apply in the case of a State
p.(None): that, as of the date of the enactment of this subsection, requires the
p.(None): use of any system for the electronic verification of visits conducted as
p.(None): part of both personal care services and home health care services, so
p.(None): long as the State continues to require the use of such system with
p.(None): respect to the electronic verification of such visits.
p.(None): ``(4)(A) In the case of a State described in subparagraph (B), the
p.(None): reduction under paragraph (1) shall not apply--
p.(None): ``(i) in the case of personal care services, for calendar
p.(None): quarters in 2019; and
p.(None): ``(ii) in the case of home health care services, for
p.(None): calendar quarters in 2023.
p.(None):
p.(None): ``(B) For purposes of subparagraph (A), a State described in this
p.(None): subparagraph is a State that demonstrates to the Secretary that the
p.(None): State--
p.(None): ``(i) has made a good faith effort to comply with the
p.(None): requirements of paragraphs (1) and (2) (including by taking
...
p.(None): amount equal to 90 per centum of so much of the sums expended during
p.(None): such quarter as are attributable to the design, development, or
p.(None): installation of such system, and 75 per centum of so much of the sums
p.(None): for the operation and maintenance of such system.
p.(None): ``(B) Subparagraph (A) shall not apply in the case in which a State
p.(None): requires personal care service and home health care service providers to
p.(None): utilize an electronic visit verification system that is not operated by
p.(None): the State or a contractor on behalf of the State.''.
p.(None): (b) <> Collection and Dissemination of
p.(None): Best Practices.--Not later than January 1, 2018, the Secretary of Health
p.(None): and Human Services shall, with respect to electronic visit verification
p.(None): systems (as defined in subsection (l)(5) of section 1903 of the Social
p.(None): Security Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect
p.(None): and disseminate best practices to State Medicaid Directors with respect
p.(None): to--
p.(None): (1) training individuals who furnish personal care services,
p.(None): home health care services, or both under the State plan under
p.(None): title XIX of such Act (or under a waiver of the plan) on such
p.(None): systems and the operation of such systems and the prevention of
p.(None): fraud with respect to the provision of personal care services or
p.(None): home health care services (as defined in such subsection
p.(None): (l)(5)); and
p.(None): (2) the provision of notice and educational materials to
p.(None): family caregivers and beneficiaries with respect to the use of
p.(None): such electronic visit verification systems and other means to
p.(None): prevent such fraud.
p.(None):
p.(None): (c) <> Rules of Construction.--
p.(None): (1) No employer-employee relationship established.--Nothing
p.(None): in the amendment made by this section may be construed as
p.(None): establishing an employer-employee relationship between the
p.(None): agency or entity that provides for personal care services or
p.(None): home health care services and the individuals who, under a
p.(None): contract with such an agency or entity, furnish such
p.(None):
p.(None): [[Page 130 STAT. 1278]]
p.(None):
p.(None): services for purposes of part 552 of title 29, Code of Federal
p.(None): Regulations (or any successor regulations).
p.(None): (2) No particular or uniform electronic visit verification
p.(None): system required.--Nothing in the amendment made by this section
p.(None): shall be construed to require the use of a particular or uniform
p.(None): electronic visit verification system (as defined in subsection
p.(None): (l)(5) of section 1903 of the Social Security Act (42 U.S.C.
p.(None): 1396b), as inserted by subsection (a)) by all agencies or
p.(None): entities that provide personal care services or home health care
p.(None): under a State plan under title XIX of the Social Security Act
p.(None): (or under a waiver of the plan) (42 U.S.C. 1396 et seq.).
p.(None): (3) No limits on provision of care.--Nothing in the
p.(None): amendment made by this section may be construed to limit, with
p.(None): respect to personal care services or home health care services
p.(None): provided under a State plan under title XIX of the Social
...
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
p.(None): other family support services for each program
p.(None): participant who requires such services;
p.(None): (E) outpatient or inpatient mental health treatment,
p.(None): as ordered by the court, that carries with it the
p.(None): possibility of dismissal of charges or reduced
p.(None): sentencing upon successful completion of such treatment;
p.(None): (F) centralized case management, including--
p.(None): (i) the consolidation of all cases, including
p.(None): violations of probations, of the program
p.(None): participant; and
p.(None): (ii) coordination of all mental health
p.(None): treatment plans and social services, including
p.(None): life skills and vocational training, housing and
p.(None): job placement, education, health care, and relapse
p.(None): prevention for each program participant who
p.(None): requires such services; and
p.(None): (G) continuing supervision of treatment plan
p.(None): compliance by the program participant for a term not to
p.(None): exceed the maximum allowable sentence or probation
p.(None): period for the charged or relevant offense and, to the
p.(None): extent practicable, continuity of psychiatric care at
p.(None): the end of the supervised period.
p.(None):
p.(None): (d) Implementation; Duration.--The pilot program established under
p.(None): subsection (b) shall be conducted--
p.(None): (1) in not less than 1 United States judicial district,
p.(None): designated by the Attorney General in consultation with the
p.(None): Director of the Administrative Office of the United States
p.(None): Courts, as appropriate for the pilot program; and
p.(None): (2) during fiscal year 2017 through fiscal year 2021.
p.(None):
p.(None): (e) Criteria for Designation.--Before making a designation under
p.(None): subsection (d)(1), the Attorney General shall--
p.(None):
...
p.(None): Protection and Affordable Care Act.--
p.(None):
p.(None): [[Page 130 STAT. 1339]]
p.(None):
p.(None): (1) In general.--Section 9831 of the Internal Revenue Code
p.(None): of 1986 is amended by adding at the end the following new
p.(None): subsection:
p.(None):
p.(None): ``(d) Exception for Qualified Small Employer Health Reimbursement
p.(None): Arrangements.--
p.(None): ``(1) In general.--For purposes of this title (except as
p.(None): provided in section 4980I(f)(4) and notwithstanding any other
p.(None): provision of this title), the term `group health plan' shall not
p.(None): include any qualified small employer health reimbursement
p.(None): arrangement.
p.(None): ``(2) Qualified small employer health reimbursement
p.(None): arrangement.--For purposes of this subsection--
p.(None): ``(A) In general.--The term `qualified small
p.(None): employer health reimbursement arrangement' means an
p.(None): arrangement which--
p.(None): ``(i) is described in subparagraph (B), and
p.(None): ``(ii) is provided on the same terms to all
p.(None): eligible employees of the eligible employer.
p.(None): ``(B) Arrangement described.--An arrangement is
p.(None): described in this subparagraph if--
p.(None): ``(i) such arrangement is funded solely by an
p.(None): eligible employer and no salary reduction
p.(None): contributions may be made under such arrangement,
p.(None): ``(ii) such arrangement provides, after the
p.(None): employee provides proof of coverage, for the
p.(None): payment of, or reimbursement of, an eligible
p.(None): employee for expenses for medical care (as defined
p.(None): in section 213(d)) incurred by the eligible
p.(None): employee or the eligible employee's family members
p.(None): (as determined under the terms of the
p.(None): arrangement), and
p.(None): ``(iii) the amount of payments and
p.(None): reimbursements described in clause (ii) for any
p.(None): year do not exceed $4,950 ($10,000 in the case of
p.(None): an arrangement that also provides for payments or
p.(None): reimbursements for family members of the
p.(None): employee).
p.(None): ``(C) Certain variation permitted.--For purposes of
p.(None): subparagraph (A)(ii), an arrangement shall not fail to
p.(None): be treated as provided on the same terms to each
p.(None): eligible employee merely because the employee's
p.(None): permitted benefit under such arrangement varies in
p.(None): accordance with the variation in the price of an
p.(None): insurance policy in the relevant individual health
p.(None): insurance market based on--
p.(None): ``(i) the age of the eligible employee (and,
p.(None): in the case of an arrangement which covers medical
p.(None): expenses of the eligible employee's family
p.(None): members, the age of such family members), or
p.(None): ``(ii) the number of family members of the
p.(None): eligible employee the medical expenses of which
p.(None): are covered under such arrangement.
p.(None): The variation permitted under the preceding sentence
p.(None): shall be determined by reference to the same insurance
p.(None): policy with respect to all eligible employees.
p.(None): ``(D) Rules relating to maximum dollar limitation.--
p.(None):
p.(None): [[Page 130 STAT. 1340]]
p.(None):
p.(None): ``(i) Amount prorated in certain cases.--In
p.(None): the case of an individual who is not covered by an
p.(None): arrangement for the entire year, the limitation
p.(None): under subparagraph (B)(iii) for such year shall be
p.(None): an amount which bears the same ratio to the amount
p.(None): which would (but for this clause) be in effect for
p.(None): such individual for such year under subparagraph
p.(None): (B)(iii) as the number of months for which such
p.(None): individual is covered by the arrangement for such
p.(None): year bears to 12.
p.(None): ``(ii) Inflation adjustment.--In the case of
p.(None): any year beginning after 2016, each of the dollar
p.(None): amounts in subparagraph (B)(iii) shall be
p.(None): increased by an amount equal to--
p.(None): ``(I) such dollar amount, multiplied
p.(None): by
p.(None): ``(II) the cost-of-living adjustment
p.(None): determined under section 1(f)(3) for the
p.(None): calendar year in which the taxable year
p.(None): begins, determined by substituting
p.(None): `calendar year 2015' for `calendar year
p.(None): 1992' in subparagraph (B) thereof.
p.(None): If any dollar amount increased under the preceding
p.(None): sentence is not a multiple of $50, such dollar
p.(None): amount shall be rounded to the next lowest
p.(None): multiple of $50.
p.(None): ``(3) Other definitions.--For purposes of this subsection--
p.(None): ``(A) Eligible employee.--The term `eligible
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
...
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
...
p.(None): years 2018 through 2022.''.
p.(None): SEC. 2062. <> TICK-BORNE DISEASES.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services
p.(None): (referred to in this section as ``the Secretary'') shall continue to
p.(None): conduct or support epidemiological, basic, translational, and clinical
p.(None): research related to vector-borne diseases, including tick-borne
p.(None): diseases.
p.(None): (b) Reports.--The Secretary shall ensure that each triennial report
p.(None): under section 403 of the Public Health Service Act (42 U.S.C. 283) (as
p.(None): amended by section 2032) includes information on actions undertaken by
p.(None): the National Institutes of Health to carry out subsection (a) with
p.(None): respect to tick-borne diseases.
p.(None): (c) Tick-borne Diseases Working Group.--
p.(None): (1) Establishment.--The Secretary shall establish a working
p.(None): group, to be known as the Tick-Borne Disease Working Group
p.(None): (referred to in this section as the ``Working Group''),
p.(None): comprised of representatives of appropriate Federal agencies and
p.(None): other non-Federal entities, to provide expertise and to review
p.(None): all efforts within the Department of Health and Human Services
p.(None): related to all tick-borne diseases, to help ensure interagency
p.(None): coordination and minimize overlap, and to examine research
p.(None): priorities.
p.(None): (2) Responsibilities.--The working group shall--
p.(None): (A) not later than 2 years after the date of
p.(None): enactment of this Act, develop or update a summary of--
p.(None): (i) ongoing tick-borne disease research,
p.(None): including research related to causes, prevention,
p.(None): treatment, surveillance, diagnosis, diagnostics,
p.(None): duration of illness, and intervention for
p.(None): individuals with tick-borne diseases;
p.(None): (ii) advances made pursuant to such research;
p.(None): (iii) Federal activities related to tick-borne
p.(None): diseases, including--
p.(None): (I) epidemiological activities
p.(None): related to tick-borne diseases; and
p.(None): (II) basic, clinical, and
p.(None): translational tick-borne disease
p.(None): research related to the pathogenesis,
p.(None): prevention, diagnosis, and treatment of
p.(None): tick-borne diseases;
p.(None): (iv) gaps in tick-borne disease research
p.(None): described in clause (iii)(II);
p.(None): (v) the Working Group's meetings required
p.(None): under paragraph (4); and
p.(None): (vi) the comments received by the Working
p.(None): Group;
p.(None): (B) make recommendations to the Secretary regarding
p.(None): any appropriate changes or improvements to such
p.(None): activities and research; and
p.(None): (C) solicit input from States, localities, and
p.(None): nongovernmental entities, including organizations
p.(None): representing patients, health care providers,
p.(None): researchers, and industry regarding scientific advances,
p.(None): research questions, surveillance activities, and
p.(None): emerging strains in species of pathogenic organisms.
p.(None):
p.(None): [[Page 130 STAT. 1080]]
p.(None):
p.(None): (3) Membership.--The members of the working group shall
p.(None): represent a diversity of scientific disciplines and views and
p.(None): shall be composed of the following members:
p.(None): (A) Federal members.--Seven Federal members,
p.(None): consisting of one or more representatives of each of the
p.(None): following:
p.(None): (i) The Office of the Assistant Secretary for
p.(None): Health.
p.(None): (ii) The Food and Drug Administration.
p.(None): (iii) The Centers for Disease Control and
p.(None): Prevention.
...
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``entities'' and inserting ``Centers'';
p.(None): (2) in subsection (d)--
p.(None): (A) in paragraph (1)--
p.(None): (i) by striking ``agencies'' each place the
p.(None): term appears and inserting ``Centers''; and
p.(None): (ii) by striking ``such agency'' and inserting
p.(None): ``such Center'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``agencies'' and inserting
p.(None): ``Centers'';
p.(None): (ii) by striking ``with respect to substance
p.(None): abuse'' and inserting ``with respect to substance
p.(None): use disorders''; and
p.(None): (iii) by striking ``and individuals who are
p.(None): substance abusers'' and inserting ``and
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
...
p.(None): subparagraph (C);
p.(None): (iv) by inserting after subparagraph (A) the
p.(None): following:
p.(None): ``(B) ensure that the director of each Center of the
p.(None): Administration consistently documents the application of
p.(None): criteria when awarding grants and the ongoing oversight
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
...
p.(None): ``(2) Eligible candidates.--The Assistant Secretary shall
p.(None): select the Chief Medical Officer from among individuals who--
p.(None): ``(A) have a doctoral degree in medicine or
p.(None): osteopathic medicine;
p.(None): ``(B) have experience in the provision of mental or
p.(None): substance use disorder services;
p.(None): ``(C) have experience working with mental or
p.(None): substance use disorder programs;
p.(None): ``(D) have an understanding of biological,
p.(None): psychosocial, and pharmaceutical treatments of mental or
p.(None): substance use disorders; and
p.(None): ``(E) are licensed to practice medicine in one or
p.(None): more States.
p.(None): ``(3) Duties.--The Chief Medical Officer shall--
p.(None): ``(A) serve as a liaison between the Administration
p.(None): and providers of mental and substance use disorders
p.(None): prevention, treatment, and recovery services;
p.(None): ``(B) assist the Assistant Secretary in the
p.(None): evaluation, organization, integration, and coordination
p.(None): of programs operated by the Administration;
p.(None): ``(C) promote evidence-based and promising best
p.(None): practices, including culturally and linguistically
p.(None): appropriate practices, as appropriate, for the
p.(None): prevention and treatment of, and recovery from, mental
p.(None): and substance use disorders, including serious mental
p.(None): illness and serious emotional disturbances;
p.(None): ``(D) participate in regular strategic planning with
p.(None): the Administration;
p.(None): ``(E) coordinate with the Assistant Secretary for
p.(None): Planning and Evaluation to assess the use of performance
p.(None): metrics to evaluate activities within the Administration
p.(None): related to mental and substance use disorders; and
p.(None): ``(F) coordinate with the Assistant Secretary to
p.(None): ensure mental and substance use disorders grant programs
p.(None): within the Administration consistently utilize
p.(None): appropriate performance metrics and evaluation
p.(None): designs.''.
p.(None): SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
p.(None):
p.(None): Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), as
p.(None): amended by section 6001(c), is amended--
p.(None): (1) by striking the section designation and heading and
p.(None): inserting the following:
p.(None):
p.(None): [[Page 130 STAT. 1208]]
p.(None):
p.(None): ``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND
p.(None): QUALITY.'';
p.(None): (2) by redesignating subsections (a) through (d) as
p.(None): subsections (b) through (e), respectively;
p.(None): (3) before subsection (b), as redesignated by paragraph (2),
p.(None): by inserting the following:
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall maintain within the
p.(None): Administration a Center for Behavioral Health Statistics and Quality (in
p.(None): this section referred to as the `Center'). The Center shall be headed by
p.(None): a Director (in this section referred to as the `Director') appointed by
p.(None): the Secretary from among individuals with extensive experience and
...
p.(None): coordination with the Centers for Disease Control
p.(None): and Prevention'' before the semicolon at the end;
p.(None): and
p.(None): (C) in paragraph (2), by striking ``Annual surveys''
p.(None): and inserting ``Annual surveys; public availability of
p.(None): data.--Annual surveys''; and
p.(None): (7) in subsection (e), as so redesignated--
p.(None): (A) by striking ``After consultation'' and inserting
p.(None): ``Consultation.--After consultation''; and
p.(None): (B) by striking ``Assistant Secretary shall
p.(None): develop'' and inserting ``Assistant Secretary shall use
p.(None): existing standards and best practices to develop''.
p.(None): SEC. 6005. STRATEGIC PLAN.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 through 6003, is further amended by inserting
p.(None): after subsection (k), as redesignated by section 6003, the following:
p.(None): ``(l) Strategic Plan.--
p.(None): ``(1) In general.--Not later than September 30, 2018, and
p.(None): every 4 years thereafter, the Assistant Secretary shall develop
p.(None): and carry out a strategic plan in accordance with this
p.(None): subsection for the planning and operation of activities carried
p.(None): out by the Administration, including evidence-based programs.
p.(None): ``(2) Coordination.--In developing and carrying out the
p.(None): strategic plan under this subsection, the Assistant Secretary
p.(None): shall take into consideration the findings and recommendations
p.(None): of the Assistant Secretary for Planning and Evaluation under
p.(None): section 6021(d) of the Helping Families in Mental Health Crisis
p.(None): Reform Act of 2016 and the report of the Interdepartmental
p.(None): Serious Mental Illness Coordinating Committee under section 6031
p.(None): of such Act.
p.(None): ``(3) Publication of plan.--Not later than September 30,
p.(None): 2018, and every 4 years thereafter, the Assistant Secretary
p.(None): shall--
p.(None): ``(A) submit the strategic plan developed under
p.(None): paragraph (1) to the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate; and
p.(None): ``(B) post such plan on the Internet website of the
p.(None): Administration.
p.(None): ``(4) Contents.--The strategic plan developed under
p.(None): paragraph (1) shall--
p.(None): ``(A) identify strategic priorities, goals, and
p.(None): measurable objectives for mental and substance use
p.(None): disorders activities and programs operated and supported
p.(None): by the Administration, including priorities to prevent
p.(None): or eliminate the burden of mental and substance use
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
p.(None): collaboration with States, local governments,
p.(None): communities, and Indian tribes and tribal organizations
p.(None): (as such terms are defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act); and
p.(None): ``(F) specify a strategy to disseminate evidence-
p.(None): based and promising best practices related to
p.(None): prevention, diagnosis, early intervention, treatment,
p.(None): and recovery services related to mental illness,
p.(None): particularly for adults with a serious mental illness
p.(None): and children with a serious emotional disturbance, and
p.(None): for individuals with a substance use disorder.''.
p.(None): SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
p.(None):
p.(None): (a) In General.--Section 501 of the Public Health Service Act (42
p.(None): U.S.C. 290aa), as so amended, is further amended by amending subsection
p.(None): (m), as redesignated by section 6003, to read as follows:
p.(None): ``(m) Biennial Report Concerning Activities and Progress.--Not later
p.(None): than September 30, 2020, and every 2 years thereafter, the Assistant
p.(None): Secretary shall prepare and submit to the Committee on Energy and
p.(None): Commerce and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the Senate, and post on
p.(None): the Internet website of the Administration, a report containing at a
p.(None): minimum--
p.(None): ``(1) a review of activities conducted or supported by the
p.(None): Administration, including progress toward strategic priorities,
p.(None): goals, and objectives identified in the strategic plan developed
p.(None): under subsection (l);
p.(None):
p.(None): [[Page 130 STAT. 1211]]
p.(None):
p.(None): ``(2) an assessment of programs and activities carried out
p.(None): by the Assistant Secretary, including the extent to which
p.(None): programs and activities under this title and part B of title XIX
p.(None): meet identified goals and performance measures developed for the
p.(None): respective programs and activities;
p.(None): ``(3) a description of the progress made in addressing gaps
p.(None): in mental and substance use disorders prevention, treatment, and
p.(None): recovery services and improving outcomes by the Administration,
p.(None): including with respect to serious mental illnesses, serious
p.(None): emotional disturbances, and co-occurring disorders;
p.(None): ``(4) a description of the manner in which the
p.(None): Administration coordinates and partners with other Federal
p.(None): agencies and departments related to mental and substance use
p.(None): disorders, including activities related to--
p.(None): ``(A) the implementation and dissemination of
p.(None): research findings into improved programs, including with
p.(None): respect to how advances in serious mental illness and
p.(None): serious emotional disturbance research have been
p.(None): incorporated into programs;
p.(None): ``(B) the recruitment, training, and retention of a
p.(None): mental and substance use disorders workforce;
p.(None): ``(C) the integration of mental disorder services,
p.(None): substance use disorder services, and physical health
p.(None): services;
p.(None): ``(D) homelessness; and
p.(None): ``(E) veterans;
p.(None): ``(5) a description of the manner in which the
p.(None): Administration promotes coordination by grantees under this
p.(None): title, and part B of title XIX, with State or local agencies;
p.(None): and
p.(None): ``(6) a description of the activities carried out under
p.(None): section 501A(e), with respect to mental and substance use
p.(None): disorders, including--
p.(None): ``(A) the number and a description of grants
p.(None): awarded;
p.(None): ``(B) the total amount of funding for grants
p.(None): awarded;
p.(None): ``(C) a description of the activities supported
p.(None): through such grants, including outcomes of programs
p.(None): supported; and
p.(None): ``(D) information on how the National Mental Health
p.(None): and Substance Use Policy Laboratory is consulting with
p.(None): the Assistant Secretary for Planning and Evaluation and
p.(None): collaborating with the Center for Substance Abuse
p.(None): Treatment, the Center for Substance Abuse Prevention,
p.(None): the Center for Behavioral Health Statistics and Quality,
...
p.(None): under this title by providing the contents of such reports as an
p.(None): addendum to the biennial report established under this subsection,
p.(None): notwithstanding the timeline of other reporting requirements in this
p.(None): title. Nothing in this subsection shall be construed to alter the
p.(None): content requirements of such reports or authorize the Assistant
p.(None): Secretary to alter the timeline of any such reports
p.(None):
p.(None): [[Page 130 STAT. 1212]]
p.(None):
p.(None): to be less frequent than biennially, unless as specified in this
p.(None): title.''.
p.(None): (b) Conforming Amendment.--Section 508(p) of the Public Health
p.(None): Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
p.(None): 501(k)'' and inserting ``section 501(m)''.
p.(None): SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
p.(None): SUBSTANCE ABUSE PREVENTION, AND
p.(None): SUBSTANCE ABUSE TREATMENT.
p.(None):
p.(None): (a) Center for Mental Health Services.--Section 520(b) of the Public
p.(None): Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
p.(None): (1) by redesignating paragraphs (3) through (15) as
p.(None): paragraphs (4) through (16), respectively;
p.(None): (2) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute of Mental Health and the Chief Medical Officer,
p.(None): appointed under section 501(g), to ensure that, as appropriate,
p.(None): programs related to the prevention and treatment of mental
p.(None): illness and the promotion of mental health and recovery support
p.(None): are carried out in a manner that reflects the best available
p.(None): science and evidence-based practices, including culturally and
p.(None): linguistically appropriate services, as appropriate;'';
p.(None): (3) in paragraph (5), as so redesignated, by inserting ``,
p.(None): including through programs that reduce risk and promote
p.(None): resiliency'' before the semicolon;
p.(None): (4) in paragraph (6), as so redesignated, by inserting ``in
p.(None): collaboration with the Director of the National Institute of
p.(None): Mental Health,'' before ``develop'';
p.(None): (5) in paragraph (8), as so redesignated, by inserting ``,
p.(None): increase meaningful participation of individuals with mental
p.(None): illness in programs and activities of the Administration,''
p.(None): before ``and protect the legal'';
p.(None): (6) in paragraph (10), as so redesignated, by striking
p.(None): ``professional and paraprofessional personnel pursuant to
p.(None): section 303'' and inserting ``health paraprofessional personnel
p.(None): and health professionals'';
p.(None): (7) in paragraph (11), as so redesignated, by inserting
p.(None): ``and tele-mental health'' after ``rural mental health'';
p.(None): (8) in paragraph (12), as so redesignated, by striking
p.(None): ``establish a clearinghouse for mental health information to
p.(None): assure the widespread dissemination of such information'' and
p.(None): inserting ``disseminate mental health information, including
p.(None): evidence-based practices,'';
p.(None): (9) in paragraph (15), as so redesignated, by striking
p.(None): ``and'' at the end;
p.(None): (10) in paragraph (16), as so redesignated, by striking the
p.(None): period and inserting ``; and''; and
p.(None): (11) by adding at the end the following:
p.(None): ``(17) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded.''.
p.(None):
p.(None): (b) Director of the Center for Substance Abuse Prevention.--Section
p.(None): 515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
p.(None): (1) in the section heading, by striking ``office'' and
p.(None): inserting ``center'';
p.(None):
p.(None): [[Page 130 STAT. 1213]]
p.(None):
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``an Office'' and inserting ``a
p.(None): Center''; and
p.(None): (B) by striking ``The Office'' and inserting ``The
...
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
p.(None): prevent substance misuse.''.
p.(None): SEC. 6009. PEER REVIEW.
p.(None):
p.(None): Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 3(b)) is amended by adding at the end the following: ``In the case of
p.(None): any such peer review group that is reviewing a grant, cooperative
p.(None): agreement, or contract related to mental illness treatment, not less
p.(None): than half of the members of such peer review group shall be licensed and
p.(None): experienced professionals in the prevention, diagnosis, or treatment of,
p.(None): or recovery from, mental illness or co-occurring mental illness and
p.(None): substance use disorders and have a medical degree, a doctoral degree in
p.(None): psychology, or an advanced degree in nursing or social work from an
p.(None): accredited program, and the Secretary, in consultation with the
p.(None): Assistant Secretary, shall, to the extent possible, ensure such peer
p.(None): review groups include broad geographic representation, including both
p.(None): urban and rural representatives.''.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): SEC. 6021. <> IMPROVING OVERSIGHT OF
p.(None): MENTAL AND SUBSTANCE USE DISORDERS
p.(None): PROGRAMS THROUGH THE ASSISTANT SECRETARY
p.(None): FOR PLANNING AND EVALUATION.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Planning and Evaluation, shall
p.(None): ensure efficient and effective planning and evaluation of mental and
p.(None): substance use disorders prevention and treatment programs and related
p.(None): activities.
p.(None): (b) Evaluation Strategy.--In carrying out subsection (a), the
p.(None): Assistant Secretary for Planning and Evaluation shall, not later than
p.(None): 180 days after the date of enactment of this Act, develop a strategy for
p.(None): conducting ongoing evaluations that identifies priority programs to be
p.(None): evaluated by the Assistant Secretary for Planning and Evaluation and
p.(None): priority programs to be evaluated by other relevant offices and agencies
p.(None): within the Department of Health and Human Services. The strategy shall--
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
p.(None): the Secretary of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, and the Congress on improving the
p.(None): quality of prevention and treatment programs and activities related to
p.(None): mental and substance use disorders, including recommendations for the
p.(None): use of performance metrics. The Assistant Secretary for Mental Health
p.(None): and Substance Use shall include such recommendations in the biennial
p.(None): report required by subsection 501(m) of the Public Health Service Act,
p.(None): as redesignated by section 6003 of this Act.
p.(None): SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
p.(None):
p.(None): (a) Public Availability of Reports.--Section 105(a)(7) of the
p.(None): Protection and Advocacy for Individuals with Mental Illness Act (42
p.(None): U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and
p.(None): inserting ``is located, and make publicly available, a report''.
p.(None): (b) Detailed Accounting.--Section 114(a) of the Protection and
p.(None): Advocacy for Individuals with Mental Illness Act (42 U.S.C. 10824(a)) is
p.(None): amended--
p.(None): (1) in paragraph (3), by striking ``and'' at the end;
p.(None): (2) in paragraph (4), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(5) using data from the existing required annual program
p.(None): progress reports submitted by each system funded under this
p.(None): title, a detailed accounting for each such system of how funds
p.(None): are spent, disaggregated according to whether the funds were
p.(None):
p.(None): [[Page 130 STAT. 1217]]
p.(None):
p.(None): received from the Federal Government, the State government, a
p.(None): local government, or a private entity.''.
p.(None): SEC. 6023. GAO STUDY.
p.(None):
p.(None): (a) In General.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States, in
p.(None): consultation with the Secretary of Health and Human Services and the
p.(None): Assistant Secretary for Mental Health and Substance Use, shall conduct
p.(None): an independent evaluation, and submit a report, to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, on programs
p.(None): funded by allotments made under title I of the Protection and Advocacy
p.(None): for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
p.(None): (b) Contents.--The report and evaluation required under subsection
p.(None): (a) shall include--
p.(None): (1) a review of the programs described in such subsection
p.(None): that are carried out by State agencies and such programs that
p.(None): are carried out by private, nonprofit organizations; and
p.(None): (2) a review of the compliance of the programs described in
p.(None): subsection (a) with statutory and regulatory responsibilities,
p.(None): such as--
p.(None): (A) responsibilities relating to family engagement;
p.(None): (B) responsibilities relating to the grievance
p.(None): procedure for clients or prospective clients of the
p.(None): system to assure that individuals with mental illness
p.(None): have full access to the services of the system, for
p.(None): individuals who have received or are receiving mental
p.(None): health services, and for family members of such
p.(None): individuals with mental illness, or representatives of
p.(None): such individuals or family members, to assure that the
p.(None): eligible system is operating in compliance with the
p.(None): provisions of the Protection and Advocacy for
p.(None): Individuals with Mental Illness Act, as required to be
p.(None): established by section 105(a)(9) of such Act (42 U.S.C.
p.(None): 10805(a)(9));
p.(None): (C) investigation of alleged abuse and neglect of
p.(None): persons with mental illness;
p.(None): (D) availability of adequate medical and behavioral
p.(None): health treatment;
p.(None): (E) denial of rights for persons with mental
p.(None): illness; and
p.(None): (F) compliance with the Federal prohibition on
p.(None): lobbying.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
p.(None): COMMITTEE.
p.(None):
p.(None): (a) Establishment.--
p.(None): (1) In general.--Not later than 3 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services, or the designee of the Secretary, shall establish a
p.(None): committee to be known as the Interdepartmental Serious Mental
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
p.(None): this section, the provisions of the Federal Advisory Committee
p.(None): Act (5 U.S.C. App.) shall apply to the Committee.
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
p.(None): services for adults with a serious mental illness or children
p.(None): with a serious emotional disturbance.
p.(None):
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
p.(None): (H) the Secretary of Labor;
p.(None): (I) the Administrator of the Centers for Medicare &
p.(None): Medicaid Services; and
p.(None): (J) the Commissioner of Social Security.
p.(None):
p.(None): [[Page 130 STAT. 1219]]
p.(None):
p.(None): (2) Non-federal members.--The Committee shall also include
p.(None): not less than 14 non-Federal public members appointed by the
p.(None): Secretary of Health and Human Services, of which--
p.(None): (A) at least 2 members shall be an individual who
p.(None): has received treatment for a diagnosis of a serious
p.(None): mental illness;
p.(None): (B) at least 1 member shall be a parent or legal
p.(None): guardian of an adult with a history of a serious mental
p.(None): illness or a child with a history of a serious emotional
p.(None): disturbance;
p.(None): (C) at least 1 member shall be a representative of a
p.(None): leading research, advocacy, or service organization for
p.(None): adults with a serious mental illness;
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
p.(None): experience treating serious mental illnesses or
p.(None): serious emotional disturbances; or
p.(None): (iv) a licensed psychiatric nurse, nurse
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
p.(None): justice or serious mental illness;
p.(None): (J) at least 1 member shall be a law enforcement
p.(None): officer or corrections officer with extensive experience
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
p.(None): (g) Sunset.--The Committee shall terminate on the date that is 6
p.(None): years after the date on which the Committee is established under
p.(None): subsection (a)(1).
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by inserting after section 501 (42 U.S.C. 290aa) the
p.(None): following:
p.(None): ``SEC. 501A. <> NATIONAL MENTAL HEALTH AND
p.(None): SUBSTANCE USE POLICY LABORATORY.
p.(None):
p.(None): ``(a) In General.--There shall be established within the
p.(None): Administration a National Mental Health and Substance Use Policy
p.(None): Laboratory (referred to in this section as the `Laboratory').
p.(None): ``(b) Responsibilities.--The Laboratory shall--
p.(None): ``(1) continue to carry out the authorities and activities
p.(None): that were in effect for the Office of Policy, Planning, and
p.(None): Innovation as such Office existed prior to the date of enactment
p.(None): of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016;
p.(None): ``(2) identify, coordinate, and facilitate the
p.(None): implementation of policy changes likely to have a significant
p.(None): effect on mental health, mental illness, recovery supports, and
p.(None): the prevention and treatment of substance use disorder services;
p.(None): ``(3) work with the Center for Behavioral Health Statistics
p.(None): and Quality to collect, as appropriate, information from
p.(None): grantees under programs operated by the Administration in order
p.(None): to evaluate and disseminate information on evidence-based
p.(None): practices, including culturally and linguistically appropriate
p.(None): services, as appropriate, and service delivery models;
p.(None): ``(4) provide leadership in identifying and coordinating
p.(None): policies and programs, including evidence-based programs,
p.(None): related to mental and substance use disorders;
p.(None): ``(5) periodically review programs and activities operated
p.(None): by the Administration relating to the diagnosis or prevention
p.(None): of, treatment for, and recovery from, mental and substance use
p.(None): disorders to--
p.(None): ``(A) identify any such programs or activities that
p.(None): are duplicative;
p.(None): ``(B) identify any such programs or activities that
p.(None): are not evidence-based, effective, or efficient; and
p.(None): ``(C) formulate recommendations for coordinating,
p.(None): eliminating, or improving programs or activities
p.(None): identified
p.(None):
p.(None): [[Page 130 STAT. 1221]]
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
p.(None): [[Page 130 STAT. 1222]]
p.(None):
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
p.(None): mental illness, serious emotional disturbances,
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
...
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or''; and
p.(None): (2) by amending subsection (f) to read as follows:
p.(None):
p.(None): ``(f) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $394,550,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None):
p.(None): [[Page 130 STAT. 1224]]
p.(None):
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``that permit States, local governments, communities,
p.(None): and Indian tribes and tribal organizations (as the terms
p.(None): `Indian tribes' and `tribal organizations' are defined
p.(None): in section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act) to focus on emerging trends in
p.(None): substance abuse and co-occurrence of substance use
p.(None): disorders with mental illness or other conditions''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (3) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (4) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$333,806,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (2) in subsection (a)--
...
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1225]]
p.(None):
p.(None): (i) in subparagraph (A), by striking ``; and''
p.(None): at the end and inserting ``;'';
p.(None): (ii) in subparagraph (B)--
p.(None): (I) by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and''; and
p.(None): (iii) by adding at the end the following:
p.(None): ``(C) substance use disorder prevention among high-
p.(None): risk groups.'';
p.(None): (4) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (5) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$211,148,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1911(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x(b)) is amended--
p.(None): (1) by redesignating paragraphs (1) through (3) as
p.(None): paragraphs (2) through (4), respectively; and
p.(None): (2) by inserting before paragraph (2) (as so redesignated)
p.(None): the following:
p.(None): ``(1) providing community mental health services for adults
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
p.(None): accordance with subsection (a), a State shall submit to the
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
p.(None): based system of care for individuals with mental
p.(None): illness, and describe available services and
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
p.(None): ``(iv) include a description of how the State
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
p.(None): providers; and
p.(None): ``(vii) as appropriate to, and reflective of,
p.(None): the uses the State proposes for the block grant
p.(None): funds, include--
p.(None): ``(I) a description of the
p.(None): activities intended to reduce
p.(None): hospitalizations and hospital stays
p.(None): using the block grant funds;
p.(None): ``(II) a description of the
p.(None): activities intended to reduce incidents
p.(None): of suicide using the block grant funds;
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
p.(None): (8) in subparagraph (D) (as so redesignated), by striking
p.(None): ``plan describes'' and inserting ``plan shall describe'';
p.(None): (9) in subparagraph (E) (as so redesignated)--
p.(None): (A) in the subparagraph heading by striking
p.(None): ``systems'' and inserting ``services'';
p.(None): (B) in the first sentence, by striking ``plan
p.(None): describes'' and all that follows through ``and provides
p.(None): for'' and inserting ``plan shall describe the financial
p.(None): resources available, the existing mental health
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
p.(None): inserting ``shall further describe''; and
p.(None): (ii) by striking ``involved.'' and inserting
p.(None): ``involved, and the manner in which the State
p.(None): intends to comply with each of the funding
p.(None): agreements in this subpart and subpart III.'';
p.(None): (10) by striking the flush matter at the end; and
p.(None): (11) by adding at the end the following:
p.(None): ``(2) Goals and objectives.--The establishment of goals and
p.(None): objectives for the period of the plan, including targets and
p.(None): milestones that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.''.
p.(None):
p.(None): [[Page 130 STAT. 1228]]
p.(None):
p.(None): (c) Early Serious Mental Illness.--Section 1920 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-9) is amended by adding at the end the
p.(None): following:
p.(None): ``(c) Early Serious Mental Illness.--
p.(None): ``(1) In general.--Except as provided in paragraph (2), a
p.(None): State shall expend not less than 10 percent of the amount the
p.(None): State receives for carrying out this section for each fiscal
p.(None): year to support evidence-based programs that address the needs
p.(None): of individuals with early serious mental illness, including
p.(None): psychotic disorders, regardless of the age of the individual at
p.(None): onset.
p.(None): ``(2) State flexibility.--In lieu of expending 10 percent of
p.(None): the amount the State receives under this section for a fiscal
p.(None): year as required under paragraph (1), a State may elect to
p.(None): expend not less than 20 percent of such amount by the end of
p.(None): such succeeding fiscal year.''.
p.(None):
p.(None): (d) Additional Provisions.--Section 1915(b) of the Public Health
p.(None): Service Act (42 U.S.C. 300x-4(b)) is amended--
p.(None): (1) in paragraph (3)--
p.(None): (A) by striking ``The Secretary'' and inserting the
p.(None): following:
p.(None): ``(A) In general.--The Secretary'';
p.(None): (B) by striking ``paragraph (1) if'' and inserting
p.(None): ``paragraph (1) in whole or in part if'';
p.(None): (C) by striking ``State justify the waiver.'' and
p.(None): inserting ``State in the fiscal year involved or in the
p.(None): previous fiscal year justify the waiver''; and
p.(None): (D) by adding at the end the following:
p.(None): ``(B) Date certain for action upon request.--The
p.(None): Secretary shall approve or deny a request for a waiver
p.(None): under this paragraph not later than 120 days after the
p.(None): date on which the request is made.
p.(None): ``(C) Applicability of waiver.--A waiver provided by
p.(None): the Secretary under this paragraph shall be applicable
p.(None): only to the fiscal year involved.''; and
p.(None): (2) in paragraph (4)--
p.(None): (A) in subparagraph (A)--
p.(None): (i) by inserting after the subparagraph
p.(None): designation the following: ``In general.--'';
p.(None): (ii) by striking ``In making a grant'' and
p.(None): inserting the following:
p.(None): ``(i) Determination.--In making a grant''; and
p.(None): (iii) by inserting at the end the following:
...
p.(None): diversion services for veterans.'';
p.(None): (6) in subsection (e), as so redesignated--
p.(None): (A) in paragraph (3), by striking ``; and'' and
p.(None): inserting a semicolon;
p.(None): (B) in paragraph (4), by striking the period and
p.(None): inserting ``; and''; and
p.(None): (C) by adding at the end the following:
p.(None): ``(5) develop programs to divert individuals prior to
p.(None): booking or arrest.''; and
p.(None): (7) in subsection (j), as so redesignated, by striking
p.(None): ``$10,000,000 for fiscal year 2001, and such sums as may be
p.(None): necessary for fiscal years 2002 through 2003'' and inserting
p.(None): ``$4,269,000 for each of fiscal years 2018 through 2022''.
p.(None): SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH
p.(None): CARE.
p.(None):
p.(None): Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
p.(None): AGREEMENTS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Eligible entity.--The term `eligible entity' means a
p.(None): State, or other appropriate State agency, in collaboration with
p.(None): 1 or more qualified community programs as described in section
p.(None): 1913(b)(1) or 1 or more community health centers as described in
p.(None): section 330.
p.(None): ``(2) Integrated care.--The term `integrated care' means
p.(None): collaborative models or practices offering mental and physical
p.(None): health services, which may include practices that share the same
p.(None): space in the same facility.
p.(None): ``(3) Special population.--The term `special population'
p.(None): means--
p.(None): ``(A) adults with a mental illness who have co-
p.(None): occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(B) adults with a serious mental illness who have
p.(None): co-occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(C) children and adolescents with a serious
p.(None): emotional disturbance with co-occurring physical health
p.(None): conditions or chronic diseases; or
p.(None): ``(D) individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Grants and Cooperative Agreements.--
p.(None): ``(1) In general.--The Secretary may award grants and
p.(None): cooperative agreements to eligible entities to support the
p.(None):
p.(None): [[Page 130 STAT. 1236]]
p.(None):
p.(None): improvement of integrated care for primary care and behavioral
p.(None): health care in accordance with paragraph (2).
p.(None): ``(2) Purposes.--A grant or cooperative agreement awarded
p.(None): under this section shall be designed to--
p.(None): ``(A) promote full integration and collaboration in
p.(None): clinical practices between primary and behavioral health
p.(None): care;
p.(None): ``(B) support the improvement of integrated care
p.(None): models for primary care and behavioral health care to
p.(None): improve the overall wellness and physical health status
p.(None): of adults with a serious mental illness or children with
p.(None): a serious emotional disturbance; and
p.(None): ``(C) promote integrated care services related to
p.(None): screening, diagnosis, prevention, and treatment of
p.(None): mental and substance use disorders, and co-occurring
p.(None): physical health conditions and chronic diseases.
p.(None):
p.(None): ``(c) Applications.--
p.(None): ``(1) In general.--An eligible entity seeking a grant or
p.(None): cooperative agreement under this section shall submit an
p.(None): application to the Secretary at such time, in such manner, and
p.(None): accompanied by such information as the Secretary may require,
p.(None): including the contents described in paragraph (2).
p.(None): ``(2) Contents.--The contents described in this paragraph
p.(None): are--
p.(None): ``(A) a description of a plan to achieve fully
p.(None): collaborative agreements to provide services to special
p.(None): populations;
p.(None): ``(B) a document that summarizes the policies, if
p.(None): any, that serve as barriers to the provision of
p.(None): integrated care, and the specific steps, if applicable,
p.(None): that will be taken to address such barriers;
p.(None): ``(C) a description of partnerships or other
p.(None): arrangements with local health care providers to provide
p.(None): services to special populations;
p.(None): ``(D) an agreement and plan to report to the
p.(None): Secretary performance measures necessary to evaluate
p.(None): patient outcomes and facilitate evaluations across
p.(None): participating projects; and
p.(None): ``(E) a plan for sustainability beyond the grant or
p.(None): cooperative agreement period under subsection (e).
p.(None):
p.(None): ``(d) Grant and Cooperative Agreement Amounts.--
p.(None): ``(1) Target amount.--The target amount that an eligible
p.(None): entity may receive for a year through a grant or cooperative
p.(None): agreement under this section shall be $2,000,000.
p.(None): ``(2) Adjustment permitted.--The Secretary, taking into
p.(None): consideration the quality of the application and the number of
p.(None): eligible entities that received grants under this section prior
p.(None): to the date of enactment of the Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016, may adjust the target amount
p.(None): that an eligible entity may receive for a year through a grant
p.(None): or cooperative agreement under this section.
p.(None): ``(3) Limitation.--An eligible entity receiving funding
p.(None): under this section may not allocate more than 10 percent of
p.(None): funds awarded under this section to administrative functions,
p.(None): and the remaining amounts shall be allocated to health
p.(None): facilities that provide integrated care.
p.(None):
p.(None): ``(e) Duration.--A grant or cooperative agreement under this section
p.(None): shall be for a period not to exceed 5 years.
p.(None):
p.(None): [[Page 130 STAT. 1237]]
p.(None):
p.(None): ``(f) Report on Program Outcomes.--An eligible entity receiving a
p.(None): grant or cooperative agreement under this section shall submit an annual
p.(None): report to the Secretary that includes--
p.(None): ``(1) the progress made to reduce barriers to integrated
p.(None): care as described in the entity's application under subsection
p.(None): (c); and
p.(None): ``(2) a description of functional outcomes of special
p.(None): populations, including--
p.(None): ``(A) with respect to adults with a serious mental
p.(None): illness, participation in supportive housing or
p.(None): independent living programs, attendance in social and
p.(None): rehabilitative programs, participation in job training
p.(None): opportunities, satisfactory performance in work
p.(None): settings, attendance at scheduled medical and mental
p.(None): health appointments, and compliance with prescribed
p.(None): medication regimes;
p.(None): ``(B) with respect to individuals with co-occurring
p.(None): mental illness and physical health conditions and
p.(None): chronic diseases, attendance at scheduled medical and
p.(None): mental health appointments, compliance with prescribed
p.(None): medication regimes, and participation in learning
p.(None): opportunities related to improved health and lifestyle
p.(None): practices; and
p.(None): ``(C) with respect to children and adolescents with
p.(None): a serious emotional disturbance who have co-occurring
p.(None): physical health conditions and chronic diseases,
p.(None): attendance at scheduled medical and mental health
p.(None): appointments, compliance with prescribed medication
p.(None): regimes, and participation in learning opportunities at
p.(None): school and extracurricular activities.
p.(None):
p.(None): ``(g) Technical Assistance for Primary-Behavioral Health Care
p.(None): Integration.--
p.(None): ``(1) In general.--The Secretary may provide appropriate
p.(None): information, training, and technical assistance to eligible
p.(None): entities that receive a grant or cooperative agreement under
p.(None): this section, in order to help such entities meet the
p.(None): requirements of this section, including assistance with--
p.(None): ``(A) development and selection of integrated care
p.(None): models;
p.(None): ``(B) dissemination of evidence-based interventions
p.(None): in integrated care;
p.(None): ``(C) establishment of organizational practices to
p.(None): support operational and administrative success; and
p.(None): ``(D) other activities, as the Secretary determines
p.(None): appropriate.
p.(None): ``(2) Additional dissemination of technical information.--
p.(None): The information and resources provided by the Secretary under
p.(None): paragraph (1) shall, as appropriate, be made available to
...
p.(None): the Internet website described in subsection (b)(2) contains information
p.(None): on any qualified practitioner that is certified to prescribe medication
p.(None): for opioid dependency under section 303(g)(2)(B) of the Controlled
p.(None): Substances Act, the Assistant Secretary--
p.(None): ``(1) shall provide an opportunity to such practitioner to
p.(None): have the contact information of the practitioner removed from
p.(None): the website at the request of the practitioner; and
p.(None): ``(2) may evaluate other methods to periodically update the
p.(None): information displayed on such website.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the Assistant Secretary from using any unobligated
p.(None): amounts otherwise made available to the Administration to maintain the
p.(None): Routing Service.''.
p.(None): SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall award competitive grants to--
p.(None): ``(1) State and local governments and Indian tribes and
p.(None): tribal organizations, to enhance community-based crisis response
p.(None): systems; or
p.(None): ``(2) States to develop, maintain, or enhance a database of
p.(None): beds at inpatient psychiatric facilities, crisis stabilization
p.(None): units, and residential community mental health and residential
p.(None): substance use disorder treatment facilities, for adults with a
p.(None): serious mental illness, children with a serious emotional
p.(None): disturbance, or individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Applications.--
p.(None): ``(1) In general.--To receive a grant under subsection (a),
p.(None): an entity shall submit to the Secretary an application, at such
p.(None): time, in such manner, and containing such information as the
p.(None): Secretary may require.
p.(None): ``(2) Community-based crisis response plan.--An application
p.(None): for a grant under subsection (a)(1) shall include a plan for--
p.(None): ``(A) promoting integration and coordination between
p.(None): local public and private entities engaged in crisis
p.(None): response, including first responders, emergency health
p.(None): care providers, primary care providers, law enforcement,
p.(None): court systems, health care payers, social service
p.(None): providers, and behavioral health providers;
p.(None): ``(B) developing memoranda of understanding with
p.(None): public and private entities to implement crisis response
p.(None): services;
p.(None): ``(C) addressing gaps in community resources for
p.(None): crisis intervention and prevention; and
p.(None):
p.(None): [[Page 130 STAT. 1241]]
p.(None):
p.(None): ``(D) developing models for minimizing hospital
p.(None): readmissions, including through appropriate discharge
p.(None): planning.
p.(None): ``(3) Beds database plan.--An application for a grant under
p.(None): subsection (a)(2) shall include a plan for developing,
p.(None): maintaining, or enhancing a real-time, Internet-based bed
...
p.(None): ``(B) Implementing evidence-based practices to
p.(None): provide treatment for individuals at risk for suicide,
p.(None): including appropriate followup services.
p.(None): ``(C) Raising awareness and reducing stigma of
p.(None): suicide.
p.(None):
p.(None): [[Page 130 STAT. 1244]]
p.(None):
p.(None): ``(b) Evaluations and Technical Assistance.--The Assistant Secretary
p.(None): shall--
p.(None): ``(1) evaluate the activities supported by grants awarded
p.(None): under subsection (a), and disseminate, as appropriate, the
p.(None): findings from the evaluation; and
p.(None): ``(2) provide appropriate information, training, and
p.(None): technical assistance, as appropriate, to eligible entities that
p.(None): receive a grant under this section, in order to help such
p.(None): entities to meet the requirements of this section, including
p.(None): assistance with selection and implementation of evidence-based
p.(None): interventions and frameworks to prevent suicide.
p.(None):
p.(None): ``(c) Duration.--A grant under this section shall be for a period of
p.(None): not more than 5 years.
p.(None): ``(d) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $30,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.(None):
p.(None): Section 520J of the Public Health Service Act (42 U.S.C. 290bb-41)
p.(None): is amended--
p.(None): (1) in the section heading, by inserting ``mental health
p.(None): awareness'' before ``training''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Illness'' and inserting ``Health'';
p.(None): (B) in paragraph (1), by inserting ``veterans, law
p.(None): enforcement, and other categories of individuals, as
p.(None): determined by the Secretary,'' after ``emergency
p.(None): services personnel'';
p.(None): (C) in paragraph (5)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``to'' and inserting ``for evidence-
p.(None): based programs that provide training and education
p.(None): in accordance with paragraph (1) on matters
p.(None): including''; and
p.(None): (ii) by striking subparagraphs (A) through (C)
p.(None): and inserting the following:
p.(None): ``(A) recognizing the signs and symptoms of mental
p.(None): illness; and
p.(None): ``(B)(i) resources available in the community for
p.(None): individuals with a mental illness and other relevant
p.(None): resources; or
p.(None): ``(ii) safely de-escalating crisis situations
p.(None): involving individuals with a mental illness.''; and
p.(None): (D) in paragraph (7), by striking ``, $25,000,000''
p.(None): and all that follows through the period at the end and
p.(None): inserting ``$14,693,000 for each of fiscal years 2018
p.(None): through 2022.''.
p.(None): SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND
p.(None): ALASKA NATIVE YOUTH WITHIN SUICIDE
p.(None): PREVENTION PROGRAMS.
p.(None):
p.(None): (a) Findings.--The Congress finds as follows:
p.(None): (1) Suicide is the eighth leading cause of death among
p.(None): American Indians and Alaska Natives across all ages.
p.(None): (2) Among American Indians and Alaska Natives who are 10 to
p.(None): 34 years of age, suicide is the second leading cause of death.
p.(None): (3) The suicide rate among American Indian and Alaska Native
p.(None): adolescents and young adults ages 15 to 34 (17.9 per
p.(None):
p.(None): [[Page 130 STAT. 1245]]
p.(None):
p.(None): 100,000) is approximately 1.3 times higher than the national
p.(None): average for that age group (13.3 per 100,000).
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that the
p.(None): Secretary of Health and Human Services, in carrying out suicide
p.(None): prevention and intervention programs, should prioritize programs and
p.(None): activities for populations with disproportionately high rates of
p.(None): suicide, such as American Indians and Alaska Natives.
p.(None): SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
p.(None):
p.(None): Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 32(e)) is amended by adding at the end the following:
...
p.(None): States, the National Violent Death Reporting System as authorized by
p.(None): title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
p.(None): Participation in the system by the States shall be voluntary.
p.(None): SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
p.(None):
p.(None): Section 224 of the Protecting Access to Medicare Act of 2014 (42
p.(None): U.S.C. 290aa note) is amended--
p.(None): (1) in subsection (e), by striking ``and 2018,'' and
p.(None): inserting ``2018, 2019, 2020, 2021, and 2022,''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in paragraph (1), by striking ``2018'' and
p.(None): inserting ``2022''; and
p.(None): (B) in paragraph (2), by striking ``is authorized to
p.(None): be appropriated to carry out this section $15,000,000
p.(None): for each of fiscal years 2015 through 2018'' and
p.(None): inserting ``are authorized to be appropriated to carry
p.(None): out this section $15,000,000 for each of fiscal years
p.(None): 2015 through 2017, $20,000,000 for fiscal year 2018,
p.(None): $19,000,000 for each of fiscal years 2019 and 2020, and
p.(None): $18,000,000 for each of fiscal years 2021 and 2022''.
p.(None): SEC. 9015. <> ASSERTIVE COMMUNITY
p.(None): TREATMENT GRANT PROGRAM.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.), as amended by section 9009, is further amended by adding at
p.(None): the end the following:
p.(None): ``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall award grants to
p.(None): eligible entities--
p.(None): ``(1) to establish assertive community treatment programs
p.(None): for adults with a serious mental illness; or
p.(None): ``(2) to maintain or expand such programs.
p.(None):
p.(None): [[Page 130 STAT. 1246]]
p.(None):
p.(None): ``(b) Eligible Entities.--To be eligible to receive a grant under
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act), mental health system, health care facility, or any other entity
p.(None): the Assistant Secretary deems appropriate.
p.(None): ``(c) Special Consideration.--In selecting among applicants for a
p.(None): grant under this section, the Assistant Secretary may give special
p.(None): consideration to the potential of the applicant's program to reduce
p.(None): hospitalization, homelessness, and involvement with the criminal justice
p.(None): system while improving the health and social outcomes of the patient.
p.(None): ``(d) Additional Activities.--The Assistant Secretary shall--
p.(None): ``(1) not later than the end of fiscal year 2021, submit a
p.(None): report to the appropriate congressional committees on the grant
p.(None): program under this section, including an evaluation of--
p.(None): ``(A) any cost savings and public health outcomes
p.(None): such as mortality, suicide, substance use disorders,
p.(None): hospitalization, and use of services;
p.(None): ``(B) rates of involvement with the criminal justice
...
p.(None):
p.(None): (a) Purpose.--It is the purpose of this section to provide for the
p.(None): establishment of a College Campus Task Force to discuss mental and
p.(None): behavioral health concerns on campuses of institutions of higher
p.(None): education.
p.(None): (b) Establishment.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall establish a
p.(None): College Campus Task Force (referred to in this section as the ``Task
p.(None): Force'') to discuss mental and behavioral health concerns on campuses of
p.(None): institutions of higher education.
p.(None): (c) Membership.--The Task Force shall be composed of a
p.(None): representative from each Federal agency (as appointed by the head of the
p.(None): agency) that has jurisdiction over, or is affected by, mental health and
p.(None): education policies and projects, including--
p.(None): (1) the Department of Education;
p.(None): (2) the Department of Health and Human Services;
p.(None): (3) the Department of Veterans Affairs; and
p.(None): (4) such other Federal agencies as the Assistant Secretary
p.(None): for Mental Health and Substance Use, in consultation with the
p.(None): Secretary, determines to be appropriate.
p.(None):
p.(None): (d) Duties.--The Task Force shall--
p.(None): (1) serve as a centralized mechanism to coordinate a
p.(None): national effort to--
p.(None): (A) discuss and evaluate evidence and knowledge on
p.(None): mental and behavioral health services available to, and
p.(None): the prevalence of mental illness among, the age
p.(None): population of students attending institutions of higher
p.(None): education in the United States;
p.(None): (B) determine the range of effective, feasible, and
p.(None): comprehensive actions to improve mental and behavioral
p.(None): health on campuses of institutions of higher education;
p.(None):
p.(None): [[Page 130 STAT. 1260]]
p.(None):
p.(None): (C) examine and better address the needs of the age
p.(None): population of students attending institutions of higher
p.(None): education dealing with mental illness;
p.(None): (D) survey Federal agencies to determine which
p.(None): policies are effective in encouraging, and how best to
p.(None): facilitate outreach without duplicating, efforts
p.(None): relating to mental and behavioral health promotion;
p.(None): (E) establish specific goals within and across
p.(None): Federal agencies for mental health promotion, including
p.(None): determinations of accountability for reaching those
p.(None): goals;
p.(None): (F) develop a strategy for allocating
p.(None): responsibilities and ensuring participation in mental
p.(None): and behavioral health promotion, particularly in the
p.(None): case of competing agency priorities;
p.(None): (G) coordinate plans to communicate research results
p.(None): relating to mental and behavioral health amongst the age
p.(None): population of students attending institutions of higher
p.(None): education to enable reporting and outreach activities to
p.(None): produce more useful and timely information;
p.(None): (H) provide a description of evidence-based
p.(None): practices, model programs, effective guidelines, and
p.(None): other strategies for promoting mental and behavioral
p.(None): health on campuses of institutions of higher education;
p.(None): (I) make recommendations to improve Federal efforts
p.(None): relating to mental and behavioral health promotion on
p.(None): campuses of institutions of higher education and to
p.(None): ensure Federal efforts are consistent with available
p.(None): standards, evidence, and other programs in existence as
p.(None): of the date of enactment of this Act;
p.(None): (J) monitor Federal progress in meeting specific
...
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): ``(a) Purpose.--It is the purpose of this section to increase access
p.(None): to, and reduce the stigma associated with, mental health services to
p.(None): ensure that students at institutions of higher education have the
p.(None): support necessary to successfully complete their studies.
p.(None): ``(b) National Public Education Campaign.--The Secretary, acting
p.(None): through the Assistant Secretary and in collaboration with the Director
p.(None): of the Centers for Disease Control and Prevention, shall convene an
p.(None): interagency, public-private sector working group to plan, establish, and
p.(None): begin coordinating and evaluating a targeted public education campaign
p.(None): that is designed to focus on mental and behavioral health on the
p.(None): campuses of institutions of higher education. Such campaign shall be
p.(None): designed to--
p.(None): ``(1) improve the general understanding of mental health and
p.(None): mental disorders;
p.(None): ``(2) encourage help-seeking behaviors relating to the
p.(None): promotion of mental health, prevention of mental disorders, and
p.(None): treatment of such disorders;
p.(None): ``(3) make the connection between mental and behavioral
p.(None): health and academic success; and
p.(None): ``(4) assist the general public in identifying the early
p.(None): warning signs and reducing the stigma of mental illness.
p.(None):
p.(None): ``(c) Composition.--The working group convened under subsection (b)
p.(None): shall include--
p.(None): ``(1) mental health consumers, including students and family
p.(None): members;
p.(None): ``(2) representatives of institutions of higher education;
p.(None): ``(3) representatives of national mental and behavioral
p.(None): health associations and associations of institutions of higher
p.(None): education;
p.(None): ``(4) representatives of health promotion and prevention
p.(None): organizations at institutions of higher education;
p.(None): ``(5) representatives of mental health providers, including
p.(None): community mental health centers; and
p.(None): ``(6) representatives of private-sector and public-sector
p.(None): groups with experience in the development of effective public
p.(None): health education campaigns.
p.(None):
p.(None): ``(d) Plan.--The working group under subsection (b) shall develop a
p.(None): plan that--
p.(None): ``(1) targets promotional and educational efforts to the age
p.(None): population of students at institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
...
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
...
p.(None): ``(B) establishing linkages with and among
p.(None): community-based resources, including mental health
p.(None): resources, primary care resources, and support groups;
p.(None): and
p.(None): ``(C) utilizing telehealth services for rural areas
p.(None): and medically underserved areas (as defined in section
p.(None): 330I(a)).
p.(None):
p.(None): ``(e) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $5,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 399Z-2. <> INFANT AND EARLY
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
p.(None): ``(B) multigenerational therapy and other services
p.(None): that support the caregiving relationship; and
p.(None): ``(2) ensure that programs funded through grants under this
p.(None): section are evidence-informed or evidence-based models,
p.(None): practices, and methods that are, as appropriate, culturally and
p.(None):
p.(None): [[Page 130 STAT. 1268]]
p.(None):
p.(None): linguistically appropriate, and can be replicated in other
p.(None): appropriate settings.
p.(None):
p.(None): ``(b) Eligible Children and Entities.--In this section:
p.(None): ``(1) Eligible child.--The term `eligible child' means a
p.(None): child from birth to not more than 12 years of age who--
p.(None): ``(A) is at risk for, shows early signs of, or has
p.(None): been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance; and
p.(None): ``(B) may benefit from infant and early childhood
p.(None): intervention or treatment programs or specialized
p.(None): preschool or elementary school programs that are
p.(None): evidence-based or that have been scientifically
p.(None): demonstrated to show promise but would benefit from
p.(None): further applied development.
p.(None): ``(2) Eligible entity.--The term `eligible entity' means a
p.(None): human services agency or nonprofit institution that--
p.(None): ``(A) employs licensed mental health professionals
p.(None): who have specialized training and experience in infant
p.(None): and early childhood mental health assessment, diagnosis,
p.(None): and treatment, or is accredited or approved by the
p.(None): appropriate State agency, as applicable, to provide for
p.(None): children from infancy to 12 years of age mental health
p.(None): promotion, intervention, or treatment services; and
p.(None): ``(B) provides services or programs described in
p.(None): subsection (a) that are evidence-based or that have been
p.(None): scientifically demonstrated to show promise but would
p.(None): benefit from further applied development.
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
p.(None): functional impairment and substantially interferes with or
p.(None): limits one or more major life activities.
p.(None): (3) In reporting on the incidence of serious mental illness,
p.(None): the Substance Abuse and Mental Health Services Administration
p.(None): includes major depression, schizophrenia, bipolar disorder, and
p.(None): other mental disorders that cause serious impairment.
p.(None): (4) Adults with a serious mental illness are at a higher
p.(None): risk for chronic physical illnesses and premature death.
p.(None): (5) According to the World Health Organization, adults with
p.(None): a serious mental illness have lifespans that are 10 to 25 years
p.(None): shorter than those without serious mental illness. The vast
p.(None): majority of these deaths are due to chronic physical medical
p.(None): conditions, such as cardiovascular, respiratory, and infectious
p.(None): diseases, as well as diabetes and hypertension.
p.(None): (6) According to the World Health Organization, the majority
p.(None): of deaths of adults with a serious mental illness that are due
p.(None): to physical medical conditions are preventable.
p.(None): (7) Supported decision making can facilitate care decisions
p.(None): in areas where serious mental illness may impact the capacity of
p.(None): an individual to determine a course of treatment while still
p.(None): allowing the individual to make decisions independently.
p.(None): (8) Help should be provided to adults with a serious mental
p.(None): illness to address their acute or chronic physical illnesses,
p.(None): make informed choices about treatment, and understand and follow
p.(None): through with appropriate treatment.
p.(None):
p.(None): [[Page 130 STAT. 1270]]
p.(None):
p.(None): (9) There is confusion in the health care community
p.(None): regarding permissible practices under the regulations
p.(None): promulgated under the Health Insurance Portability and
p.(None): Accountability Act of 1996 (commonly known as ``HIPAA''). This
p.(None): confusion may hinder appropriate communication of health care
p.(None): information or treatment preferences with appropriate
p.(None): caregivers.
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that
p.(None): clarification is needed regarding the privacy rule promulgated under
p.(None): section 264(c) of the Health Insurance Portability and Accountability
p.(None): Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses
p.(None): and disclosures of health information by health care professionals to
p.(None): communicate with caregivers of adults with a serious mental illness to
p.(None): facilitate treatment.
p.(None): SEC. 11002. CONFIDENTIALITY OF RECORDS.
p.(None): Not later than 1 year after the date on which the Secretary of
p.(None): Health and Human Services (in this title referred to as the
p.(None): ``Secretary'') first finalizes regulations updating part 2 of title 42,
p.(None): Code of Federal Regulations, relating to confidentiality of alcohol and
p.(None): drug abuse patient records, after the date of enactment of this Act, the
p.(None): Secretary shall convene relevant stakeholders to determine the effect of
p.(None): such regulations on patient care, health outcomes, and patient privacy.
p.(None): SEC. 11003. <> CLARIFICATION ON
p.(None): PERMITTED USES AND DISCLOSURES OF
p.(None): PROTECTED HEALTH INFORMATION.
p.(None):
p.(None): (a) In General.--The Secretary, acting through the Director of the
p.(None): Office for Civil Rights, shall ensure that health care providers,
p.(None): professionals, patients and their families, and others involved in
p.(None): mental or substance use disorder treatment have adequate, accessible,
p.(None): and easily comprehensible resources relating to appropriate uses and
p.(None): disclosures of protected health information under the regulations
p.(None): promulgated under section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
p.(None): (b) Guidance.--
p.(None): (1) Issuance.--In carrying out subsection (a), not later
p.(None): than 1 year after the date of enactment of this section, the
p.(None): Secretary shall issue guidance clarifying the circumstances
p.(None): under which, consistent with regulations promulgated under
...
p.(None): (2) The number of individuals receiving medical assistance
p.(None): under a State plan under such title XIX, or a waiver of such
p.(None): plan, who receive services in institutions for mental diseases
p.(None): through such organizations and plans.
p.(None): (3) The range of and average number of months, and the
p.(None): length of stay during such months, that such individuals are
p.(None): receiving such services in such institutions.
p.(None): (4) How such organizations or plans determine when to
p.(None): provide for the furnishing of such services through an
p.(None): institution for mental diseases in lieu of other benefits
p.(None): (including the full range of community-based services) under
p.(None): their contract with the State agency administering the State
p.(None): plan under such title XIX, or a waiver of such plan, to address
p.(None): psychiatric or substance use disorder treatment.
p.(None): (5) The extent to which the provision of services within
p.(None): such institutions has affected the capitated payments for such
p.(None): organizations or plans.
p.(None):
p.(None): (b) Report.--Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary shall submit to Congress a report on the
p.(None): study conducted under subsection (a).
p.(None): SEC. 12003. <> GUIDANCE ON OPPORTUNITIES
p.(None): FOR INNOVATION.
p.(None):
p.(None): Not later than 1 year after the date of the enactment of this Act,
p.(None): the Administrator of the Centers for Medicare & Medicaid Services shall
p.(None): issue a State Medicaid Director letter regarding opportunities to design
p.(None): innovative service delivery systems, including systems for providing
p.(None): community-based services, for adults with a serious mental illness or
p.(None): children with a serious emotional disturbance who are receiving medical
p.(None): assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.). The letter shall include opportunities for demonstration projects
p.(None): under section 1115 of such Act (42 U.S.C. 1315) to improve care for such
p.(None): adults and children.
p.(None): SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC
p.(None): DEMONSTRATION PROJECT.
p.(None):
p.(None): (a) Collection of Information.--The Secretary of Health and Human
p.(None): Services, acting through the Administrator of the Centers for Medicare &
p.(None): Medicaid Services, shall, to the extent practical and data is available,
p.(None): with respect to each State that has participated in the demonstration
p.(None): project established under section 2707
p.(None):
p.(None): [[Page 130 STAT. 1274]]
p.(None): of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a
p.(None): note), collect from each such State information on the following:
p.(None): (1) The number of institutions for mental diseases (as
p.(None): defined in section 1905(i) of the Social Security Act (42 U.S.C.
p.(None): 1396d(i))) and beds in such institutions that received payment
p.(None): for the provision of services to individuals who receive medical
p.(None): assistance under a State plan under the Medicaid program under
p.(None): title XIX of the Social Security Act (42 U.S.C. 1396 et seq.)
p.(None): (or under a waiver of such plan) through the demonstration
p.(None): project in each such State as compared to the total number of
p.(None): institutions for mental diseases and beds in the State.
p.(None): (2) The extent to which there is a reduction in expenditures
p.(None): under the Medicaid program under title XIX of the Social
p.(None): Security Act (42 U.S.C. 1396 et seq.) or other spending on the
p.(None): full continuum of physical or mental health care for individuals
p.(None): who receive treatment in an institution for mental diseases
p.(None): under the demonstration project, including outpatient,
p.(None): inpatient, emergency, and ambulatory care, that is attributable
p.(None): to such individuals receiving treatment in institutions for
p.(None): mental diseases under the demonstration project.
p.(None): (3) The number of forensic psychiatric hospitals, the number
p.(None): of beds in such hospitals, and the number of forensic
p.(None): psychiatric beds in other hospitals in such State, based on the
p.(None): most recent data available, to the extent practical, as
p.(None): determined by such Administrator.
p.(None): (4) The amount of any disproportionate share hospital
p.(None): payments under section 1923 of the Social Security Act (42
p.(None): U.S.C. 1396r-4) that institutions for mental diseases in the
p.(None): State received during the period beginning on July 1, 2012, and
p.(None): ending on June 30, 2015, and the extent to which the
p.(None): demonstration project reduced the amount of such payments.
p.(None): (5) The most recent data regarding all facilities or sites
p.(None): in the State in which any adults with a serious mental illness
p.(None): who are receiving medical assistance under a State plan under
p.(None): the Medicaid program under title XIX of the Social Security Act
p.(None): (42 U.S.C. 1396 et seq.) (or under a waiver of such plan) are
p.(None): treated during the period referred to in paragraph (4), to the
p.(None): extent practical, as determined by the Administrator,
p.(None): including--
p.(None): (A) the types of such facilities or sites (such as
p.(None): an institution for mental diseases, a hospital emergency
p.(None): department, or other inpatient hospital);
p.(None): (B) the average length of stay in such a facility or
p.(None): site by such an individual, disaggregated by facility
p.(None): type; and
p.(None): (C) the payment rate under the State plan (or a
p.(None): waivers of such plan) for services furnished to such an
p.(None): individual for that treatment, disaggregated by facility
p.(None): type, during the period in which the demonstration
p.(None): project is in operation.
p.(None): (6) The extent to which the utilization of hospital
p.(None): emergency departments during the period in which the
p.(None): demonstration project was is in operation differed, with respect
p.(None): to individuals who are receiving medical assistance under a
p.(None): State plan under the Medicaid program under title XIX of the
p.(None): Social Security Act (42 U.S.C. 1396 et seq.) (or under a waiver
p.(None): of such plan), between--
p.(None):
p.(None): [[Page 130 STAT. 1275]]
p.(None):
p.(None): (A) those individuals who received treatment in an
p.(None): institution for mental diseases under the demonstration
p.(None): project;
p.(None): (B) those individuals who met the eligibility
p.(None): requirements for the demonstration project but who did
p.(None): not receive treatment in an institution for mental
p.(None): diseases under the demonstration project; and
p.(None): (C) those adults with a serious mental illness who
p.(None): did not meet such eligibility requirements and did not
p.(None): receive treatment for such illness in an institution for
p.(None): mental diseases.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall submit to
p.(None): Congress a report that summarizes and analyzes the information collected
p.(None): under subsection (a). Such report may be submitted as part of the report
p.(None): required under section 2707(f) of the Patient Protection and Affordable
p.(None): Care Act (42 U.S.C. 1396a note) or separately.
p.(None): SEC. 12005. <> PROVIDING EPSDT SERVICES
p.(None): TO CHILDREN IN IMDS.
p.(None):
p.(None): (a) In General.--Section 1905(a)(16) of the Social Security Act (42
p.(None): U.S.C. 1396d(a)(16)) is amended--
p.(None): (1) by striking ``effective January 1, 1973'' and inserting
p.(None): ``(A) effective January 1, 1973''; and
p.(None): (2) by inserting before the semicolon at the end the
p.(None): following: ``, and, (B) for individuals receiving services
p.(None): described in subparagraph (A), early and periodic screening,
p.(None): diagnostic, and treatment services (as defined in subsection
p.(None): (r)), whether or not such screening, diagnostic, and treatment
p.(None): services are furnished by the provider of the services described
p.(None): in such subparagraph''.
p.(None):
p.(None): (b) Effective Date.--The amendments made by subsection (a) shall
p.(None): apply with respect to items and services furnished in calendar quarters
p.(None): beginning on or after January 1, 2019.
p.(None): SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
p.(None): PERSONAL CARE SERVICES AND HOME HEALTH
p.(None): CARE SERVICES UNDER MEDICAID.
p.(None):
...
p.(None): prescription drug formulary design; and
p.(None): ``(III) use of fail-first or step
p.(None): therapy protocols;
p.(None): ``(ii) examples of methods of determining--
p.(None): ``(I) network admission standards
p.(None): (such as credentialing); and
p.(None): ``(II) factors used in provider
p.(None): reimbursement methodologies (such as
p.(None): service type, geographic market, demand
p.(None): for services, and provider supply,
p.(None): practice size, training, experience, and
p.(None): licensure) as such factors apply to
p.(None): network adequacy;
p.(None): ``(iii) examples of sources of information
p.(None): that may serve as evidentiary standards for the
p.(None): purposes of making determinations regarding the
p.(None): development and application of nonquantitative
p.(None): treatment limitations;
p.(None): ``(iv) examples of specific factors, and the
p.(None): evidentiary standards used to evaluate such
p.(None): factors, used
p.(None):
p.(None): [[Page 130 STAT. 1282]]
p.(None):
p.(None): by such plans or issuers in performing a
p.(None): nonquantitative treatment limitation analysis;
p.(None): ``(v) examples of how specific evidentiary
p.(None): standards may be used to determine whether
p.(None): treatments are considered experimental or
p.(None): investigative;
p.(None): ``(vi) examples of how specific evidentiary
p.(None): standards may be applied to each service category
p.(None): or classification of benefits;
p.(None): ``(vii) examples of methods of reaching
p.(None): appropriate coverage determinations for new mental
p.(None): health or substance use disorder treatments, such
p.(None): as evidence-based early intervention programs for
p.(None): individuals with a serious mental illness and
p.(None): types of medical management techniques;
p.(None): ``(viii) examples of methods of reaching
p.(None): appropriate coverage determinations for which
p.(None): there is an indirect relationship between the
p.(None): covered mental health or substance use disorder
p.(None): benefit and a traditional covered medical and
p.(None): surgical benefit, such as residential treatment or
p.(None): hospitalizations involving voluntary or
p.(None): involuntary commitment; and
p.(None): ``(ix) additional illustrative examples of
p.(None): methods, processes, strategies, evidentiary
p.(None): standards, and other factors for which the
p.(None): Secretary determines that additional guidance is
p.(None): necessary to improve compliance with this section,
p.(None): section 712 of the Employee Retirement Income
p.(None): Security Act of 1974, or section 9812 of the
p.(None): Internal Revenue Code of 1986, as applicable.
p.(None): ``(D) Public comment.--Prior to issuing any final
p.(None): guidance under this paragraph, the Secretary shall
p.(None): provide a public comment period of not less than 60 days
p.(None): during which any member of the public may provide
p.(None): comments on a draft of the guidance.''.
p.(None):
p.(None): (c) Availability of Plan Information.--
p.(None): (1) Solicitation of public feedback.--Not later than 6
p.(None): months after the date of enactment of this Act, the Secretary of
p.(None): Health and Human Services, the Secretary of Labor, and the
p.(None): Secretary of the Treasury shall solicit feedback from the public
p.(None): on how the disclosure request process for documents containing
p.(None): information that health plans or health insurance issuers are
p.(None): required under Federal or State law to disclose to participants,
p.(None): beneficiaries, contracting providers, or authorized
...
p.(None): plan or health insurance issuer shall provide such benefits consistent
p.(None): with the requirements of section 2726 of the Public Health Service Act
p.(None): (42 U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal
p.(None): Revenue Code of 1986.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS,
p.(None): MENTAL HEALTH PURPOSES.
p.(None):
p.(None): (a) Edward Byrne Memorial Justice Assistance Grant Program.--Section
p.(None): 501(a)(1) of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the end the
p.(None): following:
p.(None): ``(H) Mental health programs and related law
p.(None): enforcement and corrections programs, including
p.(None): behavioral programs and crisis intervention teams.''.
p.(None):
p.(None): [[Page 130 STAT. 1288]]
p.(None):
p.(None): (b) Community Oriented Policing Services Program.--Section 1701(b)
p.(None): of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42
p.(None): U.S.C. 3796dd(b)) is amended--
p.(None): (1) in paragraph (17), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (18) as paragraph (22);
p.(None): (3) by inserting after paragraph (17) the following:
p.(None): ``(18) to provide specialized training to law enforcement
p.(None): officers to--
p.(None): ``(A) recognize individuals who have a mental
p.(None): illness; and
p.(None): ``(B) properly interact with individuals who have a
p.(None): mental illness, including strategies for verbal de-
p.(None): escalation of crises;
p.(None): ``(19) to establish collaborative programs that enhance the
p.(None): ability of law enforcement agencies to address the mental
p.(None): health, behavioral, and substance abuse problems of individuals
p.(None): encountered by law enforcement officers in the line of duty;
p.(None): ``(20) to provide specialized training to corrections
p.(None): officers to recognize individuals who have a mental illness;
p.(None): ``(21) to enhance the ability of corrections officers to
p.(None): address the mental health of individuals under the care and
p.(None): custody of jails and prisons, including specialized training and
p.(None): strategies for verbal de-escalation of crises; and''; and
p.(None): (4) in paragraph (22), as redesignated, by striking
p.(None): ``through (17)'' and inserting ``through (21)''.
p.(None):
p.(None): (c) Modifications to the Staffing for Adequate Fire and Emergency
p.(None): Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention and
p.(None): Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting
p.(None): before the period at the end the following: ``and to provide specialized
p.(None): training to paramedics, emergency medical services workers, and other
p.(None): first responders to recognize individuals who have mental illness and
p.(None): how to properly intervene with individuals with mental illness,
p.(None): including strategies for verbal de-escalation of crises''.
p.(None): SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
p.(None):
p.(None): (a) In General.--Section 2201 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
p.(None): other family support services for each program
p.(None): participant who requires such services;
p.(None): (E) outpatient or inpatient mental health treatment,
p.(None): as ordered by the court, that carries with it the
p.(None): possibility of dismissal of charges or reduced
p.(None): sentencing upon successful completion of such treatment;
p.(None): (F) centralized case management, including--
p.(None): (i) the consolidation of all cases, including
p.(None): violations of probations, of the program
p.(None): participant; and
...
p.(None):
p.(None): (f) Assistance From Other Federal Entities.--The Administrative
p.(None): Office of the United States Courts and the United States Probation
p.(None): Offices shall provide such assistance and carry out such functions as
p.(None): the Attorney General may request in monitoring, supervising, providing
p.(None): services to, and evaluating eligible offenders placed in a drug or
p.(None): mental health court under this section.
p.(None): (g) Reports.--The Attorney General, in consultation with the
p.(None): Director of the Administrative Office of the United States Courts, shall
p.(None): monitor the drug and mental health courts under this section, and shall
p.(None): submit a report to Congress on the outcomes of the program at the end of
p.(None): the period described in subsection (d)(2).
p.(None): SEC. 14004. <> MENTAL HEALTH IN THE
p.(None): JUDICIAL SYSTEM.
p.(None):
p.(None): Part V of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
p.(None): the following:
p.(None): ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
p.(None):
p.(None): ``(a) Pretrial Screening and Supervision.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand pretrial services programs to improve the
p.(None): identification and outcomes of individuals with mental illness.
p.(None): ``(2) Allowable uses.--Grants awarded under this subsection
p.(None): may be may be used for--
p.(None): ``(A) behavioral health needs and risk screening of
p.(None): defendants, including verification of interview
p.(None): information, mental health evaluation, and criminal
p.(None): history screening;
p.(None): ``(B) assessment of risk of pretrial misconduct
p.(None): through objective, statistically validated means, and
p.(None): presentation to the court of recommendations based on
p.(None): such assessment, including services that will reduce the
p.(None): risk of pre-trial misconduct;
p.(None): ``(C) followup review of defendants unable to meet
p.(None): the conditions of pretrial release;
p.(None): ``(D) evaluation of process and results of pre-trial
p.(None): service programs;
p.(None): ``(E) supervision of defendants who are on pretrial
p.(None): release, including reminders to defendants of scheduled
p.(None): court dates;
p.(None): ``(F) reporting on process and results of pretrial
p.(None): services programs to relevant public and private mental
p.(None): health stakeholders; and
p.(None): ``(G) data collection and analysis necessary to make
p.(None): available information required for assessment of risk.
p.(None):
p.(None): ``(b) Behavioral Health Assessments and Intervention.--
p.(None): ``(1) In general.--The Attorney General may award grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None):
p.(None): [[Page 130 STAT. 1292]]
p.(None):
...
p.(None): grant to an applicant under this section, the Attorney General
p.(None): shall compare the possible grant with any other grants awarded
p.(None): to the applicant under this Act to determine whether the grants
p.(None): are for the same purpose.
p.(None): ``(2) Report.--If the Attorney General awards multiple
p.(None): grants to the same applicant for the same purpose, the Attorney
p.(None): General shall submit to the Committee on the Judiciary of the
p.(None): Senate and the Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(A) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any such grants
p.(None): awarded; and
p.(None): ``(B) the reason the Attorney General awarded the
p.(None): duplicate grants.''.
p.(None): SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
p.(None):
p.(None): Section 2991 of the Omnibus Crime Control and Safe Streets Act of
p.(None): 1968 (42 U.S.C. 3797aa) is amended by--
p.(None): (1) redesignating subsection (j) as subsection (o); and
p.(None): (2) inserting after subsection (i) the following:
p.(None):
p.(None): ``(j) Forensic Assertive Community Treatment (FACT) Initiative
p.(None): Program.--
p.(None): ``(1) In general.--The Attorney General may make grants to
p.(None): States, units of local government, territories, Indian Tribes,
p.(None): nonprofit agencies, or any combination thereof, to develop,
p.(None): implement, or expand Assertive Community Treatment initiatives
p.(None): to develop forensic assertive community treatment (referred to
p.(None): in this subsection as `FACT') programs that provide high
p.(None): intensity services in the community for individuals with mental
p.(None): illness with involvement in the criminal justice system to
p.(None): prevent future incarcerations.
p.(None): ``(2) Allowable uses.--Grant funds awarded under this
p.(None): subsection may be used for--
p.(None): ``(A) multidisciplinary team initiatives for
p.(None): individuals with mental illnesses with criminal justice
p.(None): involvement that address criminal justice involvement as
p.(None): part of treatment protocols;
p.(None): ``(B) FACT programs that involve mental health
p.(None): professionals, criminal justice agencies, chemical
p.(None): dependency specialists, nurses, psychiatrists,
p.(None): vocational specialists, forensic peer specialists,
p.(None): forensic specialists, and dedicated administrative
p.(None): support staff who work together to provide recovery
p.(None): oriented, 24/7 wraparound services;
p.(None): ``(C) services such as integrated evidence-based
p.(None): practices for the treatment of co-occurring mental
p.(None): health and substance-related disorders, assertive
p.(None): outreach and engagement, community-based service
p.(None): provision at participants' residence or in the
p.(None): community, psychiatric rehabilitation, recovery oriented
p.(None): services, services to address criminogenic risk factors,
p.(None): and community tenure;
...
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
p.(None):
p.(None): The Attorney General, as part of the Preventing Violence Against Law
p.(None): Enforcement and Ensuring Officer Resilience and Survivability Initiative
p.(None): (VALOR) of the Department of Justice, may provide safety training and
...
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(B) receiving centers as alternatives to
p.(None): incarceration of eligible participants;
p.(None): ``(C) specialized response units for calls related
p.(None): to substance use disorders, mental illness, or co-
p.(None): occurring mental illness and substance use disorders;
p.(None): and
p.(None): ``(D) other arrest and pre-booking treatment
p.(None): alternatives to incarceration models; or
p.(None): ``(2) post-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) specialized clinical case management;
p.(None):
p.(None): [[Page 130 STAT. 1299]]
p.(None):
p.(None): ``(B) pre-trial services related to substances use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(C) prosecutor and defender based programs;
p.(None): ``(D) specialized probation;
p.(None): ``(E) treatment and rehabilitation programs; and
p.(None): ``(F) problem-solving courts, including mental
p.(None): health courts, drug courts, co-occurring mental health
p.(None): and substance abuse courts, DWI courts, and veterans
p.(None): treatment courts.
p.(None):
p.(None): ``(c) Application.--
p.(None): ``(1) In general.--An eligible entity desiring a grant under
p.(None): this section shall submit an application to the Attorney
p.(None): General--
p.(None): ``(A) that meets the criteria under paragraph (2);
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
...
p.(None): the duplicate grants.''.
p.(None): SEC. 14014. <> NATIONAL CRIMINAL JUSTICE
p.(None): AND MENTAL HEALTH TRAINING AND
p.(None): TECHNICAL ASSISTANCE.
p.(None):
p.(None): Part HH of title I of the Omnibus Crime Control and Safe Streets Act
p.(None): of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end the
p.(None): following:
p.(None): ``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING
p.(None): AND TECHNICAL ASSISTANCE.
p.(None):
p.(None): ``(a) Authority.--The Attorney General may make grants to eligible
p.(None): organizations to provide for the establishment of a National Criminal
p.(None): Justice and Mental Health Training and Technical Assistance Center.
p.(None): ``(b) Eligible Organization.--For purposes of subsection (a), the
p.(None): term `eligible organization' means a national nonprofit organization
p.(None): that provides technical assistance and training to, and has special
p.(None): expertise and broad, national-level experience in, mental health, crisis
p.(None): intervention, criminal justice systems, law enforcement, translating
p.(None): evidence into practice, training, and research, and education and
p.(None): support of people with mental illness and the families of such
p.(None): individuals.
p.(None): ``(c) Use of Funds.--Any organization that receives a grant under
p.(None): subsection (a) shall collaborate with other grant recipients to
p.(None): establish and operate a National Criminal Justice and Mental Health
p.(None): Training and Technical Assistance Center to--
p.(None): ``(1) provide law enforcement officer training regarding
p.(None): mental health and working with individuals with mental
p.(None): illnesses, with an emphasis on de-escalation of encounters
p.(None): between law enforcement officers and those with mental disorders
p.(None): or in crisis, which shall include support the development of in-
p.(None): person and technical information exchanges between systems and
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
...
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
p.(None): criminal justice agencies evaluation tools, mechanisms, and
p.(None): measures to better assess and document performance measures and
p.(None): outcomes relating to the provision of mental health services;
p.(None): ``(8) disseminate information to States, units of local
p.(None): government, criminal justice agencies, law enforcement agencies,
p.(None): and other relevant entities about best practices, policy
p.(None): standards, and research findings relating to the provision of
p.(None): mental health services; and
p.(None): ``(9) provide education and support to individuals with
p.(None): mental illness involved with, or at risk of involvement with,
p.(None): the criminal justice system, including the families of such
p.(None): individuals.
p.(None):
p.(None): ``(d) Accountability.--Grants awarded under this section shall be
p.(None): subject to the following accountability provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
p.(None): of Justice under subparagraph (C) that the audited
p.(None): grantee has used grant funds for an unauthorized
p.(None): expenditure or otherwise unallowable cost that is not
p.(None): closed or resolved within 1 year after the date on which
p.(None): the final audit report is issued.
p.(None): ``(B) Audits.--Beginning in the first fiscal year
p.(None): beginning after the date of enactment of this section,
p.(None): and in each fiscal year thereafter, the Inspector
p.(None): General of the Department of Justice shall conduct
p.(None): audits of grantees under this section to prevent waste,
p.(None): fraud, and abuse of funds by grantees. The Inspector
p.(None): General shall determine the appropriate number of
p.(None): grantees to be audited each year.
p.(None): ``(C) Final audit report.--The Inspector General of
p.(None): the Department of Justice shall submit to the Attorney
p.(None): General a final report on each audit conducted under
p.(None): subparagraph (B).
...
p.(None): Appropriations of the House of Representatives an annual
p.(None): certification--
p.(None): ``(A) indicating whether--
p.(None): ``(i) all final audit reports issued by the
p.(None): Office of the Inspector General under paragraph
p.(None): (1) have been completed and reviewed by the
p.(None): appropriate Assistant Attorney General or
p.(None): Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(D) have been issued; and
p.(None): ``(iii) any reimbursements required under
p.(None): paragraph (1)(F) have been made; and
p.(None): ``(B) that includes a list of any grantees excluded
p.(None): under paragraph (1)(D) from the previous year.
p.(None): ``(5) Preventing duplicative grants.--
p.(None): ``(A) In general.--Before the Attorney General
p.(None): awards a grant to an applicant under this section, the
p.(None): Attorney General shall compare potential grant awards
p.(None): with other grants awarded under this Act to determine if
p.(None): duplicate grant awards are awarded for the same purpose.
p.(None): ``(B) Report.--If the Attorney General awards
p.(None): duplicate grants to the same applicant for the same
p.(None): purpose the Attorney General shall submit to the
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
p.(None): VETERANS AFFAIRS OF MENTAL CAPACITY OF
p.(None): BENEFICIARIES.
p.(None):
p.(None): (a) In General.--Chapter 55 of title 38, United States Code, is
p.(None): amended by inserting after section 5501 the following new section:
p.(None): ``Sec. 5501A. Beneficiaries' rights in mental competence
p.(None): determinations
p.(None):
p.(None): ``The Secretary may not make an adverse determination concerning the
p.(None): mental capacity of a beneficiary to manage monetary benefits paid to or
p.(None): for the beneficiary by the Secretary under this title unless such
p.(None): beneficiary has been provided all of the following, subject to the
p.(None): procedures and timelines prescribed by the Secretary for determinations
p.(None): of incompetency:
p.(None): ``(1) Notice of the proposed adverse determination and the
p.(None): supporting evidence.
p.(None): ``(2) An opportunity to request a hearing.
p.(None): ``(3) An opportunity to present evidence, including an
p.(None): opinion from a medical professional or other person, on the
p.(None): capacity of the beneficiary to manage monetary benefits paid to
p.(None): or for the beneficiary by the Secretary under this title.
p.(None): ``(4) An opportunity to be represented at no expense to the
p.(None): Government (including by counsel) at any such hearing and to
...
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
p.(None): services and substance abuse treatment services;
p.(None): and
p.(None): ``(iii) alternatives to solitary confinement
p.(None): and segregated housing and mental health screening
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
p.(None): incidents involving inmates with mental health or co-
p.(None): occurring mental health and substance abuse
p.(None): disorders.''.
p.(None): SEC. 14023. ALLOWABLE USES.
p.(None):
...
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
p.(None): mental health and substance abuse professions develop and
p.(None): administer cooperatively.''.
p.(None): SEC. 14025. <> FEDERAL LAW
p.(None): ENFORCEMENT TRAINING.
p.(None):
p.(None): Not later than 1 year after the date of enactment of this Act, the
p.(None): Attorney General shall provide direction and guidance for the following:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training, in procedures to identify and
p.(None): appropriately respond to incidents in which the unique needs of
p.(None): individuals who have a mental illness are involved, to first
p.(None): responders and tactical units of--
p.(None): (A) Federal law enforcement agencies; and
p.(None): (B) other Federal criminal justice agencies such as
p.(None): the Bureau of Prisons, the Administrative Office of the
p.(None): United States Courts, and other agencies that the
p.(None): Attorney General determines appropriate.
p.(None): (2) Improved technology.--The establishment of, or
p.(None): improvement of existing, computerized information systems to
p.(None): provide timely information to employees of Federal law
p.(None): enforcement agencies, and Federal criminal justice agencies to
p.(None): improve the response of such employees to situations involving
p.(None): individuals who have a mental illness.
p.(None): SEC. 14026. GAO REPORT.
p.(None):
p.(None): No later than 1 year after the date of enactment of this Act, the
p.(None): Comptroller General of the United States, in coordination with the
p.(None): Attorney General, shall submit to Congress a report on--
p.(None):
p.(None): [[Page 130 STAT. 1311]]
p.(None):
p.(None): (1) the practices that Federal first responders, tactical
p.(None): units, and corrections officers are trained to use in responding
p.(None): to individuals with mental illness;
p.(None): (2) procedures to identify and appropriately respond to
p.(None): incidents in which the unique needs of individuals who have a
p.(None): mental illness are involved, to Federal first responders and
p.(None): tactical units;
p.(None): (3) the application of evidence-based practices in criminal
p.(None): justice settings to better address individuals with mental
p.(None): illnesses; and
p.(None): (4) recommendations on how the Department of Justice can
p.(None): expand and improve information sharing and dissemination of best
p.(None): practices.
p.(None): SEC. 14027. EVIDENCE BASED PRACTICES.
p.(None):
p.(None): Section 2991(c) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
p.(None): (1) in paragraph (3), by striking ``or'' at the end;
p.(None): (2) by redesignating paragraph (4) as paragraph (6); and
p.(None): (3) by inserting after paragraph (3), the following:
p.(None): ``(4) propose interventions that have been shown by
p.(None): empirical evidence to reduce recidivism;
p.(None): ``(5) when appropriate, use validated assessment tools to
p.(None): target preliminarily qualified offenders with a moderate or high
p.(None): risk of recidivism and a need for treatment and services; or''.
p.(None): SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT
p.(None): OF LOCAL AUTHORITY.
p.(None):
p.(None): (a) In General.--Section 2991(a) of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
p.(None): (1) in paragraph (7)--
p.(None): (A) in the heading, by striking ``Mental illness''
p.(None): and inserting ``Mental illness; mental health
p.(None): disorder''; and
p.(None): (B) by striking ``term `mental illness' means'' and
p.(None): inserting ``terms `mental illness' and `mental health
p.(None): disorder' mean''; and
p.(None): (2) by striking paragraph (9) and inserting the following:
p.(None): ``(9) Preliminarily qualified offender.--
p.(None): ``(A) In general.--The term `preliminarily qualified
p.(None): offender' means an adult or juvenile accused of an
p.(None): offense who--
p.(None): ``(i)(I) previously or currently has been
p.(None): diagnosed by a qualified mental health
p.(None): professional as having a mental illness or co-
p.(None): occurring mental illness and substance abuse
p.(None): disorders;
p.(None): ``(II) manifests obvious signs of mental
p.(None): illness or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or
p.(None): confinement or before any court; or
p.(None): ``(III) in the case of a veterans treatment
p.(None): court provided under subsection (i), has been
p.(None): diagnosed with, or manifests obvious signs of,
p.(None): mental illness or a substance abuse disorder or
p.(None): co-occurring mental illness and substance abuse
p.(None): disorder;
p.(None):
p.(None): [[Page 130 STAT. 1312]]
p.(None):
p.(None): ``(ii) has been unanimously approved for
p.(None): participation in a program funded under this
p.(None): section by, when appropriate--
p.(None): ``(I) the relevant--
p.(None): ``(aa) prosecuting attorney;
p.(None): ``(bb) defense attorney;
p.(None): ``(cc) probation or
p.(None): corrections official; and
p.(None): ``(dd) judge; and
p.(None): ``(II) a representative from the
p.(None): relevant mental health agency described
p.(None): in subsection (b)(5)(B)(i);
p.(None): ``(iii) has been determined, by each person
p.(None): described in clause (ii) who is involved in
p.(None): approving the adult or juvenile for participation
p.(None): in a program funded under this section, to not
p.(None): pose a risk of violence to any person in the
p.(None): program, or the public, if selected to participate
p.(None): in the program; and
p.(None): ``(iv) has not been charged with or convicted
p.(None): of--
p.(None): ``(I) any sex offense (as defined in
p.(None): section 111 of the Sex Offender
p.(None): Registration and Notification Act (42
p.(None): U.S.C. 16911)) or any offense relating
p.(None): to the sexual exploitation of children;
p.(None): or
p.(None): ``(II) murder or assault with intent
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): Sec. 2001. National Institutes of Health Reauthorization.
p.(None): Sec. 2002. EUREKA prize competitions.
p.(None):
p.(None): Subtitle B--Advancing Precision Medicine
p.(None):
p.(None): Sec. 2011. Precision Medicine Initiative.
p.(None): Sec. 2012. Privacy protection for human research subjects.
p.(None): Sec. 2013. Protection of identifiable and sensitive information.
p.(None): Sec. 2014. Data sharing.
p.(None):
p.(None): Subtitle C--Supporting Young Emerging Scientists
p.(None):
p.(None): Sec. 2021. Investing in the next generation of researchers.
p.(None): Sec. 2022. Improvement of loan repayment program.
p.(None):
p.(None): Subtitle D--National Institutes of Health Planning and Administration
p.(None):
p.(None): Sec. 2031. National Institutes of Health strategic plan.
p.(None): Sec. 2032. Triennial reports.
p.(None): Sec. 2033. Increasing accountability at the National Institutes of
p.(None): Health.
p.(None): Sec. 2034. Reducing administrative burden for researchers.
p.(None): Sec. 2035. Exemption for the National Institutes of Health from the
p.(None): Paperwork Reduction Act requirements.
p.(None): Sec. 2036. High-risk, high-reward research.
p.(None): Sec. 2037. National Center for Advancing Translational Sciences.
p.(None): Sec. 2038. Collaboration and coordination to enhance research.
p.(None): Sec. 2039. Enhancing the rigor and reproducibility of scientific
p.(None): research.
p.(None): Sec. 2040. Improving medical rehabilitation research at the National
p.(None): Institutes of Health.
p.(None):
p.(None): [[Page 130 STAT. 1034]]
p.(None):
p.(None): Sec. 2041. Task force on research specific to pregnant women and
p.(None): lactating women.
p.(None): Sec. 2042. Streamlining National Institutes of Health reporting
p.(None): requirements.
p.(None): Sec. 2043. Reimbursement for research substances and living organisms.
p.(None): Sec. 2044. Sense of Congress on increased inclusion of underrepresented
p.(None): populations in clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): Sec. 2051. Technical updates to clinical trials database.
p.(None): Sec. 2052. Compliance activities reports.
p.(None): Sec. 2053. Updates to policies to improve data.
p.(None): Sec. 2054. Consultation.
p.(None):
p.(None): Subtitle F--Facilitating Collaborative Research
p.(None):
p.(None): Sec. 2061. National neurological conditions surveillance system.
p.(None): Sec. 2062. Tick-borne diseases.
p.(None): Sec. 2063. Accessing, sharing, and using health data for research
p.(None): purposes.
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): Sec. 2071. National pediatric research network.
p.(None): Sec. 2072. Global pediatric clinical study network.
p.(None):
p.(None): TITLE III--DEVELOPMENT
p.(None):
p.(None): Subtitle A--Patient-Focused Drug Development
p.(None):
p.(None): Sec. 3001. Patient experience data.
p.(None): Sec. 3002. Patient-focused drug development guidance.
p.(None): Sec. 3003. Streamlining patient input.
p.(None): Sec. 3004. Report on patient experience drug development.
p.(None):
...
p.(None): Strategic Initiatives within the Office of the Director
p.(None): of the National Institutes of Health,'' after ``shall be
p.(None): composed of'';
p.(None): (5) in subsection (f)(3)(B)--
p.(None): (A) by redesignating clauses (ix) through (xi) as
p.(None): clauses (x) through (xii), respectively; and
p.(None): (B) by inserting after clause (viii) the following:
p.(None): ``(ix) The Director of the Division of Program Coordination,
p.(None): Planning, and Strategic Initiatives.''; and
p.(None): (6) by adding at the end the following:
p.(None):
p.(None): ``(g)(1) The Secretary and the heads of other Federal agencies shall
p.(None): jointly review the programs carried out (or proposed to be carried out)
p.(None): by each such official with respect to medical rehabilitation research
p.(None): and, as appropriate, enter into agreements preventing duplication among
p.(None): such programs.
p.(None): ``(2) The Secretary shall, as appropriate, enter into interagency
p.(None): agreements relating to the coordination of medical rehabilitation
p.(None): research conducted by agencies of the National Institutes of Health and
p.(None): other agencies of the Federal Government.
p.(None): ``(h) For purposes of this section, the term `medical rehabilitation
p.(None): research' means the science of mechanisms and interventions that
p.(None): prevent, improve, restore, or replace lost, underdeveloped, or
p.(None): deteriorating function.''.
p.(None): (b) Conforming Amendment.--Section 3 of the National Institutes of
p.(None): Health Amendments of 1990 (42 U.S.C. 285g-4 note) is amended--
p.(None): (1) in subsection (a), by striking ``In General.--''; and
p.(None): (2) by striking subsection (b).
p.(None): SEC. 2041. <> TASK FORCE ON RESEARCH
p.(None): SPECIFIC TO PREGNANT WOMEN AND LACTATING
p.(None): WOMEN.
p.(None):
p.(None): (a) Task Force on Research Specific to Pregnant Women and Lactating
p.(None): Women.--
p.(None): (1) Establishment.--Not later than 90 days after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services (referred to in this section as the ``Secretary'')
p.(None): shall establish a task force, in accordance with the Federal
p.(None): Advisory Committee Act (5 U.S.C. App.), to be known as the
p.(None): ``Task
p.(None):
p.(None): [[Page 130 STAT. 1071]]
p.(None):
p.(None): Force on Research Specific to Pregnant Women and Lactating
p.(None): Women'' (in this section referred to as the ``Task Force'').
p.(None): (2) Duties.--The Task Force shall provide advice and
p.(None): guidance to the Secretary regarding Federal activities related
p.(None): to identifying and addressing gaps in knowledge and research
p.(None): regarding safe and effective therapies for pregnant women and
p.(None): lactating women, including the development of such therapies and
p.(None): the collaboration on and coordination of such activities.
p.(None): (3) Membership.--
p.(None): (A) Federal members.--The Task Force shall be
p.(None): composed of each of the following Federal members, or
p.(None): the designees of such members:
p.(None): (i) The Director of the Centers for Disease
p.(None): Control and Prevention.
p.(None): (ii) The Director of the National Institutes
p.(None): of Health, the Director of the Eunice Kennedy
p.(None): Shriver National Institute of Child Health and
p.(None): Human Development, and the directors of such other
p.(None): appropriate national research institutes.
p.(None): (iii) The Commissioner of Food and Drugs.
p.(None): (iv) The Director of the Office on Women's
p.(None): Health.
p.(None): (v) The Director of the National Vaccine
p.(None): Program Office.
p.(None): (vi) The head of any other research-related
p.(None): agency or department not described in clauses (i)
p.(None): through (v) that the Secretary determines
p.(None): appropriate, which may include the Department of
p.(None): Veterans Affairs and the Department of Defense.
p.(None): (B) Non-federal members.--The Task Force shall be
p.(None): composed of each of the following non-Federal members,
p.(None): including--
p.(None): (i) representatives from relevant medical
p.(None): societies with subject matter expertise on
p.(None): pregnant women, lactating women, or children;
p.(None): (ii) nonprofit organizations with expertise
p.(None): related to the health of women and children;
p.(None): (iii) relevant industry representatives; and
p.(None): (iv) other representatives, as appropriate.
p.(None): (C) Limitations.--The non-Federal members described
p.(None): in subparagraph (B) shall--
p.(None): (i) compose not more than one-half, and not
p.(None): less than one-third, of the total membership of
p.(None): the Task Force; and
p.(None): (ii) be appointed by the Secretary.
p.(None): (4) Termination.--
p.(None): (A) In general.--Subject to subparagraph (B), the
p.(None): Task Force shall terminate on the date that is 2 years
p.(None): after the date on which the Task Force is established
p.(None): under paragraph (1).
p.(None): (B) Extension.--The Secretary may extend the
p.(None): operation of the Task Force for one additional 2-year
p.(None): period following the 2-year period described in
p.(None): subparagraph (A), if the Secretary determines that the
p.(None): extension is appropriate for carrying out the purpose of
p.(None): this section.
p.(None): (5) Meetings.--The Task Force shall meet not less than 2
p.(None): times each year and shall convene public meetings, as
p.(None): appropriate, to fulfill its duties under paragraph (2).
p.(None):
p.(None): [[Page 130 STAT. 1072]]
p.(None):
p.(None): (6) Task force report to congress.--Not later than 18 months
p.(None): after the date on which the Task Force is established under
p.(None): paragraph (1), the Task Force shall prepare and submit to the
p.(None): Secretary, the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate, and the Committee on Energy and Commerce
p.(None): of the House of Representatives a report that includes each of
p.(None): the following:
p.(None): (A) A plan to identify and address gaps in knowledge
p.(None): and research regarding safe and effective therapies for
p.(None): pregnant women and lactating women, including the
p.(None): development of such therapies.
p.(None): (B) Ethical issues surrounding the inclusion of
p.(None): pregnant women and lactating women in clinical research.
p.(None): (C) Effective communication strategies with health
p.(None): care providers and the public on information relevant to
p.(None): pregnant women and lactating women.
p.(None): (D) Identification of Federal activities,
p.(None): including--
p.(None): (i) the state of research on pregnancy and
p.(None): lactation;
p.(None): (ii) recommendations for the coordination of,
p.(None): and collaboration on research related to pregnant
p.(None): women and lactating women;
p.(None): (iii) dissemination of research findings and
p.(None): information relevant to pregnant women and
p.(None): lactating women to providers and the public; and
p.(None): (iv) existing Federal efforts and programs to
p.(None): improve the scientific understanding of the health
p.(None): impacts on pregnant women, lactating women, and
p.(None): related birth and pediatric outcomes, including
p.(None): with respect to pharmacokinetics,
p.(None): pharmacodynamics, and toxicities.
p.(None): (E) Recommendations to improve the development of
p.(None): safe and effective therapies for pregnant women and
p.(None): lactating women.
p.(None):
p.(None): (b) Confidentiality.--Nothing in this section shall authorize the
p.(None): Secretary of Health and Human Services to disclose any information that
p.(None): is a trade secret, or other privileged or confidential information,
p.(None): described in section 552(b)(4) of title 5, United States Code, or
p.(None): section 1905 of title 18, United States Code.
p.(None): (c) Updating Protections for Pregnant Women and Lactating Women in
p.(None): Research.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Secretary, considering any
p.(None): recommendations of the Task Force available at such time and in
p.(None): consultation with the heads of relevant agencies of the
p.(None): Department of Health and Human Services, shall, as appropriate,
p.(None): update regulations and guidance, as applicable, regarding the
p.(None): inclusion of pregnant women and lactating women in clinical
p.(None): research.
p.(None): (2) Criteria for excluding pregnant or lactating women.--In
p.(None): updating any regulations or guidance described in paragraph (1),
p.(None): the Secretary shall consider any appropriate criteria to be used
p.(None): by institutional review boards and individuals reviewing grant
p.(None): proposals for excluding pregnant women or lactating women as a
p.(None): study population requiring additional protections from
p.(None): participating in human subject research.
p.(None):
p.(None): [[Page 130 STAT. 1073]]
p.(None):
p.(None): SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH REPORTING
p.(None): REQUIREMENTS.
p.(None):
p.(None): (a) Trans-National Institutes of Health Research Reporting.--Section
p.(None): 402A(c)(2) of the Public Health Service Act (42 U.S.C. 282a(c)(2)) is
p.(None): amended--
p.(None): (1) by amending subparagraph (B) to read as follows:
p.(None): ``(B) Reporting.--Not later than 2 years after the
p.(None): date of enactment of 21st Century Cures Act, the head of
p.(None): each national research institute or national center
p.(None): shall submit to the Director of the National Institutes
p.(None): of Health a report, to be included in the triennial
p.(None): report under section 403, on the amount made available
p.(None): by the institute or center for conducting or supporting
p.(None): research that involves collaboration between the
p.(None): institute or center and 1 or more other national
p.(None): research institutes or national centers.''; and
p.(None): (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' each
p.(None): place it appears and inserting ``(B)''.
p.(None):
p.(None): (b) Fraud and Abuse Reporting.--Section 403B of the Public Health
p.(None): Service Act (42 U.S.C. 283a-1) is amended--
p.(None): (1) by striking subsection (b);
p.(None): (2) by redesignating subsection (c) as subsection (b); and
p.(None): (3) in subsection (b) (as so redesignated), by striking
p.(None): ``subsections (a) and (b)'' and inserting ``subsection (a)''.
p.(None):
...
p.(None): promote innovation in the development of vaccines that minimize
p.(None): the burden of infectious disease.
p.(None): (2) Contents.--The report described in paragraph (1) shall
p.(None): review the current status of vaccine development and, as
p.(None): appropriate--
p.(None): (A) consider the optimal process to determine which
p.(None): vaccines would be beneficial to public health and how
p.(None): information on such vaccines is disseminated to key
p.(None): stakeholders;
p.(None): (B) examine and identify whether obstacles exist
p.(None): that inhibit the development of beneficial vaccines; and
p.(None): (C) make recommendations about how best to remove
p.(None): any obstacles identified under subparagraph (B) in order
p.(None): to promote and incentivize vaccine innovation and
p.(None): development.
p.(None): (3) Consultation.--In preparing the report under this
p.(None): subsection, the Secretary may consult with--
p.(None): (A) representatives of relevant Federal agencies and
p.(None): departments, including the Department of Defense and the
p.(None): Department of Veterans Affairs;
p.(None): (B) academic researchers;
p.(None): (C) developers and manufacturers of vaccines;
p.(None): (D) medical and public health practitioners;
p.(None): (E) representatives of patient, policy, and advocacy
p.(None): organizations; and
p.(None):
p.(None): [[Page 130 STAT. 1152]]
p.(None):
p.(None): (F) representatives of other entities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): (c) Updates Related to Maternal Immunization.--
p.(None): (1) Additional vaccines.--Section 2114(e) of the Public
p.(None): Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding
p.(None): at the end the following:
p.(None): ``(3) Vaccines recommended for use in pregnant women.--The
p.(None): Secretary shall revise the Vaccine Injury Table included in
p.(None): subsection (a), through the process described in subsection (c),
p.(None): to include vaccines recommended by the Centers for Disease
p.(None): Control and Prevention for routine administration in pregnant
p.(None): women and the information described in subparagraphs (B) and (C)
p.(None): of paragraph (2) with respect to such vaccines.''.
p.(None): (2) Petition content.--Section 2111 of the Public Health
p.(None): Service Act (42 U.S.C. 300aa-11) is amended by adding at the end
p.(None): the following:
p.(None):
p.(None): ``(f) Maternal Immunization.--
p.(None): ``(1) In general.--Notwithstanding any other provision of
p.(None): law, for purposes of this subtitle, both a woman who received a
p.(None): covered vaccine while pregnant and any child who was in utero at
p.(None): the time such woman received the vaccine shall be considered
p.(None): persons to whom the covered vaccine was administered and persons
p.(None): who received the covered vaccine.
p.(None): ``(2) Definition.--As used in this subsection, the term
p.(None): `child' shall have the meaning given that term by subsections
p.(None): (a) and (b) of section 8 of title 1, United States Code, except
p.(None): that, for purposes of this subsection, such section 8 shall be
p.(None): applied as if the term `include' in subsection (a) of such
p.(None): section were replaced with the term `mean'.''.
p.(None): (3) Petitioners.--Section 2111(b)(2) of the Public Health
p.(None): Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A
p.(None): covered vaccine administered to a pregnant woman shall
p.(None): constitute more than one administration, one to the mother and
p.(None): one to each child (as such term is defined in subsection (f)(2))
p.(None): who was in utero at the time such woman was administered the
p.(None): vaccine.'' at the end.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): SEC. 3101. TECHNICAL CORRECTIONS.
p.(None):
p.(None): (a) FFDCA.--
p.(None): (1) References.--Except as otherwise expressly provided,
p.(None): whenever in this subsection an amendment is expressed in terms
p.(None): of an amendment to a section or other provision, the reference
p.(None): shall be considered to be made to that section or other
p.(None): provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 301 et seq.).
p.(None): (2) Amendments.--
p.(None): (A) Prohibited acts.--Section 301(r) (21 U.S.C.
p.(None): 331(r)) is amended by inserting ``, drug,'' after
p.(None): ``device'' each place the term appears.
p.(None): (B) New drugs.--Section 505 (21 U.S.C. 355) is
p.(None): amended--
p.(None):
p.(None): [[Page 130 STAT. 1153]]
p.(None):
p.(None): (i) in subsection (d), in the last sentence,
p.(None): by striking ``premarket approval'' and inserting
p.(None): ``marketing approval''; and
p.(None): (ii) in subsection (q)(5)(A), by striking
p.(None): ``subsection (b)(2) or (j) of the Act or 351(k)''
p.(None): and inserting ``subsection (b)(2) or (j) of this
p.(None): section or section 351(k)''.
p.(None): (C) Risk evaluation and mitigation strategies.--
p.(None): Section 505-1(h)(21 U.S.C. 355-1(h)) is amended--
p.(None): (i) in paragraph (2)(A)(iii)--
p.(None): (I) in the clause heading, by
...
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
p.(None): pregnant women, women with dependent children,
p.(None): individuals with a co-occurring mental health and
p.(None): substance use disorder, persons who inject drugs,
p.(None): and persons who are experiencing homelessness;
p.(None): ``(iii) provides aggregate information on the
p.(None): number of individuals in treatment within the
p.(None): State, including the number of such individuals
p.(None): who are pregnant women, women with dependent
p.(None): children, individuals with a co-occurring mental
p.(None): health and substance use disorder, persons who
p.(None): inject drugs, and persons who are experiencing
p.(None): homelessness;
p.(None): ``(iv) provides a description of the system
p.(None): that is available to provide services by modality,
p.(None): including the provision of recovery support
p.(None): services;
p.(None): ``(v) provides a description of the State's
p.(None): comprehensive statewide prevention efforts,
p.(None): including the number of individuals being served
p.(None): in the system, target populations, and priority
p.(None): needs, and provides a description of the amount of
p.(None): funds from the prevention set-aside expended on
p.(None): primary prevention;
p.(None): ``(vi) provides a description of the financial
p.(None): resources available;
p.(None): ``(vii) describes the existing substance use
p.(None): disorders workforce and workforce trained in
p.(None): treating co-occurring substance use and mental
p.(None): disorders;
p.(None): ``(viii) includes a description of how the
p.(None): State promotes evidence-based practices; and
p.(None): ``(ix) describes how the State integrates
p.(None): substance use disorder services and primary health
p.(None): care, which in the case of those individuals with
p.(None): co-occurring mental health and substance use
...
p.(None): grant under subsection (a)(1)--
p.(None): ``(A) shall use the grant funds--
p.(None): ``(i)(I) to plan, develop, and operate a
p.(None): training program for medical psychiatry residents
p.(None): and fellows in addiction medicine practicing in
p.(None): eligible entities described in subsection (c)(1);
p.(None): or
p.(None): ``(II) to train new psychiatric residents and
p.(None): fellows in addiction medicine to provide and
p.(None): expand access to integrated mental and substance
p.(None): use disorders services; and
p.(None): ``(ii) to provide at least 1 training track
p.(None): that is--
p.(None): ``(I) a virtual training track that
p.(None): includes an in-person rotation at a
p.(None): teaching health center or in a
p.(None): community-based setting, followed by a
p.(None): virtual rotation in which the resident
p.(None): or fellow continues to support the care
p.(None): of patients at the teaching health
p.(None): center or in the community-based setting
p.(None): through the use of health information
p.(None): technology and, as appropriate,
p.(None): telehealth services;
p.(None): ``(II) an in-person training track
p.(None): that includes a rotation, during which
p.(None): the resident or fellow practices at a
p.(None): teaching health center or in a
p.(None): community-based setting; or
p.(None): ``(III) an in-person training track
p.(None): that includes a rotation during which
p.(None): the resident practices in a community-
p.(None): based setting that specializes in the
p.(None):
p.(None): [[Page 130 STAT. 1251]]
p.(None):
p.(None): treatment of infants, children,
p.(None): adolescents, or pregnant or postpartum
p.(None): women; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such training.
p.(None): ``(2) Training for other providers.--A recipient of a grant
p.(None): under subsection (a)(2)--
p.(None): ``(A) shall use the grant funds to plan, develop, or
p.(None): operate a training program to provide mental and
p.(None): substance use disorders services in underserved,
p.(None): community-based settings, as appropriate, that integrate
p.(None): primary care and mental and substance use disorders
p.(None): prevention and treatment services; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such program.
p.(None): ``(3) Academic units or programs.--A recipient of a grant
p.(None): under subsection (a)(3) shall enter into a partnership with
p.(None): organizations such as an education accrediting organization
p.(None): (such as the Liaison Committee on Medical Education, the
p.(None): Accreditation Council for Graduate Medical Education, the
p.(None): Commission on Osteopathic College Accreditation, the
...
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
...
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
...
p.(None): experts in the field as part of a consensus-review process. The
p.(None): Secretary shall include review criteria related to expertise and
p.(None): experience in child trauma and evidence-based practices.'';
p.(None): (5) in subsection (g) (as so redesignated), by striking
p.(None): ``with respect to centers of excellence are distributed
p.(None): equitably among the regions of the country'' and inserting ``are
p.(None): distributed equitably among the regions of the United States'';
p.(None): (6) in subsection (i) (as so redesignated), by striking
p.(None): ``recipient may not exceed 5 years'' and inserting ``recipient
p.(None): shall not be less than 4 years, but shall not exceed 5 years'';
p.(None): and
p.(None): (7) in subsection (j) (as so redesignated), by striking
p.(None): ``$50,000,000'' and all that follows through ``2006'' and
p.(None): inserting ``$46,887,000 for each of fiscal years 2018 through
p.(None): 2022''.
p.(None): SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.(None): Part B of title III of the Public Health Service Act (42 U.S.C. 243
p.(None): et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13)
p.(None): the following:
p.(None): ``SEC. 317L-1. <> SCREENING AND TREATMENT
p.(None): FOR MATERNAL DEPRESSION.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall make grants to States to
p.(None): establish, improve, or maintain programs for screening, assessment, and
p.(None): treatment services, including culturally and linguistically appropriate
p.(None): services, as appropriate, for women who are pregnant, or who have given
p.(None): birth within the preceding 12 months, for maternal depression.
p.(None): ``(b) Application.--To seek a grant under this section, a State
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may
p.(None):
p.(None): [[Page 130 STAT. 1267]]
p.(None):
p.(None): require. At a minimum, any such application shall include explanations
p.(None): of--
p.(None): ``(1) how a program, or programs, will increase the
p.(None): percentage of women screened and treated, as appropriate, for
p.(None): maternal depression in 1 or more communities; and
p.(None): ``(2) how a program, or programs, if expanded, would
p.(None): increase access to screening and treatment services for maternal
p.(None): depression.
p.(None):
p.(None): ``(c) Priority.--In awarding grants under this section, the
p.(None): Secretary may give priority to States proposing to improve or enhance
p.(None): access to screening services for maternal depression in primary care
p.(None): settings.
p.(None): ``(d) Use of Funds.--The activities eligible for funding through a
p.(None): grant under subsection (a)--
p.(None): ``(1) shall include--
p.(None): ``(A) providing appropriate training to health care
p.(None): providers; and
p.(None): ``(B) providing information to health care
p.(None): providers, including information on maternal depression
p.(None): screening, treatment, and followup support services, and
p.(None): linkages to community-based resources; and
p.(None): ``(2) may include--
p.(None): ``(A) enabling health care providers (including
p.(None): obstetrician-gynecologists, pediatricians,
p.(None): psychiatrists, mental health care providers, and adult
p.(None): primary care clinicians) to provide or receive real-time
p.(None): psychiatric consultation (in-person or remotely) to aid
p.(None): in the treatment of pregnant and parenting women;
p.(None): ``(B) establishing linkages with and among
p.(None): community-based resources, including mental health
p.(None): resources, primary care resources, and support groups;
p.(None): and
p.(None): ``(C) utilizing telehealth services for rural areas
p.(None): and medically underserved areas (as defined in section
p.(None): 330I(a)).
p.(None):
p.(None): ``(e) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $5,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 399Z-2. <> INFANT AND EARLY
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
...
Health / alcoholism
Searching for indicator alcoholism:
(return to top)
p.(None): (9) in paragraph (15), as so redesignated, by striking
p.(None): ``and'' at the end;
p.(None): (10) in paragraph (16), as so redesignated, by striking the
p.(None): period and inserting ``; and''; and
p.(None): (11) by adding at the end the following:
p.(None): ``(17) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded.''.
p.(None):
p.(None): (b) Director of the Center for Substance Abuse Prevention.--Section
p.(None): 515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
p.(None): (1) in the section heading, by striking ``office'' and
p.(None): inserting ``center'';
p.(None):
p.(None): [[Page 130 STAT. 1213]]
p.(None):
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``an Office'' and inserting ``a
p.(None): Center''; and
p.(None): (B) by striking ``The Office'' and inserting ``The
p.(None): Prevention Center''; and
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by inserting ``through the
p.(None): reduction of risk and the promotion of resiliency''
p.(None): before the semicolon;
p.(None): (B) by redesignating paragraphs (3) through (11) as
p.(None): paragraphs (4) through (12), respectively;
p.(None): (C) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute on Drug Abuse, the Director of the National Institute
p.(None): on Alcohol Abuse and Alcoholism, and States to promote the study
p.(None): of substance abuse prevention and the dissemination and
p.(None): implementation of research findings that will improve the
p.(None): delivery and effectiveness of substance abuse prevention
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
...
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 1(b)) is amended--
p.(None): (1) in paragraph (2)--
p.(None): (A) in subparagraph (E), by striking ``and'' after
p.(None): the semicolon;
p.(None): (B) by redesignating subparagraph (F) as
p.(None): subparagraph (J); and
p.(None): (C) by inserting after subparagraph (E), the
p.(None): following:
p.(None): ``(F) the Chief Medical Officer, appointed under
p.(None): section 501(g);
p.(None): ``(G) the Director of the National Institute of
p.(None): Mental Health for the advisory councils appointed under
p.(None): subsections (a)(1)(A) and (a)(1)(D);
p.(None): ``(H) the Director of the National Institute on Drug
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
p.(None): prevent substance misuse.''.
p.(None): SEC. 6009. PEER REVIEW.
p.(None):
p.(None): Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 3(b)) is amended by adding at the end the following: ``In the case of
p.(None): any such peer review group that is reviewing a grant, cooperative
...
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
p.(None): [[Page 130 STAT. 1222]]
p.(None):
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
...
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
p.(None): the Assistant Secretary may establish a period for the
...
p.(None): (4) in subsection (e)--
p.(None): (A) in paragraph (1), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder''; and
p.(None): (B) in paragraph (2), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (5) by striking subsection (g) and redesignating subsections
p.(None): (h) and (i) as (g) and (h), accordingly; and
p.(None): (6) in subsection (g), as redesignated by paragraph (5), by
p.(None): striking ``substance abuse'' each place such term appears and
p.(None): inserting ``substance use disorder''.
p.(None):
p.(None): (c) Description of Intended Expenditures of Grant.--Section 527 of
p.(None): the Public Health Service Act (42 U.S.C. 290cc-27) is amended by
p.(None): striking ``substance abuse'' each place such term appears and inserting
p.(None): ``substance use disorder''.
p.(None): (d) Technical Assistance.--Section 530 of the Public Health Service
p.(None): Act (42 U.S.C. 290cc-30) is amended by striking ``through the National
p.(None): Institute of Mental Health, the National Institute of Alcohol Abuse and
p.(None): Alcoholism, and the National Institute on Drug Abuse'' and inserting
p.(None): ``acting through the Assistant Secretary''.
p.(None): (e) Definitions.--Section 534(4) of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-34(4)) is amended to read as follows:
p.(None): ``(4) Substance use disorder services.--The term `substance
p.(None): use disorder services' has the meaning given the term `substance
p.(None): abuse services' in section 330(h)(5)(C).''.
p.(None):
p.(None): (f) Funding.--Section 535(a) of the Public Health Service Act (42
p.(None): U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the
p.(None): fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of
p.(None): fiscal years 2018 through 2022''.
p.(None): (g) Study Concerning Formula.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Assistant Secretary for Mental Health
p.(None): and Substance Use (referred to in this section as the
p.(None): ``Assistant Secretary'') shall conduct a study concerning the
p.(None): formula used under section 524 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-24) for making allotments to States under
p.(None): section 521 of such Act (42 U.S.C. 290cc-21). Such study shall
p.(None): include an evaluation of quality indicators of need for purposes
p.(None):
p.(None): [[Page 130 STAT. 1239]]
p.(None):
p.(None): of revising the formula for determining the amount of each
...
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p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
p.(None): Sec. 15004. Regulatory relief for LTCHs.
p.(None): Sec. 15005. Savings from IPPS MACRA pay-for through not applying
p.(None): documentation and coding adjustments.
p.(None): Sec. 15006. Extension of certain LTCH Medicare payment rules.
...
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
...
p.(None): health problems,'' after ``problems''; and
p.(None): (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
p.(None): ``, including training for drug court personnel and officials on
p.(None): identifying and addressing co-occurring substance abuse and
p.(None): mental health problems'' after ``part''.
p.(None): SEC. 14008. <> MENTAL HEALTH
p.(None): TRAINING FOR FEDERAL UNIFORMED
p.(None): SERVICES.
p.(None):
p.(None): (a) In General.--Not later than 180 days after the date of enactment
p.(None): of this Act, the Secretary of Defense, the Secretary of Homeland
p.(None): Security, the Secretary of Health and Human Services, and the Secretary
p.(None): of Commerce shall provide the following to each of the uniformed
p.(None): services (as that term is defined in section 101 of title 10, United
p.(None): States Code) under their direction:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training in procedures to identify and respond
p.(None): appropriately to incidents in which the unique needs of
p.(None): individuals with mental illnesses are involved.
p.(None): (2) Improved technology.--Computerized information systems
p.(None): or technological improvements to provide timely information to
p.(None): Federal law enforcement personnel, other branches of the
p.(None): uniformed services, and criminal justice system personnel to
p.(None): improve the Federal response to mentally ill individuals.
p.(None):
p.(None): [[Page 130 STAT. 1297]]
p.(None):
p.(None): (3) Cooperative programs.--The establishment and expansion
p.(None): of cooperative efforts to promote public safety through the use
p.(None): of effective intervention with respect to mentally ill
p.(None): individuals encountered by members of the uniformed services.
p.(None): SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
p.(None):
p.(None): (a) Reentry Demonstration Projects.--Section 2976(f) of title I of
p.(None): the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797w(f)), as amended by section 14006, is amended--
p.(None): (1) in paragraph (3)(C), by inserting ``mental health
p.(None): services,'' before ``drug treatment''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
...
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
p.(None): VETERANS AFFAIRS OF MENTAL CAPACITY OF
p.(None): BENEFICIARIES.
p.(None):
p.(None): (a) In General.--Chapter 55 of title 38, United States Code, is
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p.(None): ``(B) that includes a list of any grantees excluded
p.(None): under paragraph (1)(D) from the previous year.
p.(None): ``(5) Preventing duplicative grants.--
p.(None): ``(A) In general.--Before the Attorney General
p.(None): awards a grant to an applicant under this section, the
p.(None): Attorney General shall compare potential grant awards
p.(None): with other grants awarded under this Act to determine if
p.(None): duplicate grant awards are awarded for the same purpose.
p.(None): ``(B) Report.--If the Attorney General awards
p.(None): duplicate grants to the same applicant for the same
p.(None): purpose the Attorney General shall submit to the
p.(None): Committee on the Judiciary of the Senate and the
p.(None): Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
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p.(None): this subsection.
p.(None): ``(4) Termination of waiver.--Upon determining that the
p.(None): circumstances necessitating a waiver under paragraph (1) no
p.(None): longer exist, the Secretary shall promptly update the Internet
p.(None): website of the Department of Health and Human Services to
p.(None): reflect the termination of such waiver.
p.(None): ``(5) Limitations.--
p.(None): ``(A) Period of waiver.--The period of a waiver
p.(None): under paragraph (1) shall not exceed the period of time
p.(None): for the related public health emergency, including a
p.(None): public health emergency declared pursuant to subsection
p.(None): (a), and any immediate postresponse review regarding the
p.(None): public health emergency consistent with the requirements
p.(None): of this subsection.
p.(None): ``(B) Subsequent compliance.--An initiative subject
p.(None): to a waiver under paragraph (1) that is ongoing after
p.(None): the date on which the waiver expires, shall be subject
p.(None): to the requirements of subchapter I of chapter 35 of
p.(None): title 44, United States Code, and the Secretary shall
p.(None): ensure that compliance with such requirements occurs in
p.(None): as timely a manner as possible based on the applicable
p.(None): circumstances, but not to exceed 30 calendar days after
p.(None): the expiration of the applicable waiver.''.
p.(None): SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE
p.(None): AUTHORIZATION.
p.(None):
p.(None): (a) Authorization for Medical Products for Use in Emergencies.--
p.(None): Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360bbb-3) is amended--
p.(None): (1) in subsection (a)(2)--
p.(None): (A) in subparagraph (A)--
p.(None): (i) by striking ``or 515'' and inserting
p.(None): ``512, or 515''; and
p.(None): (ii) by inserting ``or conditionally approved
p.(None): under section 571 of this Act'' after ``Public
p.(None): Health Service Act''; and
p.(None):
p.(None): [[Page 130 STAT. 1149]]
p.(None):
p.(None): (B) in subparagraph (B), by inserting
p.(None): ``conditionally approved under section 571,'' after
p.(None): ``approved,'' each place the term appears;
p.(None): (2) in subsection (b)(4), by striking the second comma after
p.(None): ``determination'';
p.(None): (3) in subsection (e)(3)(B), by striking ``section 503(b)''
p.(None): and inserting ``subsection (b) or (f) of section 503 or under
p.(None): section 504'';
p.(None): (4) in subsection (f)(2)--
p.(None): (A) by inserting ``, or an animal to which,'' after
p.(None): ``to a patient to whom''; and
p.(None): (B) by inserting ``or by the veterinarian caring for
p.(None): such animal, as applicable'' after ``attending
p.(None): physician'';
p.(None): (5) in subsection (g)(1), by inserting ``conditional
p.(None): approval under section 571,'' after ``approval,'';
p.(None): (6) in subsection (h)(1), by striking ``or section
p.(None): 520(g)''and inserting ``512(j), or 520(g)''; and
p.(None): (7) in subsection (k), by striking ``section 520(g),''and
p.(None): inserting ``512(j), or 520(g)''.
p.(None):
p.(None): (b) New Animal Drugs.--Section 512(a)(1) of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended--
p.(None): (1) in subparagraph (B), by striking ``or'' at the end;
...
p.(None): (2) in paragraph (7), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''.
p.(None): (k) Funding.--Section 1935 of the Public Health Service Act (42
p.(None): U.S.C. 300x-35) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(d)''; and
p.(None): (B) by striking ``$2,000,000,000 for fiscal year
p.(None): 2001, and such sums as may be necessary for each of the
p.(None): fiscal years 2002 and 2003'' and inserting
p.(None): ``$1,858,079,000 for each of fiscal years 2018 through
p.(None): 2022.''; and
p.(None): (2) in subsection (b)(1)(B) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(d) and''.
p.(None): SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
p.(None):
p.(None): Subpart III of part B of title XIX of the Public Health Service Act
p.(None): (42 U.S.C. 300x-51 et seq.) is amended--
p.(None): (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
p.(None): striking ``section 505'' and inserting ``subsections (c) and (d)
p.(None): of section 505'';
p.(None):
p.(None): [[Page 130 STAT. 1233]]
p.(None):
p.(None): (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
p.(None): ``substance abuse'' and inserting ``substance use disorder'';
p.(None): and
p.(None): (3) by adding at the end the following:
p.(None): ``SEC. 1957. <> PUBLIC HEALTH EMERGENCIES.
p.(None):
p.(None): ``In the case of a public health emergency (as determined under
p.(None): section 319), the Secretary, on a State by State basis, may, as the
p.(None): circumstances of the emergency reasonably require and for the period of
p.(None): the emergency, grant an extension, or waive application deadlines or
p.(None): compliance with any other requirement, of a grant authorized under
p.(None): section 521, 1911, or 1921 or an allotment authorized under Public Law
p.(None): 99-319 (42 U.S.C. 10801 et seq.).
p.(None): ``SEC. 1958. <> JOINT APPLICATIONS.
p.(None):
p.(None): ``The Secretary, acting through the Assistant Secretary for Mental
p.(None): Health and Substance Use, shall permit a joint application to be
p.(None): submitted for grants under subpart I and subpart II upon the request of
p.(None): a State. Such application may be jointly reviewed and approved by the
p.(None): Secretary with respect to such subparts, consistent with the purposes
p.(None): and authorized activities of each such grant program. A State submitting
p.(None): such a joint application shall otherwise meet the requirements with
p.(None): respect to each such subpart.''.
p.(None): SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
p.(None): ABUSE PREVENTION AND TREATMENT BLOCK
p.(None): GRANT AND THE COMMUNITY MENTAL HEALTH
p.(None): SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.(None): (i) For fiscal year 2017, $10,000,000.
p.(None): (ii) For fiscal year 2018, $86,000,000.
p.(None): (iii) For fiscal year 2019, $115,000,000.
p.(None): (iv) For fiscal year 2020, $140,000,000.
p.(None): (v) For fiscal year 2021, $100,000,000.
p.(None): (vi) For fiscal year 2022, $152,000,000.
p.(None): (vii) For fiscal year 2023, $450,000,000.
p.(None): (viii) For fiscal year 2024, $172,000,000.
p.(None): (ix) For fiscal year 2025, $91,000,000.
p.(None): (x) For fiscal year 2026, $195,000,000.
p.(None): (C) To support cancer research, such as the
p.(None): development of cancer vaccines, the development of more
p.(None): sensitive
p.(None):
p.(None): [[Page 130 STAT. 1041]]
p.(None):
p.(None): diagnostic tests for cancer, immunotherapy and the
p.(None): development of combination therapies, and research that
p.(None): has the potential to transform the scientific field,
p.(None): that has inherently higher risk, and that seeks to
p.(None): address major challenges related to cancer, not to
p.(None): exceed a total of $1,800,000,000, as follows:
p.(None): (i) For fiscal year 2017, $300,000,000.
p.(None): (ii) For fiscal year 2018, $300,000,000.
p.(None): (iii) For fiscal year 2019, $400,000,000.
p.(None): (iv) For fiscal year 2020, $195,000,000.
p.(None): (v) For fiscal year 2021, $195,000,000.
p.(None): (vi) For fiscal year 2022, $194,000,000.
p.(None): (vii) For fiscal year 2023, $216,000,000.
p.(None): (D) For the National Institutes of Health, in
p.(None): coordination with the Food and Drug Administration, to
p.(None): award grants and contracts for clinical research to
p.(None): further the field of regenerative medicine using adult
p.(None): stem cells, including autologous stem cells, for which
p.(None): grants and contracts shall be contingent upon the
p.(None): recipient making available non-Federal contributions
p.(None): toward the costs of such research in an amount not less
p.(None): than $1 for each $1 of Federal funds provided in the
p.(None): award, not to exceed a total of $30,000,000, as follows:
p.(None): (i) For fiscal year 2017, $2,000,000.
p.(None): (ii) For each of fiscal years 2018 and 2019,
p.(None): $10,000,000.
p.(None): (iii) For fiscal year 2020, $8,000,000.
p.(None): (iv) For each of fiscal years 2021 through
p.(None): 2026, $0.
p.(None):
p.(None): (c) Accountability and Oversight.--
p.(None): (1) Work plan.--
p.(None): (A) In general.--Not later than 180 days after the
p.(None): date of enactment of this Act, the Director of NIH shall
p.(None): submit to the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the
p.(None): Senate and the Committee on Energy and Commerce and the
p.(None): Committee on Appropriations of the House of
p.(None): Representatives, a work plan including the proposed
p.(None): allocation of funds authorized to be appropriated
p.(None): pursuant to subsection (b)(3) for each of fiscal years
p.(None): 2017 through 2026 for the NIH Innovation Projects and
p.(None): the contents described in subparagraph (B).
p.(None): (B) Contents.--The work plan submitted under
p.(None): subparagraph (A) shall include--
p.(None): (i) recommendations from the Advisory
p.(None): Committee described in subparagraph (C);
p.(None): (ii) the amount of money to be obligated or
p.(None): expended in each fiscal year for each NIH
p.(None): Innovation Project;
p.(None): (iii) a description and justification of each
p.(None): such project; and
p.(None): (iv) a description of how each such project
p.(None): supports the strategic research priorities
...
Health / substance use
Searching for indicator substance use:
(return to top)
p.(None): Sec. 4008. GAO study on patient access to health information.
p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
...
p.(None): States with an incidence or prevalence of opioid use disorders
p.(None): that is substantially higher relative to other States.
p.(None): (2) Opioid grants.--Grants awarded to a State under this
p.(None): subsection shall be used for carrying out activities that
p.(None): supplement activities pertaining to opioids undertaken by the
p.(None): State agency responsible for administering the substance abuse
p.(None): prevention and treatment block grant under subpart II of part B
p.(None): of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
p.(None): et seq.), which may include public health-related activities
p.(None): such as the following:
p.(None): (A) Improving State prescription drug monitoring
p.(None): programs.
p.(None):
p.(None): [[Page 130 STAT. 1046]]
p.(None): (B) Implementing prevention activities, and
p.(None): evaluating such activities to identify effective
p.(None): strategies to prevent opioid abuse.
p.(None): (C) Training for health care practitioners, such as
p.(None): best practices for prescribing opioids, pain management,
p.(None): recognizing potential cases of substance abuse, referral
p.(None): of patients to treatment programs, and overdose
p.(None): prevention.
p.(None): (D) Supporting access to health care services,
p.(None): including those services provided by Federally certified
p.(None): opioid treatment programs or other appropriate health
p.(None): care providers to treat substance use disorders.
p.(None): (E) Other public health-related activities, as the
p.(None): State determines appropriate, related to addressing the
p.(None): opioid abuse crisis within the State.
p.(None):
p.(None): (d) Accountability and Oversight.--A State receiving a grant under
p.(None): subsection (c) shall include in a report related to substance abuse
p.(None): submitted to the Secretary pursuant to section 1942 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-52), a description of--
p.(None): (1) the purposes for which the grant funds received by the
p.(None): State under such subsection for the preceding fiscal year were
p.(None): expended and a description of the activities of the State under
p.(None): the program; and
p.(None): (2) the ultimate recipients of amounts provided to the State
p.(None): in the grant.
p.(None):
p.(None): (e) Limitations.--Any funds made available pursuant to the
p.(None): authorization of appropriations under subsection (b)--
p.(None): (1) notwithstanding any transfer authority in any
p.(None): appropriations Act, shall not be used for any purpose other than
p.(None): the grant program in subsection (c); and
p.(None): (2) shall be subject to the same requirements as substance
p.(None): abuse prevention and treatment programs under titles V and XIX
p.(None): of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w
p.(None): et seq.).
p.(None):
p.(None): (f) Sunset.--This section shall expire on September 30, 2026.
p.(None): SEC. 1004. BUDGETARY TREATMENT.
p.(None):
...
p.(None): therapy, payment shall be made to the qualified home
p.(None): infusion therapy supplier''.
p.(None): (3) Exclusion from home health services.--Section 1861(m) of
p.(None): the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the
p.(None): first sentence, by inserting the following before the period at
p.(None): the end: ``and home infusion therapy (as defined in subsection
p.(None): (iii)(i))''.
p.(None):
p.(None): (d) <> Effective Date.--The amendments
p.(None): made by this section shall apply to items and services furnished on or
p.(None): after January 1, 2021.
p.(None):
p.(None): DIVISION <p.(None): 2016.>> B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None): SEC. 6000. <> SHORT TITLE.
p.(None):
p.(None): This division may be cited as the ``Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016''.
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE
p.(None): USE.
p.(None):
p.(None): (a) Assistant Secretary.--Section 501(c) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
p.(None): ``(c) Assistant Secretary and Deputy Assistant Secretary.--
p.(None):
p.(None): [[Page 130 STAT. 1203]]
p.(None):
p.(None): ``(1) Assistant secretary.--The Administration shall be
p.(None): headed by an official to be known as the Assistant Secretary for
p.(None): Mental Health and Substance Use (hereinafter in this title
p.(None): referred to as the `Assistant Secretary') who shall be appointed
p.(None): by the President, by and with the advice and consent of the
p.(None): Senate.
p.(None): ``(2) Deputy assistant secretary.--The Assistant Secretary,
p.(None): with the approval of the Secretary, may appoint a Deputy
p.(None): Assistant Secretary and may employ and prescribe the functions
p.(None): of such officers and employees, including attorneys, as are
p.(None): necessary to administer the activities to be carried out through
p.(None): the Administration.''.
p.(None):
p.(None): (b) <> Transfer of Authorities.--The
p.(None): Secretary of Health and Human Services shall delegate to the Assistant
p.(None): Secretary for Mental Health and Substance Use all duties and authorities
p.(None): that--
p.(None): (1) as of the day before the date of enactment of this Act,
p.(None): were vested in the Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration; and
p.(None): (2) are not terminated by this Act.
p.(None):
p.(None): (c) Conforming Amendments.--Title V of the Public Health Service Act
p.(None): (42 U.S.C. 290aa et seq.), as amended by the previous provisions of this
p.(None): section, is further amended--
p.(None): (1) by striking ``Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration'' each place it appears
p.(None): and inserting ``Assistant Secretary for Mental Health and
p.(None): Substance Use''; and
p.(None): (2) by striking ``Administrator'' or ``Administrator'' each
p.(None): place it appears (including in any headings) and inserting
p.(None): ``Assistant Secretary'' or ``Assistant Secretary'',
p.(None): respectively, except where the term ``Administrator'' appears--
p.(None): (A) in each of subsections (e) and (f) of section
p.(None): 501 of such Act (42 U.S.C. 290aa), including the
p.(None): headings of such subsections, within the term
p.(None): ``Associate Administrator'';
p.(None): (B) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Health Resources and Services Administration'';
p.(None): (C) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Centers for Medicare & Medicaid Services'';
p.(None): (D) in section 519B(c)(1)(B) of such Act (42 U.S.C.
p.(None): 290bb-25b(c)(1)(B)), within the term ``Administrator of
p.(None): the National Highway Traffic Safety Administration''; or
p.(None): (E) in each of sections 519B(c)(1)(B), 520C(a), and
p.(None): 520D(a) of such Act (42 U.S.C. 290bb-25b(c)(1)(B),
p.(None): 290bb-34(a), 290bb-35(a)), within the term
p.(None): ``Administrator of the Office of Juvenile Justice and
p.(None): Delinquency Prevention''.
p.(None):
p.(None): (d) <> References.--After executing
p.(None): subsections (a), (b), and (c), any reference in statute, regulation, or
p.(None): guidance to the Administrator of the Substance Abuse and Mental Health
p.(None): Services Administration shall be construed to be a reference to the
p.(None): Assistant Secretary for Mental Health and Substance Use.
p.(None):
p.(None): [[Page 130 STAT. 1204]]
p.(None):
p.(None): SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND
p.(None): MENTAL HEALTH SERVICES ADMINISTRATION.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by section 6001, is further amended--
p.(None): (1) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Agencies'' and inserting ``Centers''; and
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``entities'' and inserting ``Centers'';
p.(None): (2) in subsection (d)--
p.(None): (A) in paragraph (1)--
p.(None): (i) by striking ``agencies'' each place the
p.(None): term appears and inserting ``Centers''; and
p.(None): (ii) by striking ``such agency'' and inserting
p.(None): ``such Center'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``agencies'' and inserting
p.(None): ``Centers'';
p.(None): (ii) by striking ``with respect to substance
p.(None): abuse'' and inserting ``with respect to substance
p.(None): use disorders''; and
p.(None): (iii) by striking ``and individuals who are
p.(None): substance abusers'' and inserting ``and
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (I) by striking paragraph (11) and inserting the
p.(None): following:
p.(None): ``(11) work with relevant agencies of the Department of
p.(None): Health and Human Services on integrating mental health promotion
p.(None): and substance use disorder prevention with general health
p.(None): promotion and disease prevention and integrating mental and
p.(None): substance use disorders treatment services with physical health
p.(None): treatment services;'';
p.(None): (J) in paragraph (13)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``this title, assure that'' and
p.(None): inserting ``this title or part B of title XIX, or
p.(None): grant programs otherwise funded by the
p.(None): Administration'';
p.(None): (ii) in subparagraph (A)--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) by striking ``and'' at the end;
p.(None): (iii) by redesignating subparagraph (B) as
p.(None): subparagraph (C);
p.(None): (iv) by inserting after subparagraph (A) the
p.(None): following:
p.(None): ``(B) ensure that the director of each Center of the
p.(None): Administration consistently documents the application of
p.(None): criteria when awarding grants and the ongoing oversight
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
p.(None): and report on required performance measures; and
p.(None): ``(E) the extent to which the grantee is proposing
p.(None): to use evidence-based practices; and
p.(None): ``(25) advance, through existing programs, the use of
p.(None): performance metrics, including those based on the
p.(None): recommendations on performance metrics from the Assistant
p.(None): Secretary for Planning and Evaluation under section 6021(d) of
p.(None): the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016.''; and
p.(None): (3) in subsection (m), by adding at the end the following:
p.(None): ``(4) Emergency response.--Amounts made available for
p.(None): carrying out this subsection shall remain available through the
p.(None): end of the fiscal year following the fiscal year for which such
p.(None): amounts are appropriated.''.
p.(None): SEC. 6003. CHIEF MEDICAL OFFICER.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 and 6002, is further amended--
p.(None):
p.(None): [[Page 130 STAT. 1207]]
p.(None):
p.(None): (1) by redesignating subsections (g) through (j) and
p.(None): subsections (k) through (o) as subsections (h) through (k) and
p.(None): subsections (m) through (q), respectively;
p.(None): (2) in subsection (e)(3)(C), by striking ``subsection (k)''
p.(None): and inserting ``subsection (m)'';
p.(None): (3) in subsection (f)(2)(C)(iii), by striking ``subsection
p.(None): (k)'' and inserting ``subsection (m)''; and
p.(None): (4) by inserting after subsection (f) the following:
p.(None):
p.(None): ``(g) Chief Medical Officer.--
p.(None): ``(1) In general.--The Assistant Secretary, with the
p.(None): approval of the Secretary, shall appoint a Chief Medical Officer
p.(None): to serve within the Administration.
p.(None): ``(2) Eligible candidates.--The Assistant Secretary shall
p.(None): select the Chief Medical Officer from among individuals who--
p.(None): ``(A) have a doctoral degree in medicine or
p.(None): osteopathic medicine;
p.(None): ``(B) have experience in the provision of mental or
p.(None): substance use disorder services;
p.(None): ``(C) have experience working with mental or
p.(None): substance use disorder programs;
p.(None): ``(D) have an understanding of biological,
p.(None): psychosocial, and pharmaceutical treatments of mental or
p.(None): substance use disorders; and
p.(None): ``(E) are licensed to practice medicine in one or
p.(None): more States.
p.(None): ``(3) Duties.--The Chief Medical Officer shall--
p.(None): ``(A) serve as a liaison between the Administration
p.(None): and providers of mental and substance use disorders
p.(None): prevention, treatment, and recovery services;
p.(None): ``(B) assist the Assistant Secretary in the
p.(None): evaluation, organization, integration, and coordination
p.(None): of programs operated by the Administration;
p.(None): ``(C) promote evidence-based and promising best
p.(None): practices, including culturally and linguistically
p.(None): appropriate practices, as appropriate, for the
p.(None): prevention and treatment of, and recovery from, mental
p.(None): and substance use disorders, including serious mental
p.(None): illness and serious emotional disturbances;
p.(None): ``(D) participate in regular strategic planning with
p.(None): the Administration;
p.(None): ``(E) coordinate with the Assistant Secretary for
p.(None): Planning and Evaluation to assess the use of performance
p.(None): metrics to evaluate activities within the Administration
p.(None): related to mental and substance use disorders; and
p.(None): ``(F) coordinate with the Assistant Secretary to
p.(None): ensure mental and substance use disorders grant programs
p.(None): within the Administration consistently utilize
p.(None): appropriate performance metrics and evaluation
p.(None): designs.''.
p.(None): SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
p.(None):
p.(None): Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), as
p.(None): amended by section 6001(c), is amended--
p.(None): (1) by striking the section designation and heading and
p.(None): inserting the following:
p.(None):
p.(None): [[Page 130 STAT. 1208]]
p.(None):
p.(None): ``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND
p.(None): QUALITY.'';
p.(None): (2) by redesignating subsections (a) through (d) as
p.(None): subsections (b) through (e), respectively;
p.(None): (3) before subsection (b), as redesignated by paragraph (2),
p.(None): by inserting the following:
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall maintain within the
p.(None): Administration a Center for Behavioral Health Statistics and Quality (in
p.(None): this section referred to as the `Center'). The Center shall be headed by
p.(None): a Director (in this section referred to as the `Director') appointed by
p.(None): the Secretary from among individuals with extensive experience and
p.(None): academic qualifications in research and analysis in behavioral health
p.(None): care or related fields.'';
p.(None): (4) in subsection (b), as redesignated by paragraph (2)--
p.(None): (A) by redesignating paragraphs (1) and (2) as
p.(None): subparagraphs (A) and (B), respectively;
p.(None): (B) by striking ``The Secretary, acting'' and all
p.(None): that follows through ``year on--'' and inserting ``The
p.(None): Director shall--
p.(None): ``(1) coordinate the Administration's integrated data
p.(None): strategy, including by collecting data each year on--'';
p.(None): (C) in the subparagraph (B), as redesignated by
...
p.(None): ``(l) Strategic Plan.--
p.(None): ``(1) In general.--Not later than September 30, 2018, and
p.(None): every 4 years thereafter, the Assistant Secretary shall develop
p.(None): and carry out a strategic plan in accordance with this
p.(None): subsection for the planning and operation of activities carried
p.(None): out by the Administration, including evidence-based programs.
p.(None): ``(2) Coordination.--In developing and carrying out the
p.(None): strategic plan under this subsection, the Assistant Secretary
p.(None): shall take into consideration the findings and recommendations
p.(None): of the Assistant Secretary for Planning and Evaluation under
p.(None): section 6021(d) of the Helping Families in Mental Health Crisis
p.(None): Reform Act of 2016 and the report of the Interdepartmental
p.(None): Serious Mental Illness Coordinating Committee under section 6031
p.(None): of such Act.
p.(None): ``(3) Publication of plan.--Not later than September 30,
p.(None): 2018, and every 4 years thereafter, the Assistant Secretary
p.(None): shall--
p.(None): ``(A) submit the strategic plan developed under
p.(None): paragraph (1) to the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate; and
p.(None): ``(B) post such plan on the Internet website of the
p.(None): Administration.
p.(None): ``(4) Contents.--The strategic plan developed under
p.(None): paragraph (1) shall--
p.(None): ``(A) identify strategic priorities, goals, and
p.(None): measurable objectives for mental and substance use
p.(None): disorders activities and programs operated and supported
p.(None): by the Administration, including priorities to prevent
p.(None): or eliminate the burden of mental and substance use
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
p.(None): collaboration with States, local governments,
p.(None): communities, and Indian tribes and tribal organizations
p.(None): (as such terms are defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act); and
p.(None): ``(F) specify a strategy to disseminate evidence-
p.(None): based and promising best practices related to
p.(None): prevention, diagnosis, early intervention, treatment,
p.(None): and recovery services related to mental illness,
p.(None): particularly for adults with a serious mental illness
p.(None): and children with a serious emotional disturbance, and
p.(None): for individuals with a substance use disorder.''.
p.(None): SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
p.(None):
p.(None): (a) In General.--Section 501 of the Public Health Service Act (42
p.(None): U.S.C. 290aa), as so amended, is further amended by amending subsection
p.(None): (m), as redesignated by section 6003, to read as follows:
p.(None): ``(m) Biennial Report Concerning Activities and Progress.--Not later
p.(None): than September 30, 2020, and every 2 years thereafter, the Assistant
p.(None): Secretary shall prepare and submit to the Committee on Energy and
p.(None): Commerce and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the Senate, and post on
p.(None): the Internet website of the Administration, a report containing at a
p.(None): minimum--
p.(None): ``(1) a review of activities conducted or supported by the
p.(None): Administration, including progress toward strategic priorities,
p.(None): goals, and objectives identified in the strategic plan developed
p.(None): under subsection (l);
p.(None):
p.(None): [[Page 130 STAT. 1211]]
p.(None):
p.(None): ``(2) an assessment of programs and activities carried out
p.(None): by the Assistant Secretary, including the extent to which
p.(None): programs and activities under this title and part B of title XIX
p.(None): meet identified goals and performance measures developed for the
p.(None): respective programs and activities;
p.(None): ``(3) a description of the progress made in addressing gaps
p.(None): in mental and substance use disorders prevention, treatment, and
p.(None): recovery services and improving outcomes by the Administration,
p.(None): including with respect to serious mental illnesses, serious
p.(None): emotional disturbances, and co-occurring disorders;
p.(None): ``(4) a description of the manner in which the
p.(None): Administration coordinates and partners with other Federal
p.(None): agencies and departments related to mental and substance use
p.(None): disorders, including activities related to--
p.(None): ``(A) the implementation and dissemination of
p.(None): research findings into improved programs, including with
p.(None): respect to how advances in serious mental illness and
p.(None): serious emotional disturbance research have been
p.(None): incorporated into programs;
p.(None): ``(B) the recruitment, training, and retention of a
p.(None): mental and substance use disorders workforce;
p.(None): ``(C) the integration of mental disorder services,
p.(None): substance use disorder services, and physical health
p.(None): services;
p.(None): ``(D) homelessness; and
p.(None): ``(E) veterans;
p.(None): ``(5) a description of the manner in which the
p.(None): Administration promotes coordination by grantees under this
p.(None): title, and part B of title XIX, with State or local agencies;
p.(None): and
p.(None): ``(6) a description of the activities carried out under
p.(None): section 501A(e), with respect to mental and substance use
p.(None): disorders, including--
p.(None): ``(A) the number and a description of grants
p.(None): awarded;
p.(None): ``(B) the total amount of funding for grants
p.(None): awarded;
p.(None): ``(C) a description of the activities supported
p.(None): through such grants, including outcomes of programs
p.(None): supported; and
p.(None): ``(D) information on how the National Mental Health
p.(None): and Substance Use Policy Laboratory is consulting with
p.(None): the Assistant Secretary for Planning and Evaluation and
p.(None): collaborating with the Center for Substance Abuse
p.(None): Treatment, the Center for Substance Abuse Prevention,
p.(None): the Center for Behavioral Health Statistics and Quality,
p.(None): and the Center for Mental Health Services to carry out
p.(None): such activities; and
p.(None): ``(7) recommendations made by the Assistant Secretary for
p.(None): Planning and Evaluation under section 6021 of the Helping
p.(None): Families in Mental Health Crisis Reform Act of 2016 to improve
p.(None): programs within the Administration, and actions taken in
p.(None): response to such recommendations to improve programs within the
p.(None): Administration.
p.(None):
p.(None): The Assistant Secretary may meet reporting requirements established
p.(None): under this title by providing the contents of such reports as an
p.(None): addendum to the biennial report established under this subsection,
p.(None): notwithstanding the timeline of other reporting requirements in this
p.(None): title. Nothing in this subsection shall be construed to alter the
p.(None): content requirements of such reports or authorize the Assistant
p.(None): Secretary to alter the timeline of any such reports
p.(None):
p.(None): [[Page 130 STAT. 1212]]
p.(None):
p.(None): to be less frequent than biennially, unless as specified in this
p.(None): title.''.
p.(None): (b) Conforming Amendment.--Section 508(p) of the Public Health
p.(None): Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
p.(None): 501(k)'' and inserting ``section 501(m)''.
...
p.(None): before the semicolon;
p.(None): (B) by redesignating paragraphs (3) through (11) as
p.(None): paragraphs (4) through (12), respectively;
p.(None): (C) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute on Drug Abuse, the Director of the National Institute
p.(None): on Alcohol Abuse and Alcoholism, and States to promote the study
p.(None): of substance abuse prevention and the dissemination and
p.(None): implementation of research findings that will improve the
p.(None): delivery and effectiveness of substance abuse prevention
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
p.(None): Disease Control and Prevention, develop and disseminate
p.(None): educational materials to increase awareness for individuals at
p.(None): greatest risk for substance use disorders to prevent the
p.(None): transmission of communicable diseases, such as HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases;'';
p.(None): (G) in paragraph (9), as so redesignated--
p.(None): (i) by striking ``to discourage'' and
p.(None): inserting ``that reduce the risk of''; and
p.(None): (ii) by inserting before the semicolon ``and
p.(None): promote resiliency'';
p.(None): (H) in paragraph (11), as so redesignated, by
p.(None): striking ``and'' after the semicolon;
p.(None): (I) in paragraph (12), as so redesignated, by
p.(None): striking the period and inserting a semicolon; and
p.(None): (J) by adding at the end the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) assist and support States in preventing illicit drug
p.(None): use, including emerging illicit drug use issues.''.
p.(None):
p.(None): [[Page 130 STAT. 1214]]
p.(None):
p.(None): (c) Director of the Center for Substance Abuse Treatment.--Section
p.(None): 507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``treatment of substance abuse'' and
p.(None): inserting ``treatment of substance use disorders''; and
p.(None): (B) by striking ``abuse treatment systems'' and
p.(None): inserting ``use disorder treatment systems''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (B) in paragraph (3), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (C) in paragraph (4), by striking ``individuals who
p.(None): abuse drugs'' and inserting ``individuals who illicitly
p.(None): use drugs'';
p.(None): (D) in paragraph (9), by striking ``carried out by
p.(None): the Director'';
p.(None): (E) by striking paragraph (10);
p.(None): (F) by redesignating paragraphs (11) through (14) as
p.(None): paragraphs (10) through (13), respectively;
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 1(b)) is amended--
p.(None): (1) in paragraph (2)--
p.(None): (A) in subparagraph (E), by striking ``and'' after
p.(None): the semicolon;
...
p.(None): subsections (a)(1)(A) and (a)(1)(D);
p.(None): ``(H) the Director of the National Institute on Drug
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
p.(None): prevent substance misuse.''.
p.(None): SEC. 6009. PEER REVIEW.
p.(None):
p.(None): Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 3(b)) is amended by adding at the end the following: ``In the case of
p.(None): any such peer review group that is reviewing a grant, cooperative
p.(None): agreement, or contract related to mental illness treatment, not less
p.(None): than half of the members of such peer review group shall be licensed and
p.(None): experienced professionals in the prevention, diagnosis, or treatment of,
p.(None): or recovery from, mental illness or co-occurring mental illness and
p.(None): substance use disorders and have a medical degree, a doctoral degree in
p.(None): psychology, or an advanced degree in nursing or social work from an
p.(None): accredited program, and the Secretary, in consultation with the
p.(None): Assistant Secretary, shall, to the extent possible, ensure such peer
p.(None): review groups include broad geographic representation, including both
p.(None): urban and rural representatives.''.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): SEC. 6021. <> IMPROVING OVERSIGHT OF
p.(None): MENTAL AND SUBSTANCE USE DISORDERS
p.(None): PROGRAMS THROUGH THE ASSISTANT SECRETARY
p.(None): FOR PLANNING AND EVALUATION.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Planning and Evaluation, shall
p.(None): ensure efficient and effective planning and evaluation of mental and
p.(None): substance use disorders prevention and treatment programs and related
p.(None): activities.
p.(None): (b) Evaluation Strategy.--In carrying out subsection (a), the
p.(None): Assistant Secretary for Planning and Evaluation shall, not later than
p.(None): 180 days after the date of enactment of this Act, develop a strategy for
p.(None): conducting ongoing evaluations that identifies priority programs to be
p.(None): evaluated by the Assistant Secretary for Planning and Evaluation and
p.(None): priority programs to be evaluated by other relevant offices and agencies
p.(None): within the Department of Health and Human Services. The strategy shall--
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
p.(None): the Secretary of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, and the Congress on improving the
p.(None): quality of prevention and treatment programs and activities related to
p.(None): mental and substance use disorders, including recommendations for the
p.(None): use of performance metrics. The Assistant Secretary for Mental Health
p.(None): and Substance Use shall include such recommendations in the biennial
p.(None): report required by subsection 501(m) of the Public Health Service Act,
p.(None): as redesignated by section 6003 of this Act.
p.(None): SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
p.(None):
p.(None): (a) Public Availability of Reports.--Section 105(a)(7) of the
p.(None): Protection and Advocacy for Individuals with Mental Illness Act (42
p.(None): U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and
p.(None): inserting ``is located, and make publicly available, a report''.
p.(None): (b) Detailed Accounting.--Section 114(a) of the Protection and
p.(None): Advocacy for Individuals with Mental Illness Act (42 U.S.C. 10824(a)) is
p.(None): amended--
p.(None): (1) in paragraph (3), by striking ``and'' at the end;
p.(None): (2) in paragraph (4), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(5) using data from the existing required annual program
p.(None): progress reports submitted by each system funded under this
p.(None): title, a detailed accounting for each such system of how funds
p.(None): are spent, disaggregated according to whether the funds were
p.(None):
p.(None): [[Page 130 STAT. 1217]]
p.(None):
p.(None): received from the Federal Government, the State government, a
p.(None): local government, or a private entity.''.
p.(None): SEC. 6023. GAO STUDY.
p.(None):
p.(None): (a) In General.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States, in
p.(None): consultation with the Secretary of Health and Human Services and the
p.(None): Assistant Secretary for Mental Health and Substance Use, shall conduct
p.(None): an independent evaluation, and submit a report, to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, on programs
p.(None): funded by allotments made under title I of the Protection and Advocacy
p.(None): for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
p.(None): (b) Contents.--The report and evaluation required under subsection
p.(None): (a) shall include--
p.(None): (1) a review of the programs described in such subsection
p.(None): that are carried out by State agencies and such programs that
p.(None): are carried out by private, nonprofit organizations; and
p.(None): (2) a review of the compliance of the programs described in
p.(None): subsection (a) with statutory and regulatory responsibilities,
p.(None): such as--
p.(None): (A) responsibilities relating to family engagement;
p.(None): (B) responsibilities relating to the grievance
p.(None): procedure for clients or prospective clients of the
p.(None): system to assure that individuals with mental illness
p.(None): have full access to the services of the system, for
p.(None): individuals who have received or are receiving mental
p.(None): health services, and for family members of such
p.(None): individuals with mental illness, or representatives of
...
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
p.(None): this section, the provisions of the Federal Advisory Committee
p.(None): Act (5 U.S.C. App.) shall apply to the Committee.
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
p.(None): services for adults with a serious mental illness or children
p.(None): with a serious emotional disturbance.
p.(None):
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
p.(None): (H) the Secretary of Labor;
p.(None): (I) the Administrator of the Centers for Medicare &
p.(None): Medicaid Services; and
p.(None): (J) the Commissioner of Social Security.
p.(None):
p.(None): [[Page 130 STAT. 1219]]
p.(None):
p.(None): (2) Non-federal members.--The Committee shall also include
p.(None): not less than 14 non-Federal public members appointed by the
p.(None): Secretary of Health and Human Services, of which--
p.(None): (A) at least 2 members shall be an individual who
p.(None): has received treatment for a diagnosis of a serious
p.(None): mental illness;
p.(None): (B) at least 1 member shall be a parent or legal
p.(None): guardian of an adult with a history of a serious mental
p.(None): illness or a child with a history of a serious emotional
p.(None): disturbance;
p.(None): (C) at least 1 member shall be a representative of a
p.(None): leading research, advocacy, or service organization for
p.(None): adults with a serious mental illness;
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
...
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
p.(None): (g) Sunset.--The Committee shall terminate on the date that is 6
p.(None): years after the date on which the Committee is established under
p.(None): subsection (a)(1).
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by inserting after section 501 (42 U.S.C. 290aa) the
p.(None): following:
p.(None): ``SEC. 501A. <> NATIONAL MENTAL HEALTH AND
p.(None): SUBSTANCE USE POLICY LABORATORY.
p.(None):
p.(None): ``(a) In General.--There shall be established within the
p.(None): Administration a National Mental Health and Substance Use Policy
p.(None): Laboratory (referred to in this section as the `Laboratory').
p.(None): ``(b) Responsibilities.--The Laboratory shall--
p.(None): ``(1) continue to carry out the authorities and activities
p.(None): that were in effect for the Office of Policy, Planning, and
p.(None): Innovation as such Office existed prior to the date of enactment
p.(None): of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016;
p.(None): ``(2) identify, coordinate, and facilitate the
p.(None): implementation of policy changes likely to have a significant
p.(None): effect on mental health, mental illness, recovery supports, and
p.(None): the prevention and treatment of substance use disorder services;
p.(None): ``(3) work with the Center for Behavioral Health Statistics
p.(None): and Quality to collect, as appropriate, information from
p.(None): grantees under programs operated by the Administration in order
p.(None): to evaluate and disseminate information on evidence-based
p.(None): practices, including culturally and linguistically appropriate
p.(None): services, as appropriate, and service delivery models;
p.(None): ``(4) provide leadership in identifying and coordinating
p.(None): policies and programs, including evidence-based programs,
p.(None): related to mental and substance use disorders;
p.(None): ``(5) periodically review programs and activities operated
p.(None): by the Administration relating to the diagnosis or prevention
p.(None): of, treatment for, and recovery from, mental and substance use
p.(None): disorders to--
p.(None): ``(A) identify any such programs or activities that
p.(None): are duplicative;
p.(None): ``(B) identify any such programs or activities that
p.(None): are not evidence-based, effective, or efficient; and
p.(None): ``(C) formulate recommendations for coordinating,
p.(None): eliminating, or improving programs or activities
p.(None): identified
p.(None):
p.(None): [[Page 130 STAT. 1221]]
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
...
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
p.(None): [[Page 130 STAT. 1222]]
p.(None):
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
p.(None): mental illness, serious emotional disturbances,
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
p.(None): the Assistant Secretary may establish a period for the
p.(None): submission of applications for evidence-based programs and
p.(None): practices to be posted publicly in accordance with subsection
p.(None): (a).
p.(None): ``(2) Notice.--In establishing the application period under
p.(None): paragraph (1), the Assistant Secretary shall provide for the
p.(None): public notice of such application period in the Federal
p.(None): Register.
p.(None):
p.(None): [[Page 130 STAT. 1223]]
p.(None):
p.(None): Such notice may solicit applications for evidence-based programs
p.(None): and practices to address gaps in information identified by the
p.(None): Assistant Secretary, the National Mental Health and Substance
p.(None): Use Policy Laboratory established under section 501A, or the
p.(None): Assistant Secretary for Planning and Evaluation, including
p.(None): pursuant to the evaluation and recommendations under section
p.(None): 6021 of the Helping Families in Mental Health Crisis Reform Act
p.(None): of 2016 or priorities identified in the strategic plan under
p.(None): section 501(l).
p.(None):
p.(None): ``(c) Requirements.--The Assistant Secretary may establish minimum
p.(None): requirements for the applications submitted under subsection (b),
p.(None): including applications related to the submission of research and
p.(None): evaluation.
p.(None): ``(d) Review and Rating.--
...
p.(None): the evidence-based programs and practices and a rating of the
p.(None): methodological rigor of the research supporting the
p.(None): applications.
p.(None): ``(3) Public access to metrics and rating.--The Assistant
p.(None): Secretary shall make the metrics used to evaluate applications
p.(None): under this section, and any resulting ratings of such
p.(None): applications, publicly available.''.
p.(None): SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
p.(None): SIGNIFICANCE.
p.(None):
p.(None): Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32)
p.(None): is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in paragraph (4), by inserting before the period
p.(None): ``, which may include technical assistance centers'';
p.(None): and
p.(None): (B) in the flush sentence following paragraph (4)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or''; and
p.(None): (2) by amending subsection (f) to read as follows:
p.(None):
p.(None): ``(f) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $394,550,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None):
p.(None): [[Page 130 STAT. 1224]]
p.(None):
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``that permit States, local governments, communities,
p.(None): and Indian tribes and tribal organizations (as the terms
p.(None): `Indian tribes' and `tribal organizations' are defined
p.(None): in section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act) to focus on emerging trends in
p.(None): substance abuse and co-occurrence of substance use
p.(None): disorders with mental illness or other conditions''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (3) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (4) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$333,806,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``, including such programs that focus on emerging drug
p.(None): abuse issues''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health
p.(None): Service,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1225]]
p.(None):
p.(None): (i) in subparagraph (A), by striking ``; and''
p.(None): at the end and inserting ``;'';
p.(None): (ii) in subparagraph (B)--
p.(None): (I) by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and''; and
p.(None): (iii) by adding at the end the following:
p.(None): ``(C) substance use disorder prevention among high-
p.(None): risk groups.'';
p.(None): (4) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (5) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$211,148,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1911(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x(b)) is amended--
p.(None): (1) by redesignating paragraphs (1) through (3) as
p.(None): paragraphs (2) through (4), respectively; and
p.(None): (2) by inserting before paragraph (2) (as so redesignated)
p.(None): the following:
p.(None): ``(1) providing community mental health services for adults
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
p.(None): accordance with subsection (a), a State shall submit to the
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
...
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
p.(None): providers; and
p.(None): ``(vii) as appropriate to, and reflective of,
p.(None): the uses the State proposes for the block grant
p.(None): funds, include--
p.(None): ``(I) a description of the
p.(None): activities intended to reduce
p.(None): hospitalizations and hospital stays
p.(None): using the block grant funds;
p.(None): ``(II) a description of the
p.(None): activities intended to reduce incidents
p.(None): of suicide using the block grant funds;
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
p.(None): (8) in subparagraph (D) (as so redesignated), by striking
p.(None): ``plan describes'' and inserting ``plan shall describe'';
p.(None): (9) in subparagraph (E) (as so redesignated)--
p.(None): (A) in the subparagraph heading by striking
p.(None): ``systems'' and inserting ``services'';
p.(None): (B) in the first sentence, by striking ``plan
p.(None): describes'' and all that follows through ``and provides
p.(None): for'' and inserting ``plan shall describe the financial
p.(None): resources available, the existing mental health
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
p.(None): inserting ``shall further describe''; and
p.(None): (ii) by striking ``involved.'' and inserting
p.(None): ``involved, and the manner in which the State
p.(None): intends to comply with each of the funding
p.(None): agreements in this subpart and subpart III.'';
p.(None): (10) by striking the flush matter at the end; and
p.(None): (11) by adding at the end the following:
p.(None): ``(2) Goals and objectives.--The establishment of goals and
p.(None): objectives for the period of the plan, including targets and
p.(None): milestones that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.''.
p.(None):
p.(None): [[Page 130 STAT. 1228]]
p.(None):
p.(None): (c) Early Serious Mental Illness.--Section 1920 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-9) is amended by adding at the end the
p.(None): following:
p.(None): ``(c) Early Serious Mental Illness.--
p.(None): ``(1) In general.--Except as provided in paragraph (2), a
p.(None): State shall expend not less than 10 percent of the amount the
p.(None): State receives for carrying out this section for each fiscal
p.(None): year to support evidence-based programs that address the needs
p.(None): of individuals with early serious mental illness, including
p.(None): psychotic disorders, regardless of the age of the individual at
p.(None): onset.
p.(None): ``(2) State flexibility.--In lieu of expending 10 percent of
p.(None): the amount the State receives under this section for a fiscal
...
p.(None): accordance with section 1932(b) and for'' after ``for the
p.(None): purpose of''; and
p.(None): (2) by striking ``abuse'' and inserting ``use disorders''.
p.(None):
p.(None): (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the
p.(None): Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
p.(None): (1) in the subsection heading, by striking ``Regarding
p.(None): Intravenous Substance Abuse'' and inserting ``to Persons Who
p.(None): Inject Drugs''; and
p.(None): (2) by striking ``for intravenous drug abuse'' and inserting
p.(None): ``for persons who inject drugs''.
p.(None):
p.(None): (c) Requirements Regarding Tuberculosis and Human Immunodeficiency
p.(None): Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
p.(None): 24) is amended--
p.(None): (1) in subsection (a)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``substance abuse'' and inserting ``substance
p.(None): use disorders''; and
p.(None): (B) in subparagraph (A), by striking ``such abuse''
p.(None): and inserting ``such disorders'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1)(A), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (B) in paragraph (2), by inserting ``and
p.(None): Prevention'' after ``Disease Control'';
p.(None): (C) in paragraph (3)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``abuse'' and inserting ``use disorders''; and
p.(None): (ii) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None):
p.(None): [[Page 130 STAT. 1230]]
p.(None):
p.(None): (D) in paragraph (6)(B), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (3) by striking subsection (d); and
p.(None): (4) by redesignating subsection (e) as subsection (d).
p.(None):
p.(None): (d) Group Homes.--Section 1925 of the Public Health Service Act (42
p.(None): U.S.C. 300x-25) is amended--
p.(None): (1) in the section heading, by striking ``recovering
p.(None): substance abusers'' and inserting ``persons in recovery from
p.(None): substance use disorders''; and
p.(None): (2) in subsection (a), in the matter preceding paragraph
p.(None): (1), by striking ``recovering substance abusers'' and inserting
p.(None): ``persons in recovery from substance use disorders''.
p.(None):
p.(None): (e) Additional Agreements.--Section 1928 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-28) is amended--
p.(None): (1) in subsection (a), by striking ``(relative to fiscal
p.(None): year 1992)'';
p.(None): (2) by striking subsection (b) and inserting the following:
p.(None):
p.(None): ``(b) Professional Development.--A funding agreement for a grant
p.(None): under section 1921 is that the State involved will ensure that
p.(None): prevention, treatment, and recovery personnel operating in the State's
p.(None): substance use disorder prevention, treatment, and recovery systems have
p.(None): an opportunity to receive training, on an ongoing basis, concerning--
p.(None): ``(1) recent trends in substance use disorders in the State;
p.(None): ``(2) improved methods and evidence-based practices for
p.(None): providing substance use disorder prevention and treatment
p.(None): services;
p.(None): ``(3) performance-based accountability;
p.(None): ``(4) data collection and reporting requirements; and
p.(None): ``(5) any other matters that would serve to further improve
p.(None): the delivery of substance use disorder prevention and treatment
p.(None): services within the State.''; and
p.(None): (3) in subsection (d)(1), by striking ``substance abuse''
p.(None): and inserting ``substance use disorders''.
p.(None):
p.(None): (f) Repeal.--Section 1929 of the Public Health Service Act (42
p.(None): U.S.C. 300x-29) is repealed.
p.(None): (g) Maintenance of Effort.--Section 1930 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-30) is amended--
p.(None): (1) in subsection (c)(1), by striking ``in the State justify
p.(None): the waiver'' and inserting ``exist in the State, or any part of
p.(None): the State, to justify the waiver''; and
p.(None): (2) in subsection (d), by inserting at the end the
p.(None): following:
p.(None): ``(3) Alternative.--A State that has failed to comply with
p.(None): this section and would otherwise be subject to a reduction in
p.(None): the State's allotment under section 1921, may, upon request by
p.(None): the State, in lieu of having the State's allotment under section
p.(None): 1921 reduced, agree to comply with a negotiated agreement that
p.(None): is approved by the Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State fails to enter
p.(None): into or comply with a negotiated agreement, the Secretary may
p.(None): take action under this paragraph or the terms of the negotiated
p.(None): agreement.''.
p.(None):
p.(None): (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
p.(None): Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
p.(None): ``substance abuse'' and inserting ``substance use disorders''.
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
p.(None): pregnant women, women with dependent children,
p.(None): individuals with a co-occurring mental health and
p.(None): substance use disorder, persons who inject drugs,
p.(None): and persons who are experiencing homelessness;
p.(None): ``(iii) provides aggregate information on the
p.(None): number of individuals in treatment within the
p.(None): State, including the number of such individuals
p.(None): who are pregnant women, women with dependent
p.(None): children, individuals with a co-occurring mental
p.(None): health and substance use disorder, persons who
p.(None): inject drugs, and persons who are experiencing
p.(None): homelessness;
p.(None): ``(iv) provides a description of the system
p.(None): that is available to provide services by modality,
p.(None): including the provision of recovery support
p.(None): services;
p.(None): ``(v) provides a description of the State's
p.(None): comprehensive statewide prevention efforts,
p.(None): including the number of individuals being served
p.(None): in the system, target populations, and priority
p.(None): needs, and provides a description of the amount of
p.(None): funds from the prevention set-aside expended on
p.(None): primary prevention;
p.(None): ``(vi) provides a description of the financial
p.(None): resources available;
p.(None): ``(vii) describes the existing substance use
p.(None): disorders workforce and workforce trained in
p.(None): treating co-occurring substance use and mental
p.(None): disorders;
p.(None): ``(viii) includes a description of how the
p.(None): State promotes evidence-based practices; and
p.(None): ``(ix) describes how the State integrates
p.(None): substance use disorder services and primary health
p.(None): care, which in the case of those individuals with
p.(None): co-occurring mental health and substance use
p.(None): disorders may include
p.(None):
p.(None): [[Page 130 STAT. 1232]]
p.(None):
p.(None): providing both mental health and substance use
p.(None): disorder services in primary care settings or
p.(None): providing primary and specialty care services in
p.(None): community-based mental health and substance use
p.(None): disorder service settings.
p.(None): ``(B) The establishment of goals and objectives for
p.(None): the period of the plan, including targets and milestones
p.(None): that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.
p.(None): ``(C) A description of how the State will comply
p.(None): with each funding agreement for a grant under section
p.(None): 1921 that is applicable to the State, including a
p.(None): description of the manner in which the State intends to
p.(None): expend grant funds.''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``authority of secretary regarding modifications''
p.(None): and inserting ``modifications'';
p.(None): (ii) by striking ``As a condition'' and
p.(None): inserting the following:
p.(None): ``(A) Authority of secretary.--As a condition;'';
p.(None): and
p.(None): (iii) by adding at the end the following:
p.(None): ``(B) State request for modification.--If the State
p.(None): determines that a modification to such plan is
p.(None): necessary, the State may request the Secretary to
p.(None): approve the modification. Any such modification shall be
p.(None): in accordance with paragraph (1) and section 1941.'';
p.(None): and
p.(None): (C) in paragraph (3), by inserting, ``, including
p.(None): any modification under paragraph (2)'' after
p.(None): ``subsection (a)(6)''; and
p.(None): (3) in subsection (e)(2), by striking ``section 1922(c)''
p.(None): and inserting ``section 1922(b)''.
p.(None):
p.(None): (j) Definitions.--Section 1934 of the Public Health Service Act (42
p.(None): U.S.C. 300x-34) is amended--
p.(None): (1) in paragraph (3), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None): (2) in paragraph (7), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''.
p.(None): (k) Funding.--Section 1935 of the Public Health Service Act (42
p.(None): U.S.C. 300x-35) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(d)''; and
p.(None): (B) by striking ``$2,000,000,000 for fiscal year
p.(None): 2001, and such sums as may be necessary for each of the
p.(None): fiscal years 2002 and 2003'' and inserting
p.(None): ``$1,858,079,000 for each of fiscal years 2018 through
p.(None): 2022.''; and
p.(None): (2) in subsection (b)(1)(B) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(d) and''.
p.(None): SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
p.(None):
p.(None): Subpart III of part B of title XIX of the Public Health Service Act
p.(None): (42 U.S.C. 300x-51 et seq.) is amended--
p.(None): (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
p.(None): striking ``section 505'' and inserting ``subsections (c) and (d)
p.(None): of section 505'';
p.(None):
p.(None): [[Page 130 STAT. 1233]]
p.(None):
p.(None): (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
p.(None): ``substance abuse'' and inserting ``substance use disorder'';
p.(None): and
p.(None): (3) by adding at the end the following:
p.(None): ``SEC. 1957. <> PUBLIC HEALTH EMERGENCIES.
p.(None):
p.(None): ``In the case of a public health emergency (as determined under
p.(None): section 319), the Secretary, on a State by State basis, may, as the
p.(None): circumstances of the emergency reasonably require and for the period of
p.(None): the emergency, grant an extension, or waive application deadlines or
p.(None): compliance with any other requirement, of a grant authorized under
p.(None): section 521, 1911, or 1921 or an allotment authorized under Public Law
p.(None): 99-319 (42 U.S.C. 10801 et seq.).
p.(None): ``SEC. 1958. <> JOINT APPLICATIONS.
p.(None):
p.(None): ``The Secretary, acting through the Assistant Secretary for Mental
p.(None): Health and Substance Use, shall permit a joint application to be
p.(None): submitted for grants under subpart I and subpart II upon the request of
p.(None): a State. Such application may be jointly reviewed and approved by the
p.(None): Secretary with respect to such subparts, consistent with the purposes
p.(None): and authorized activities of each such grant program. A State submitting
p.(None): such a joint application shall otherwise meet the requirements with
p.(None): respect to each such subpart.''.
p.(None): SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
p.(None): ABUSE PREVENTION AND TREATMENT BLOCK
p.(None): GRANT AND THE COMMUNITY MENTAL HEALTH
p.(None): SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Mental Health and Substance Use,
p.(None): shall through a grant or contract, or through an agreement with a third
p.(None): party, conduct a study on the formulas for distribution of funds under
p.(None): the substance abuse prevention and treatment block grant, and the
p.(None): community mental health services block grant, under part B of title XIX
p.(None): of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend
p.(None): changes if necessary. Such study shall include--
p.(None): (1) an analysis of whether the distributions under such
p.(None): block grants accurately reflect the need for the services under
p.(None): the grants in the States;
p.(None): (2) an examination of whether the indices used under the
p.(None): formulas for distribution of funds under such block grants are
p.(None): appropriate, and if not, alternatives recommended by the
p.(None): Secretary;
p.(None): (3) where recommendations are included under paragraph (2)
p.(None): for the use of different indices, a description of the variables
p.(None): and data sources that should be used to determine the indices;
p.(None): (4) an evaluation of the variables and data sources that are
p.(None): being used for each of the indices involved, and whether such
p.(None): variables and data sources accurately represent the need for
p.(None): services, the cost of providing services, and the ability of the
p.(None): States to pay for such services;
p.(None): (5) the effect that the minimum allotment requirements for
p.(None): each such block grant have on each State's final allotment and
p.(None): the effect of such requirements, if any, on each State's
p.(None): formula-based allotment;
p.(None):
p.(None): [[Page 130 STAT. 1234]]
p.(None):
p.(None): (6) recommendations for modifications to the minimum
p.(None): allotment provisions to ensure an appropriate distribution of
p.(None): funds; and
p.(None): (7) any other information that the Secretary determines
p.(None): appropriate.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of enactment of
p.(None): this Act, the Secretary of Health and Human Services shall submit to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and
p.(None): the Committee on Energy and Commerce of the House of Representatives, a
p.(None): report containing the findings and recommendations of the study
p.(None): conducted under subsection (a) and the study conducted under section
p.(None): 9004(g).
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
p.(None): INDIVIDUALS.
p.(None):
p.(None): Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is
p.(None): amended--
p.(None): (1) in subsection (a), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraphs (1) and (3), by striking
p.(None): ``substance abuse'' each place the term appears and
p.(None): inserting ``substance use disorder''; and
p.(None): (B) in paragraph (4), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder'';
p.(None): (3) in subsection (c)--
p.(None): (A) in paragraph (1), by striking ``substance abuse
p.(None): disorder'' and inserting ``substance use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in subparagraph (A), by striking
p.(None): ``substance abuse'' and inserting ``a substance
p.(None): use disorder''; and
p.(None): (ii) in subparagraph (B), by striking
p.(None): ``substance abuse'' and inserting ``substance use
p.(None): disorder''; and
p.(None): (4) in subsection (e), by striking ``, $50,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$41,304,000 for
p.(None): each of fiscal years 2018 through 2022''.
p.(None): SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
p.(None):
p.(None): Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38)
p.(None): is amended--
p.(None): (1) by striking ``substance abuse'' each place such term
p.(None): appears and inserting ``substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Indian tribes, and tribal
p.(None): organizations'' and inserting ``and Indian tribes and
p.(None): tribal organizations (as the terms `Indian tribes' and
p.(None): `tribal organizations' are
p.(None):
p.(None): [[Page 130 STAT. 1235]]
p.(None):
p.(None): defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act)''; and
p.(None): (B) by inserting ``or a health facility or program
p.(None): operated by or in accordance with a contract or grant
p.(None): with the Indian Health Service,'' after ``entities,'';
p.(None): (3) in subsection (c)(2)(A)(i), by striking ``the best
p.(None): known'' and inserting ``evidence-based'';
p.(None): (4) by redesignating subsections (d) through (i) as
p.(None): subsections (e) through (j), respectively;
p.(None): (5) by inserting after subsection (c) the following:
p.(None):
p.(None): ``(d) Special Consideration Regarding Veterans.--In awarding grants
p.(None): under subsection (a), the Secretary shall, as appropriate, give special
p.(None): consideration to entities proposing to use grant funding to support jail
p.(None): diversion services for veterans.'';
p.(None): (6) in subsection (e), as so redesignated--
p.(None): (A) in paragraph (3), by striking ``; and'' and
p.(None): inserting a semicolon;
p.(None): (B) in paragraph (4), by striking the period and
p.(None): inserting ``; and''; and
p.(None): (C) by adding at the end the following:
p.(None): ``(5) develop programs to divert individuals prior to
p.(None): booking or arrest.''; and
p.(None): (7) in subsection (j), as so redesignated, by striking
p.(None): ``$10,000,000 for fiscal year 2001, and such sums as may be
p.(None): necessary for fiscal years 2002 through 2003'' and inserting
p.(None): ``$4,269,000 for each of fiscal years 2018 through 2022''.
p.(None): SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH
p.(None): CARE.
p.(None):
p.(None): Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
p.(None): AGREEMENTS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Eligible entity.--The term `eligible entity' means a
p.(None): State, or other appropriate State agency, in collaboration with
p.(None): 1 or more qualified community programs as described in section
p.(None): 1913(b)(1) or 1 or more community health centers as described in
p.(None): section 330.
p.(None): ``(2) Integrated care.--The term `integrated care' means
p.(None): collaborative models or practices offering mental and physical
p.(None): health services, which may include practices that share the same
p.(None): space in the same facility.
p.(None): ``(3) Special population.--The term `special population'
p.(None): means--
p.(None): ``(A) adults with a mental illness who have co-
p.(None): occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(B) adults with a serious mental illness who have
p.(None): co-occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(C) children and adolescents with a serious
p.(None): emotional disturbance with co-occurring physical health
p.(None): conditions or chronic diseases; or
p.(None): ``(D) individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Grants and Cooperative Agreements.--
p.(None): ``(1) In general.--The Secretary may award grants and
p.(None): cooperative agreements to eligible entities to support the
p.(None):
p.(None): [[Page 130 STAT. 1236]]
p.(None):
p.(None): improvement of integrated care for primary care and behavioral
p.(None): health care in accordance with paragraph (2).
p.(None): ``(2) Purposes.--A grant or cooperative agreement awarded
p.(None): under this section shall be designed to--
p.(None): ``(A) promote full integration and collaboration in
p.(None): clinical practices between primary and behavioral health
p.(None): care;
p.(None): ``(B) support the improvement of integrated care
p.(None): models for primary care and behavioral health care to
p.(None): improve the overall wellness and physical health status
p.(None): of adults with a serious mental illness or children with
p.(None): a serious emotional disturbance; and
p.(None): ``(C) promote integrated care services related to
p.(None): screening, diagnosis, prevention, and treatment of
p.(None): mental and substance use disorders, and co-occurring
p.(None): physical health conditions and chronic diseases.
p.(None):
p.(None): ``(c) Applications.--
p.(None): ``(1) In general.--An eligible entity seeking a grant or
p.(None): cooperative agreement under this section shall submit an
p.(None): application to the Secretary at such time, in such manner, and
p.(None): accompanied by such information as the Secretary may require,
p.(None): including the contents described in paragraph (2).
p.(None): ``(2) Contents.--The contents described in this paragraph
p.(None): are--
p.(None): ``(A) a description of a plan to achieve fully
p.(None): collaborative agreements to provide services to special
p.(None): populations;
p.(None): ``(B) a document that summarizes the policies, if
p.(None): any, that serve as barriers to the provision of
p.(None): integrated care, and the specific steps, if applicable,
p.(None): that will be taken to address such barriers;
p.(None): ``(C) a description of partnerships or other
p.(None): arrangements with local health care providers to provide
p.(None): services to special populations;
p.(None): ``(D) an agreement and plan to report to the
p.(None): Secretary performance measures necessary to evaluate
p.(None): patient outcomes and facilitate evaluations across
p.(None): participating projects; and
p.(None): ``(E) a plan for sustainability beyond the grant or
p.(None): cooperative agreement period under subsection (e).
p.(None):
p.(None): ``(d) Grant and Cooperative Agreement Amounts.--
p.(None): ``(1) Target amount.--The target amount that an eligible
p.(None): entity may receive for a year through a grant or cooperative
p.(None): agreement under this section shall be $2,000,000.
p.(None): ``(2) Adjustment permitted.--The Secretary, taking into
p.(None): consideration the quality of the application and the number of
p.(None): eligible entities that received grants under this section prior
...
p.(None): tribal organizations (as defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act), outpatient
p.(None): mental health and addiction treatment centers, community mental
p.(None): health centers that meet the criteria under section 1913(c),
p.(None): certified community behavioral health clinics described in
p.(None): section 223 of the Protecting Access to Medicare Act of 2014,
p.(None): primary care organizations such as Federally qualified health
p.(None): centers or rural health clinics as defined in section 1861(aa)
p.(None):
p.(None): [[Page 130 STAT. 1238]]
p.(None):
p.(None): of the Social Security Act, other community-based organizations,
p.(None): or other entities engaging in integrated care activities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): ``(h) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $51,878,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
p.(None): HOMELESSNESS.
p.(None):
p.(None): (a) Formula Grants to States.--Section 521 of the Public Health
p.(None): Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through
p.(None): 1994'' and inserting ``2018 through 2022''.
p.(None): (b) Purpose of Grants.--Section 522 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-22) is amended--
p.(None): (1) in subsection (a)(1)(B), by striking ``substance abuse''
p.(None): and inserting ``a substance use disorder'';
p.(None): (2) in subsection (b)(6), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (3) in subsection (c), by striking ``substance abuse'' and
p.(None): inserting ``a substance use disorder'';
p.(None): (4) in subsection (e)--
p.(None): (A) in paragraph (1), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder''; and
p.(None): (B) in paragraph (2), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (5) by striking subsection (g) and redesignating subsections
p.(None): (h) and (i) as (g) and (h), accordingly; and
p.(None): (6) in subsection (g), as redesignated by paragraph (5), by
p.(None): striking ``substance abuse'' each place such term appears and
p.(None): inserting ``substance use disorder''.
p.(None):
p.(None): (c) Description of Intended Expenditures of Grant.--Section 527 of
p.(None): the Public Health Service Act (42 U.S.C. 290cc-27) is amended by
p.(None): striking ``substance abuse'' each place such term appears and inserting
p.(None): ``substance use disorder''.
p.(None): (d) Technical Assistance.--Section 530 of the Public Health Service
p.(None): Act (42 U.S.C. 290cc-30) is amended by striking ``through the National
p.(None): Institute of Mental Health, the National Institute of Alcohol Abuse and
p.(None): Alcoholism, and the National Institute on Drug Abuse'' and inserting
p.(None): ``acting through the Assistant Secretary''.
p.(None): (e) Definitions.--Section 534(4) of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-34(4)) is amended to read as follows:
p.(None): ``(4) Substance use disorder services.--The term `substance
p.(None): use disorder services' has the meaning given the term `substance
p.(None): abuse services' in section 330(h)(5)(C).''.
p.(None):
p.(None): (f) Funding.--Section 535(a) of the Public Health Service Act (42
p.(None): U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the
p.(None): fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of
p.(None): fiscal years 2018 through 2022''.
p.(None): (g) Study Concerning Formula.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Assistant Secretary for Mental Health
p.(None): and Substance Use (referred to in this section as the
p.(None): ``Assistant Secretary'') shall conduct a study concerning the
p.(None): formula used under section 524 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-24) for making allotments to States under
p.(None): section 521 of such Act (42 U.S.C. 290cc-21). Such study shall
p.(None): include an evaluation of quality indicators of need for purposes
p.(None):
p.(None): [[Page 130 STAT. 1239]]
p.(None):
p.(None): of revising the formula for determining the amount of each
p.(None): allotment for the fiscal years following the submission of the
p.(None): study.
p.(None): (2) Report.--In accordance with section 8004(b), the
p.(None): Assistant Secretary shall submit to the committees of Congress
p.(None): described in such section a report concerning the results of the
p.(None): study conducted under paragraph (1).
p.(None): SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2
p.(None): (42 U.S.C. 290bb-36b) the following:
p.(None): ``SEC. 520E-3. <> NATIONAL SUICIDE
p.(None): PREVENTION LIFELINE PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Suicide Prevention Lifeline
p.(None): program (referred to in this section as the `program'), authorized under
p.(None): section 520A and in effect prior to the date of enactment of the Helping
p.(None): Families in Mental Health Crisis Reform Act of 2016.
p.(None): ``(b) Activities.--In maintaining the program, the activities of the
p.(None): Secretary shall include--
p.(None): ``(1) coordinating a network of crisis centers across the
p.(None): United States for providing suicide prevention and crisis
p.(None): intervention services to individuals seeking help at any time,
p.(None): day or night;
p.(None): ``(2) maintaining a suicide prevention hotline to link
p.(None): callers to local emergency, mental health, and social services
p.(None): resources; and
p.(None): ``(3) consulting with the Secretary of Veterans Affairs to
p.(None): ensure that veterans calling the suicide prevention hotline have
p.(None): access to a specialized veterans' suicide prevention hotline.
p.(None):
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $7,198,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.), as amended by section 9005, is further amended
p.(None): by inserting after section 520E-3 the following:
p.(None): ``SEC. 520E-4. <> TREATMENT REFERRAL
p.(None): ROUTING SERVICE.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Treatment Referral Routing
p.(None): Service (referred to in this section as the `Routing Service') to assist
p.(None): individuals and families in locating mental and substance use disorders
p.(None): treatment providers.
p.(None): ``(b) Activities of the Secretary.--To maintain the Routing Service,
p.(None): the activities of the Assistant Secretary shall include administering--
p.(None): ``(1) a nationwide, telephone number providing year-round
p.(None): access to information that is updated on a regular basis
p.(None): regarding local behavioral health providers and community-based
p.(None): organizations in a manner that is confidential, without
p.(None): requiring individuals to identify themselves, is in languages
p.(None): that include at least English and Spanish, and is at no cost to
p.(None): the individual using the Routing Service; and
p.(None):
p.(None): [[Page 130 STAT. 1240]]
p.(None):
p.(None): ``(2) an Internet website to provide a searchable, online
p.(None): treatment services locator of behavioral health treatment
p.(None): providers and community-based organizations, which shall include
p.(None): information on the name, location, contact information, and
p.(None): basic services provided by such providers and organizations.
p.(None):
p.(None): ``(c) Removing Practitioner Contact Information.--In the event that
p.(None): the Internet website described in subsection (b)(2) contains information
p.(None): on any qualified practitioner that is certified to prescribe medication
p.(None): for opioid dependency under section 303(g)(2)(B) of the Controlled
p.(None): Substances Act, the Assistant Secretary--
p.(None): ``(1) shall provide an opportunity to such practitioner to
p.(None): have the contact information of the practitioner removed from
p.(None): the website at the request of the practitioner; and
p.(None): ``(2) may evaluate other methods to periodically update the
p.(None): information displayed on such website.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the Assistant Secretary from using any unobligated
p.(None): amounts otherwise made available to the Administration to maintain the
p.(None): Routing Service.''.
p.(None): SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall award competitive grants to--
p.(None): ``(1) State and local governments and Indian tribes and
p.(None): tribal organizations, to enhance community-based crisis response
p.(None): systems; or
p.(None): ``(2) States to develop, maintain, or enhance a database of
p.(None): beds at inpatient psychiatric facilities, crisis stabilization
p.(None): units, and residential community mental health and residential
p.(None): substance use disorder treatment facilities, for adults with a
p.(None): serious mental illness, children with a serious emotional
p.(None): disturbance, or individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Applications.--
p.(None): ``(1) In general.--To receive a grant under subsection (a),
p.(None): an entity shall submit to the Secretary an application, at such
p.(None): time, in such manner, and containing such information as the
p.(None): Secretary may require.
p.(None): ``(2) Community-based crisis response plan.--An application
p.(None): for a grant under subsection (a)(1) shall include a plan for--
p.(None): ``(A) promoting integration and coordination between
p.(None): local public and private entities engaged in crisis
p.(None): response, including first responders, emergency health
p.(None): care providers, primary care providers, law enforcement,
p.(None): court systems, health care payers, social service
p.(None): providers, and behavioral health providers;
p.(None): ``(B) developing memoranda of understanding with
p.(None): public and private entities to implement crisis response
p.(None): services;
p.(None): ``(C) addressing gaps in community resources for
p.(None): crisis intervention and prevention; and
p.(None):
p.(None): [[Page 130 STAT. 1241]]
p.(None):
p.(None): ``(D) developing models for minimizing hospital
p.(None): readmissions, including through appropriate discharge
p.(None): planning.
p.(None): ``(3) Beds database plan.--An application for a grant under
p.(None): subsection (a)(2) shall include a plan for developing,
p.(None): maintaining, or enhancing a real-time, Internet-based bed
p.(None): database to collect, aggregate, and display information about
p.(None): beds in inpatient psychiatric facilities and crisis
p.(None): stabilization units, and residential community mental health and
p.(None): residential substance use disorder treatment facilities to
p.(None): facilitate the identification and designation of facilities for
p.(None): the temporary treatment of individuals in mental or substance
p.(None): use disorder crisis.
p.(None):
p.(None): ``(c) Database Requirements.--A bed database described in this
p.(None): section is a database that--
p.(None): ``(1) includes information on inpatient psychiatric
p.(None): facilities, crisis stabilization units, and residential
p.(None): community mental health and residential substance use disorder
p.(None): facilities in the State involved, including contact information
p.(None): for the facility or unit;
p.(None): ``(2) provides real-time information about the number of
p.(None): beds available at each facility or unit and, for each available
p.(None): bed, the type of patient that may be admitted, the level of
p.(None): security provided, and any other information that may be
p.(None): necessary to allow for the proper identification of appropriate
p.(None): facilities for treatment of individuals in mental or substance
p.(None): use disorder crisis; and
p.(None): ``(3) enables searches of the database to identify available
p.(None): beds that are appropriate for the treatment of individuals in
p.(None): mental or substance use disorder crisis.
p.(None):
p.(None): ``(d) Evaluation.--An entity receiving a grant under subsection
p.(None): (a)(1) shall submit to the Secretary, at such time, in such manner, and
p.(None): containing such information as the Secretary may reasonably require, a
p.(None): report, including an evaluation of the effect of such grant on--
p.(None): ``(1) local crisis response services and measures for
p.(None): individuals receiving crisis planning and early intervention
p.(None): supports;
p.(None): ``(2) individuals reporting improved functional outcomes;
p.(None): and
p.(None): ``(3) individuals receiving regular followup care following
p.(None): a crisis.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section, $12,500,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
p.(None):
p.(None): (a) Suicide Prevention Technical Assistance Center.--Section 520C of
p.(None): the Public Health Service Act (42 U.S.C. 290bb-34), as amended by
p.(None): section 6001, is further amended--
p.(None): (1) in the section heading, by striking ``youth interagency
p.(None): research, training, and technical assistance centers'' and
p.(None): inserting ``suicide prevention technical assistance center'';
p.(None): (2) in subsection (a), by striking ``acting through the
p.(None): Assistant Secretary for Mental Health and Substance Use'' and
p.(None): all that follows through the period at the end of paragraph (2)
p.(None): and inserting ``acting through the Assistant Secretary, shall
p.(None): establish a research, training, and technical assistance
p.(None): resource
p.(None):
p.(None): [[Page 130 STAT. 1242]]
p.(None):
p.(None): center to provide appropriate information, training, and
p.(None): technical assistance to States, political subdivisions of
p.(None): States, federally recognized Indian tribes, tribal
p.(None): organizations, institutions of higher education, public
p.(None): organizations, or private nonprofit organizations regarding the
p.(None): prevention of suicide among all ages, particularly among groups
p.(None): that are at a high risk for suicide.'';
p.(None): (3) by striking subsections (b) and (c);
p.(None): (4) by redesignating subsection (d) as subsection (b);
p.(None): (5) in subsection (b), as so redesignated--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Additional Center'' and inserting ``Responsibilities
p.(None): of the Center'';
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``The additional research'' and all that
p.(None): follows through ``nonprofit organizations for'' and
p.(None): inserting ``The center established under subsection (a)
p.(None): shall conduct activities for the purpose of'';
p.(None): (C) by striking ``youth suicide'' each place such
p.(None): term appears and inserting ``suicide'';
p.(None): (D) in paragraph (1)--
p.(None): (i) by striking ``the development or
p.(None): continuation of'' and inserting ``developing and
p.(None): continuing''; and
p.(None): (ii) by inserting ``for all ages, particularly
p.(None): among groups that are at a high risk for suicide''
p.(None): before the semicolon at the end;
p.(None): (E) in paragraph (2), by inserting ``for all ages,
p.(None): particularly among groups that are at a high risk for
p.(None): suicide'' before the semicolon at the end;
p.(None): (F) in paragraph (3), by inserting ``and tribal''
p.(None): after ``statewide'';
p.(None): (G) in paragraph (5), by inserting ``and
p.(None): prevention'' after ``intervention'';
p.(None): (H) in paragraph (8), by striking ``in youth'';
p.(None): (I) in paragraph (9), by striking ``and behavioral
p.(None): health'' and inserting ``health and substance use
p.(None): disorder''; and
p.(None): (J) in paragraph (10), by inserting ``conducting''
p.(None): before ``other''; and
p.(None): (6) by striking subsection (e) and inserting the following:
p.(None):
p.(None): ``(c) Authorization of Appropriations.--For the purpose of carrying
p.(None): out this section, there are authorized to be appropriated $5,988,000 for
p.(None): each of fiscal years 2018 through 2022.
p.(None): ``(d) Annual Report.--Not later than 2 years after the date of
p.(None): enactment of this subsection, the Secretary shall submit to Congress a
p.(None): report on the activities carried out by the center established under
p.(None): subsection (a) during the year involved, including the potential effects
p.(None): of such activities, and the States, organizations, and institutions that
p.(None): have worked with the center.''.
p.(None): (b) Youth Suicide Early Intervention and Prevention Strategies.--
p.(None): Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is
p.(None): amended--
p.(None): (1) in paragraph (1) of subsection (a) and in subsection
p.(None): (c), by striking ``substance abuse'' each place such term
p.(None): appears and inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1243]]
p.(None):
p.(None): (i) by striking ``ensure that each State is
p.(None): awarded only 1 grant or cooperative agreement
p.(None): under this section'' and inserting ``ensure that a
p.(None): State does not receive more than 1 grant or
p.(None): cooperative agreement under this section at any 1
p.(None): time''; and
p.(None): (ii) by striking ``been awarded'' and
p.(None): inserting ``received''; and
p.(None): (B) by adding after paragraph (2) the following:
p.(None): ``(3) Consideration.--In awarding grants under this section,
p.(None): the Secretary shall take into consideration the extent of the
p.(None): need of the applicant, including the incidence and prevalence of
p.(None): suicide in the State and among the populations of focus,
p.(None): including rates of suicide determined by the Centers for Disease
p.(None): Control and Prevention for the State or population of focus.'';
p.(None): (3) in subsection (g)(2), by striking ``2 years after the
p.(None): date of enactment of this section,'' and insert ``2 years after
p.(None): the date of enactment of Helping Families in Mental Health
p.(None): Crisis Reform Act of 2016,''; and
p.(None): (4) by striking subsection (m) and inserting the following:
p.(None):
p.(None): ``(m) Authorization of Appropriations.--For the purpose of carrying
p.(None): out this section, there are authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2018 through 2022.''.
p.(None): SEC. 9009. <> ADULT SUICIDE PREVENTION.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 520L. ADULT SUICIDE PREVENTION.
p.(None):
p.(None): ``(a) Grants.--
...
p.(None): PREVENTION PROGRAMS.
p.(None):
p.(None): (a) Findings.--The Congress finds as follows:
p.(None): (1) Suicide is the eighth leading cause of death among
p.(None): American Indians and Alaska Natives across all ages.
p.(None): (2) Among American Indians and Alaska Natives who are 10 to
p.(None): 34 years of age, suicide is the second leading cause of death.
p.(None): (3) The suicide rate among American Indian and Alaska Native
p.(None): adolescents and young adults ages 15 to 34 (17.9 per
p.(None):
p.(None): [[Page 130 STAT. 1245]]
p.(None):
p.(None): 100,000) is approximately 1.3 times higher than the national
p.(None): average for that age group (13.3 per 100,000).
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that the
p.(None): Secretary of Health and Human Services, in carrying out suicide
p.(None): prevention and intervention programs, should prioritize programs and
p.(None): activities for populations with disproportionately high rates of
p.(None): suicide, such as American Indians and Alaska Natives.
p.(None): SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
p.(None):
p.(None): Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 32(e)) is amended by adding at the end the following:
p.(None): ``(3) Geriatric mental disorders.--The Secretary shall, as
p.(None): appropriate, provide technical assistance to grantees regarding
p.(None): evidence-based practices for the prevention and treatment of
p.(None): geriatric mental disorders and co-occurring mental health and
p.(None): substance use disorders among geriatric populations, as well as
p.(None): disseminate information about such evidence-based practices to
p.(None): States and nongrantees throughout the United States.''.
p.(None): SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
p.(None):
p.(None): The Secretary of Health and Human Services, acting through the
p.(None): Director of the Centers for Disease Control and Prevention, is
p.(None): encouraged to improve, particularly through the inclusion of additional
p.(None): States, the National Violent Death Reporting System as authorized by
p.(None): title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
p.(None): Participation in the system by the States shall be voluntary.
p.(None): SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
p.(None):
p.(None): Section 224 of the Protecting Access to Medicare Act of 2014 (42
p.(None): U.S.C. 290aa note) is amended--
p.(None): (1) in subsection (e), by striking ``and 2018,'' and
p.(None): inserting ``2018, 2019, 2020, 2021, and 2022,''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in paragraph (1), by striking ``2018'' and
p.(None): inserting ``2022''; and
p.(None): (B) in paragraph (2), by striking ``is authorized to
p.(None): be appropriated to carry out this section $15,000,000
p.(None): for each of fiscal years 2015 through 2018'' and
p.(None): inserting ``are authorized to be appropriated to carry
p.(None): out this section $15,000,000 for each of fiscal years
p.(None): 2015 through 2017, $20,000,000 for fiscal year 2018,
p.(None): $19,000,000 for each of fiscal years 2019 and 2020, and
p.(None): $18,000,000 for each of fiscal years 2021 and 2022''.
p.(None): SEC. 9015. <> ASSERTIVE COMMUNITY
p.(None): TREATMENT GRANT PROGRAM.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
...
p.(None): eligible entities--
p.(None): ``(1) to establish assertive community treatment programs
p.(None): for adults with a serious mental illness; or
p.(None): ``(2) to maintain or expand such programs.
p.(None):
p.(None): [[Page 130 STAT. 1246]]
p.(None):
p.(None): ``(b) Eligible Entities.--To be eligible to receive a grant under
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act), mental health system, health care facility, or any other entity
p.(None): the Assistant Secretary deems appropriate.
p.(None): ``(c) Special Consideration.--In selecting among applicants for a
p.(None): grant under this section, the Assistant Secretary may give special
p.(None): consideration to the potential of the applicant's program to reduce
p.(None): hospitalization, homelessness, and involvement with the criminal justice
p.(None): system while improving the health and social outcomes of the patient.
p.(None): ``(d) Additional Activities.--The Assistant Secretary shall--
p.(None): ``(1) not later than the end of fiscal year 2021, submit a
p.(None): report to the appropriate congressional committees on the grant
p.(None): program under this section, including an evaluation of--
p.(None): ``(A) any cost savings and public health outcomes
p.(None): such as mortality, suicide, substance use disorders,
p.(None): hospitalization, and use of services;
p.(None): ``(B) rates of involvement with the criminal justice
p.(None): system of patients;
p.(None): ``(C) rates of homelessness among patients; and
p.(None): ``(D) patient and family satisfaction with program
p.(None): participation; and
p.(None): ``(2) provide appropriate information, training, and
p.(None): technical assistance to grant recipients under this section to
p.(None): help such recipients to establish, maintain, or expand their
p.(None): assertive community treatment programs.
p.(None):
p.(None): ``(e) Authorization of Appropriations.--
p.(None): ``(1) In general.--To carry out this section, there is
p.(None): authorized to be appropriated $5,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None): ``(2) Use of certain funds.--Of the funds appropriated to
p.(None): carry out this section in any fiscal year, not more than 5
p.(None): percent shall be available to the Assistant Secretary for
p.(None): carrying out subsection (d).''.
p.(None): SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
p.(None): REAUTHORIZATION.
p.(None):
p.(None): Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
p.(None): is amended--
p.(None): (1) in subsection (c)(3), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (2) in subsection (d)(4), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (3) in subsection (e)(1)(I), by striking ``fiscal year
...
p.(None): validated patient interview techniques to identify and
p.(None): assess the existence and extent of alcohol use in a
p.(None): patient.''.
p.(None):
p.(None): [[Page 130 STAT. 1248]]
p.(None):
p.(None): SEC. 9017. CENTER AND PROGRAM REPEALS.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
p.(None): second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
p.(None): amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
p.(None): 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
p.(None): 25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
p.(None): GRANTS.
p.(None):
p.(None): Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``of higher education''; and
p.(None): (B) by striking paragraphs (1) through (4) and
p.(None): inserting the following:
p.(None): ``(1) accredited institutions of higher education or
p.(None): accredited professional training programs that are establishing
p.(None): or expanding internships or other field placement programs in
p.(None): mental health in psychiatry, psychology, school psychology,
p.(None): behavioral pediatrics, psychiatric nursing (which may include
p.(None): master's and doctoral level programs), social work, school
p.(None): social work, substance use disorder prevention and treatment,
p.(None): marriage and family therapy, occupational therapy, school
p.(None): counseling, or professional counseling, including such programs
p.(None): with a focus on child and adolescent mental health and
p.(None): transitional-age youth;
p.(None): ``(2) accredited doctoral, internship, and post-doctoral
p.(None): residency programs of health service psychology (including
p.(None): clinical psychology, counseling, and school psychology) for the
p.(None): development and implementation of interdisciplinary training of
p.(None): psychology graduate students for providing behavioral health
p.(None): services, including substance use disorder prevention and
p.(None): treatment services, as well as the development of faculty in
p.(None): health service psychology;
p.(None): ``(3) accredited master's and doctoral degree programs of
p.(None): social work for the development and implementation of
p.(None): interdisciplinary training of social work graduate students for
p.(None): providing behavioral health services, including substance use
p.(None): disorder prevention and treatment services, and the development
p.(None): of faculty in social work; and
p.(None): ``(4) State-licensed mental health nonprofit and for-profit
p.(None): organizations to enable such organizations to pay for programs
p.(None): for preservice or in-service training in a behavioral health-
p.(None): related paraprofessional field with preference for preservice or
p.(None): in-service training of paraprofessional child and adolescent
p.(None): mental health workers.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (5);
p.(None): [[Page 130 STAT. 1249]]
p.(None):
p.(None): (B) by redesignating paragraphs (1) through (4) as
p.(None): paragraphs (2) through (5), respectively;
p.(None): (C) by inserting before paragraph (2), as so
p.(None): redesignated, the following:
p.(None): ``(1) an ability to recruit and place the students described
p.(None): in subsection (a) in areas with a high need and high demand
p.(None): population;'';
p.(None): (D) in paragraph (3), as so redesignated, by
p.(None): striking ``subsection (a)'' and inserting ``paragraph
p.(None): (2), especially individuals with mental disorder
p.(None): symptoms or diagnoses, particularly children and
p.(None): adolescents, and transitional-age youth'';
p.(None): (E) in paragraph (4), as so redesignated, by
p.(None): striking ``;'' and inserting ``; and''; and
p.(None): (F) in paragraph (5), as so redesignated, by
p.(None): striking ``; and'' and inserting a period;
p.(None): (3) in subsection (c), by striking ``authorized under
p.(None): subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
p.(None): and (3) of subsection (a)'';
...
p.(None): ``(e) Report to Congress.--Not later than 4 years after the date of
p.(None): enactment of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016, the Secretary shall include in the biennial report submitted to
p.(None): Congress under section 501(m) an assessment on the effectiveness of the
p.(None): grants under this section in--
p.(None): ``(1) providing graduate students support for experiential
p.(None): training (internship or field placement);
p.(None): ``(2) recruiting students interested in behavioral health
p.(None): practice;
p.(None): ``(3) recruiting students in accordance with subsection
p.(None): (b)(1);
p.(None): ``(4) developing and implementing interprofessional training
p.(None): and integration within primary care;
p.(None): ``(5) developing and implementing accredited field
p.(None): placements and internships; and
p.(None): ``(6) collecting data on the number of students trained in
p.(None): behavioral health care and the number of available accredited
p.(None): internships and field placements.
p.(None):
p.(None): ``(f) Authorization of Appropriations.--For each of fiscal years
p.(None): 2018 through 2022, there are authorized to be appropriated to carry out
p.(None): this section $50,000,000, to be allocated as follows:
p.(None): ``(1) For grants described in subsection (a)(1),
p.(None): $15,000,000.
p.(None): ``(2) For grants described in subsection (a)(2),
p.(None): $15,000,000.
p.(None): ``(3) For grants described in subsection (a)(3),
p.(None): $10,000,000.
p.(None): ``(4) For grants described in subsection (a)(4),
p.(None): $10,000,000.''.
p.(None):
p.(None): [[Page 130 STAT. 1250]]
p.(None):
p.(None): SEC. 9022. <> STRENGTHENING THE MENTAL AND
p.(None): SUBSTANCE USE DISORDERS WORKFORCE.
p.(None):
p.(None): Part D of title VII of the Public Health Service Act (42 U.S.C. 294
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 760. TRAINING DEMONSTRATION PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Secretary shall establish a training
p.(None): demonstration program to award grants to eligible entities to support--
p.(None): ``(1) training for medical residents and fellows to practice
p.(None): psychiatry and addiction medicine in underserved, community-
p.(None): based settings that integrate primary care with mental and
p.(None): substance use disorders prevention and treatment services;
p.(None): ``(2) training for nurse practitioners, physician
p.(None): assistants, health service psychologists, and social workers to
p.(None): provide mental and substance use disorders services in
p.(None): underserved community-based settings that integrate primary care
p.(None): and mental and substance use disorders services; and
p.(None): ``(3) establishing, maintaining, or improving academic units
p.(None): or programs that--
p.(None): ``(A) provide training for students or faculty,
p.(None): including through clinical experiences and research, to
p.(None): improve the ability to be able to recognize, diagnose,
p.(None): and treat mental and substance use disorders, with a
p.(None): special focus on addiction; or
p.(None): ``(B) develop evidence-based practices or
p.(None): recommendations for the design of the units or programs
p.(None): described in subparagraph (A), including curriculum
p.(None): content standards.
p.(None):
p.(None): ``(b) Activities.--
p.(None): ``(1) Training for residents and fellows.--A recipient of a
p.(None): grant under subsection (a)(1)--
p.(None): ``(A) shall use the grant funds--
p.(None): ``(i)(I) to plan, develop, and operate a
p.(None): training program for medical psychiatry residents
p.(None): and fellows in addiction medicine practicing in
p.(None): eligible entities described in subsection (c)(1);
p.(None): or
p.(None): ``(II) to train new psychiatric residents and
p.(None): fellows in addiction medicine to provide and
p.(None): expand access to integrated mental and substance
p.(None): use disorders services; and
p.(None): ``(ii) to provide at least 1 training track
p.(None): that is--
p.(None): ``(I) a virtual training track that
p.(None): includes an in-person rotation at a
p.(None): teaching health center or in a
p.(None): community-based setting, followed by a
p.(None): virtual rotation in which the resident
p.(None): or fellow continues to support the care
p.(None): of patients at the teaching health
p.(None): center or in the community-based setting
p.(None): through the use of health information
p.(None): technology and, as appropriate,
p.(None): telehealth services;
p.(None): ``(II) an in-person training track
p.(None): that includes a rotation, during which
p.(None): the resident or fellow practices at a
p.(None): teaching health center or in a
p.(None): community-based setting; or
p.(None): ``(III) an in-person training track
p.(None): that includes a rotation during which
p.(None): the resident practices in a community-
p.(None): based setting that specializes in the
p.(None):
p.(None): [[Page 130 STAT. 1251]]
p.(None):
p.(None): treatment of infants, children,
p.(None): adolescents, or pregnant or postpartum
p.(None): women; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such training.
p.(None): ``(2) Training for other providers.--A recipient of a grant
p.(None): under subsection (a)(2)--
p.(None): ``(A) shall use the grant funds to plan, develop, or
p.(None): operate a training program to provide mental and
p.(None): substance use disorders services in underserved,
p.(None): community-based settings, as appropriate, that integrate
p.(None): primary care and mental and substance use disorders
p.(None): prevention and treatment services; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such program.
p.(None): ``(3) Academic units or programs.--A recipient of a grant
p.(None): under subsection (a)(3) shall enter into a partnership with
p.(None): organizations such as an education accrediting organization
p.(None): (such as the Liaison Committee on Medical Education, the
p.(None): Accreditation Council for Graduate Medical Education, the
p.(None): Commission on Osteopathic College Accreditation, the
p.(None): Accreditation Commission for Education in Nursing, the
p.(None): Commission on Collegiate Nursing Education, the Accreditation
p.(None): Council for Pharmacy Education, the Council on Social Work
p.(None): Education, American Psychological Association Commission on
p.(None): Accreditation, or the Accreditation Review Commission on
p.(None): Education for the Physician Assistant) to carry out activities
p.(None): under subsection (a)(3).
p.(None):
p.(None): ``(c) Eligible Entities.--
p.(None): ``(1) Training for residents and fellows.--To be eligible to
p.(None): receive a grant under subsection (a)(1), an entity shall--
p.(None): ``(A) be a consortium consisting of--
p.(None): ``(i) at least one teaching health center; and
p.(None): ``(ii) the sponsoring institution (or parent
p.(None): institution of the sponsoring institution) of--
p.(None): ``(I) a psychiatry residency program
p.(None): that is accredited by the Accreditation
p.(None): Council of Graduate Medical Education
p.(None): (or the parent institution of such a
p.(None): program); or
p.(None): ``(II) a fellowship in addiction
p.(None): medicine, as determined appropriate by
p.(None): the Secretary; or
p.(None): ``(B) be an entity described in subparagraph (A)(ii)
p.(None): that provides opportunities for residents or fellows to
p.(None): train in community-based settings that integrate primary
p.(None): care with mental and substance use disorders prevention
p.(None): and treatment services.
p.(None): ``(2) Training for other providers.--To be eligible to
p.(None): receive a grant under subsection (a)(2), an entity shall be--
p.(None): ``(A) a teaching health center (as defined in
p.(None): section 749A(f));
p.(None): ``(B) a Federally qualified health center (as
p.(None): defined in section 1905(l)(2)(B) of the Social Security
p.(None): Act);
p.(None):
p.(None): [[Page 130 STAT. 1252]]
p.(None):
p.(None): ``(C) a community mental health center (as defined
p.(None): in section 1861(ff)(3)(B) of the Social Security Act);
p.(None): ``(D) a rural health clinic (as defined in section
p.(None): 1861(aa) of the Social Security Act);
p.(None): ``(E) a health center operated by the Indian Health
p.(None): Service, an Indian tribe, a tribal organization, or an
p.(None): urban Indian organization (as defined in section 4 of
p.(None): the Indian Health Care Improvement Act); or
p.(None): ``(F) an entity with a demonstrated record of
p.(None): success in providing training for nurse practitioners,
p.(None): physician assistants, health service psychologists, and
p.(None): social workers.
p.(None): ``(3) Academic units or programs.--To be eligible to receive
p.(None): a grant under subsection (a)(3), an entity shall be a school of
p.(None): medicine or osteopathic medicine, a nursing school, a physician
p.(None): assistant training program, a school of pharmacy, a school of
p.(None): social work, an accredited public or nonprofit private hospital,
p.(None): an accredited medical residency program, or a public or private
p.(None): nonprofit entity which the Secretary has determined is capable
p.(None): of carrying out such grant.
p.(None):
p.(None): ``(d) Priority.--
p.(None): ``(1) In general.--In awarding grants under subsection
p.(None): (a)(1) or (a)(2), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) demonstrate sufficient size, scope, and
p.(None): capacity to undertake the requisite training of an
p.(None): appropriate number of psychiatric residents, fellows,
p.(None): nurse practitioners, physician assistants, or social
p.(None): workers in addiction medicine per year to meet the needs
p.(None): of the area served;
p.(None): ``(B) demonstrate experience in training providers
p.(None): to practice team-based care that integrates mental and
p.(None): substance use disorder prevention and treatment services
p.(None): with primary care in community-based settings;
p.(None): ``(C) demonstrate experience in using health
p.(None): information technology and, as appropriate, telehealth
p.(None): to support--
p.(None): ``(i) the delivery of mental and substance use
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
p.(None): ``(B) an analysis of the effect of the demonstration
p.(None): program on the prevalence of untreated mental and
p.(None): substance use disorders in the surrounding communities
p.(None): of health centers participating in the demonstration;
p.(None): and
p.(None): ``(C) recommendations on whether the demonstration
p.(None): program should be expanded.
p.(None):
p.(None): ``(g) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $10,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9023. <> CLARIFICATION ON CURRENT
p.(None): ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
p.(None):
p.(None): The Administrator of the Health Resources and Services
p.(None): Administration shall clarify the eligibility pursuant to section
p.(None): 338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
p.(None): 1(b)(1)(B)) of child and adolescent psychiatrists for the National
p.(None): Health Service Corps Loan Repayment Program under subpart III of part D
p.(None): of title III of such Act (42 U.S.C. 254l et seq.).
p.(None): SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by adding at the end the following:
p.(None):
p.(None): ``PART K--MINORITY FELLOWSHIP PROGRAM
p.(None):
p.(None): ``SEC. 597. <> FELLOWSHIPS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall maintain a program, to be
p.(None): known as the Minority Fellowship Program, under which the Secretary
p.(None): shall award fellowships, which may include stipends, for the purposes
p.(None): of--
p.(None):
p.(None): [[Page 130 STAT. 1254]]
p.(None): ``(1) increasing the knowledge of mental and substance use
p.(None): disorders practitioners on issues related to prevention,
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
p.(None): practitioner shall for purposes of this subsection be considered to be a
p.(None): health professional volunteer at an entity described in subsection
p.(None): (g)(4) if the following conditions are met:
p.(None): ``(A) The service is provided to the individual at the
p.(None): facilities of an entity described in subsection (g)(4), or
p.(None): through offsite programs or events carried out by the entity.
p.(None): ``(B) The entity is sponsoring the health care practitioner
p.(None): pursuant to paragraph (3)(B).
p.(None): ``(C) The health care practitioner does not receive any
p.(None): compensation for the service from the individual, the entity
...
p.(None):
p.(None): [[Page 130 STAT. 1256]]
p.(None):
p.(None): under such subsection regarding officers, governing board members,
p.(None): employees, and contractors of entities described in subsection (g)(4).
p.(None): ``(iii) The report shall include a summary of the data relied upon
p.(None): for the estimate in clause (i), including the number of claims filed and
p.(None): paid from the previous calendar year.
p.(None): ``(C) Not later than December 31 of each fiscal year, the Secretary
p.(None): shall transfer from the fund under subsection (k)(2) to the appropriate
p.(None): accounts in the Treasury an amount equal to the estimate made under
p.(None): subparagraph (B) for the calendar year beginning in such fiscal year,
p.(None): subject to the extent of amounts in the fund.
p.(None): ``(5)(A) This subsection shall take effect on October 1, 2017,
p.(None): except as provided in subparagraph (B) and paragraph (6).
p.(None): ``(B) Effective on the date of the enactment of this subsection--
p.(None): ``(i) the Secretary may issue regulations for carrying out
p.(None): this subsection, and the Secretary may accept and consider
p.(None): applications submitted pursuant to paragraph (3)(B); and
p.(None): ``(ii) reports under paragraph (4)(B) may be submitted to
p.(None): Congress.
p.(None):
p.(None): ``(6) Beginning on October 1, 2022, this subsection shall cease to
p.(None): have any force or effect.''.
p.(None): SEC. 9026. REPORTS.
p.(None):
p.(None): (a) Workforce Development Report.--
p.(None): (1) In general.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Administrator of the Health Resources
p.(None): and Services Administration, in consultation with the Assistant
p.(None): Secretary for Mental Health and Substance Use, shall conduct a
p.(None): study and publicly post on the appropriate Internet website of
p.(None): the Department of Health and Human Services a report on the
p.(None): adult and pediatric mental health and substance use disorder
p.(None): workforce in order to inform Federal, State, and local efforts
p.(None): related to workforce enhancement.
p.(None): (2) Contents.--The report under this subsection shall
p.(None): contain--
p.(None): (A) national and State-level projections of the
p.(None): supply and demand of the mental health and substance use
p.(None): disorder health workforce, disaggregated by profession;
p.(None): (B) an assessment of the mental health and substance
p.(None): use disorder workforce capacity, strengths, and
p.(None): weaknesses as of the date of the report, including the
p.(None): extent to which primary care providers are preventing,
p.(None): screening, or referring for mental and substance use
p.(None): disorder services;
p.(None): (C) information on trends within the mental health
p.(None): and substance use disorder provider workforce, including
p.(None): the number of individuals expected to enter the mental
p.(None): health workforce over the next 5 years; and
p.(None): (D) any additional information determined by the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, in consultation with the Assistant
p.(None): Secretary for Mental Health and Substance Use, to be
p.(None): relevant to the mental health and substance use disorder
p.(None): provider workforce.
p.(None):
p.(None): (b) Peer-Support Specialist Programs.--
p.(None): (1) In general.--The Comptroller General of the United
p.(None): States shall conduct a study on peer-support specialist programs
p.(None): in up to 10 States that receive funding from the Substance Abuse
p.(None): and Mental Health Services Administration.
p.(None):
p.(None): [[Page 130 STAT. 1257]]
p.(None):
p.(None): (2) Contents of study.--In conducting the study under
p.(None): paragraph (1), the Comptroller General of the United States
p.(None): shall examine and identify best practices, in the States
p.(None): selected pursuant to such paragraph, related to training and
p.(None): credential requirements for peer-support specialist programs,
p.(None): such as--
p.(None): (A) hours of formal work or volunteer experience
p.(None): related to mental and substance use disorders conducted
p.(None): through such programs;
p.(None): (B) types of peer-support specialist exams required
p.(None): for such programs in the selected States;
p.(None): (C) codes of ethics used by such programs in the
p.(None): selected States;
p.(None): (D) required or recommended skill sets for such
p.(None): programs in the selected States; and
p.(None): (E) requirements for continuing education.
p.(None): (3) Report.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Comptroller General of the United
p.(None): States shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives a report on the
p.(None): study conducted under paragraph (1).
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON
p.(None): CAMPUS.
p.(None):
p.(None): Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 36b) is amended--
p.(None): (1) in the section heading, by striking ``and behavioral
p.(None): health'' and inserting ``health and substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Services,'' and inserting
p.(None): ``Services and'';
p.(None): (B) by striking ``and behavioral health problems''
p.(None): and inserting ``health or substance use disorders'';
p.(None): (C) by striking ``substance abuse'' and inserting
p.(None): ``substance use disorders''; and
p.(None): (D) by adding after, ``suicide attempts,'' the
p.(None): following: ``prevent mental and substance use disorders,
p.(None): reduce stigma, and improve the identification and
p.(None): treatment for students at risk,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``for--'' and inserting ``for one or more of
p.(None): the following:''; and
p.(None): (B) by striking paragraphs (1) through (6) and
p.(None): inserting the following:
p.(None): ``(1) Educating students, families, faculty, and staff to
p.(None): increase awareness of mental and substance use disorders.
p.(None): ``(2) The operation of hotlines.
p.(None): ``(3) Preparing informational material.
p.(None): ``(4) Providing outreach services to notify students about
p.(None): available mental and substance use disorder services.
p.(None): ``(5) Administering voluntary mental and substance use
p.(None): disorder screenings and assessments.
p.(None):
p.(None): [[Page 130 STAT. 1258]]
p.(None):
p.(None): ``(6) Supporting the training of students, faculty, and
p.(None): staff to respond effectively to students with mental and
p.(None): substance use disorders.
p.(None): ``(7) Creating a network infrastructure to link institutions
p.(None): of higher education with health care providers who treat mental
p.(None): and substance use disorders.
p.(None): ``(8) Providing mental and substance use disorders
p.(None): prevention and treatment services to students, which may include
p.(None): recovery support services and programming and early
p.(None): intervention, treatment, and management, including through the
p.(None): use of telehealth services.
p.(None): ``(9) Conducting research through a counseling or health
p.(None): center at the institution of higher education involved regarding
p.(None): improving the behavioral health of students through clinical
p.(None): services, outreach, prevention, or academic success, in a manner
p.(None): that is in compliance with all applicable personal privacy laws.
p.(None): ``(10) Supporting student groups on campus, including
p.(None): athletic teams, that engage in activities to educate students,
p.(None): including activities to reduce stigma surrounding mental and
p.(None): behavioral disorders, and promote mental health.
p.(None): ``(11) Employing appropriately trained staff.
p.(None): ``(12) Developing and supporting evidence-based and emerging
p.(None): best practices, including a focus on culturally and
p.(None): linguistically appropriate best practices.'';
p.(None): (4) in subsection (c)(5), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (5) in subsection (d)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``An institution of higher education desiring a
p.(None): grant under this section'' and inserting ``To be
p.(None): eligible to receive a grant under this section, an
p.(None): institution of higher education'';
p.(None): (B) by striking paragraph (1) and inserting--
p.(None): ``(1) A description of the population to be targeted by the
p.(None): program carried out under the grant, including veterans whenever
p.(None): possible and appropriate, and of identified mental and substance
p.(None): use disorder needs of students at the institution of higher
p.(None): education.'';
p.(None): (C) in paragraph (2), by inserting ``, which may
p.(None): include, as appropriate and in accordance with
p.(None): subsection (b)(7), a plan to seek input from relevant
p.(None): stakeholders in the community, including appropriate
p.(None): public and private entities, in order to carry out the
p.(None): program under the grant'' before the period at the end;
p.(None): and
p.(None): (D) by adding after paragraph (5) the following new
p.(None): paragraphs:
p.(None): ``(6) An outline of the objectives of the program carried
p.(None): out under the grant.
p.(None): ``(7) For an institution of higher education proposing to
p.(None): use the grant for an activity described in paragraph (8) or (9)
p.(None): of subsection (b), a description of the policies and procedures
p.(None): of the institution of higher education that are related to
p.(None): applicable laws regarding access to, and sharing of, treatment
p.(None): records of students at any campus-based mental health center or
p.(None): partner organization, including the policies and State laws
p.(None): governing when such records can be accessed and shared for non-
p.(None): treatment purposes and a description of the process used
p.(None):
p.(None): [[Page 130 STAT. 1259]]
p.(None):
p.(None): by the institution of higher education to notify students of
p.(None): these policies and procedures, including the extent to which
p.(None): written consent is required.
p.(None): ``(8) An assurance that grant funds will be used to
p.(None): supplement and not supplant any other Federal, State, or local
p.(None): funds available to carry out activities of the type carried out
p.(None): under the grant.'';
p.(None): (6) in subsection (e)(1), by striking ``and behavioral
p.(None): health problems'' and inserting ``health and substance use
p.(None): disorders'';
p.(None): (7) in subsection (f)(2)--
p.(None): (A) by striking ``and behavioral health'' and
p.(None): inserting ``health and substance use disorder''; and
p.(None): (B) by striking ``suicide and substance abuse'' and
p.(None): inserting ``suicide and substance use disorders'';
p.(None): (8) by redesignating subsection (h) as subsection (i);
p.(None): (9) by inserting after subsection (g) the following new
p.(None): subsection:
p.(None):
p.(None): ``(h) Technical Assistance.--The Secretary may provide technical
p.(None): assistance to grantees in carrying out this section.''; and
p.(None): (10) in subsection (i), as redesignated by paragraph (8), by
p.(None): striking ``$5,000,000 for fiscal year 2005'' and all that
p.(None): follows through the period at the end and inserting ``$7,000,000
p.(None): for each of fiscal years 2018 through 2022.''.
p.(None): SEC. 9032. <> INTERAGENCY WORKING
p.(None): GROUP ON COLLEGE MENTAL HEALTH.
p.(None):
p.(None): (a) Purpose.--It is the purpose of this section to provide for the
p.(None): establishment of a College Campus Task Force to discuss mental and
p.(None): behavioral health concerns on campuses of institutions of higher
p.(None): education.
p.(None): (b) Establishment.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall establish a
p.(None): College Campus Task Force (referred to in this section as the ``Task
p.(None): Force'') to discuss mental and behavioral health concerns on campuses of
p.(None): institutions of higher education.
p.(None): (c) Membership.--The Task Force shall be composed of a
p.(None): representative from each Federal agency (as appointed by the head of the
p.(None): agency) that has jurisdiction over, or is affected by, mental health and
p.(None): education policies and projects, including--
p.(None): (1) the Department of Education;
p.(None): (2) the Department of Health and Human Services;
p.(None): (3) the Department of Veterans Affairs; and
p.(None): (4) such other Federal agencies as the Assistant Secretary
p.(None): for Mental Health and Substance Use, in consultation with the
p.(None): Secretary, determines to be appropriate.
p.(None):
p.(None): (d) Duties.--The Task Force shall--
p.(None): (1) serve as a centralized mechanism to coordinate a
p.(None): national effort to--
p.(None): (A) discuss and evaluate evidence and knowledge on
p.(None): mental and behavioral health services available to, and
p.(None): the prevalence of mental illness among, the age
p.(None): population of students attending institutions of higher
p.(None): education in the United States;
p.(None): (B) determine the range of effective, feasible, and
p.(None): comprehensive actions to improve mental and behavioral
p.(None): health on campuses of institutions of higher education;
p.(None):
p.(None): [[Page 130 STAT. 1260]]
p.(None):
p.(None): (C) examine and better address the needs of the age
p.(None): population of students attending institutions of higher
p.(None): education dealing with mental illness;
p.(None): (D) survey Federal agencies to determine which
p.(None): policies are effective in encouraging, and how best to
p.(None): facilitate outreach without duplicating, efforts
p.(None): relating to mental and behavioral health promotion;
p.(None): (E) establish specific goals within and across
p.(None): Federal agencies for mental health promotion, including
p.(None): determinations of accountability for reaching those
p.(None): goals;
p.(None): (F) develop a strategy for allocating
p.(None): responsibilities and ensuring participation in mental
...
p.(None): population of students at institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
p.(None): ``(3) provides support for local efforts to reduce stigma by
p.(None): using the National Health Information Center as a primary point
p.(None): of contact for information, publications, and service program
p.(None): referrals; and
p.(None):
p.(None): [[Page 130 STAT. 1262]]
p.(None):
p.(None): ``(4) develops and proposes the implementation of a social
p.(None): marketing campaign that is targeted at the population of
p.(None): students attending institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education.
p.(None):
p.(None): ``(e) Definition.--In this section, the term `institution of higher
p.(None): education' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
p.(None): DISTURBANCE.
p.(None):
p.(None): (a) Comprehensive Community Mental Health Services for Children With
p.(None): a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
p.(None): may include efforts to identify and serve children at risk'' before the
p.(None): period.
p.(None): (b) Requirements With Respect to Carrying Out Purpose of Grants.--
p.(None): Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b))
p.(None): is amended by striking ``will not provide an individual with access to
p.(None): the system if the individual is more than 21 years of age'' and
p.(None): inserting ``will provide an individual with access to the system through
p.(None): the age of 21 years''.
p.(None): (c) Additional Provisions.--Section 564(f) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and
p.(None): provide a copy to the State involved)'' after ``to the Secretary''.
p.(None): (d) General Provisions.--Section 565 of the Public Health Service
p.(None): Act (42 U.S.C. 290ff-4) is amended--
p.(None): (1) in subsection (b)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
...
p.(None): ``(d) Evaluation.--A State, political subdivision of a State, Indian
p.(None): tribe, or tribal organization that receives a grant under this section
p.(None): shall prepare and submit an evaluation of activities that are carried
p.(None): out with funds received under such grant to the Secretary at such time,
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
p.(None): under this section unless the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization involved agrees, with respect to
p.(None): the costs to be incurred by the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization in carrying out the purpose
p.(None): described in this section, to make available non-Federal contributions
p.(None): (in cash or in kind) toward such costs in an amount that is not less
p.(None): than 20 percent of Federal funds provided in the grant.
p.(None): ``(g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated, $9,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
p.(None): INTERVENTION SERVICES FOR CHILDREN AND
p.(None): ADOLESCENTS.
p.(None):
p.(None): The first section 514 of the Public Health Service Act (42 U.S.C.
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
...
p.(None): confusion may hinder appropriate communication of health care
p.(None): information or treatment preferences with appropriate
p.(None): caregivers.
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that
p.(None): clarification is needed regarding the privacy rule promulgated under
p.(None): section 264(c) of the Health Insurance Portability and Accountability
p.(None): Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses
p.(None): and disclosures of health information by health care professionals to
p.(None): communicate with caregivers of adults with a serious mental illness to
p.(None): facilitate treatment.
p.(None): SEC. 11002. CONFIDENTIALITY OF RECORDS.
p.(None): Not later than 1 year after the date on which the Secretary of
p.(None): Health and Human Services (in this title referred to as the
p.(None): ``Secretary'') first finalizes regulations updating part 2 of title 42,
p.(None): Code of Federal Regulations, relating to confidentiality of alcohol and
p.(None): drug abuse patient records, after the date of enactment of this Act, the
p.(None): Secretary shall convene relevant stakeholders to determine the effect of
p.(None): such regulations on patient care, health outcomes, and patient privacy.
p.(None): SEC. 11003. <> CLARIFICATION ON
p.(None): PERMITTED USES AND DISCLOSURES OF
p.(None): PROTECTED HEALTH INFORMATION.
p.(None):
p.(None): (a) In General.--The Secretary, acting through the Director of the
p.(None): Office for Civil Rights, shall ensure that health care providers,
p.(None): professionals, patients and their families, and others involved in
p.(None): mental or substance use disorder treatment have adequate, accessible,
p.(None): and easily comprehensible resources relating to appropriate uses and
p.(None): disclosures of protected health information under the regulations
p.(None): promulgated under section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
p.(None): (b) Guidance.--
p.(None): (1) Issuance.--In carrying out subsection (a), not later
p.(None): than 1 year after the date of enactment of this section, the
p.(None): Secretary shall issue guidance clarifying the circumstances
p.(None): under which, consistent with regulations promulgated under
p.(None): section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996, a health care provider or covered
p.(None): entity may use or disclose protected health information.
p.(None): (2) Circumstances addressed.--The guidance issued under this
p.(None): section shall address circumstances including those that--
p.(None): (A) require the consent of the patient;
p.(None): (B) require providing the patient with an
p.(None): opportunity to object;
p.(None): (C) are based on the exercise of professional
p.(None): judgment regarding whether the patient would object when
p.(None): the opportunity to object cannot practicably be provided
p.(None): because of the incapacity of the patient or an emergency
p.(None): treatment circumstance; and
p.(None): (D) are determined, based on the exercise of
p.(None): professional judgment, to be in the best interest of the
p.(None): patient when the patient is not present or otherwise
p.(None): incapacitated.
p.(None):
p.(None): [[Page 130 STAT. 1271]]
p.(None):
...
p.(None): hold or involuntary treatment.
p.(None): SEC. 11004. <> DEVELOPMENT AND
p.(None): DISSEMINATION OF MODEL TRAINING
p.(None): PROGRAMS.
p.(None):
p.(None): (a) Initial Programs and Materials.--Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary, in consultation with
p.(None): appropriate experts, shall identify the following model programs and
p.(None): materials, or (in the case that no such programs or materials exist)
p.(None): recognize private or public entities to develop and disseminate each of
p.(None): the following:
p.(None): (1) Model programs and materials for training health care
p.(None): providers (including physicians, emergency medical personnel,
p.(None): psychiatrists, including child and adolescent psychiatrists,
p.(None): psychologists, counselors, therapists, nurse practitioners,
p.(None): physician assistants, behavioral health facilities and clinics,
p.(None): care managers, and hospitals, including individuals such as
p.(None): general counsels or regulatory compliance staff who are
p.(None): responsible for establishing provider privacy policies)
p.(None): regarding the permitted uses and disclosures, consistent with
p.(None): the standards governing the privacy and security of individually
p.(None): identifiable health information promulgated by the Secretary
p.(None): under part C of title XI of the Social Security Act (42 U.S.C.
p.(None): 1320d et seq.) and regulations promulgated under section 264(c)
p.(None): of the Health Insurance Portability and Accountability Act of
p.(None): 1996 (42 U.S.C. 1320d-2 note) and such part C, of the protected
p.(None): health information of patients seeking or undergoing mental or
p.(None): substance use disorder treatment.
p.(None):
p.(None): [[Page 130 STAT. 1272]]
p.(None):
p.(None): (2) A model program and materials for training patients and
p.(None): their families regarding their rights to protect and obtain
p.(None): information under the standards and regulations specified in
p.(None): paragraph (1).
p.(None):
p.(None): (b) Periodic Updates.--The Secretary shall--
p.(None): (1) periodically review and update the model programs and
p.(None): materials identified or developed under subsection (a); and
p.(None): (2) disseminate the updated model programs and materials to
p.(None): the individuals described in subsection (a).
p.(None):
p.(None): (c) Coordination.--The Secretary shall carry out this section in
p.(None): coordination with the Director of the Office for Civil Rights within the
p.(None): Department of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, the Administrator of the Health
p.(None): Resources and Services Administration, and the heads of other relevant
p.(None): agencies within the Department of Health and Human Services.
p.(None): (d) Input of Certain Entities.--In identifying, reviewing, or
p.(None): updating the model programs and materials under subsections (a) and (b),
p.(None): the Secretary shall solicit the input of relevant national, State, and
p.(None): local associations; medical societies; licensing boards; providers of
p.(None): mental and substance use disorder treatment; organizations with
p.(None): expertise on domestic violence, sexual assault, elder abuse, and child
p.(None): abuse; and organizations representing patients and consumers and the
p.(None): families of patients and consumers.
p.(None): (e) Funding.--There are authorized to be appropriated to carry out
p.(None): this section--
p.(None): (1) $4,000,000 for fiscal year 2018;
p.(None): (2) $2,000,000 for each of fiscal years 2019 and 2020; and
p.(None): (3) $1,000,000 for each of fiscal years 2021 and 2022.
p.(None):
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): SEC. 12001. <> RULE OF CONSTRUCTION
p.(None): RELATED TO MEDICAID COVERAGE OF MENTAL
p.(None): HEALTH SERVICES AND PRIMARY CARE
p.(None): SERVICES FURNISHED ON THE SAME DAY.
p.(None):
p.(None): Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.) shall be construed as prohibiting separate payment under the State
p.(None): plan under such title (or under a waiver of the plan) for the provision
p.(None): of a mental health service or primary care service under such plan, with
p.(None): respect to an individual, because such service is--
p.(None): (1) a primary care service furnished to the individual by a
p.(None): provider at a facility on the same day a mental health service
p.(None): is furnished to such individual by such provider (or another
p.(None): provider) at the facility; or
p.(None): (2) a mental health service furnished to the individual by a
p.(None): provider at a facility on the same day a primary care service is
p.(None): furnished to such individual by such provider (or another
...
p.(None): (as defined in section 1903(m) of such Act (42 U.S.C. 1396b(m)) or a
p.(None): prepaid inpatient health plan (as defined in section 438.2 of title 42,
p.(None): Code of Federal Regulations (or any successor regulation)) with respect
p.(None): to individuals over the age of 21 and under the age of 65 for the
p.(None): treatment of a mental health disorder in institutions for mental
p.(None): diseases (as defined in section 1905(i) of such Act (42 U.S.C.
p.(None): 1396d(i))). Such study shall include information on the following:
p.(None): (1) The extent to which States, including the District of
p.(None): Columbia and each territory or possession of the United States,
p.(None): are providing capitated payments to such organizations or plans
p.(None): for enrollees who are receiving services in institutions for
p.(None): mental diseases.
p.(None): (2) The number of individuals receiving medical assistance
p.(None): under a State plan under such title XIX, or a waiver of such
p.(None): plan, who receive services in institutions for mental diseases
p.(None): through such organizations and plans.
p.(None): (3) The range of and average number of months, and the
p.(None): length of stay during such months, that such individuals are
p.(None): receiving such services in such institutions.
p.(None): (4) How such organizations or plans determine when to
p.(None): provide for the furnishing of such services through an
p.(None): institution for mental diseases in lieu of other benefits
p.(None): (including the full range of community-based services) under
p.(None): their contract with the State agency administering the State
p.(None): plan under such title XIX, or a waiver of such plan, to address
p.(None): psychiatric or substance use disorder treatment.
p.(None): (5) The extent to which the provision of services within
p.(None): such institutions has affected the capitated payments for such
p.(None): organizations or plans.
p.(None):
p.(None): (b) Report.--Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary shall submit to Congress a report on the
p.(None): study conducted under subsection (a).
p.(None): SEC. 12003. <> GUIDANCE ON OPPORTUNITIES
p.(None): FOR INNOVATION.
p.(None):
p.(None): Not later than 1 year after the date of the enactment of this Act,
p.(None): the Administrator of the Centers for Medicare & Medicaid Services shall
p.(None): issue a State Medicaid Director letter regarding opportunities to design
p.(None): innovative service delivery systems, including systems for providing
p.(None): community-based services, for adults with a serious mental illness or
p.(None): children with a serious emotional disturbance who are receiving medical
p.(None): assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.). The letter shall include opportunities for demonstration projects
p.(None): under section 1115 of such Act (42 U.S.C. 1315) to improve care for such
p.(None): adults and children.
p.(None): SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC
p.(None): DEMONSTRATION PROJECT.
p.(None):
p.(None): (a) Collection of Information.--The Secretary of Health and Human
p.(None): Services, acting through the Administrator of the Centers for Medicare &
p.(None): Medicaid Services, shall, to the extent practical and data is available,
...
p.(None): Services and the Department of Labor, entitled `Warning
p.(None): Signs - Plan or Policy Non-Quantitative Treatment
p.(None): Limitations (NQTLs) that Require Additional Analysis to
p.(None): Determine Mental Health Parity Compliance'.
p.(None): ``(B) Examples illustrating compliance and
p.(None): noncompliance.--
p.(None):
p.(None): [[Page 130 STAT. 1279]]
p.(None):
p.(None): ``(i) In general.--The compliance program
p.(None): guidance document required under this paragraph
p.(None): shall provide illustrative, de-identified examples
p.(None): (that do not disclose any protected health
p.(None): information or individually identifiable
p.(None): information) of previous findings of compliance
p.(None): and noncompliance with this section, section 712
p.(None): of the Employee Retirement Income Security Act of
p.(None): 1974, or section 9812 of the Internal Revenue Code
p.(None): of 1986, as applicable, based on investigations of
p.(None): violations of such sections, including--
p.(None): ``(I) examples illustrating
p.(None): requirements for information disclosures
p.(None): and nonquantitative treatment
p.(None): limitations; and
p.(None): ``(II) descriptions of the
p.(None): violations uncovered during the course
p.(None): of such investigations.
p.(None): ``(ii) Nonquantitative treatment
p.(None): limitations.--To the extent that any example
p.(None): described in clause (i) involves a finding of
p.(None): compliance or noncompliance with regard to any
p.(None): requirement for nonquantitative treatment
p.(None): limitations, the example shall provide sufficient
p.(None): detail to fully explain such finding, including a
p.(None): full description of the criteria involved for
p.(None): approving medical and surgical benefits and the
p.(None): criteria involved for approving mental health and
p.(None): substance use disorder benefits.
p.(None): ``(iii) Access to additional information
p.(None): regarding compliance.--In developing and issuing
p.(None): the compliance program guidance document required
p.(None): under this paragraph, the Secretaries specified in
p.(None): subparagraph (A)--
p.(None): ``(I) shall enter into interagency
p.(None): agreements with the Inspector General of
p.(None): the Department of Health and Human
p.(None): Services, the Inspector General of the
p.(None): Department of Labor, and the Inspector
p.(None): General of the Department of the
p.(None): Treasury to share findings of compliance
p.(None): and noncompliance with this section,
p.(None): section 712 of the Employee Retirement
p.(None): Income Security Act of 1974, or section
p.(None): 9812 of the Internal Revenue Code of
p.(None): 1986, as applicable; and
p.(None): ``(II) shall seek to enter into an
p.(None): agreement with a State to share
p.(None): information on findings of compliance
p.(None): and noncompliance with this section,
p.(None): section 712 of the Employee Retirement
p.(None): Income Security Act of 1974, or section
p.(None): 9812 of the Internal Revenue Code of
p.(None): 1986, as applicable.
p.(None): ``(C) Recommendations.--The compliance program
p.(None): guidance document shall include recommendations to
p.(None): advance compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, or
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable, and encourage the development and use of
p.(None): internal controls to monitor adherence to applicable
p.(None): statutes, regulations, and program requirements. Such
p.(None): internal controls may include illustrative examples of
p.(None): nonquantitative treatment limitations on mental health
p.(None): and substance use disorder benefits, which may fail to
p.(None): comply with this
p.(None):
p.(None): [[Page 130 STAT. 1280]]
p.(None):
p.(None): section, section 712 of the Employee Retirement Income
p.(None): Security Act of 1974, or section 9812 of the Internal
p.(None): Revenue Code of 1986, as applicable, in relation to
p.(None): nonquantitative treatment limitations on medical and
p.(None): surgical benefits.
p.(None): ``(D) Updating the compliance program guidance
p.(None): document.--The Secretary, the Secretary of Labor, and
p.(None): the Secretary of the Treasury, in consultation with the
p.(None): Inspector General of the Department of Health and Human
p.(None): Services, the Inspector General of the Department of
p.(None): Labor, and the Inspector General of the Department of
p.(None): the Treasury, shall update the compliance program
p.(None): guidance document every 2 years to include illustrative,
p.(None): de-identified examples (that do not disclose any
p.(None): protected health information or individually
p.(None): identifiable information) of previous findings of
p.(None): compliance and noncompliance with this section, section
p.(None): 712 of the Employee Retirement Income Security Act of
p.(None): 1974, or section 9812 of the Internal Revenue Code of
p.(None): 1986, as applicable.''.
p.(None):
p.(None): (b) Additional Guidance.--Section 2726(a) of the Public Health
p.(None): Service Act (42 U.S.C. 300gg-26(a)), as amended by subsection (a), is
p.(None): further amended by adding at the end the following:
p.(None): ``(7) Additional guidance.--
p.(None): ``(A) In general.--Not later than 12 months after
p.(None): the date of enactment of the Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016, the Secretary, the
p.(None): Secretary of Labor, and the Secretary of the Treasury
p.(None): shall issue guidance to group health plans and health
...
p.(None): health insurance coverage may use for disclosing
p.(None): information to ensure compliance with the
p.(None): requirements under this section, section 712 of
p.(None): the Employee Retirement Income Security Act of
p.(None): 1974, or section 9812 of the Internal Revenue Code
p.(None): of 1986, as applicable, (and any regulations
p.(None): promulgated pursuant to such sections, as
p.(None): applicable).
p.(None): ``(ii) Documents for participants,
p.(None): beneficiaries, contracting providers, or
p.(None): authorized representatives.--The guidance issued
p.(None): under this paragraph shall include clarifying
p.(None): information and illustrative examples of methods
p.(None): that group health plans and health insurance
p.(None): issuers offering group or individual health
p.(None): insurance coverage may use to provide any
p.(None): participant, beneficiary, contracting provider, or
p.(None): authorized representative, as applicable, with
p.(None): documents containing information that the health
p.(None): plans or issuers are required to disclose to
p.(None): participants, beneficiaries, contracting
p.(None): providers, or authorized representatives to ensure
p.(None): compliance with this section,
p.(None):
p.(None): [[Page 130 STAT. 1281]]
p.(None):
p.(None): section 712 of the Employee Retirement Income
p.(None): Security Act of 1974, or section 9812 of the
p.(None): Internal Revenue Code of 1986, as applicable,
p.(None): compliance with any regulation issued pursuant to
p.(None): such respective section, or compliance with any
p.(None): other applicable law or regulation. Such guidance
p.(None): shall include information that is comparative in
p.(None): nature with respect to--
p.(None): ``(I) nonquantitative treatment
p.(None): limitations for both medical and
p.(None): surgical benefits and mental health and
p.(None): substance use disorder benefits;
p.(None): ``(II) the processes, strategies,
p.(None): evidentiary standards, and other factors
p.(None): used to apply the limitations described
p.(None): in subclause (I); and
p.(None): ``(III) the application of the
p.(None): limitations described in subclause (I)
p.(None): to ensure that such limitations are
p.(None): applied in parity with respect to both
p.(None): medical and surgical benefits and mental
p.(None): health and substance use disorder
p.(None): benefits.
p.(None): ``(C) Nonquantitative treatment limitations.--The
p.(None): guidance issued under this paragraph shall include
p.(None): clarifying information and illustrative examples of
p.(None): methods, processes, strategies, evidentiary standards,
p.(None): and other factors that group health plans and health
p.(None): insurance issuers offering group or individual health
p.(None): insurance coverage may use regarding the development and
p.(None): application of nonquantitative treatment limitations to
p.(None): ensure compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, or
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable, (and any regulations promulgated pursuant to
p.(None): such respective section), including--
p.(None): ``(i) examples of methods of determining
p.(None): appropriate types of nonquantitative treatment
p.(None): limitations with respect to both medical and
p.(None): surgical benefits and mental health and substance
p.(None): use disorder benefits, including nonquantitative
p.(None): treatment limitations pertaining to--
p.(None): ``(I) medical management standards
p.(None): based on medical necessity or
p.(None): appropriateness, or whether a treatment
p.(None): is experimental or investigative;
p.(None): ``(II) limitations with respect to
p.(None): prescription drug formulary design; and
p.(None): ``(III) use of fail-first or step
p.(None): therapy protocols;
p.(None): ``(ii) examples of methods of determining--
p.(None): ``(I) network admission standards
p.(None): (such as credentialing); and
p.(None): ``(II) factors used in provider
p.(None): reimbursement methodologies (such as
p.(None): service type, geographic market, demand
p.(None): for services, and provider supply,
p.(None): practice size, training, experience, and
p.(None): licensure) as such factors apply to
p.(None): network adequacy;
p.(None): ``(iii) examples of sources of information
p.(None): that may serve as evidentiary standards for the
p.(None): purposes of making determinations regarding the
p.(None): development and application of nonquantitative
p.(None): treatment limitations;
p.(None): ``(iv) examples of specific factors, and the
p.(None): evidentiary standards used to evaluate such
p.(None): factors, used
p.(None):
p.(None): [[Page 130 STAT. 1282]]
p.(None):
p.(None): by such plans or issuers in performing a
p.(None): nonquantitative treatment limitation analysis;
p.(None): ``(v) examples of how specific evidentiary
p.(None): standards may be used to determine whether
p.(None): treatments are considered experimental or
p.(None): investigative;
p.(None): ``(vi) examples of how specific evidentiary
p.(None): standards may be applied to each service category
p.(None): or classification of benefits;
p.(None): ``(vii) examples of methods of reaching
p.(None): appropriate coverage determinations for new mental
p.(None): health or substance use disorder treatments, such
p.(None): as evidence-based early intervention programs for
p.(None): individuals with a serious mental illness and
p.(None): types of medical management techniques;
p.(None): ``(viii) examples of methods of reaching
p.(None): appropriate coverage determinations for which
p.(None): there is an indirect relationship between the
p.(None): covered mental health or substance use disorder
p.(None): benefit and a traditional covered medical and
p.(None): surgical benefit, such as residential treatment or
p.(None): hospitalizations involving voluntary or
p.(None): involuntary commitment; and
p.(None): ``(ix) additional illustrative examples of
p.(None): methods, processes, strategies, evidentiary
p.(None): standards, and other factors for which the
p.(None): Secretary determines that additional guidance is
p.(None): necessary to improve compliance with this section,
p.(None): section 712 of the Employee Retirement Income
p.(None): Security Act of 1974, or section 9812 of the
p.(None): Internal Revenue Code of 1986, as applicable.
p.(None): ``(D) Public comment.--Prior to issuing any final
p.(None): guidance under this paragraph, the Secretary shall
p.(None): provide a public comment period of not less than 60 days
p.(None): during which any member of the public may provide
p.(None): comments on a draft of the guidance.''.
p.(None):
p.(None): (c) Availability of Plan Information.--
p.(None): (1) Solicitation of public feedback.--Not later than 6
p.(None): months after the date of enactment of this Act, the Secretary of
p.(None): Health and Human Services, the Secretary of Labor, and the
p.(None): Secretary of the Treasury shall solicit feedback from the public
p.(None): on how the disclosure request process for documents containing
p.(None): information that health plans or health insurance issuers are
p.(None): required under Federal or State law to disclose to participants,
p.(None): beneficiaries, contracting providers, or authorized
p.(None): representatives to ensure compliance with existing mental health
p.(None): parity and addiction equity requirements can be improved while
p.(None): continuing to ensure consumers' rights to access all information
p.(None): required by Federal or State law to be disclosed.
...
p.(None):
p.(None): [[Page 130 STAT. 1283]]
p.(None):
p.(None): may be taken into consideration by the National Association of
p.(None): Insurance Commissioners and other appropriate entities for the
p.(None): voluntary development and voluntary use of common templates and
p.(None): other sample standardized forms to improve consumer access to
p.(None): plan information.
p.(None):
p.(None): (d) Improving Compliance.--
p.(None): (1) <> In general.--In the
p.(None): case that the Secretary of Health and Human Services, the
p.(None): Secretary of Labor, or the Secretary of the Treasury determines
p.(None): that a group health plan or health insurance issuer offering
p.(None): group or individual health insurance coverage has violated, at
p.(None): least 5 times, section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), or section 9812 of the
p.(None): Internal Revenue Code of 1986, respectively, the appropriate
p.(None): Secretary shall audit plan documents for such health plan or
p.(None): issuer in the plan year following the Secretary's determination
p.(None): in order to help improve compliance with such section.
p.(None): (2) Rule of construction.--Nothing in this subsection shall
p.(None): be construed to limit the authority, as in effect on the day
p.(None): before the date of enactment of this Act, of the Secretary of
p.(None): Health and Human Services, the Secretary of Labor, or the
p.(None): Secretary of the Treasury to audit documents of health plans or
p.(None): health insurance issuers.
p.(None): SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL HEALTH
p.(None): AND SUBSTANCE USE DISORDER COVERAGE.
p.(None):
p.(None): (a) Public Meeting.--
p.(None): (1) In general.--Not later than 6 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services shall convene a public meeting of stakeholders
p.(None): described in paragraph (2) to produce an action plan for
p.(None): improved Federal and State coordination related to the
p.(None): enforcement of section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the
p.(None): Internal Revenue Code of 1986, and any comparable provisions of
p.(None): State law (in this section such sections and provisions are
p.(None): collectively referred to as ``mental health parity and addiction
p.(None): equity requirements'').
p.(None): (2) Stakeholders.--The stakeholders described in this
p.(None): paragraph shall include each of the following:
p.(None): (A) The Federal Government, including
p.(None): representatives from--
p.(None): (i) the Department of Health and Human
p.(None): Services;
p.(None): (ii) the Department of the Treasury;
p.(None): (iii) the Department of Labor; and
p.(None): (iv) the Department of Justice.
p.(None): (B) State governments, including--
p.(None): (i) State health insurance commissioners;
p.(None): (ii) appropriate State agencies, including
p.(None): agencies on public health or mental health; and
p.(None): (iii) State attorneys general or other
p.(None): representatives of State entities involved in the
p.(None): enforcement of mental health parity and addiction
p.(None): equity requirements.
p.(None):
p.(None): [[Page 130 STAT. 1284]]
p.(None):
p.(None): (C) Representatives from key stakeholder groups,
p.(None): including--
p.(None): (i) the National Association of Insurance
p.(None): Commissioners;
p.(None): (ii) health insurance issuers;
p.(None): (iii) providers of mental health and substance
p.(None): use disorder treatment;
p.(None): (iv) employers; and
p.(None): (v) patients or their advocates.
p.(None):
p.(None): (b) Action Plan.--Not later than 6 months after the conclusion of
p.(None): the public meeting under subsection (a), the Secretary of Health and
p.(None): Human Services shall finalize the action plan described in such
p.(None): subsection and make it plainly available on the Internet website of the
p.(None): Department of Health and Human Services.
p.(None): (c) Content.--The action plan under this section shall--
p.(None): (1) take into consideration the recommendations of the
p.(None): Mental Health and Substance Use Disorder Parity Task Force in
p.(None): its final report issued in October of 2016, and any subsequent
p.(None): Federal and State actions in relation to such recommendations;
p.(None): (2) reflect the input of the stakeholders participating in
p.(None): the public meeting under subsection (a);
p.(None): (3) identify specific strategic objectives regarding how the
p.(None): various Federal and State agencies charged with enforcement of
p.(None): mental health parity and addiction equity requirements will
p.(None): collaborate to improve enforcement of such requirements;
p.(None): (4) provide a timeline for implementing the action plan; and
p.(None): (5) provide specific examples of how such objectives may be
p.(None): met, which may include--
p.(None): (A) providing common educational information and
p.(None): documents, such as the Consumer Guide to Disclosure
p.(None): Rights, to patients about their rights under mental
p.(None): health parity and addiction equity requirements;
p.(None): (B) facilitating the centralized collection of,
p.(None): monitoring of, and response to patient complaints or
p.(None): inquiries relating to mental health parity and addiction
p.(None): equity requirements, which may be through the
p.(None): development and administration of--
p.(None): (i) a single, toll-free telephone number; and
p.(None): (ii) a new parity website--
p.(None): (I) to help consumers find the
p.(None): appropriate Federal or State agency to
p.(None): assist with their parity complaints,
p.(None): appeals, and other actions; and
p.(None): (II) that takes into consideration,
p.(None): but is not duplicative of, the parity
p.(None): beta site being tested, and released for
p.(None): public comment, by the Department of
p.(None): Health and Human Services as of the date
...
p.(None): coordinate enforcement responsibilities and information
p.(None): sharing--
p.(None): (i) including whether such agencies should
p.(None): make the results of enforcement actions related to
p.(None): mental health parity and addiction equity
p.(None): requirements publicly available; and
p.(None):
p.(None): [[Page 130 STAT. 1285]]
p.(None):
p.(None): (ii) which may include State Policy Academies
p.(None): on Parity Implementation for State Officials and
p.(None): other forums to bring together national experts to
p.(None): provide technical assistance to teams of State
p.(None): officials on strategies to advance compliance with
p.(None): mental health parity and addiction equity
p.(None): requirements in both the commercial market, and in
p.(None): the Medicaid program under title XIX of the Social
p.(None): Security Act and the State Children's Health
p.(None): Insurance Program under title XXI of such Act; and
p.(None): (D) recommendations to the Congress regarding the
p.(None): need for additional legal authority to improve
p.(None): enforcement of mental health parity and addiction equity
p.(None): requirements, including the need for additional legal
p.(None): authority to ensure that nonquantitative treatment
p.(None): limitations are applied, and the extent and frequency of
p.(None): the applications of such limitations, both to medical
p.(None): and surgical benefits and to mental health and substance
p.(None): use disorder benefits in a comparable manner.
p.(None): SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL
p.(None): HEALTH AND SUBSTANCE USE DISORDER
p.(None): BENEFITS.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, and annually thereafter for the subsequent 5 years, the
p.(None): Assistant Secretary of Labor of the Employee Benefits Security
p.(None): Administration, in collaboration with the Administrator of the Centers
p.(None): for Medicare & Medicaid Services and the Secretary of the Treasury,
p.(None): shall submit to the Committee on Energy and Commerce of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report summarizing the results of all closed
p.(None): Federal investigations completed during the preceding 12-month period
p.(None): with findings of any serious violation regarding compliance with mental
p.(None): health and substance use disorder coverage requirements under section
p.(None): 2726 of the Public Health Service Act (42 U.S.C. 300gg-26), section 712
p.(None): of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
p.(None): 1185a), and section 9812 of the Internal Revenue Code of 1986.
p.(None): (b) Contents.--Subject to subsection (c), a report under subsection
p.(None): (a) shall, with respect to investigations described in such subsection,
p.(None): include each of the following:
p.(None): (1) The number of closed Federal investigations conducted
p.(None): during the covered reporting period.
p.(None): (2) Each benefit classification examined by any such
p.(None): investigation conducted during the covered reporting period.
p.(None): (3) Each subject matter, including compliance with
p.(None): requirements for quantitative and nonquantitative treatment
p.(None): limitations, of any such investigation conducted during the
p.(None): covered reporting period.
p.(None): (4) A summary of the basis of the final decision rendered
p.(None): for each closed investigation conducted during the covered
p.(None): reporting period that resulted in a finding of a serious
p.(None): violation.
p.(None):
p.(None): (c) Limitation.--Any individually identifiable information shall be
p.(None): excluded from reports under subsection (a) consistent with protections
p.(None): under the health privacy and security rules promulgated under section
p.(None): 264(c) of the Health Insurance Portability and Accountability Act of
p.(None): 1996 (42 U.S.C. 1320d-2 note).
p.(None):
p.(None): [[Page 130 STAT. 1286]]
p.(None):
p.(None): SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE
p.(None): DISORDER BENEFITS.
p.(None):
p.(None): Not later than 3 years after the date of enactment of this Act, the
p.(None): Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, the Secretary of Labor, and the
p.(None): Secretary of the Treasury, shall submit to the Committee on Energy and
p.(None): Commerce of the House of Representatives and the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate a report detailing the
p.(None): extent to which group health plans or health insurance issuers offering
p.(None): group or individual health insurance coverage that provides both medical
p.(None): and surgical benefits and mental health or substance use disorder
p.(None): benefits, medicaid managed care organizations with a contract under
p.(None): section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), and
p.(None): health plans provided under the State Children's Health Insurance
p.(None): Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et
p.(None): seq.) comply with section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income Security
p.(None): Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal Revenue
p.(None): Code of 1986, including--
p.(None): (1) how nonquantitative treatment limitations, including
p.(None): medical necessity criteria, of such plans or issuers comply with
p.(None): such sections;
p.(None): (2) how the responsible Federal departments and agencies
p.(None): ensure that such plans or issuers comply with such sections,
p.(None): including an assessment of how the Secretary of Health and Human
p.(None): Services has used its authority to conduct audits of such plans
p.(None): to ensure compliance;
p.(None): (3) a review of how the various Federal and State agencies
p.(None): responsible for enforcing mental health parity requirements have
p.(None): improved enforcement of such requirements in accordance with the
p.(None): objectives and timeline described in the action plan under
p.(None): section 13002; and
p.(None): (4) recommendations for how additional enforcement,
p.(None): education, and coordination activities by responsible Federal
p.(None): and State departments and agencies could better ensure
p.(None): compliance with such sections, including recommendations
...
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(B) receiving centers as alternatives to
p.(None): incarceration of eligible participants;
p.(None): ``(C) specialized response units for calls related
p.(None): to substance use disorders, mental illness, or co-
p.(None): occurring mental illness and substance use disorders;
p.(None): and
p.(None): ``(D) other arrest and pre-booking treatment
p.(None): alternatives to incarceration models; or
p.(None): ``(2) post-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) specialized clinical case management;
p.(None):
p.(None): [[Page 130 STAT. 1299]]
p.(None):
p.(None): ``(B) pre-trial services related to substances use
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(C) prosecutor and defender based programs;
p.(None): ``(D) specialized probation;
p.(None): ``(E) treatment and rehabilitation programs; and
p.(None): ``(F) problem-solving courts, including mental
p.(None): health courts, drug courts, co-occurring mental health
p.(None): and substance abuse courts, DWI courts, and veterans
p.(None): treatment courts.
p.(None):
p.(None): ``(c) Application.--
p.(None): ``(1) In general.--An eligible entity desiring a grant under
p.(None): this section shall submit an application to the Attorney
p.(None): General--
p.(None): ``(A) that meets the criteria under paragraph (2);
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
...
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
p.(None): VETERANS AFFAIRS OF MENTAL CAPACITY OF
p.(None): BENEFICIARIES.
p.(None):
p.(None): (a) In General.--Chapter 55 of title 38, United States Code, is
p.(None): amended by inserting after section 5501 the following new section:
p.(None): ``Sec. 5501A. Beneficiaries' rights in mental competence
p.(None): determinations
p.(None):
p.(None): ``The Secretary may not make an adverse determination concerning the
p.(None): mental capacity of a beneficiary to manage monetary benefits paid to or
p.(None): for the beneficiary by the Secretary under this title unless such
p.(None): beneficiary has been provided all of the following, subject to the
p.(None): procedures and timelines prescribed by the Secretary for determinations
p.(None): of incompetency:
p.(None): ``(1) Notice of the proposed adverse determination and the
p.(None): supporting evidence.
p.(None): ``(2) An opportunity to request a hearing.
p.(None): ``(3) An opportunity to present evidence, including an
p.(None): opinion from a medical professional or other person, on the
p.(None): capacity of the beneficiary to manage monetary benefits paid to
p.(None): or for the beneficiary by the Secretary under this title.
p.(None): ``(4) An opportunity to be represented at no expense to the
...
p.(None): (1) In general.--Section 1853(a)(1) of the Social Security
p.(None): Act (42 U.S.C. 1395w-23(a)(1)) is amended--
p.(None): (A) in subparagraph (C)(i), by striking ``The
p.(None): Secretary'' and inserting ``Subject to subparagraph (I),
p.(None): the Secretary''; and
p.(None): (B) by adding at the end the following new
p.(None): subparagraph:
p.(None): ``(I) Improvements to risk adjustment for 2019 and
p.(None): subsequent years.--
p.(None): ``(i) In general.--In order to determine the
p.(None): appropriate adjustment for health status under
p.(None): subparagraph (C)(i), the following shall apply:
p.(None): ``(I) Taking into account total
p.(None): number of diseases or conditions.--The
p.(None): Secretary shall take into account the
p.(None): total number of diseases or conditions
p.(None): of an individual enrolled in an MA plan.
p.(None): The Secretary shall make an additional
p.(None): adjustment under such subparagraph as
p.(None): the number of diseases or conditions of
p.(None): an individual increases.
p.(None): ``(II) Using at least 2 years of
p.(None): diagnostic data.--The Secretary may use
p.(None): at least 2 years of diagnosis data.
p.(None): ``(III) Providing separate
p.(None): adjustments for dual eligible
p.(None): individuals.--With respect to
p.(None): individuals who are dually eligible for
p.(None): benefits under this title and title XIX,
p.(None): the Secretary shall
p.(None):
p.(None): [[Page 130 STAT. 1337]]
p.(None):
p.(None): make separate adjustments for each of
p.(None): the following:
p.(None): ``(aa) Full-benefit dual
p.(None): eligible individuals (as defined
p.(None): in section 1935(c)(6)).
p.(None): ``(bb) Such individuals not
p.(None): described in item (aa).
p.(None): ``(IV) Evaluation of mental health
p.(None): and substance use disorders.--The
p.(None): Secretary shall evaluate the impact of
p.(None): including additional diagnosis codes
p.(None): related to mental health and substance
p.(None): use disorders in the risk adjustment
p.(None): model.
p.(None): ``(V) Evaluation of chronic kidney
p.(None): disease.--The Secretary shall evaluate
p.(None): the impact of including the severity of
p.(None): chronic kidney disease in the risk
p.(None): adjustment model.
p.(None): ``(VI) Evaluation of payment rates
p.(None): for end-stage renal disease.--The
p.(None): Secretary shall evaluate whether other
p.(None): factors (in addition to those described
p.(None): in subparagraph (H)) should be taken
p.(None): into consideration when computing
p.(None): payment rates under such subparagraph.
p.(None): ``(ii) Phased-in implementation.--The
p.(None): Secretary shall phase-in any changes to risk
p.(None): adjustment payment amounts under subparagraph
p.(None): (C)(i) under this subparagraph over a 3-year
p.(None): period, beginning with 2019, with such changes
p.(None): being fully implemented for 2022 and subsequent
p.(None): years.
p.(None): ``(iii) Opportunity for review and public
p.(None): comment.--The Secretary shall provide an
p.(None): opportunity for review of the proposed changes to
p.(None): such risk adjustment payment amounts under this
p.(None): subparagraph and a public comment period of not
p.(None): less than 60 days before implementing such
p.(None): changes.''.
p.(None): (2) Studies and reports.--
p.(None): (A) Reports on the risk adjustment system.--
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None):
p.(None): Sec. 2021. Investing in the next generation of researchers.
p.(None): Sec. 2022. Improvement of loan repayment program.
p.(None):
p.(None): Subtitle D--National Institutes of Health Planning and Administration
p.(None):
p.(None): Sec. 2031. National Institutes of Health strategic plan.
p.(None): Sec. 2032. Triennial reports.
p.(None): Sec. 2033. Increasing accountability at the National Institutes of
p.(None): Health.
p.(None): Sec. 2034. Reducing administrative burden for researchers.
p.(None): Sec. 2035. Exemption for the National Institutes of Health from the
p.(None): Paperwork Reduction Act requirements.
p.(None): Sec. 2036. High-risk, high-reward research.
p.(None): Sec. 2037. National Center for Advancing Translational Sciences.
p.(None): Sec. 2038. Collaboration and coordination to enhance research.
p.(None): Sec. 2039. Enhancing the rigor and reproducibility of scientific
p.(None): research.
p.(None): Sec. 2040. Improving medical rehabilitation research at the National
p.(None): Institutes of Health.
p.(None):
p.(None): [[Page 130 STAT. 1034]]
p.(None):
p.(None): Sec. 2041. Task force on research specific to pregnant women and
p.(None): lactating women.
p.(None): Sec. 2042. Streamlining National Institutes of Health reporting
p.(None): requirements.
p.(None): Sec. 2043. Reimbursement for research substances and living organisms.
p.(None): Sec. 2044. Sense of Congress on increased inclusion of underrepresented
p.(None): populations in clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): Sec. 2051. Technical updates to clinical trials database.
p.(None): Sec. 2052. Compliance activities reports.
p.(None): Sec. 2053. Updates to policies to improve data.
p.(None): Sec. 2054. Consultation.
p.(None):
p.(None): Subtitle F--Facilitating Collaborative Research
p.(None):
p.(None): Sec. 2061. National neurological conditions surveillance system.
p.(None): Sec. 2062. Tick-borne diseases.
p.(None): Sec. 2063. Accessing, sharing, and using health data for research
p.(None): purposes.
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): Sec. 2071. National pediatric research network.
p.(None): Sec. 2072. Global pediatric clinical study network.
p.(None):
p.(None): TITLE III--DEVELOPMENT
p.(None):
p.(None): Subtitle A--Patient-Focused Drug Development
p.(None):
p.(None): Sec. 3001. Patient experience data.
p.(None): Sec. 3002. Patient-focused drug development guidance.
p.(None): Sec. 3003. Streamlining patient input.
p.(None): Sec. 3004. Report on patient experience drug development.
p.(None):
p.(None): Subtitle B--Advancing New Drug Therapies
p.(None):
p.(None): Sec. 3011. Qualification of drug development tools.
p.(None): Sec. 3012. Targeted drugs for rare diseases.
p.(None): Sec. 3013. Reauthorization of program to encourage treatments for rare
p.(None): pediatric diseases.
p.(None): Sec. 3014. GAO study of priority review voucher programs.
p.(None): Sec. 3015. Amendments to the Orphan Drug grants.
p.(None): Sec. 3016. Grants for studying continuous drug manufacturing.
p.(None):
p.(None): Subtitle C--Modern Trial Design and Evidence Development
p.(None):
p.(None): Sec. 3021. Novel clinical trial designs.
p.(None): Sec. 3022. Real world evidence.
p.(None): Sec. 3023. Protection of human research subjects.
p.(None): Sec. 3024. Informed consent waiver or alteration for clinical
p.(None): investigations.
p.(None):
p.(None): Subtitle D--Patient Access to Therapies and Information
p.(None):
p.(None): Sec. 3031. Summary level review.
p.(None): Sec. 3032. Expanded access policy.
p.(None): Sec. 3033. Accelerated approval for regenerative advanced therapies.
p.(None): Sec. 3034. Guidance regarding devices used in the recovery, isolation,
p.(None): or delivery of regenerative advanced therapies.
p.(None): Sec. 3035. Report on regenerative advanced therapies.
p.(None): Sec. 3036. Standards for regenerative medicine and regenerative advanced
p.(None): therapies.
p.(None): Sec. 3037. Health care economic information.
p.(None): Sec. 3038. Combination product innovation.
p.(None): Subtitle E--Antimicrobial Innovation and Stewardship
p.(None):
p.(None): Sec. 3041. Antimicrobial resistance monitoring.
p.(None): Sec. 3042. Limited population pathway.
p.(None): Sec. 3043. Prescribing authority.
p.(None): Sec. 3044. Susceptibility test interpretive criteria for microorganisms;
p.(None): antimicrobial susceptibility testing devices.
p.(None):
p.(None): Subtitle F--Medical Device Innovations
p.(None):
p.(None): Sec. 3051. Breakthrough devices.
p.(None): Sec. 3052. Humanitarian device exemption.
p.(None): Sec. 3053. Recognition of standards.
p.(None): Sec. 3054. Certain class I and class II devices.
p.(None):
p.(None): [[Page 130 STAT. 1035]]
p.(None):
p.(None): Sec. 3055. Classification panels.
p.(None): Sec. 3056. Institutional review board flexibility.
p.(None): Sec. 3057. CLIA waiver improvements.
p.(None): Sec. 3058. Least burdensome device review.
p.(None): Sec. 3059. Cleaning instructions and validation data requirement.
p.(None): Sec. 3060. Clarifying medical software regulation.
p.(None):
p.(None): Subtitle G--Improving Scientific Expertise and Outreach at FDA
p.(None):
p.(None): Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical
p.(None): Product Assessment Service.
p.(None): Sec. 3072. Hiring authority for scientific, technical, and professional
p.(None): personnel.
p.(None): Sec. 3073. Establishment of Food and Drug Administration Intercenter
p.(None): Institutes.
p.(None): Sec. 3074. Scientific engagement.
p.(None): Sec. 3075. Drug surveillance.
p.(None): Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
p.(None):
p.(None): Subtitle H--Medical Countermeasures Innovation
p.(None):
p.(None): Sec. 3081. Medical countermeasure guidelines.
p.(None): Sec. 3082. Clarifying BARDA contracting authority.
p.(None): Sec. 3083. Countermeasure budget plan.
p.(None): Sec. 3084. Medical countermeasures innovation.
p.(None): Sec. 3085. Streamlining Project BioShield procurement.
p.(None): Sec. 3086. Encouraging treatments for agents that present a national
p.(None): security threat.
p.(None): Sec. 3087. Paperwork Reduction Act waiver during a public health
p.(None): emergency.
p.(None): Sec. 3088. Clarifying Food and Drug Administration emergency use
p.(None): authorization.
p.(None):
p.(None): Subtitle I--Vaccine Access, Certainty, and Innovation
p.(None):
p.(None): Sec. 3091. Predictable review timelines of vaccines by the Advisory
p.(None): Committee on Immunization Practices.
p.(None): Sec. 3092. Review of processes and consistency of Advisory Committee on
p.(None): Immunization Practices recommendations.
p.(None): Sec. 3093. Encouraging vaccine innovation.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): Sec. 3101. Technical corrections.
p.(None): Sec. 3102. Completed studies.
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): Sec. 4001. Assisting doctors and hospitals in improving quality of care
p.(None): for patients.
p.(None): Sec. 4002. Transparent reporting on usability, security, and
p.(None): functionality.
p.(None): Sec. 4003. Interoperability.
p.(None): Sec. 4004. Information blocking.
p.(None): Sec. 4005. Leveraging electronic health records to improve patient care.
p.(None): Sec. 4006. Empowering patients and improving patient access to their
p.(None): electronic health information.
p.(None): Sec. 4007. GAO study on patient matching.
p.(None): Sec. 4008. GAO study on patient access to health information.
p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
...
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
...
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
p.(None): Sec. 15004. Regulatory relief for LTCHs.
p.(None): Sec. 15005. Savings from IPPS MACRA pay-for through not applying
p.(None): documentation and coding adjustments.
p.(None): Sec. 15006. Extension of certain LTCH Medicare payment rules.
p.(None): Sec. 15007. Application of rules on the calculation of hospital length
p.(None): of stay to all LTCHs.
p.(None): Sec. 15008. Change in Medicare classification for certain hospitals.
p.(None): Sec. 15009. Temporary exception to the application of the Medicare LTCH
p.(None): site neutral provisions for certain spinal cord specialty
p.(None): hospitals.
p.(None): Sec. 15010. Temporary extension to the application of the Medicare LTCH
p.(None): site neutral provisions for certain discharges with severe
p.(None): wounds.
p.(None):
p.(None): TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
p.(None):
p.(None): Sec. 16001. Continuing Medicare payment under HOPD prospective payment
p.(None): system for services furnished by mid-build off-campus
p.(None): outpatient departments of providers.
p.(None): Sec. 16002. Treatment of cancer hospitals in off-campus outpatient
p.(None): department of a provider policy.
p.(None): Sec. 16003. Treatment of eligible professionals in ambulatory surgical
p.(None): centers for meaningful use and MIPS.
p.(None): Sec. 16004. Continuing Access to Hospitals Act of 2016.
p.(None): Sec. 16005. Delay of implementation of Medicare fee schedule adjustments
p.(None): for wheelchair accessories and seating systems when used in
p.(None): conjunction with complex rehabilitation technology (CRT)
p.(None): wheelchairs.
p.(None): Sec. 16006. Allowing physical therapists to utilize locum tenens
p.(None): arrangements under Medicare.
p.(None): Sec. 16007. Extension of the transition to new payment rates for durable
p.(None): medical equipment under the Medicare program.
p.(None): Sec. 16008. Requirements in determining adjustments using information
p.(None): from competitive bidding programs.
p.(None):
p.(None): TITLE XVII--OTHER MEDICARE PROVISIONS
p.(None):
p.(None): Sec. 17001. Delay in authority to terminate contracts for Medicare
p.(None): Advantage plans failing to achieve minimum quality ratings.
p.(None):
p.(None): [[Page 130 STAT. 1039]]
p.(None):
p.(None): Sec. 17002. Requirement for enrollment data reporting for Medicare.
p.(None): Sec. 17003. Updating the Welcome to Medicare package.
p.(None): Sec. 17004. No payment for items and services furnished by newly
p.(None): enrolled providers or suppliers within a temporary moratorium
p.(None): area.
p.(None): Sec. 17005. Preservation of Medicare beneficiary choice under Medicare
p.(None): Advantage.
p.(None): Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a
p.(None): Medicare Advantage plan.
p.(None): Sec. 17007. Improvements to the assignment of beneficiaries under the
p.(None): Medicare Shared Savings Program.
p.(None):
p.(None): TITLE XVIII--OTHER PROVISIONS
p.(None):
p.(None): Sec. 18001. Exception from group health plan requirements for qualified
p.(None): small employer health reimbursement arrangements.
p.(None):
p.(None): DIVISION <> A--21ST CENTURY CURES
...
p.(None): grants to States for the purpose of addressing the opioid abuse
p.(None): crisis within such States, in accordance with subparagraph (B).
p.(None): In awarding such grants, the Secretary shall give preference to
p.(None): States with an incidence or prevalence of opioid use disorders
p.(None): that is substantially higher relative to other States.
p.(None): (2) Opioid grants.--Grants awarded to a State under this
p.(None): subsection shall be used for carrying out activities that
p.(None): supplement activities pertaining to opioids undertaken by the
p.(None): State agency responsible for administering the substance abuse
p.(None): prevention and treatment block grant under subpart II of part B
p.(None): of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
p.(None): et seq.), which may include public health-related activities
p.(None): such as the following:
p.(None): (A) Improving State prescription drug monitoring
p.(None): programs.
p.(None):
p.(None): [[Page 130 STAT. 1046]]
p.(None): (B) Implementing prevention activities, and
p.(None): evaluating such activities to identify effective
p.(None): strategies to prevent opioid abuse.
p.(None): (C) Training for health care practitioners, such as
p.(None): best practices for prescribing opioids, pain management,
p.(None): recognizing potential cases of substance abuse, referral
p.(None): of patients to treatment programs, and overdose
p.(None): prevention.
p.(None): (D) Supporting access to health care services,
p.(None): including those services provided by Federally certified
p.(None): opioid treatment programs or other appropriate health
p.(None): care providers to treat substance use disorders.
p.(None): (E) Other public health-related activities, as the
p.(None): State determines appropriate, related to addressing the
p.(None): opioid abuse crisis within the State.
p.(None):
p.(None): (d) Accountability and Oversight.--A State receiving a grant under
p.(None): subsection (c) shall include in a report related to substance abuse
p.(None): submitted to the Secretary pursuant to section 1942 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-52), a description of--
p.(None): (1) the purposes for which the grant funds received by the
p.(None): State under such subsection for the preceding fiscal year were
p.(None): expended and a description of the activities of the State under
p.(None): the program; and
p.(None): (2) the ultimate recipients of amounts provided to the State
p.(None): in the grant.
p.(None):
p.(None): (e) Limitations.--Any funds made available pursuant to the
p.(None): authorization of appropriations under subsection (b)--
p.(None): (1) notwithstanding any transfer authority in any
p.(None): appropriations Act, shall not be used for any purpose other than
p.(None): the grant program in subsection (c); and
p.(None): (2) shall be subject to the same requirements as substance
p.(None): abuse prevention and treatment programs under titles V and XIX
...
p.(None):
p.(None): ``(c) Authority of the Secretary.--In carrying out this section, the
p.(None): Secretary may--
p.(None): ``(1) coordinate with the Secretary of Energy, private
p.(None): industry, and others, as the Secretary determines appropriate,
p.(None): to identify and address the advanced supercomputing and other
p.(None): advanced technology needs for the Initiative;
p.(None): ``(2) develop and utilize public-private partnerships; and
p.(None): ``(3) leverage existing data sources.
p.(None):
p.(None): ``(d) Requirements.--In the implementation of the Initiative under
p.(None): subsection (a), the Secretary shall--
p.(None): ``(1) ensure the collaboration of the National Institutes of
p.(None): Health, the Food and Drug Administration, the Office of the
p.(None): National Coordinator for Health Information Technology, and the
p.(None): Office for Civil Rights of the Department of Health and Human
p.(None): Services;
p.(None): ``(2) comply with existing laws and regulations for the
p.(None): protection of human subjects involved in research, including the
p.(None): protection of participant privacy;
p.(None): ``(3) implement policies and mechanisms for appropriate
p.(None): secure data sharing across systems that include protections for
p.(None): privacy and security of data;
p.(None): ``(4) consider the diversity of the cohort to ensure
p.(None): inclusion of a broad range of participants, including
p.(None): consideration of biological, social, and other determinants of
p.(None): health that contribute to health disparities;
p.(None): ``(5) ensure that only authorized individuals may access
p.(None): controlled or sensitive, identifiable biological material and
p.(None): associated information collected or stored in connection with
p.(None): the Initiative; and
p.(None): ``(6) on the appropriate Internet website of the Department
p.(None): of Health and Human Services, identify any entities with access
p.(None): to such information and provide information with respect to the
p.(None): purpose of such access, a summary of the research project for
p.(None): which such access is granted, as applicable, and a description
p.(None): of the biological material and associated information to which
p.(None): the entity has access.
p.(None):
p.(None): ``(e) Report.--Not later than 1 year after the date of enactment of
p.(None): the 21st Century Cures Act, the Secretary shall submit a report
p.(None):
p.(None): [[Page 130 STAT. 1049]]
p.(None):
p.(None): on the relevant data access policies and procedures to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives. Such report
p.(None): shall include steps the Secretary has taken to consult with experts or
p.(None): other heads of departments or agencies of the Federal Government in the
p.(None): development of such policies.''.
p.(None): SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.
p.(None):
p.(None): (a) In General.--Subsection (d) of section 301 of the Public Health
p.(None): Service Act (42 U.S.C. 241) is amended to read as follows:
p.(None): ``(d)(1)(A) If a person is engaged in biomedical, behavioral,
p.(None): clinical, or other research, in which identifiable, sensitive
p.(None): information is collected (including research on mental health and
p.(None): research on the use and effect of alcohol and other psychoactive drugs),
p.(None): the Secretary, in coordination with other agencies, as applicable--
p.(None): ``(i) shall issue to such person a certificate of
p.(None): confidentiality to protect the privacy of individuals who are
p.(None): the subjects of such research if the research is funded wholly
p.(None): or in part by the Federal Government; and
p.(None): ``(ii) may, upon application by a person engaged in
p.(None): research, issue to such person a certificate of confidentiality
p.(None): to protect the privacy of such individuals if the research is
p.(None): not so funded.
p.(None):
p.(None): ``(B) Except as provided in subparagraph (C), any person to whom a
...
p.(None): biospecimen that contains identifiable, sensitive information about the
p.(None): individual and that was created or compiled for purposes of the
p.(None): research, except in the circumstance described in subparagraph (C)(iii).
p.(None): ``(E) Identifiable, sensitive information protected under
p.(None): subparagraph (A), and all copies thereof, shall be immune from the legal
p.(None): process, and shall not, without the consent of the individual to whom
p.(None): the information pertains, be admissible as evidence or used
p.(None):
p.(None): [[Page 130 STAT. 1050]]
p.(None):
p.(None): for any purpose in any action, suit, or other judicial, legislative, or
p.(None): administrative proceeding.
p.(None): ``(F) Identifiable, sensitive information collected by a person to
p.(None): whom a certificate has been issued under subparagraph (A), and all
p.(None): copies thereof, shall be subject to the protections afforded by this
p.(None): section for perpetuity.
p.(None): ``(G) The Secretary shall take steps to minimize the burden to
p.(None): researchers, streamline the process, and reduce the time it takes to
p.(None): comply with the requirements of this subsection.
p.(None): ``(2) The Secretary shall coordinate with the heads of other
p.(None): applicable Federal agencies to ensure that such departments have
p.(None): policies in place with respect to the issuance of a certificate of
p.(None): confidentiality pursuant to paragraph (1) and other requirements of this
p.(None): subsection.
p.(None): ``(3) Nothing in this subsection shall be construed to limit the
p.(None): access of an individual who is a subject of research to information
p.(None): about himself or herself collected during such individual's
p.(None): participation in the research.
p.(None): ``(4) For purposes of this subsection, the term `identifiable,
p.(None): sensitive information' means information that is about an individual and
p.(None): that is gathered or used during the course of research described in
p.(None): paragraph (1)(A) and--
p.(None): ``(A) through which an individual is identified; or
p.(None): ``(B) for which there is at least a very small risk, as
p.(None): determined by current scientific practices or statistical
p.(None): methods, that some combination of the information, a request for
p.(None): the information, and other available data sources could be used
p.(None): to deduce the identity of an individual.''.
p.(None):
p.(None): (b) <> Applicability.--Beginning 180 days
p.(None): after the date of enactment of this Act, all persons engaged in research
p.(None): and authorized by the Secretary of Health and Human Services to protect
p.(None): information under section 301(d) of the Public Health Service Act (42
p.(None): U.S.C. 241(d)) prior to the date of enactment of this Act shall be
p.(None): subject to the requirements of such section (as amended by this Act).
p.(None): SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
p.(None):
p.(None): Section 301 of the Public Health Service Act (42 U.S.C. 241) is
p.(None): amended by adding at the end the following:
p.(None): ``(f)(1) The Secretary may exempt from disclosure under section
...
p.(None): amended by section 2035, is further amended--
p.(None): (1) in the flush matter at the end of subsection (a)--
p.(None): (A) by redesignating such matter as subsection
p.(None): (h)(1); and
p.(None): (B) by moving such matter so as to appear at the end
p.(None): of such section; and
p.(None): (2) in subsection (h) (as so redesignated), by adding at the
p.(None): end the following:
p.(None):
p.(None): ``(2) Where research substances and living organisms are made
p.(None): available under paragraph (1) through contractors, the Secretary may
p.(None): direct such contractors to collect payments on behalf of the Secretary
p.(None): for the costs incurred to make available such substances and organisms
p.(None): and to forward amounts so collected to the Secretary, in the time and
p.(None): manner specified by the Secretary.
p.(None): ``(3) Amounts collected under paragraph (2) shall be credited to the
p.(None): appropriations accounts that incurred the costs to make available the
p.(None): research substances and living organisms involved, and shall remain
p.(None): available until expended for carrying out activities under such
p.(None): accounts.''.
p.(None): SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF
p.(None): UNDERREPRESENTED POPULATIONS IN CLINICAL
p.(None): TRIALS.
p.(None):
p.(None): It is the sense of Congress that the National Institute on Minority
p.(None): Health and Health Disparities should include within its strategic plan
p.(None): under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m))
p.(None): ways to increase representation of underrepresented populations in
p.(None): clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
p.(None):
p.(None): Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
p.(None): 282(j)(2)(D)) is amended--
p.(None): (1) in clause (ii)(I), by inserting before the semicolon ``,
p.(None): unless the responsible party affirmatively requests that the
p.(None): Director of the National Institutes of Health publicly post such
p.(None): clinical trial information for an applicable device clinical
p.(None): trial prior to such date of clearance or approval''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(iii) Option to make certain clinical trial
p.(None): information available earlier.--The Director of
p.(None): the National Institutes of Health shall inform
p.(None): responsible parties of the option to request that
p.(None): clinical trial information for an applicable
p.(None): device clinical trial be publicly posted prior to
p.(None): the date of clearance or approval, in accordance
p.(None): with clause (ii)(I).
p.(None): ``(iv) Combination products.--An applicable
p.(None): clinical trial for a product that is a combination
p.(None): of drug, device, or biological product shall be
p.(None): considered--
p.(None):
p.(None): [[Page 130 STAT. 1075]]
p.(None):
p.(None): ``(I) an applicable drug clinical
p.(None): trial, if the Secretary determines under
p.(None): section 503(g) of the Federal Food,
p.(None): Drug, and Cosmetic Act that the primary
p.(None): mode of action of such product is that
p.(None): of a drug or biological product; or
p.(None): ``(II) an applicable device clinical
...
p.(None): shall consult with individuals with appropriate expertise, which may
p.(None): include--
p.(None): ``(1) epidemiologists with experience in disease
p.(None): surveillance or registries;
p.(None): ``(2) representatives of national voluntary health
p.(None): associations that--
p.(None): ``(A) focus on neurological diseases; and
p.(None): ``(B) have demonstrated experience in research,
p.(None): care, or patient services;
p.(None): ``(3) health information technology experts or other
p.(None): information management specialists;
p.(None): ``(4) clinicians with expertise in neurological diseases;
p.(None): and
p.(None): ``(5) research scientists with experience conducting
p.(None): translational research or utilizing surveillance systems for
p.(None): scientific research purposes.
p.(None):
p.(None): [[Page 130 STAT. 1078]]
p.(None):
p.(None): ``(e) Grants.--The Secretary may award grants to, or enter into
p.(None): contracts or cooperative agreements with, public or private nonprofit
p.(None): entities to carry out activities under this section.
p.(None): ``(f) Coordination With Other Federal, State, and Local Agencies.--
p.(None): Subject to subsection (h), the Secretary shall--
p.(None): ``(1) make information and analysis in the National
p.(None): Neurological Conditions Surveillance System available, as
p.(None): appropriate--
p.(None): ``(A) to Federal departments and agencies, such as
p.(None): the National Institutes of Health and the Department of
p.(None): Veterans Affairs; and
p.(None): ``(B) to State and local agencies; and
p.(None): ``(2) identify, build upon, leverage, and coordinate among
p.(None): existing data and surveillance systems, surveys, registries, and
p.(None): other Federal public health infrastructure, wherever
p.(None): practicable.
p.(None):
p.(None): ``(g) Public Access.--Subject to subsection (h), the Secretary shall
p.(None): ensure that information and analysis in the National Neurological
p.(None): Conditions Surveillance System are available, as appropriate, to the
p.(None): public, including researchers.
p.(None): ``(h) Privacy.--The Secretary shall ensure that information and
p.(None): analysis in the National Neurological Conditions Surveillance System are
p.(None): made available only to the extent permitted by applicable Federal and
p.(None): State law, and in a manner that protects personal privacy, to the extent
p.(None): required by applicable Federal and State privacy law, at a minimum.
p.(None): ``(i) Reports.--
p.(None): ``(1) Report on information and analyses.--Not later than 1
p.(None): year after the date on which any system is established under
p.(None): this section, the Secretary shall submit an interim report to
p.(None): the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of
p.(None): Representatives regarding aggregate information collected
p.(None): pursuant to this section and epidemiological analyses, as
p.(None): appropriate. Such report shall be posted on the Internet website
p.(None): of the Department of Health and Human Services and shall be
p.(None): updated biennially.
p.(None): ``(2) Implementation report.--Not later than 4 years after
p.(None): the date of the enactment of this section, the Secretary shall
p.(None): submit a report to the Congress concerning the implementation of
p.(None): this section. Such report shall include information on--
p.(None): ``(A) the development and maintenance of the
p.(None): National Neurological Conditions Surveillance System;
p.(None): ``(B) the type of information collected and stored
p.(None): in the surveillance system;
...
p.(None): borne diseases.
p.(None): (ii) Scientists or researchers with expertise.
p.(None): (iii) Patients and their family members.
p.(None): (iv) Nonprofit organizations that advocate for
p.(None): patients with respect to tick-borne diseases.
p.(None): (v) Other individuals whose expertise is
p.(None): determined by the Secretary to be beneficial to
p.(None): the functioning of the Working Group.
p.(None): (4) Meetings.--The Working Group shall meet not less than
p.(None): twice each year.
p.(None): (5) Reporting.--Not later than 2 years after the date of
p.(None): enactment of this Act, and every 2 years thereafter until
p.(None): termination of the Working Group pursuant to paragraph (7), the
p.(None): Working Group shall--
p.(None): (A) submit a report on its activities under
p.(None): paragraph (2)(A) and any recommendations under paragraph
p.(None): (2)(B) to the Secretary, the Committee on Energy and
p.(None): Commerce of the House of Representatives, and the
p.(None): Committee on Health, Education, Labor, and Pensions of
p.(None): the Senate; and
p.(None): (B) make such report publicly available on the
p.(None): Internet website of the Department of Health and Human
p.(None): Services.
p.(None): (6) Applicability of faca.--The Working Group shall be
p.(None): treated as an advisory committee subject to the Federal Advisory
p.(None): Committee Act (5 U.S.C. App.).
p.(None): (7) Sunset.--The Working Group under this section shall
p.(None): terminate 6 years after the date of enactment of this Act.
p.(None): SEC. 2063. <> ACCESSING, SHARING, AND
p.(None): USING HEALTH DATA FOR RESEARCH PURPOSES.
p.(None):
p.(None): (a) Guidance Related to Remote Access.--Not later than 1 year after
p.(None): the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services (referred to in this section as the ``Secretary'') shall issue
p.(None): guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii)
p.(None): of part 164 of the Rule (prohibiting the removal of protected health
p.(None): information by a researcher) does not prohibit remote access to health
p.(None): information by a researcher for such purposes as described in section
p.(None): 164.512(i)(1)(ii) of part 164 of the Rule so long as--
p.(None):
p.(None): [[Page 130 STAT. 1081]]
p.(None):
p.(None): (1) at a minimum, security and privacy safeguards,
p.(None): consistent with the requirements of the Rule, are maintained by
p.(None): the covered entity and the researcher; and
p.(None): (2) the protected health information is not copied or
p.(None): otherwise retained by the researcher.
p.(None):
p.(None): (b) Guidance Related to Streamlining Authorization.--Not later than
p.(None): 1 year after the date of enactment of this Act, the Secretary shall
p.(None): issue guidance on the following:
p.(None): (1) Authorization for use and disclosure of health
p.(None): information.--Clarification of the circumstances under which the
p.(None): authorization for the use or disclosure of protected health
p.(None): information, with respect to an individual, for future research
p.(None): purposes contains a sufficient description of the purpose of the
p.(None): use or disclosure, such as if the authorization--
p.(None): (A) sufficiently describes the purposes such that it
p.(None): would be reasonable for the individual to expect that
p.(None): the protected health information could be used or
p.(None): disclosed for such future research;
p.(None): (B) either--
p.(None): (i) states that the authorization will expire
p.(None): on a particular date or on the occurrence of a
p.(None): particular event; or
p.(None): (ii) states that the authorization will remain
p.(None): valid unless and until it is revoked by the
p.(None): individual; and
p.(None): (C) provides instruction to the individual on how to
p.(None): revoke such authorization at any time.
p.(None): (2) Reminder of the right to revoke.--Clarification of the
p.(None): circumstances under which it is appropriate to provide an
...
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
p.(None): policy related to protecting the privacy of
p.(None): individuals, and
p.(None): (vi) existing barriers to research related to
p.(None): the current restrictions on the uses and
p.(None): disclosures of protected health information; and
p.(None): (B) consider, at a minimum--
p.(None): (i) expectations and preferences on how an
p.(None): individual's protected health information is
p.(None): shared and used;
p.(None): (ii) issues related to specific subgroups of
p.(None): people, such as children, incarcerated
p.(None): individuals, and individuals with a cognitive or
p.(None): intellectual disability impacting capacity to
p.(None): consent;
p.(None): (iii) relevant Federal and State laws;
p.(None): (iv) models of facilitating data access and
p.(None): levels of data access, including data
p.(None): segmentation, where applicable;
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
p.(None): or part 164, as appropriate, of title 45, Code of Federal
p.(None): Regulations (or any successor regulation).
p.(None): (2) Part 164.--References to a specified section of ``part
p.(None): 164'', refer to such specified section of part 164 of title 45,
p.(None): Code of Federal Regulations (or any successor section).
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
p.(None):
p.(None): Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d))
p.(None): is amended--
p.(None): (1) in paragraph (1), by striking ``in consultation with the
p.(None): Director of the Eunice Kennedy Shriver National Institute of
p.(None): Child Health and Human Development and in collaboration with
p.(None): other appropriate national research institutes and national
...
p.(None): Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
p.(None): (1) in subparagraph (D), by striking ``except where subject
p.(None): to such conditions as the Secretary may prescribe, the
p.(None): investigator'' and inserting the following: ``except where,
p.(None): subject to such conditions as the Secretary may prescribe--
p.(None): ``(i) the proposed clinical testing poses no more
p.(None): than minimal risk to the human subject and includes
p.(None): appropriate safeguards to protect the rights, safety,
p.(None): and welfare of the human subject; or
p.(None): ``(ii) the investigator''; and
p.(None): (2) in the matter following subparagraph (D), by striking
p.(None): ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
p.(None):
p.(None): (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where
p.(None): it is not feasible or it is contrary to the best interests of such human
p.(None): beings'' and inserting ``except where it is not feasible, it is contrary
p.(None): to the best interests of such human beings, or the proposed clinical
p.(None): testing poses no more than minimal risk to such human beings and
p.(None): includes appropriate safeguards as prescribed to protect the rights,
p.(None): safety, and welfare of such human beings''.
p.(None):
p.(None): Subtitle D--Patient Access to Therapies and Information
p.(None):
p.(None): SEC. 3031. SUMMARY LEVEL REVIEW.
p.(None):
p.(None): (a) FFDCA.--Section 505(c) of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 355(c)) is amended by adding at the end the following:
p.(None): ``(5)(A) The Secretary may rely upon qualified data summaries to
p.(None): support the approval of a supplemental application, with respect
p.(None):
p.(None): [[Page 130 STAT. 1100]]
p.(None):
p.(None): to a qualified indication for a drug, submitted under subsection (b), if
p.(None): such supplemental application complies with subparagraph (B).
p.(None): ``(B) A supplemental application is eligible for review as described
p.(None): in subparagraph (A) only if--
p.(None): ``(i) there is existing data available and acceptable to the
p.(None): Secretary demonstrating the safety of the drug; and
p.(None): ``(ii) all data used to develop the qualified data summaries
p.(None): are submitted to the Secretary as part of the supplemental
p.(None): application.
p.(None):
p.(None): ``(C) The Secretary shall post on the Internet website of the Food
p.(None): and Drug Administration and update annually--
p.(None): ``(i) the number of applications reviewed solely under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act;
p.(None): ``(ii) the average time for completion of review under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act;
p.(None): ``(iii) the average time for review of supplemental
p.(None): applications where the Secretary did not use review flexibility
p.(None): under subparagraph (A) or section 351(a)(2)(E) of the Public
p.(None): Health Service Act; and
p.(None): ``(iv) the number of applications reviewed under
p.(None): subparagraph (A) or section 351(a)(2)(E) of the Public Health
p.(None): Service Act for which the Secretary made use of full data sets
p.(None): in addition to the qualified data summary.
p.(None):
p.(None): ``(D) In this paragraph--
p.(None): ``(i) the term `qualified indication' means an indication
p.(None): for a drug that the Secretary determines to be appropriate for
p.(None): summary level review under this paragraph; and
p.(None): ``(ii) the term `qualified data summary' means a summary of
p.(None): clinical data that demonstrates the safety and effectiveness of
p.(None): a drug with respect to a qualified indication.''.
p.(None):
p.(None): (b) PHSA.--Section 351(a)(2) of the Public Health Service Act (42
p.(None): U.S.C. 262(a)(2)) is amended by adding at the end the following:
p.(None): ``(E)(i) The Secretary may rely upon qualified data summaries to
p.(None): support the approval of a supplemental application, with respect to a
p.(None): qualified indication for a drug, submitted under this subsection, if
p.(None): such supplemental application complies with the requirements of
p.(None): subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ``(ii) In this subparagraph, the terms `qualified indication' and
p.(None): `qualified data summary' have the meanings given such terms in section
p.(None): 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.''.
p.(None): SEC. 3032. EXPANDED ACCESS POLICY.
p.(None):
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
p.(None): inserting after section 561 (21 U.S.C. 360bbb) the following:
p.(None): ``SEC. 561A. <> EXPANDED ACCESS POLICY
p.(None): REQUIRED FOR INVESTIGATIONAL DRUGS.
p.(None):
p.(None): ``(a) In General.--The manufacturer or distributor of one or more
p.(None): investigational drugs for the diagnosis, monitoring, or treatment of one
p.(None): or more serious diseases or conditions shall make available the policy
p.(None): of the manufacturer or distributor on evaluating and responding to
p.(None): requests submitted under section 561(b) for provision of such a drug.
p.(None):
p.(None): [[Page 130 STAT. 1101]]
p.(None):
p.(None): ``(b) Public Availability of Expanded Access Policy.--The policies
p.(None): under subsection (a) shall be made public and readily available, such as
p.(None): by posting such policies on a publicly available Internet website. Such
p.(None): policies may be generally applicable to all investigational drugs of
p.(None): such manufacturer or distributor.
p.(None): ``(c) Content of Policy.--A policy described in subsection (a) shall
p.(None): include--
p.(None): ``(1) contact information for the manufacturer or
p.(None): distributor to facilitate communication about requests described
p.(None): in subsection (a);
p.(None): ``(2) procedures for making such requests;
p.(None): ``(3) the general criteria the manufacturer or distributor
p.(None): will use to evaluate such requests for individual patients, and
p.(None): for responses to such requests;
p.(None): ``(4) the length of time the manufacturer or distributor
p.(None): anticipates will be necessary to acknowledge receipt of such
p.(None): requests; and
p.(None): ``(5) a hyperlink or other reference to the clinical trial
p.(None): record containing information about the expanded access for such
p.(None): drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of
p.(None): the Public Health Service Act.
p.(None):
p.(None): ``(d) No Guarantee of Access.--The posting of policies by
p.(None): manufacturers and distributors under subsection (a) shall not serve as a
p.(None): guarantee of access to any specific investigational drug by any
p.(None): individual patient.
p.(None): ``(e) Revised Policy.--Nothing in this section shall prevent a
p.(None): manufacturer or distributor from revising a policy required under this
p.(None): section at any time.
p.(None): ``(f) Application.--This section shall apply to a manufacturer or
p.(None): distributor with respect to an investigational drug beginning on the
p.(None): later of--
p.(None): ``(1) the date that is 60 calendar days after the date of
p.(None): enactment of the 21st Century Cures Act; or
p.(None): ``(2) the first initiation of a phase 2 or phase 3 study (as
p.(None): such terms are defined in section 312.21(b) and (c) of title 21,
p.(None): Code of Federal Regulations (or any successor regulations)) with
p.(None): respect to such investigational drug.''.
p.(None): SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
p.(None): THERAPIES.
p.(None):
p.(None): (a) In General.--Section 506 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 356) is amended--
p.(None): (1) by transferring subsection (e) (relating to
p.(None): construction) so that it appears before subsection (f) (relating
p.(None): to awareness efforts); and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(g) Regenerative Advanced Therapy.--
p.(None): ``(1) In general.--The Secretary, at the request of the
p.(None): sponsor of a drug, shall facilitate an efficient development
p.(None): program for, and expedite review of, such drug if the drug
...
p.(None): request the Secretary to designate the drug as a regenerative
p.(None): advanced therapy concurrently with, or at any time after,
p.(None): submission of an application for the investigation of the drug
p.(None): under section 505(i) of this Act or section 351(a)(3) of the
p.(None): Public Health Service Act.
p.(None): ``(4) Designation.--Not later than 60 calendar days after
p.(None): the receipt of a request under paragraph (3), the Secretary
p.(None): shall determine whether the drug that is the subject of the
p.(None): request meets the criteria described in paragraph (2). If the
p.(None): Secretary determines that the drug meets the criteria, the
p.(None): Secretary shall designate the drug as a regenerative advanced
p.(None): therapy and shall take such actions as are appropriate under
p.(None): paragraph (1). If the Secretary determines that a drug does not
p.(None): meet the criteria for such designation, the Secretary shall
p.(None): include with the determination a written description of the
p.(None): rationale for such determination.
p.(None): ``(5) Actions.--The sponsor of a regenerative advanced
p.(None): therapy shall be eligible for the actions to expedite
p.(None): development and review of such therapy under subsection
p.(None): (a)(3)(B), including early interactions to discuss any potential
p.(None): surrogate or intermediate endpoint to be used to support the
p.(None): accelerated approval of an application for the product under
p.(None): subsection (c).
p.(None): ``(6) Access to expedited approval pathways.--An application
p.(None): for a regenerative advanced therapy under section 505(b)(1) of
p.(None): this Act or section 351(a) of the Public Health Service Act may
p.(None): be--
p.(None): ``(A) eligible for priority review, as described in
p.(None): the Manual of Policies and Procedures of the Food and
p.(None): Drug Administration and goals identified in the letters
p.(None): described in section 101(b) of the Prescription Drug
p.(None): User Fee Amendments of 2012; and
p.(None): ``(B) eligible for accelerated approval under
p.(None): subsection (c), as agreed upon pursuant to subsection
p.(None): (a)(3)(B), through, as appropriate--
p.(None): ``(i) surrogate or intermediate endpoints
p.(None): reasonably likely to predict long-term clinical
p.(None): benefit; or
p.(None): ``(ii) reliance upon data obtained from a
p.(None): meaningful number of sites, including through
p.(None): expansion to additional sites, as appropriate.
p.(None): ``(7) Postapproval requirements.--The sponsor of a
p.(None): regenerative advanced therapy that is granted accelerated
p.(None): approval and is subject to the postapproval requirements under
p.(None): subsection (c) may, as appropriate, fulfill such requirements,
p.(None): as the Secretary may require, through--
p.(None): ``(A) the submission of clinical evidence, clinical
p.(None): studies, patient registries, or other sources of real
p.(None): world evidence, such as electronic health records;
p.(None): ``(B) the collection of larger confirmatory data
p.(None): sets, as agreed upon pursuant to subsection (a)(3)(B);
p.(None): or
p.(None):
p.(None): [[Page 130 STAT. 1103]]
p.(None):
p.(None): ``(C) postapproval monitoring of all patients
p.(None): treated with such therapy prior to approval of the
p.(None): therapy.
...
p.(None): (1) in subparagraph (B), by striking ``or'' at the end;
p.(None): (2) in subparagraph (C), by striking the period and
p.(None): inserting ``; or''; and
p.(None): (3) by inserting after subparagraph (C) the following:
p.(None): ``(D) there is in effect an authorization pursuant to
p.(None): section 564 with respect to such use or intended use of such
p.(None): drug, and such drug, its labeling, and such use conform to any
p.(None): conditions of such authorization.''.
p.(None):
p.(None): (c) Emergency Use of Medical Products.--Section 564A of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
p.(None): (1) in subsection (a)(1)(A), by inserting ``, conditionally
p.(None): approved under section 571,'' after ``chapter''; and
p.(None): (2) in subsection (d), by striking ``sections 503(b) and
p.(None): 520(e)'' and inserting ``subsections (b) and (f) of section 503,
p.(None): section 504, and section 520(e)''.
p.(None):
p.(None): (d) Products Held for Emergency Use.--Section 564B(2) of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is amended--
p.(None): (1) in subparagraph (A)--
p.(None): (A) by inserting ``or conditionally approved under
p.(None): section 571 of this Act'' after ``Public Health Service
p.(None): Act''; and
p.(None): (B) by striking ``or 515'' and inserting ``512, or
p.(None): 515''; and
p.(None): (2) in subparagraph (B), by striking ``or 520'' and
p.(None): inserting ``512, or 520''.
p.(None):
p.(None): Subtitle I--Vaccine Access, Certainty, and Innovation
p.(None):
p.(None): SEC. 3091. <> PREDICTABLE REVIEW
p.(None): TIMELINES OF VACCINES BY THE ADVISORY
p.(None): COMMITTEE ON IMMUNIZATION PRACTICES.
p.(None):
p.(None): (a) Consideration of New Vaccines.--Upon the licensure of any
p.(None): vaccine or any new indication for a vaccine, the Advisory
p.(None):
p.(None): [[Page 130 STAT. 1150]]
p.(None):
p.(None): Committee on Immunization Practices (in this section referred to as the
p.(None): ``Advisory Committee'') shall, as appropriate, consider the use of the
p.(None): vaccine at its next regularly scheduled meeting.
p.(None): (b) Additional Information.--If the Advisory Committee does not make
p.(None): a recommendation with respect to the use of a vaccine at the Advisory
p.(None): Committee's first regularly scheduled meeting after the licensure of the
p.(None): vaccine or any new indication for the vaccine, the Advisory Committee
p.(None): shall provide an update on the status of such committee's review.
p.(None): (c) Consideration for Breakthrough Therapies and for Potential Use
p.(None): During Public Health Emergency.--The Advisory Committee shall make
p.(None): recommendations with respect to the use of certain vaccines in a timely
p.(None): manner, as appropriate, including vaccines that--
p.(None): (1) are designated as a breakthrough therapy under section
p.(None): 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356)
p.(None): and licensed under section 351 of the Public Health Service Act
p.(None): (42 U.S.C. 262); or
p.(None): (2) could be used in a public health emergency.
p.(None):
p.(None): (d) Definition.--In this section, the terms ``Advisory Committee on
...
p.(None): year after the date of enactment of the 21st Century Cures Act,
p.(None): develop a strategy and recommendations to meet the goal in
p.(None): accordance with this subsection.
p.(None): ``(2) Strategy.--The strategy developed under paragraph (1)
p.(None): shall address the regulatory and administrative burdens (such as
p.(None): documentation requirements) relating to the use of electronic
p.(None): health records. Such strategy shall include broad public comment
p.(None): and shall prioritize--
p.(None): ``(A)(i) incentives for meaningful use of certified
p.(None): EHR technology for eligible professionals and hospitals
p.(None): under sections 1848(a)(7) and 1886(b)(3)(B)(ix),
p.(None): respectively, of the Social Security Act (42 U.S.C.
p.(None): 1395w-4(a)(7), 1395ww(b)(3)(B)(ix));
p.(None): ``(ii) the program for making payments under section
p.(None): 1903(a)(3)(F) of the Social Security Act (42 U.S.C.
p.(None): 1396b(a)(3)(F)) to encourage the adoption and use of
p.(None): certified EHR technology by Medicaid providers;
p.(None): ``(iii) the Merit-based Incentive Payment System
p.(None): under section 1848(q) of the Social Security Act (42
p.(None): U.S.C. 1395w-4(q));
p.(None): ``(iv) alternative payment models (as defined in
p.(None): section 1833(z)(3)(C) of the Social Security Act (42
p.(None): U.S.C. 1395l(z)(3)(C));
p.(None): ``(v) the Hospital Value-Based Purchasing Program
p.(None): under section 1886(o) of the Social Security Act (42
p.(None): U.S.C. 1395ww(o)); and
p.(None):
p.(None): [[Page 130 STAT. 1158]]
p.(None):
p.(None): ``(vi) other value-based payment programs, as the
p.(None): Secretary determines appropriate;
p.(None): ``(B) health information technology certification;
p.(None): ``(C) standards and implementation specifications,
p.(None): as appropriate;
p.(None): ``(D) activities that provide individuals access to
p.(None): their electronic health information;
p.(None): ``(E) activities related to protecting the privacy
p.(None): of electronic health information;
p.(None): ``(F) activities related to protecting the security
p.(None): of electronic health information;
p.(None): ``(G) activities related to facilitating health and
p.(None): clinical research;
p.(None): ``(H) activities related to public health;
p.(None): ``(I) activities related to aligning and simplifying
p.(None): quality measures across Federal programs and other
p.(None): payers;
p.(None): ``(J) activities related to reporting clinical data
p.(None): for administrative purposes; and
p.(None): ``(K) other areas, as the Secretary determines
p.(None): appropriate.
p.(None): ``(3) Recommendations.--The recommendations developed under
p.(None): paragraph (1) shall address--
p.(None): ``(A) actions that improve the clinical
p.(None): documentation experience;
p.(None): ``(B) actions that improve patient care;
p.(None): ``(C) actions to be taken by the Secretary and by
p.(None): other entities; and
p.(None): ``(D) other areas, as the Secretary determines
p.(None): appropriate, to reduce the reporting burden required of
p.(None): health care providers.
p.(None): ``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C.
p.(None): App.) shall not apply to the development of the goal,
p.(None): strategies, or recommendations described in this section.
p.(None):
p.(None): ``(c) Application of Certain Regulatory Requirements.--A physician
p.(None): (as defined in section 1861(r)(1) of the Social Security Act), to the
p.(None): extent consistent with applicable State law, may delegate electronic
p.(None): medical record documentation requirements specified in regulations
p.(None): promulgated by the Centers for Medicare & Medicaid Services to a person
p.(None): performing a scribe function who is not such physician if such physician
...
p.(None): at least a quarterly basis.
p.(None): (2) Authority to alter format.--The Secretary of Health and
p.(None): Human Services may alter the format of the reports on the
p.(None): attestation of eligible health care professionals following the
p.(None): first performance year of the Merit-based Incentive Payment
p.(None): System to account for changes arising from the implementation of
p.(None): such payment system.
p.(None): SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND
p.(None): FUNCTIONALITY.
p.(None):
p.(None): (a) Enhancements to Certification.--Section 3001(c)(5) of the Public
p.(None): Health Service Act (42 U.S.C. 300jj-11), as amended by section 4001(b),
p.(None): is further amended by adding at the end the following:
p.(None): ``(D) Conditions of certification.--Not later than 1
p.(None): year after the date of enactment of the 21st Century
p.(None): Cures Act, the Secretary, through notice and comment
p.(None): rulemaking, shall require, as a condition of
p.(None): certification and maintenance of certification for
p.(None): programs maintained or recognized under this paragraph,
p.(None): consistent with other
p.(None):
p.(None): [[Page 130 STAT. 1160]]
p.(None):
p.(None): conditions and requirements under this title, that the
p.(None): health information technology developer or entity--
p.(None): ``(i) does not take any action that
p.(None): constitutes information blocking as defined in
p.(None): section 3022(a);
p.(None): ``(ii) provides assurances satisfactory to the
p.(None): Secretary that such developer or entity, unless
p.(None): for legitimate purposes specified by the
p.(None): Secretary, will not take any action described in
p.(None): clause (i) or any other action that may inhibit
p.(None): the appropriate exchange, access, and use of
p.(None): electronic health information;
p.(None): ``(iii) does not prohibit or restrict
p.(None): communication regarding--
p.(None): ``(I) the usability of the health
p.(None): information technology;
p.(None): ``(II) the interoperability of the
p.(None): health information technology;
p.(None): ``(III) the security of the health
p.(None): information technology;
p.(None): ``(IV) relevant information
p.(None): regarding users' experiences when using
p.(None): the health information technology;
p.(None): ``(V) the business practices of
p.(None): developers of health information
p.(None): technology related to exchanging
p.(None): electronic health information; and
p.(None): ``(VI) the manner in which a user of
p.(None): the health information technology has
p.(None): used such technology;
p.(None): ``(iv) has published application programming
p.(None): interfaces and allows health information from such
p.(None): technology to be accessed, exchanged, and used
p.(None): without special effort through the use of
p.(None): application programming interfaces or successor
p.(None): technology or standards, as provided for under
p.(None): applicable law, including providing access to all
p.(None): data elements of a patient's electronic health
p.(None): record to the extent permissible under applicable
p.(None): privacy laws;
p.(None): ``(v) has successfully tested the real world
p.(None): use of the technology for interoperability (as
p.(None): defined in section 3000) in the type of setting in
p.(None): which such technology would be marketed;
p.(None): ``(vi) provides to the Secretary an
p.(None): attestation that the developer or entity--
p.(None): ``(I) has not engaged in any of the
p.(None): conduct described in clause (i);
p.(None): ``(II) has provided assurances
p.(None): satisfactory to the Secretary in
p.(None): accordance with clause (ii);
p.(None): ``(III) does not prohibit or
p.(None): restrict communication as described in
p.(None): clause (iii);
p.(None): ``(IV) has published information in
p.(None): accordance with clause (iv);
p.(None): ``(V) ensures that its technology
p.(None): allows for health information to be
p.(None): exchanged, accessed, and used, in the
p.(None): manner described in clause (iv); and
p.(None): ``(VI) has undertaken real world
p.(None): testing as described in clause (v); and
p.(None): ``(vii) submits reporting criteria in
p.(None): accordance with section 3009A(b).''.
p.(None):
p.(None): [[Page 130 STAT. 1161]]
p.(None):
p.(None): ``(E) Compliance with conditions of certification.--
p.(None): The Secretary may encourage compliance with the
p.(None): conditions of certification described in subparagraph
p.(None): (D) and take action to discourage noncompliance, as
p.(None): appropriate.''.
p.(None):
p.(None): (b) EHR Significant Hardship Exception.--
p.(None): (1) Application to eligible professionals.--
p.(None): (A) In case of decertification.--Section
p.(None): 1848(a)(7)(B) of the Social Security Act (42 U.S.C.
p.(None): 1395w-4(a)(7)(B)) is amended by inserting after the
...
p.(None): products developed by such developer prior to the publication of such
p.(None): report under subsection (d).
p.(None): ``(f) Additional Resources.--The Secretary may provide additional
p.(None): resources on the Internet website of the Office of the National
p.(None):
p.(None): [[Page 130 STAT. 1165]]
p.(None):
p.(None): Coordinator to better inform consumers of health information technology.
p.(None): Such reports may be carried out through partnerships with private
p.(None): organizations with appropriate expertise.''.
p.(None): (d) Authorization of Appropriations.--There is authorized to be
p.(None): appropriated $15,000,000 for purposes of carrying out subparagraph (D)
p.(None): of section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-
p.(None): 11) (as added by subsection (a)) and section 3009A of the Public Health
p.(None): Service Act (as added by subsection (b)), including for purposes of
p.(None): administering any contracts, grants, or agreements, to remain available
p.(None): until expended.
p.(None): SEC. 4003. INTEROPERABILITY.
p.(None):
p.(None): (a) Definition.--Section 3000 of the Public Health Service Act (42
p.(None): U.S.C. 300jj) is amended--
p.(None): (1) by redesignating paragraphs (10) through (14), as
p.(None): paragraphs (11) through (15), respectively; and
p.(None): (2) by inserting after paragraph (9) the following:
p.(None): ``(10) Interoperability.--The term `interoperability', with
p.(None): respect to health information technology, means such health
p.(None): information technology that--
p.(None): ``(A) enables the secure exchange of electronic
p.(None): health information with, and use of electronic health
p.(None): information from, other health information technology
p.(None): without special effort on the part of the user;
p.(None): ``(B) allows for complete access, exchange, and use
p.(None): of all electronically accessible health information for
p.(None): authorized use under applicable State or Federal law;
p.(None): and
p.(None): ``(C) does not constitute information blocking as
p.(None): defined in section 3022(a).''.
p.(None):
p.(None): (b) Support for Interoperable Network Exchange.--Section 3001(c) of
p.(None): the Public Health Service Act (42 U.S.C. 300jj-11(c)) is amended by
p.(None): adding at the end the following:
p.(None): ``(9) Support for interoperable networks exchange.--
p.(None): ``(A) In general.--The National Coordinator shall,
p.(None): in collaboration with the National Institute of
p.(None): Standards and Technology and other relevant agencies
p.(None): within the Department of Health and Human Services, for
p.(None): the purpose of ensuring full network-to-network exchange
p.(None): of health information, convene public-private and
p.(None): public-public partnerships to build consensus and
p.(None): develop or support a trusted exchange framework,
p.(None): including a common agreement among health information
p.(None): networks nationally. Such convention may occur at a
p.(None): frequency determined appropriate by the Secretary.
p.(None): ``(B) Establishing a trusted exchange framework.--
p.(None): ``(i) In general.--Not later than 6 months
p.(None): after the date of enactment of the 21st Century
p.(None): Cures Act, the National Coordinator shall convene
p.(None): appropriate public and private stakeholders to
p.(None): develop or support a trusted exchange framework
p.(None): for trust policies and practices and for a common
p.(None): agreement for exchange between health information
p.(None): networks. The common agreement may include--
p.(None): ``(I) a common method for
p.(None): authenticating trusted health
p.(None): information network participants;
p.(None):
p.(None): [[Page 130 STAT. 1166]]
p.(None):
...
p.(None): exchange of health information.
p.(None): (B) Limitation.--In no case shall exclusion from the
p.(None): index of providers be used as a measure to achieve
p.(None): objectives other the objectives described in
p.(None): subparagraph (A).
p.(None):
p.(None): (d) Standards Development Organizations.--Section 3004 of the Public
p.(None): Health Service Act (42 U.S.C. 300jj-14) is amended by adding at the end
p.(None): the following:
p.(None): ``(c) Deference to Standards Development Organizations.--In adopting
p.(None): and implementing standards under this section, the Secretary shall give
p.(None): deference to standards published by standards development organizations
p.(None): and voluntary consensus-based standards bodies.''.
p.(None): (e) Health Information Technology Advisory Committee.--
p.(None): (1) In general.--Title XXX of the Public Health Service Act
p.(None): (42 U.S.C. 300jj et seq.) is amended by striking sections 3002
p.(None): (42 U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and inserting
p.(None): the following:
p.(None): ``SEC. 3002. <> HEALTH INFORMATION
p.(None): TECHNOLOGY ADVISORY COMMITTEE.
p.(None):
p.(None): ``(a) Establishment.--There is established a Health Information
p.(None): Technology Advisory Committee (referred to in this section as the `HIT
p.(None): Advisory Committee') to recommend to the National Coordinator,
p.(None): consistent with the implementation of the strategic plan described in
p.(None): section 3001(c)(3), policies, and, for purposes of adoption under
p.(None): section 3004, standards, implementation specifications, and
p.(None): certification criteria, relating to the implementation of a health
p.(None): information technology infrastructure, nationally and locally, that
p.(None): advances the electronic access, exchange, and use of health information.
p.(None): Such Committee shall serve to unify the roles of, and replace, the HIT
p.(None): Policy Committee and the HIT Standards Committee, as in existence before
p.(None): the date of the enactment of the 21st Century Cures Act.
p.(None): ``(b) Duties.--
p.(None): ``(1) Recommendations on policy framework to advance an
p.(None): interoperable health information technology infrastructure.--
p.(None): ``(A) In general.--The HIT Advisory Committee shall
p.(None): recommend to the National Coordinator a policy framework
p.(None): for adoption by the Secretary consistent with the
p.(None): strategic plan under section 3001(c)(3) for advancing
p.(None): the target areas described in this subsection. Such
p.(None): policy framework shall seek to prioritize achieving
p.(None): advancements in the target areas specified in
p.(None): subparagraph (B) of paragraph (2) and may, to the extent
p.(None): consistent with this section, incorporate policy
p.(None): recommendations made by the HIT Policy Committee, as in
p.(None): existence before the date of the enactment of the 21st
p.(None): Century Cures Act.
p.(None): ``(B) Updates.--The HIT Advisory Committee shall
p.(None): propose updates to such recommendations to the policy
p.(None): framework and make new recommendations, as appropriate.
p.(None):
p.(None): [[Page 130 STAT. 1169]]
p.(None):
p.(None): ``(2) General duties and target areas.--
p.(None): ``(A) In general.--The HIT Advisory Committee shall
p.(None): recommend to the National Coordinator for purposes of
p.(None): adoption under section 3004, standards, implementation
p.(None): specifications, and certification criteria and an order
p.(None): of priority for the development, harmonization, and
p.(None): recognition of such standards, specifications, and
p.(None): certification criteria. Such recommendations shall
p.(None): include recommended standards, architectures, and
p.(None): software schemes for access to electronic individually
p.(None): identifiable health information across disparate systems
p.(None): including user vetting, authentication, privilege
p.(None): management, and access control.
p.(None): ``(B) Priority target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee shall make
p.(None): recommendations under subparagraph (A) with respect to
p.(None): at least each of the following target areas:
p.(None): ``(i) Achieving a health information
p.(None): technology infrastructure, nationally and locally,
p.(None): that allows for the electronic access, exchange,
p.(None): and use of health information, including through
p.(None): technology that provides accurate patient
p.(None): information for the correct patient, including
p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
...
p.(None): specifications.--In the development, harmonization, or
p.(None): recognition of standards and implementation
p.(None): specifications, the HIT Advisory Committee for purposes
p.(None): of recommendations under paragraph (2)(B), shall, as
p.(None): appropriate, provide for the testing of such standards
p.(None): and specifications by the National Institute for
p.(None): Standards and Technology under section 13201(a) of the
p.(None): Health Information Technology for Economic and Clinical
p.(None): Health Act.
p.(None): ``(D) Consistency.--The standards, implementation
p.(None): specifications, and certification criteria recommended
p.(None): under paragraph (2)(B) shall be consistent with the
p.(None): standards for information transactions and data elements
p.(None): adopted pursuant to section 1173 of the Social Security
p.(None): Act.
p.(None): ``(E) Special rule related to interoperability.--Any
p.(None): recommendation made by the HIT Advisory Committee after
p.(None): the date of the enactment of this subparagraph with
p.(None): respect to interoperability of health information
p.(None): technology shall be consistent with interoperability as
p.(None): described in section 3000.
p.(None): ``(4) Forum.--The HIT Advisory Committee shall serve as a
p.(None): forum for the participation of a broad range of stakeholders
p.(None): with specific expertise in policies, including technical
p.(None): expertise, relating to the matters described in paragraphs (1),
p.(None): (2), and (3) to provide input on the development, harmonization,
p.(None): and recognition of standards, implementation specifications, and
p.(None): certification criteria necessary for the development and
p.(None): adoption of health information technology infrastructure
p.(None): nationally and locally that allows for the electronic access,
p.(None): exchange, and use of health information.
p.(None): ``(5) Schedule.--Not later than 30 days after the date on
p.(None): which the HIT Advisory Committee first meets, such HIT Advisory
p.(None): Committee shall develop a schedule for the assessment of policy
p.(None): recommendations developed under paragraph (1). The HIT Advisory
p.(None): Committee shall update such schedule annually. The Secretary
p.(None): shall publish such schedule in the Federal Register.
p.(None): ``(6) Public input.--The HIT Advisory Committee shall
p.(None): conduct open public meetings and develop a process to allow for
p.(None): public comment on the schedule described in paragraph (5) and
p.(None): recommendations described in this subsection. Under such process
p.(None): comments shall be submitted in a timely manner after the date of
p.(None): publication of a recommendation under this subsection.
p.(None):
p.(None): ``(c) Measured Progress in Advancing Priority Areas.--
p.(None):
p.(None): [[Page 130 STAT. 1172]]
p.(None):
p.(None): ``(1) In general.--For purposes of this section, the
p.(None): National Coordinator, in collaboration with the Secretary, shall
p.(None): establish, and update as appropriate, objectives and benchmarks
p.(None): for advancing and measuring the advancement of the priority
p.(None): target areas described in subsection (b)(2)(B).
p.(None): ``(2) Annual progress reports on advancing
p.(None): interoperability.--
p.(None): ``(A) In general.--The HIT Advisory Committee, in
p.(None): consultation with the National Coordinator, shall
p.(None): annually submit to the Secretary and Congress a report
p.(None): on the progress made during the preceding fiscal year
p.(None): in--
p.(None): ``(i) achieving a health information
p.(None): technology infrastructure, nationally and locally,
p.(None): that allows for the electronic access, exchange,
p.(None): and use of health information; and
p.(None): ``(ii) meeting the objectives and benchmarks
p.(None): described in paragraph (1).
p.(None): ``(B) Content.--Each such report shall include, for
p.(None): a fiscal year--
p.(None): ``(i) a description of the work conducted by
p.(None): the HIT Advisory Committee during the preceding
p.(None): fiscal year with respect to the areas described in
p.(None): subsection (b)(2)(B);
p.(None): ``(ii) an assessment of the status of the
p.(None): infrastructure described in subparagraph (A),
p.(None): including the extent to which electronic health
p.(None): information is appropriately and readily available
p.(None): to enhance the access, exchange, and the use of
p.(None): electronic health information between users and
p.(None): across technology offered by different developers;
p.(None): ``(iii) the extent to which advancements have
p.(None): been achieved with respect to areas described in
p.(None): subsection (b)(2)(B);
p.(None): ``(iv) an analysis identifying existing gaps
p.(None): in policies and resources for--
p.(None): ``(I) achieving the objectives and
p.(None): benchmarks established under paragraph
p.(None): (1); and
p.(None): ``(II) furthering interoperability
p.(None): throughout the health information
p.(None): technology infrastructure;
p.(None): ``(v) recommendations for addressing the gaps
p.(None): identified in clause (iii); and
p.(None): ``(vi) a description of additional initiatives
p.(None): as the HIT Advisory Committee and National
p.(None): Coordinator determine appropriate.
p.(None): ``(3) Significant advancement determination.--The Secretary
p.(None): shall periodically, based on the reports submitted under this
p.(None): subsection, review the target areas described in subsection
p.(None): (b)(2)(B), and, based on the objectives and benchmarks
p.(None): established under paragraph (1), the Secretary shall determine
p.(None): if significant advancement has been achieved with respect to
p.(None): such an area. Such determination shall be taken into
p.(None): consideration by the HIT Advisory Committee when determining to
p.(None): what extent the Committee makes recommendations for an area
p.(None): other than an area described in subsection (b)(2)(B).
p.(None):
p.(None): ``(d) Membership and Operations.--
p.(None):
p.(None): [[Page 130 STAT. 1173]]
p.(None):
p.(None): ``(1) In general.--The National Coordinator shall take a
p.(None): leading position in the establishment and operations of the HIT
p.(None): Advisory Committee.
p.(None): ``(2) Membership.--The membership of the HIT Advisory
...
p.(None): shall provide for an orderly and timely transition to the HIT
p.(None): Advisory Committee established under amendments made by this
p.(None): section.
p.(None):
p.(None): (f) Priorities for Adoption of Standards, Implementation
p.(None): Specifications, and Certification Criteria.--Title XXX of the Public
p.(None): Health Service Act (42 U.S.C. 300jj et seq.), as amended by subsection
p.(None): (e), is further amended by inserting after section 3002 the following:
p.(None): ``SEC. 3003. <> SETTING PRIORITIES FOR
p.(None): STANDARDS ADOPTION.
p.(None):
p.(None): ``(a) Identifying Priorities.--
p.(None): ``(1) In general.--Not later than 6 months after the date on
p.(None): which the HIT Advisory Committee first meets, the National
p.(None): Coordinator shall periodically convene the HIT Advisory
p.(None): Committee to--
p.(None): ``(A) identify priority uses of health information
p.(None): technology, focusing on priorities--
p.(None): ``(i) arising from the implementation of the
p.(None): incentive programs for the meaningful use of
p.(None): certified EHR technology, the Merit-based
p.(None): Incentive Payment System, Alternative Payment
p.(None): Models, the Hospital Value-Based Purchasing
p.(None): Program, and any other value-based payment program
p.(None): determined appropriate by the Secretary;
p.(None): ``(ii) related to the quality of patient care;
p.(None): ``(iii) related to public health;
p.(None): ``(iv) related to clinical research;
p.(None): ``(v) related to the privacy and security of
p.(None): electronic health information;
p.(None): ``(vi) related to innovation in the field of
p.(None): health information technology;
p.(None): ``(vii) related to patient safety;
p.(None): ``(viii) related to the usability of health
p.(None): information technology;
p.(None): ``(ix) related to individuals' access to
p.(None): electronic health information; and
p.(None): ``(x) other priorities determined appropriate
p.(None): by the Secretary;
p.(None): ``(B) identify existing standards and implementation
p.(None): specifications that support the use and exchange of
p.(None): electronic health information needed to meet the
p.(None): priorities identified in subparagraph (A); and
p.(None): ``(C) publish a report summarizing the findings of
p.(None): the analysis conducted under subparagraphs (A) and (B)
p.(None): and make appropriate recommendations.
p.(None):
p.(None): [[Page 130 STAT. 1176]]
p.(None):
p.(None): ``(2) Prioritization.--In identifying such standards and
p.(None): implementation specifications under paragraph (1)(B), the HIT
p.(None): Advisory Committee shall prioritize standards and implementation
p.(None): specifications developed by consensus-based standards
p.(None): development organizations.
p.(None): ``(3) Guidelines for review of existing standards and
p.(None): specifications.--In consultation with the consensus-based entity
p.(None): described in section 1890 of the Social Security Act and other
p.(None): appropriate Federal agencies, the analysis of existing standards
p.(None): under paragraph (1)(B) shall include an evaluation of the need
p.(None): for a core set of common data elements and associated value sets
p.(None): to enhance the ability of certified health information
p.(None): technology to capture, use, and exchange structured electronic
p.(None): health information.
p.(None):
p.(None): ``(b) Review of Adopted Standards.--
p.(None): ``(1) In general.--Beginning 5 years after the date of
p.(None): enactment of the 21st Century Cures Act and every 3 years
p.(None): thereafter, the National Coordinator shall convene stakeholders
p.(None): to review the existing set of adopted standards and
p.(None): implementation specifications and make recommendations with
p.(None): respect to whether to--
p.(None): ``(A) maintain the use of such standards and
p.(None): implementation specifications; or
p.(None): ``(B) phase out such standards and implementation
p.(None): specifications.
p.(None): ``(2) Priorities.--The HIT Advisory Committee, in
p.(None): collaboration with the National Institute for Standards and
p.(None): Technology, shall annually and through the use of public input,
p.(None): review and publish priorities for the use of health information
p.(None): technology, standards, and implementation specifications to
p.(None): support those priorities.
p.(None):
p.(None): ``(c) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the use or adoption of novel standards that improve
p.(None): upon the existing health information technology infrastructure and
p.(None): facilitate the secure exchange of health information.''.
p.(None): SEC. 4004. INFORMATION BLOCKING.
p.(None):
p.(None): Subtitle C of title XXX of the Public Health Service Act (42 U.S.C.
p.(None): 300jj-51 et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 3022. <> INFORMATION BLOCKING.
p.(None):
p.(None): ``(a) Definition.--
p.(None): ``(1) In general.--In this section, the term `information
p.(None): blocking' means a practice that--
p.(None): ``(A) except as required by law or specified by the
p.(None): Secretary pursuant to rulemaking under paragraph (3), is
p.(None): likely to interfere with, prevent, or materially
p.(None): discourage access, exchange, or use of electronic health
p.(None): information; and
p.(None): ``(B)(i) if conducted by a health information
p.(None): technology developer, exchange, or network, such
p.(None): developer, exchange, or network knows, or should know,
p.(None): that such practice is likely to interfere with, prevent,
p.(None): or materially discourage the access, exchange, or use of
p.(None): electronic health information; or
p.(None): ``(ii) if conducted by a health care provider, such
p.(None): provider knows that such practice is unreasonable and is
p.(None):
p.(None): [[Page 130 STAT. 1177]]
p.(None):
p.(None): likely to interfere with, prevent, or materially
p.(None): discourage access, exchange, or use of electronic health
p.(None): information.
p.(None): ``(2) Practices described.--The information blocking
p.(None): practices described in paragraph (1) may include--
p.(None): ``(A) practices that restrict authorized access,
p.(None): exchange, or use under applicable State or Federal law
p.(None): of such information for treatment and other permitted
p.(None): purposes under such applicable law, including
p.(None): transitions between certified health information
p.(None): technologies;
p.(None): ``(B) implementing health information technology in
p.(None): nonstandard ways that are likely to substantially
p.(None): increase the complexity or burden of accessing,
p.(None): exchanging, or using electronic health information; and
p.(None): ``(C) implementing health information technology in
p.(None): ways that are likely to--
p.(None): ``(i) restrict the access, exchange, or use of
p.(None): electronic health information with respect to
p.(None): exporting complete information sets or in
p.(None): transitioning between health information
p.(None): technology systems; or
p.(None): ``(ii) lead to fraud, waste, or abuse, or
p.(None): impede innovations and advancements in health
p.(None): information access, exchange, and use, including
p.(None): care delivery enabled by health information
p.(None): technology.
p.(None): ``(3) Rulemaking.--The Secretary, through rulemaking, shall
p.(None): identify reasonable and necessary activities that do not
p.(None): constitute information blocking for purposes of paragraph (1).
p.(None): ``(4) No enforcement before exception identified.--The term
p.(None): `information blocking' does not include any practice or conduct
p.(None): occurring prior to the date that is 30 days after the date of
p.(None): enactment of the 21st Century Cures Act.
p.(None): ``(5) Consultation.--The Secretary may consult with the
p.(None): Federal Trade Commission in promulgating regulations under this
p.(None): subsection, to the extent that such regulations define practices
p.(None): that are necessary to promote competition and consumer welfare.
p.(None): ``(6) Application.--The term `information blocking', with
p.(None): respect to an individual or entity, shall not include an act or
p.(None): practice other than an act or practice committed by such
p.(None): individual or entity.
p.(None): ``(7) Clarification.--In carrying out this section, the
p.(None): Secretary shall ensure that health care providers are not
p.(None): penalized for the failure of developers of health information
p.(None): technology or other entities offering health information
p.(None): technology to such providers to ensure that such technology
p.(None): meets the requirements to be certified under this title.
p.(None):
p.(None): ``(b) Inspector General Authority.--
p.(None): ``(1) In general.--The inspector general of the Department
p.(None): of Health and Human Services (referred to in this section as the
p.(None): `Inspector General') may investigate any claim that--
...
p.(None): health care data, using standardized data elements and
p.(None): having procedures in place to verify the completeness
p.(None): and validity of those data; and
p.(None): (B) being subject to regular data checks or audits
p.(None): to verify completeness and validity; and
p.(None): (5) that provides ongoing participant training and support.
p.(None):
p.(None): (c) Treatment of Health Information Technology Developers With
p.(None): Respect to Patient Safety Organizations.--
p.(None): (1) In general.--In applying part C of title IX of the
p.(None): Public Health Service Act (42 U.S.C. 299b-21 et seq.), a health
p.(None): information technology developer shall be treated as a provider
p.(None): (as defined in section 921 of such Act) for purposes of
p.(None): reporting and conducting patient safety activities concerning
p.(None): improving clinical care through the use of health information
p.(None): technology that could result in improved patient safety, health
p.(None): care quality, or health care outcomes.
p.(None): (2) Report.--Not later than 4 years after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives, a report
p.(None): concerning best practices and current trends voluntarily
p.(None): provided, without identifying individual providers or disclosing
p.(None): or using protected health information or individually
p.(None): identifiable information, by patient safety organizations to
p.(None): improve the integration of health information technology into
p.(None): clinical practice.
p.(None): SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS TO
p.(None): THEIR ELECTRONIC HEALTH INFORMATION.
p.(None):
p.(None): (a) Use of Health Information Exchanges for Patient Access.--Section
p.(None): 3009 of the Public Health Service Act (42 U.S.C. 300jj-19) is amended by
p.(None): adding at the end the following:
p.(None): ``(c) Promoting Patient Access to Electronic Health Information
p.(None): Through Health Information Exchanges .--
p.(None): ``(1) In general.--The Secretary shall use existing
p.(None): authorities to encourage partnerships between health information
p.(None): exchange organizations and networks and health care providers,
p.(None): health plans, and other appropriate entities with the goal of
p.(None): offering patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically.
p.(None): ``(2) Education of providers.--The Secretary, in
p.(None): coordination with the Office for Civil Rights of the Department
p.(None): of Health and Human Services, shall--
p.(None): ``(A) educate health care providers on ways of
p.(None): leveraging the capabilities of health information
p.(None): exchanges
p.(None):
p.(None): [[Page 130 STAT. 1182]]
p.(None):
p.(None): (or other relevant platforms) to provide patients with
p.(None): access to their electronic health information;
p.(None): ``(B) clarify misunderstandings by health care
p.(None): providers about using health information exchanges (or
p.(None): other relevant platforms) for patient access to
p.(None): electronic health information; and
p.(None): ``(C) to the extent practicable, educate providers
p.(None): about health information exchanges (or other relevant
p.(None): platforms) that employ some or all of the capabilities
p.(None): described in paragraph (1).
p.(None): ``(3) Requirements.--In carrying out paragraph (1), the
p.(None): Secretary, in coordination with the Office for Civil Rights,
p.(None): shall issue guidance to health information exchanges related to
p.(None): best practices to ensure that the electronic health information
p.(None): provided to patients is--
p.(None): ``(A) private and secure;
p.(None): ``(B) accurate;
p.(None): ``(C) verifiable; and
p.(None): ``(D) where a patient's authorization to exchange
p.(None): information is required by law, easily exchanged
p.(None): pursuant to such authorization.
p.(None): ``(4) Rule of construction.--Nothing in this subsection
p.(None): shall be construed to preempt State laws applicable to patient
p.(None): consent for the access of information through a health
p.(None): information exchange (or other relevant platform) that provide
p.(None): protections to patients that are greater than the protections
p.(None): otherwise provided for under applicable Federal law.
p.(None):
p.(None): ``(d) Efforts To Promote Access to Health Information.--The National
p.(None): Coordinator and the Office for Civil Rights of the Department of Health
p.(None): and Human Services shall jointly promote patient access to health
p.(None): information in a manner that would ensure that such information is
p.(None): available in a form convenient for the patient, in a reasonable manner,
p.(None): without burdening the health care provider involved.
p.(None): ``(e) Accessibility of Patient Records.--
p.(None): ``(1) Accessibility and updating of information.--
p.(None): ``(A) In general.--The Secretary, in consultation
p.(None): with the National Coordinator, shall promote policies
p.(None): that ensure that a patient's electronic health
p.(None): information is accessible to that patient and the
p.(None): patient's designees, in a manner that facilitates
p.(None): communication with the patient's health care providers
p.(None): and other individuals, including researchers, consistent
p.(None): with such patient's consent.
p.(None): ``(B) Updating education on accessing and exchanging
p.(None): personal health information.--To promote awareness that
p.(None): an individual has a right of access to inspect, obtain a
p.(None): copy of, and transmit to a third party a copy of such
p.(None): individual's protected health information pursuant to
p.(None): the Health Information Portability and Accountability
p.(None): Act, Privacy Rule (subpart E of part 164 of title 45,
p.(None): Code of Federal Regulations), the Director of the Office
p.(None): for Civil Rights, in consultation with the National
p.(None): Coordinator, shall assist individuals and health care
p.(None): providers in understanding a patient's rights to access
p.(None): and protect personal health information under the Health
p.(None): Insurance Portability and Accountability Act of 1996
p.(None): (Public Law 104-191), including providing best practices
p.(None):
p.(None): [[Page 130 STAT. 1183]]
p.(None):
p.(None): for requesting personal health information in a
p.(None): computable format, including using patient portals or
p.(None): third-party applications and common cases when a
p.(None): provider is permitted to exchange and provide access to
p.(None): health information.''.
p.(None): ``(2) Certifying usability for patients.--In carrying out
p.(None): certification programs under section 3001(c)(5), the National
p.(None): Coordinator may require that--
p.(None): ``(A) the certification criteria support--
p.(None): ``(i) patient access to their electronic
p.(None): health information, including in a single
p.(None): longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically;
p.(None): ``(ii) the patient's ability to electronically
p.(None): communicate patient-reported information (such as
p.(None): family history and medical history); and
p.(None): ``(iii) patient access to their personal
p.(None): electronic health information for research at the
p.(None): option of the patient; and
p.(None): ``(B) the HIT Advisory Committee develop and
p.(None): prioritize standards, implementation specifications, and
p.(None): certification criteria required to help support patient
p.(None): access to electronic health information, patient
p.(None): usability, and support for technologies that offer
p.(None): patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to
p.(None): understand, secure, and may be updated automatically.''.
p.(None):
p.(None): (b) Access to Information in an Electronic Format.--Section 13405(e)
p.(None): of the Health Information Technology for Economic and Clinical Health
p.(None): Act (42 U.S.C. 17935) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (2) as paragraph (3); and
p.(None): (3) by inserting after paragraph (1), the following:
p.(None): ``(2) if the individual makes a request to a business
p.(None): associate for access to, or a copy of, protected health
p.(None): information about the individual, or if an individual makes a
p.(None): request to a business associate to grant such access to, or
p.(None): transmit such copy directly to, a person or entity designated by
p.(None): the individual, a business associate may provide the individual
p.(None): with such access or copy, which may be in an electronic form, or
p.(None): grant or transmit such access or copy to such person or entity
p.(None): designated by the individual; and''.
p.(None): SEC. 4007. GAO STUDY ON PATIENT MATCHING.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, the Comptroller General of the United States shall conduct
p.(None): a study to--
p.(None): (1) review the policies and activities of the Office of the
p.(None): National Coordinator for Health Information Technology and other
p.(None): relevant stakeholders, which may include standards development
p.(None): organizations, experts in the technical aspects of health
p.(None): information technology, health information technology
p.(None): developers, providers of health services, health care suppliers,
p.(None): health care payers, health care quality organizations, States,
p.(None): health information technology policy experts, and other
p.(None): appropriate entities, to ensure appropriate patient matching to
p.(None): protect patient privacy and security with respect to electronic
p.(None):
p.(None): [[Page 130 STAT. 1184]]
p.(None):
p.(None): health records and the exchange of electronic health
p.(None): information; and
p.(None): (2) survey ongoing efforts related to the policies and
p.(None): activities described in paragraph (1) and the effectiveness of
p.(None): such efforts occurring in the private sector.
p.(None):
p.(None): (b) Areas of Concentration.--In conducting the study under
p.(None): subsection (a), the Comptroller General shall--
p.(None): (1) evaluate current methods used in certified electronic
p.(None): health records for patient matching based on performance related
p.(None): to factors such as--
p.(None): (A) the privacy of patient information;
p.(None): (B) the security of patient information;
p.(None): (C) improving matching rates;
p.(None): (D) reducing matching errors; and
p.(None): (E) reducing duplicate records; and
p.(None): (2) determine whether the Office of the National Coordinator
p.(None): for Health Information Technology could improve patient matching
p.(None): by taking steps including--
p.(None): (A) defining additional data elements to assist in
p.(None): patient data matching;
p.(None): (B) agreeing on a required minimum set of elements
p.(None): that need to be collected and exchanged;
p.(None): (C) requiring electronic health records to have the
p.(None): ability to make certain fields required and use specific
p.(None): standards; and
p.(None): (D) other options recommended by the relevant
p.(None): stakeholders consulted pursuant to subsection (a).
p.(None):
p.(None): (c) Report.--Not later than 2 years after the date of enactment of
p.(None): this Act, the Comptroller General shall submit to the appropriate
p.(None): committees of Congress a report concerning the findings of the study
p.(None): conducted under subsection (a).
p.(None): SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
p.(None):
p.(None): (a) Study.--
p.(None): (1) In general.--The Comptroller General of the United
p.(None): States (referred to in this section as the ``Comptroller
p.(None): General'') shall build on prior Government Accountability Office
p.(None): studies and other literature review and conduct a study to
p.(None): review patient access to their own protected health information,
p.(None): including barriers to such patient access and complications or
p.(None): difficulties providers experience in providing access to
p.(None): patients. In conducting such study, the Comptroller General
p.(None): shall consider the increase in adoption of health information
p.(None): technology and the increasing prevalence of protected health
p.(None): information that is maintained electronically.
p.(None): (2) Areas of concentration.--In conducting the review under
p.(None): paragraph (1), the Comptroller General shall consider--
p.(None): (A) instances when covered entities charge
p.(None): individuals, including patients, third parties, and
p.(None): health care providers, for record requests, including
p.(None): records that are requested in an electronic format;
p.(None): (B) examples of the amounts and types of fees
p.(None): charged to individuals for record requests, including
p.(None): instances when the record is requested to be transmitted
p.(None): to a third party;
p.(None): (C) the extent to which covered entities are unable
p.(None): to provide the access requested by individuals in the
p.(None): form
p.(None):
p.(None): [[Page 130 STAT. 1185]]
p.(None):
p.(None): and format requested by the individual, including
p.(None): examples of such instances;
p.(None): (D) instances in which third parties may request
p.(None): protected health information through patients'
p.(None): individual right of access, including instances where
p.(None): such requests may be used to circumvent appropriate fees
p.(None): that may be charged to third parties;
p.(None): (E) opportunities that permit covered entities to
p.(None): charge appropriate fees to third parties for patient
p.(None): records while providing patients with access to their
p.(None): protected health information at low or no cost;
p.(None): (F) the ability of providers to distinguish between
p.(None): requests originating from an individual that require
p.(None): limitation to a cost-based fee and requests originating
p.(None): from third parties that may not be limited to cost-based
p.(None): fees; and
p.(None): (G) other circumstances that may inhibit the ability
p.(None): of providers to provide patients with access to their
p.(None): records, and the ability of patients to gain access to
p.(None): their records.
p.(None):
p.(None): (b) Report.--Not later than 18 months after the date of enactment of
p.(None): this Act, the Comptroller General shall submit a report to Congress on
p.(None): the findings of the study conducted under subsection (a).
p.(None): SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
p.(None):
p.(None): (a) In General.--Section 1862(l)(5) of the Social Security Act (42
p.(None): U.S.C. 1395y(l)(5)) is amended by adding at the end the following new
p.(None): subparagraph:
p.(None): ``(D) Local coverage determinations.--The Secretary
p.(None): shall require each Medicare administrative contractor
p.(None): that develops a local coverage determination to make
p.(None): available on the Internet website of such contractor and
p.(None): on the Medicare Internet website, at least 45 days
p.(None): before the effective date of such determination, the
p.(None): following information:
p.(None): ``(i) Such determination in its entirety.
p.(None): ``(ii) Where and when the proposed
p.(None): determination was first made public.
p.(None): ``(iii) Hyperlinks to the proposed
p.(None): determination and a response to comments submitted
p.(None): to the contractor with respect to such proposed
p.(None): determination.
p.(None): ``(iv) A summary of evidence that was
p.(None): considered by the contractor during the
p.(None): development of such determination and a list of
p.(None): the sources of such evidence.
p.(None): ``(v) An explanation of the rationale that
p.(None): supports such determination.''.
p.(None):
p.(None): (b) <> Effective Date.--The amendment
p.(None): made by subsection (a) shall apply with respect to local coverage
p.(None): determinations that are proposed or revised on or after the date that is
p.(None): 180 days after the date of enactment of this Act.
...
p.(None): entity, but excluding a program beneficiary, as defined in subsection
p.(None): (q)(4)) that, with respect to a grant, contract, or other agreement for
p.(None): which the Secretary provides funding--
p.(None): ``(1) knowingly presents or causes to be presented a
p.(None): specified claim (as defined in subsection (r)) under such grant,
p.(None): contract, or other agreement that the person knows or should
p.(None): know is false or fraudulent;
p.(None): ``(2) knowingly makes, uses, or causes to be made or used
p.(None): any false statement, omission, or misrepresentation of a
p.(None): material fact in any application, proposal, bid, progress
p.(None): report, or other document that is required to be submitted in
p.(None): order to directly or indirectly receive or retain funds provided
p.(None): in whole or in part by such Secretary pursuant to such grant,
p.(None): contract, or other agreement;
p.(None): ``(3) knowingly makes, uses, or causes to be made or used, a
p.(None): false record or statement material to a false or fraudulent
p.(None): specified claim under such grant, contract, or other agreement;
p.(None): ``(4) knowingly makes, uses, or causes to be made or used, a
p.(None): false record or statement material to an obligation (as defined
p.(None): in subsection (s)) to pay or transmit funds or property to such
p.(None): Secretary with respect to such grant, contract, or other
p.(None): agreement, or knowingly conceals or knowingly and improperly
p.(None): avoids or decreases an obligation to pay or transmit funds or
p.(None): property to such Secretary with respect to such grant, contract,
p.(None): or other agreement; or
p.(None): ``(5) fails to grant timely access, upon reasonable request
p.(None): (as defined by such Secretary in regulations), to the Inspector
p.(None): General of the Department, for the purpose of audits,
p.(None): investigations, evaluations, or other statutory functions of
p.(None): such Inspector General in matters involving such grants,
p.(None): contracts, or other agreements;
p.(None):
p.(None): [[Page 130 STAT. 1189]]
p.(None):
p.(None): shall be subject, in addition to any other penalties that may be
p.(None): prescribed by law, to a civil money penalty in cases under paragraph
p.(None): (1), of not more than $10,000 for each specified claim; in cases under
p.(None): paragraph (2), not more than $50,000 for each false statement, omission,
p.(None): or misrepresentation of a material fact; in cases under paragraph (3),
p.(None): not more than $50,000 for each false record or statement; in cases under
p.(None): paragraph (4), not more than $50,000 for each false record or statement
p.(None): or $10,000 for each day that the person knowingly conceals or knowingly
p.(None): and improperly avoids or decreases an obligation to pay; or in cases
p.(None): under paragraph (5), not more than $15,000 for each day of the failure
p.(None): described in such paragraph. In addition, in cases under paragraphs (1)
p.(None): and (3), such a person shall be subject to an assessment of not more
p.(None): than 3 times the amount claimed in the specified claim described in such
p.(None): paragraph in lieu of damages sustained by the United States or a
p.(None): specified State agency because of such specified claim, and in cases
p.(None): under paragraphs (2) and (4), such a person shall be subject to an
p.(None): assessment of not more than 3 times the total amount of the funds
p.(None): described in paragraph (2) or (4), respectively (or, in the case of an
...
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
p.(None): and report on required performance measures; and
p.(None): ``(E) the extent to which the grantee is proposing
p.(None): to use evidence-based practices; and
p.(None): ``(25) advance, through existing programs, the use of
p.(None): performance metrics, including those based on the
p.(None): recommendations on performance metrics from the Assistant
p.(None): Secretary for Planning and Evaluation under section 6021(d) of
p.(None): the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016.''; and
p.(None): (3) in subsection (m), by adding at the end the following:
p.(None): ``(4) Emergency response.--Amounts made available for
p.(None): carrying out this subsection shall remain available through the
p.(None): end of the fiscal year following the fiscal year for which such
p.(None): amounts are appropriated.''.
p.(None): SEC. 6003. CHIEF MEDICAL OFFICER.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 and 6002, is further amended--
p.(None):
p.(None): [[Page 130 STAT. 1207]]
p.(None):
p.(None): (1) by redesignating subsections (g) through (j) and
p.(None): subsections (k) through (o) as subsections (h) through (k) and
p.(None): subsections (m) through (q), respectively;
p.(None): (2) in subsection (e)(3)(C), by striking ``subsection (k)''
p.(None): and inserting ``subsection (m)'';
p.(None): (3) in subsection (f)(2)(C)(iii), by striking ``subsection
p.(None): (k)'' and inserting ``subsection (m)''; and
p.(None): (4) by inserting after subsection (f) the following:
p.(None):
...
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate; and
p.(None): ``(B) post such plan on the Internet website of the
p.(None): Administration.
p.(None): ``(4) Contents.--The strategic plan developed under
p.(None): paragraph (1) shall--
p.(None): ``(A) identify strategic priorities, goals, and
p.(None): measurable objectives for mental and substance use
p.(None): disorders activities and programs operated and supported
p.(None): by the Administration, including priorities to prevent
p.(None): or eliminate the burden of mental and substance use
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
...
p.(None): local government, or a private entity.''.
p.(None): SEC. 6023. GAO STUDY.
p.(None):
p.(None): (a) In General.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States, in
p.(None): consultation with the Secretary of Health and Human Services and the
p.(None): Assistant Secretary for Mental Health and Substance Use, shall conduct
p.(None): an independent evaluation, and submit a report, to the Committee on
p.(None): Health, Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, on programs
p.(None): funded by allotments made under title I of the Protection and Advocacy
p.(None): for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
p.(None): (b) Contents.--The report and evaluation required under subsection
p.(None): (a) shall include--
p.(None): (1) a review of the programs described in such subsection
p.(None): that are carried out by State agencies and such programs that
p.(None): are carried out by private, nonprofit organizations; and
p.(None): (2) a review of the compliance of the programs described in
p.(None): subsection (a) with statutory and regulatory responsibilities,
p.(None): such as--
p.(None): (A) responsibilities relating to family engagement;
p.(None): (B) responsibilities relating to the grievance
p.(None): procedure for clients or prospective clients of the
p.(None): system to assure that individuals with mental illness
p.(None): have full access to the services of the system, for
p.(None): individuals who have received or are receiving mental
p.(None): health services, and for family members of such
p.(None): individuals with mental illness, or representatives of
p.(None): such individuals or family members, to assure that the
p.(None): eligible system is operating in compliance with the
p.(None): provisions of the Protection and Advocacy for
p.(None): Individuals with Mental Illness Act, as required to be
p.(None): established by section 105(a)(9) of such Act (42 U.S.C.
p.(None): 10805(a)(9));
p.(None): (C) investigation of alleged abuse and neglect of
p.(None): persons with mental illness;
p.(None): (D) availability of adequate medical and behavioral
p.(None): health treatment;
p.(None): (E) denial of rights for persons with mental
p.(None): illness; and
p.(None): (F) compliance with the Federal prohibition on
p.(None): lobbying.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
p.(None): COMMITTEE.
p.(None):
p.(None): (a) Establishment.--
p.(None): (1) In general.--Not later than 3 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services, or the designee of the Secretary, shall establish a
p.(None): committee to be known as the Interdepartmental Serious Mental
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
p.(None): this section, the provisions of the Federal Advisory Committee
p.(None): Act (5 U.S.C. App.) shall apply to the Committee.
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
...
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
p.(None): the Assistant Secretary may establish a period for the
p.(None): submission of applications for evidence-based programs and
p.(None): practices to be posted publicly in accordance with subsection
p.(None): (a).
p.(None): ``(2) Notice.--In establishing the application period under
p.(None): paragraph (1), the Assistant Secretary shall provide for the
p.(None): public notice of such application period in the Federal
p.(None): Register.
p.(None):
p.(None): [[Page 130 STAT. 1223]]
p.(None):
p.(None): Such notice may solicit applications for evidence-based programs
p.(None): and practices to address gaps in information identified by the
p.(None): Assistant Secretary, the National Mental Health and Substance
p.(None): Use Policy Laboratory established under section 501A, or the
p.(None): Assistant Secretary for Planning and Evaluation, including
p.(None): pursuant to the evaluation and recommendations under section
p.(None): 6021 of the Helping Families in Mental Health Crisis Reform Act
p.(None): of 2016 or priorities identified in the strategic plan under
p.(None): section 501(l).
p.(None):
p.(None): ``(c) Requirements.--The Assistant Secretary may establish minimum
p.(None): requirements for the applications submitted under subsection (b),
p.(None): including applications related to the submission of research and
p.(None): evaluation.
p.(None): ``(d) Review and Rating.--
p.(None): ``(1) In general.--The Assistant Secretary shall review
p.(None): applications prior to public posting in accordance with
p.(None): subsection (a), and may prioritize the review of applications
p.(None): for evidence-based programs and practices that are related to
p.(None): topics included in the notice provided under subsection (b)(2).
p.(None): ``(2) System.--In carrying out paragraph (1), the Assistant
p.(None): Secretary may utilize a rating and review system, which may
p.(None): include information on the strength of evidence associated with
p.(None): the evidence-based programs and practices and a rating of the
p.(None): methodological rigor of the research supporting the
p.(None): applications.
p.(None): ``(3) Public access to metrics and rating.--The Assistant
p.(None): Secretary shall make the metrics used to evaluate applications
p.(None): under this section, and any resulting ratings of such
p.(None): applications, publicly available.''.
p.(None): SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
p.(None): SIGNIFICANCE.
p.(None):
p.(None): Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32)
p.(None): is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in paragraph (4), by inserting before the period
p.(None): ``, which may include technical assistance centers'';
p.(None): and
p.(None): (B) in the flush sentence following paragraph (4)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or''; and
p.(None): (2) by amending subsection (f) to read as follows:
p.(None):
p.(None): ``(f) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $394,550,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None):
...
p.(None): formulas for distribution of funds under such block grants are
p.(None): appropriate, and if not, alternatives recommended by the
p.(None): Secretary;
p.(None): (3) where recommendations are included under paragraph (2)
p.(None): for the use of different indices, a description of the variables
p.(None): and data sources that should be used to determine the indices;
p.(None): (4) an evaluation of the variables and data sources that are
p.(None): being used for each of the indices involved, and whether such
p.(None): variables and data sources accurately represent the need for
p.(None): services, the cost of providing services, and the ability of the
p.(None): States to pay for such services;
p.(None): (5) the effect that the minimum allotment requirements for
p.(None): each such block grant have on each State's final allotment and
p.(None): the effect of such requirements, if any, on each State's
p.(None): formula-based allotment;
p.(None):
p.(None): [[Page 130 STAT. 1234]]
p.(None):
p.(None): (6) recommendations for modifications to the minimum
p.(None): allotment provisions to ensure an appropriate distribution of
p.(None): funds; and
p.(None): (7) any other information that the Secretary determines
p.(None): appropriate.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of enactment of
p.(None): this Act, the Secretary of Health and Human Services shall submit to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and
p.(None): the Committee on Energy and Commerce of the House of Representatives, a
p.(None): report containing the findings and recommendations of the study
p.(None): conducted under subsection (a) and the study conducted under section
p.(None): 9004(g).
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
p.(None): INDIVIDUALS.
p.(None):
p.(None): Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is
p.(None): amended--
p.(None): (1) in subsection (a), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraphs (1) and (3), by striking
p.(None): ``substance abuse'' each place the term appears and
p.(None): inserting ``substance use disorder''; and
p.(None): (B) in paragraph (4), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder'';
p.(None): (3) in subsection (c)--
p.(None): (A) in paragraph (1), by striking ``substance abuse
p.(None): disorder'' and inserting ``substance use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in subparagraph (A), by striking
...
p.(None): appointments, compliance with prescribed medication
p.(None): regimes, and participation in learning opportunities at
p.(None): school and extracurricular activities.
p.(None):
p.(None): ``(g) Technical Assistance for Primary-Behavioral Health Care
p.(None): Integration.--
p.(None): ``(1) In general.--The Secretary may provide appropriate
p.(None): information, training, and technical assistance to eligible
p.(None): entities that receive a grant or cooperative agreement under
p.(None): this section, in order to help such entities meet the
p.(None): requirements of this section, including assistance with--
p.(None): ``(A) development and selection of integrated care
p.(None): models;
p.(None): ``(B) dissemination of evidence-based interventions
p.(None): in integrated care;
p.(None): ``(C) establishment of organizational practices to
p.(None): support operational and administrative success; and
p.(None): ``(D) other activities, as the Secretary determines
p.(None): appropriate.
p.(None): ``(2) Additional dissemination of technical information.--
p.(None): The information and resources provided by the Secretary under
p.(None): paragraph (1) shall, as appropriate, be made available to
p.(None): States, political subdivisions of States, Indian tribes or
p.(None): tribal organizations (as defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act), outpatient
p.(None): mental health and addiction treatment centers, community mental
p.(None): health centers that meet the criteria under section 1913(c),
p.(None): certified community behavioral health clinics described in
p.(None): section 223 of the Protecting Access to Medicare Act of 2014,
p.(None): primary care organizations such as Federally qualified health
p.(None): centers or rural health clinics as defined in section 1861(aa)
p.(None):
p.(None): [[Page 130 STAT. 1238]]
p.(None):
p.(None): of the Social Security Act, other community-based organizations,
p.(None): or other entities engaging in integrated care activities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): ``(h) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $51,878,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
p.(None): HOMELESSNESS.
p.(None):
p.(None): (a) Formula Grants to States.--Section 521 of the Public Health
p.(None): Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through
p.(None): 1994'' and inserting ``2018 through 2022''.
p.(None): (b) Purpose of Grants.--Section 522 of the Public Health Service Act
p.(None): (42 U.S.C. 290cc-22) is amended--
p.(None): (1) in subsection (a)(1)(B), by striking ``substance abuse''
p.(None): and inserting ``a substance use disorder'';
p.(None): (2) in subsection (b)(6), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (3) in subsection (c), by striking ``substance abuse'' and
p.(None): inserting ``a substance use disorder'';
...
p.(None): allotment for the fiscal years following the submission of the
p.(None): study.
p.(None): (2) Report.--In accordance with section 8004(b), the
p.(None): Assistant Secretary shall submit to the committees of Congress
p.(None): described in such section a report concerning the results of the
p.(None): study conducted under paragraph (1).
p.(None): SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2
p.(None): (42 U.S.C. 290bb-36b) the following:
p.(None): ``SEC. 520E-3. <> NATIONAL SUICIDE
p.(None): PREVENTION LIFELINE PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Suicide Prevention Lifeline
p.(None): program (referred to in this section as the `program'), authorized under
p.(None): section 520A and in effect prior to the date of enactment of the Helping
p.(None): Families in Mental Health Crisis Reform Act of 2016.
p.(None): ``(b) Activities.--In maintaining the program, the activities of the
p.(None): Secretary shall include--
p.(None): ``(1) coordinating a network of crisis centers across the
p.(None): United States for providing suicide prevention and crisis
p.(None): intervention services to individuals seeking help at any time,
p.(None): day or night;
p.(None): ``(2) maintaining a suicide prevention hotline to link
p.(None): callers to local emergency, mental health, and social services
p.(None): resources; and
p.(None): ``(3) consulting with the Secretary of Veterans Affairs to
p.(None): ensure that veterans calling the suicide prevention hotline have
p.(None): access to a specialized veterans' suicide prevention hotline.
p.(None):
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $7,198,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.), as amended by section 9005, is further amended
p.(None): by inserting after section 520E-3 the following:
p.(None): ``SEC. 520E-4. <> TREATMENT REFERRAL
p.(None): ROUTING SERVICE.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Treatment Referral Routing
p.(None): Service (referred to in this section as the `Routing Service') to assist
p.(None): individuals and families in locating mental and substance use disorders
p.(None): treatment providers.
p.(None): ``(b) Activities of the Secretary.--To maintain the Routing Service,
p.(None): the activities of the Assistant Secretary shall include administering--
p.(None): ``(1) a nationwide, telephone number providing year-round
p.(None): access to information that is updated on a regular basis
p.(None): regarding local behavioral health providers and community-based
p.(None): organizations in a manner that is confidential, without
p.(None): requiring individuals to identify themselves, is in languages
p.(None): that include at least English and Spanish, and is at no cost to
p.(None): the individual using the Routing Service; and
p.(None):
p.(None): [[Page 130 STAT. 1240]]
p.(None):
p.(None): ``(2) an Internet website to provide a searchable, online
...
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that the
p.(None): Secretary of Health and Human Services, in carrying out suicide
p.(None): prevention and intervention programs, should prioritize programs and
p.(None): activities for populations with disproportionately high rates of
p.(None): suicide, such as American Indians and Alaska Natives.
p.(None): SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
p.(None):
p.(None): Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 32(e)) is amended by adding at the end the following:
p.(None): ``(3) Geriatric mental disorders.--The Secretary shall, as
p.(None): appropriate, provide technical assistance to grantees regarding
p.(None): evidence-based practices for the prevention and treatment of
p.(None): geriatric mental disorders and co-occurring mental health and
p.(None): substance use disorders among geriatric populations, as well as
p.(None): disseminate information about such evidence-based practices to
p.(None): States and nongrantees throughout the United States.''.
p.(None): SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
p.(None):
p.(None): The Secretary of Health and Human Services, acting through the
p.(None): Director of the Centers for Disease Control and Prevention, is
p.(None): encouraged to improve, particularly through the inclusion of additional
p.(None): States, the National Violent Death Reporting System as authorized by
p.(None): title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
p.(None): Participation in the system by the States shall be voluntary.
p.(None): SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
p.(None):
p.(None): Section 224 of the Protecting Access to Medicare Act of 2014 (42
p.(None): U.S.C. 290aa note) is amended--
p.(None): (1) in subsection (e), by striking ``and 2018,'' and
p.(None): inserting ``2018, 2019, 2020, 2021, and 2022,''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in paragraph (1), by striking ``2018'' and
p.(None): inserting ``2022''; and
p.(None): (B) in paragraph (2), by striking ``is authorized to
p.(None): be appropriated to carry out this section $15,000,000
p.(None): for each of fiscal years 2015 through 2018'' and
p.(None): inserting ``are authorized to be appropriated to carry
p.(None): out this section $15,000,000 for each of fiscal years
p.(None): 2015 through 2017, $20,000,000 for fiscal year 2018,
p.(None): $19,000,000 for each of fiscal years 2019 and 2020, and
p.(None): $18,000,000 for each of fiscal years 2021 and 2022''.
p.(None): SEC. 9015. <> ASSERTIVE COMMUNITY
p.(None): TREATMENT GRANT PROGRAM.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.), as amended by section 9009, is further amended by adding at
p.(None): the end the following:
p.(None): ``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall award grants to
p.(None): eligible entities--
p.(None): ``(1) to establish assertive community treatment programs
p.(None): for adults with a serious mental illness; or
p.(None): ``(2) to maintain or expand such programs.
p.(None):
p.(None): [[Page 130 STAT. 1246]]
p.(None):
p.(None): ``(b) Eligible Entities.--To be eligible to receive a grant under
p.(None): this section, an entity shall be a State, political subdivision of a
p.(None): State, Indian tribe or tribal organization (as such terms are defined in
...
p.(None): based settings that integrate primary care with mental and
p.(None): substance use disorders prevention and treatment services;
p.(None): ``(2) training for nurse practitioners, physician
p.(None): assistants, health service psychologists, and social workers to
p.(None): provide mental and substance use disorders services in
p.(None): underserved community-based settings that integrate primary care
p.(None): and mental and substance use disorders services; and
p.(None): ``(3) establishing, maintaining, or improving academic units
p.(None): or programs that--
p.(None): ``(A) provide training for students or faculty,
p.(None): including through clinical experiences and research, to
p.(None): improve the ability to be able to recognize, diagnose,
p.(None): and treat mental and substance use disorders, with a
p.(None): special focus on addiction; or
p.(None): ``(B) develop evidence-based practices or
p.(None): recommendations for the design of the units or programs
p.(None): described in subparagraph (A), including curriculum
p.(None): content standards.
p.(None):
p.(None): ``(b) Activities.--
p.(None): ``(1) Training for residents and fellows.--A recipient of a
p.(None): grant under subsection (a)(1)--
p.(None): ``(A) shall use the grant funds--
p.(None): ``(i)(I) to plan, develop, and operate a
p.(None): training program for medical psychiatry residents
p.(None): and fellows in addiction medicine practicing in
p.(None): eligible entities described in subsection (c)(1);
p.(None): or
p.(None): ``(II) to train new psychiatric residents and
p.(None): fellows in addiction medicine to provide and
p.(None): expand access to integrated mental and substance
p.(None): use disorders services; and
p.(None): ``(ii) to provide at least 1 training track
p.(None): that is--
p.(None): ``(I) a virtual training track that
p.(None): includes an in-person rotation at a
p.(None): teaching health center or in a
p.(None): community-based setting, followed by a
p.(None): virtual rotation in which the resident
p.(None): or fellow continues to support the care
p.(None): of patients at the teaching health
p.(None): center or in the community-based setting
p.(None): through the use of health information
p.(None): technology and, as appropriate,
p.(None): telehealth services;
p.(None): ``(II) an in-person training track
p.(None): that includes a rotation, during which
p.(None): the resident or fellow practices at a
p.(None): teaching health center or in a
p.(None): community-based setting; or
p.(None): ``(III) an in-person training track
p.(None): that includes a rotation during which
p.(None): the resident practices in a community-
p.(None): based setting that specializes in the
p.(None):
p.(None): [[Page 130 STAT. 1251]]
p.(None):
p.(None): treatment of infants, children,
p.(None): adolescents, or pregnant or postpartum
p.(None): women; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such training.
p.(None): ``(2) Training for other providers.--A recipient of a grant
p.(None): under subsection (a)(2)--
...
p.(None): social work, an accredited public or nonprofit private hospital,
p.(None): an accredited medical residency program, or a public or private
p.(None): nonprofit entity which the Secretary has determined is capable
p.(None): of carrying out such grant.
p.(None):
p.(None): ``(d) Priority.--
p.(None): ``(1) In general.--In awarding grants under subsection
p.(None): (a)(1) or (a)(2), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) demonstrate sufficient size, scope, and
p.(None): capacity to undertake the requisite training of an
p.(None): appropriate number of psychiatric residents, fellows,
p.(None): nurse practitioners, physician assistants, or social
p.(None): workers in addiction medicine per year to meet the needs
p.(None): of the area served;
p.(None): ``(B) demonstrate experience in training providers
p.(None): to practice team-based care that integrates mental and
p.(None): substance use disorder prevention and treatment services
p.(None): with primary care in community-based settings;
p.(None): ``(C) demonstrate experience in using health
p.(None): information technology and, as appropriate, telehealth
p.(None): to support--
p.(None): ``(i) the delivery of mental and substance use
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
...
p.(None): striking ``An institution of higher education desiring a
p.(None): grant under this section'' and inserting ``To be
p.(None): eligible to receive a grant under this section, an
p.(None): institution of higher education'';
p.(None): (B) by striking paragraph (1) and inserting--
p.(None): ``(1) A description of the population to be targeted by the
p.(None): program carried out under the grant, including veterans whenever
p.(None): possible and appropriate, and of identified mental and substance
p.(None): use disorder needs of students at the institution of higher
p.(None): education.'';
p.(None): (C) in paragraph (2), by inserting ``, which may
p.(None): include, as appropriate and in accordance with
p.(None): subsection (b)(7), a plan to seek input from relevant
p.(None): stakeholders in the community, including appropriate
p.(None): public and private entities, in order to carry out the
p.(None): program under the grant'' before the period at the end;
p.(None): and
p.(None): (D) by adding after paragraph (5) the following new
p.(None): paragraphs:
p.(None): ``(6) An outline of the objectives of the program carried
p.(None): out under the grant.
p.(None): ``(7) For an institution of higher education proposing to
p.(None): use the grant for an activity described in paragraph (8) or (9)
p.(None): of subsection (b), a description of the policies and procedures
p.(None): of the institution of higher education that are related to
p.(None): applicable laws regarding access to, and sharing of, treatment
p.(None): records of students at any campus-based mental health center or
p.(None): partner organization, including the policies and State laws
p.(None): governing when such records can be accessed and shared for non-
p.(None): treatment purposes and a description of the process used
p.(None):
p.(None): [[Page 130 STAT. 1259]]
p.(None):
p.(None): by the institution of higher education to notify students of
p.(None): these policies and procedures, including the extent to which
p.(None): written consent is required.
p.(None): ``(8) An assurance that grant funds will be used to
p.(None): supplement and not supplant any other Federal, State, or local
p.(None): funds available to carry out activities of the type carried out
p.(None): under the grant.'';
p.(None): (6) in subsection (e)(1), by striking ``and behavioral
p.(None): health problems'' and inserting ``health and substance use
p.(None): disorders'';
p.(None): (7) in subsection (f)(2)--
p.(None): (A) by striking ``and behavioral health'' and
p.(None): inserting ``health and substance use disorder''; and
p.(None): (B) by striking ``suicide and substance abuse'' and
p.(None): inserting ``suicide and substance use disorders'';
p.(None): (8) by redesignating subsection (h) as subsection (i);
p.(None): (9) by inserting after subsection (g) the following new
p.(None): subsection:
p.(None):
p.(None): ``(h) Technical Assistance.--The Secretary may provide technical
p.(None): assistance to grantees in carrying out this section.''; and
...
p.(None): (3) consult with and seek input from mental health
p.(None): professionals working on campuses of institutions of higher
p.(None): education as appropriate.
p.(None):
p.(None): (e) Meetings.--
p.(None): (1) In general.--The Task Force shall meet not fewer than
p.(None): three times each year.
p.(None): (2) Annual conference.--The Secretary shall sponsor an
p.(None): annual conference on mental and behavioral health in settings of
p.(None): institutions of higher education to enhance coordination, build
p.(None): partnerships, and share best practices in mental and behavioral
p.(None): health promotion, data collection, analysis, and services.
p.(None):
p.(None): (f) Definition.--In this section, the term ``institution of higher
p.(None): education'' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): (g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None):
p.(None): [[Page 130 STAT. 1261]]
p.(None):
p.(None): SEC. 9033. <> IMPROVING MENTAL HEALTH ON
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): ``(a) Purpose.--It is the purpose of this section to increase access
p.(None): to, and reduce the stigma associated with, mental health services to
p.(None): ensure that students at institutions of higher education have the
p.(None): support necessary to successfully complete their studies.
p.(None): ``(b) National Public Education Campaign.--The Secretary, acting
p.(None): through the Assistant Secretary and in collaboration with the Director
p.(None): of the Centers for Disease Control and Prevention, shall convene an
p.(None): interagency, public-private sector working group to plan, establish, and
p.(None): begin coordinating and evaluating a targeted public education campaign
p.(None): that is designed to focus on mental and behavioral health on the
p.(None): campuses of institutions of higher education. Such campaign shall be
p.(None): designed to--
p.(None): ``(1) improve the general understanding of mental health and
p.(None): mental disorders;
p.(None): ``(2) encourage help-seeking behaviors relating to the
p.(None): promotion of mental health, prevention of mental disorders, and
p.(None): treatment of such disorders;
p.(None): ``(3) make the connection between mental and behavioral
p.(None): health and academic success; and
p.(None): ``(4) assist the general public in identifying the early
p.(None): warning signs and reducing the stigma of mental illness.
p.(None):
p.(None): ``(c) Composition.--The working group convened under subsection (b)
p.(None): shall include--
...
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education.
p.(None):
p.(None): ``(e) Definition.--In this section, the term `institution of higher
p.(None): education' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
p.(None): DISTURBANCE.
p.(None):
p.(None): (a) Comprehensive Community Mental Health Services for Children With
p.(None): a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
p.(None): may include efforts to identify and serve children at risk'' before the
p.(None): period.
p.(None): (b) Requirements With Respect to Carrying Out Purpose of Grants.--
p.(None): Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b))
p.(None): is amended by striking ``will not provide an individual with access to
p.(None): the system if the individual is more than 21 years of age'' and
p.(None): inserting ``will provide an individual with access to the system through
p.(None): the age of 21 years''.
p.(None): (c) Additional Provisions.--Section 564(f) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and
p.(None): provide a copy to the State involved)'' after ``to the Secretary''.
p.(None): (d) General Provisions.--Section 565 of the Public Health Service
p.(None): Act (42 U.S.C. 290ff-4) is amended--
p.(None): (1) in subsection (b)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``receiving a grant under section 561(a)'' and
p.(None): inserting ``, regardless of whether such public entity
p.(None): is receiving a grant under section 561(a)''; and
p.(None): (B) in subparagraph (B), by striking ``pursuant to''
p.(None): and inserting ``described in'';
p.(None): (2) in subsection (d)(1), by striking ``not more than 21
p.(None): years of age'' and inserting ``through the age of 21 years'';
p.(None): and
p.(None): (3) in subsection (f)(1), by striking ``$100,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$119,026,000
p.(None): for each of fiscal years 2018 through 2022''.
p.(None): SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.
p.(None):
p.(None): Title III of the Public Health Service Act is amended by inserting
p.(None): after section 330L of such Act (42 U.S.C. 254c-18) the following new
p.(None): section:
p.(None):
p.(None): [[Page 130 STAT. 1263]]
p.(None):
p.(None): ``SEC. 330M <> PEDIATRIC MENTAL HEALTH
p.(None): CARE ACCESS GRANTS.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Administrator
p.(None): of the Health Resources and Services Administration and in coordination
p.(None): with other relevant Federal agencies, shall award grants to States,
p.(None): political subdivisions of States, and Indian tribes and tribal
p.(None): organizations (for purposes of this section, as such terms are defined
p.(None): in section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act (25 U.S.C. 450b)) to promote behavioral health integration in
p.(None): pediatric primary care by--
p.(None): ``(1) supporting the development of statewide or regional
p.(None): pediatric mental health care telehealth access programs; and
p.(None): ``(2) supporting the improvement of existing statewide or
p.(None): regional pediatric mental health care telehealth access
p.(None): programs.
p.(None):
p.(None): ``(b) Program Requirements.--
p.(None): ``(1) In general.--A pediatric mental health care telehealth
p.(None): access program referred to in subsection (a), with respect to
p.(None): which a grant under such subsection may be used, shall--
p.(None): ``(A) be a statewide or regional network of
p.(None): pediatric mental health teams that provide support to
p.(None): pediatric primary care sites as an integrated team;
p.(None): ``(B) support and further develop organized State or
p.(None): regional networks of pediatric mental health teams to
p.(None): provide consultative support to pediatric primary care
p.(None): sites;
p.(None): ``(C) conduct an assessment of critical behavioral
p.(None): consultation needs among pediatric providers and such
p.(None): providers' preferred mechanisms for receiving
p.(None): consultation, training, and technical assistance;
p.(None): ``(D) develop an online database and communication
p.(None): mechanisms, including telehealth, to facilitate
p.(None): consultation support to pediatric practices;
p.(None): ``(E) provide rapid statewide or regional clinical
p.(None): telephone or telehealth consultations when requested
p.(None): between the pediatric mental health teams and pediatric
p.(None): primary care providers;
p.(None): ``(F) conduct training and provide technical
p.(None): assistance to pediatric primary care providers to
p.(None): support the early identification, diagnosis, treatment,
p.(None): and referral of children with behavioral health
p.(None): conditions;
p.(None): ``(G) provide information to pediatric providers
p.(None): about, and assist pediatric providers in accessing,
p.(None): pediatric mental health care providers, including child
p.(None): and adolescent psychiatrists, and licensed mental health
p.(None): professionals, such as psychologists, social workers, or
p.(None): mental health counselors and in scheduling and
p.(None): conducting technical assistance;
p.(None): ``(H) assist with referrals to specialty care and
p.(None): community or behavioral health resources; and
p.(None): ``(I) establish mechanisms for measuring and
p.(None): monitoring increased access to pediatric mental health
p.(None): care services by pediatric primary care providers and
p.(None): expanded capacity of pediatric primary care providers to
p.(None): identify, treat, and refer children with mental health
p.(None): problems.
p.(None): ``(2) Pediatric mental health teams.--In this subsection,
p.(None): the term `pediatric mental health team' means a team consisting
p.(None): of at least one case coordinator, at least one child and
p.(None): adolescent psychiatrist, and at least one licensed clinical
p.(None):
p.(None): [[Page 130 STAT. 1264]]
p.(None):
p.(None): mental health professional, such as a psychologist, social
p.(None): worker, or mental health counselor. Such a team may be
p.(None): regionally based.
p.(None):
p.(None): ``(c) Application.--A State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization seeking a grant under this section
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may require,
p.(None): including a plan for the comprehensive evaluation of activities that are
p.(None): carried out with funds received under such grant.
p.(None): ``(d) Evaluation.--A State, political subdivision of a State, Indian
p.(None): tribe, or tribal organization that receives a grant under this section
p.(None): shall prepare and submit an evaluation of activities that are carried
p.(None): out with funds received under such grant to the Secretary at such time,
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
p.(None): under this section unless the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization involved agrees, with respect to
p.(None): the costs to be incurred by the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization in carrying out the purpose
p.(None): described in this section, to make available non-Federal contributions
p.(None): (in cash or in kind) toward such costs in an amount that is not less
p.(None): than 20 percent of Federal funds provided in the grant.
p.(None): ``(g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated, $9,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
p.(None): INTERVENTION SERVICES FOR CHILDREN AND
p.(None): ADOLESCENTS.
p.(None):
p.(None): The first section 514 of the Public Health Service Act (42 U.S.C.
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
...
p.(None): (7) in subsection (j) (as so redesignated), by striking
p.(None): ``$50,000,000'' and all that follows through ``2006'' and
p.(None): inserting ``$46,887,000 for each of fiscal years 2018 through
p.(None): 2022''.
p.(None): SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.(None): Part B of title III of the Public Health Service Act (42 U.S.C. 243
p.(None): et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13)
p.(None): the following:
p.(None): ``SEC. 317L-1. <> SCREENING AND TREATMENT
p.(None): FOR MATERNAL DEPRESSION.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall make grants to States to
p.(None): establish, improve, or maintain programs for screening, assessment, and
p.(None): treatment services, including culturally and linguistically appropriate
p.(None): services, as appropriate, for women who are pregnant, or who have given
p.(None): birth within the preceding 12 months, for maternal depression.
p.(None): ``(b) Application.--To seek a grant under this section, a State
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may
p.(None):
p.(None): [[Page 130 STAT. 1267]]
p.(None):
p.(None): require. At a minimum, any such application shall include explanations
p.(None): of--
p.(None): ``(1) how a program, or programs, will increase the
p.(None): percentage of women screened and treated, as appropriate, for
p.(None): maternal depression in 1 or more communities; and
p.(None): ``(2) how a program, or programs, if expanded, would
p.(None): increase access to screening and treatment services for maternal
p.(None): depression.
p.(None):
p.(None): ``(c) Priority.--In awarding grants under this section, the
p.(None): Secretary may give priority to States proposing to improve or enhance
p.(None): access to screening services for maternal depression in primary care
p.(None): settings.
p.(None): ``(d) Use of Funds.--The activities eligible for funding through a
p.(None): grant under subsection (a)--
p.(None): ``(1) shall include--
p.(None): ``(A) providing appropriate training to health care
p.(None): providers; and
p.(None): ``(B) providing information to health care
p.(None): providers, including information on maternal depression
p.(None): screening, treatment, and followup support services, and
p.(None): linkages to community-based resources; and
p.(None): ``(2) may include--
p.(None): ``(A) enabling health care providers (including
p.(None): obstetrician-gynecologists, pediatricians,
p.(None): psychiatrists, mental health care providers, and adult
p.(None): primary care clinicians) to provide or receive real-time
p.(None): psychiatric consultation (in-person or remotely) to aid
p.(None): in the treatment of pregnant and parenting women;
p.(None): ``(B) establishing linkages with and among
p.(None): community-based resources, including mental health
p.(None): resources, primary care resources, and support groups;
p.(None): and
p.(None): ``(C) utilizing telehealth services for rural areas
p.(None): and medically underserved areas (as defined in section
p.(None): 330I(a)).
p.(None):
p.(None): ``(e) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $5,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
...
p.(None): Limitations (NQTLs) that Require Additional Analysis to
p.(None): Determine Mental Health Parity Compliance'.
p.(None): ``(B) Examples illustrating compliance and
p.(None): noncompliance.--
p.(None):
p.(None): [[Page 130 STAT. 1279]]
p.(None):
p.(None): ``(i) In general.--The compliance program
p.(None): guidance document required under this paragraph
p.(None): shall provide illustrative, de-identified examples
p.(None): (that do not disclose any protected health
p.(None): information or individually identifiable
p.(None): information) of previous findings of compliance
p.(None): and noncompliance with this section, section 712
p.(None): of the Employee Retirement Income Security Act of
p.(None): 1974, or section 9812 of the Internal Revenue Code
p.(None): of 1986, as applicable, based on investigations of
p.(None): violations of such sections, including--
p.(None): ``(I) examples illustrating
p.(None): requirements for information disclosures
p.(None): and nonquantitative treatment
p.(None): limitations; and
p.(None): ``(II) descriptions of the
p.(None): violations uncovered during the course
p.(None): of such investigations.
p.(None): ``(ii) Nonquantitative treatment
p.(None): limitations.--To the extent that any example
p.(None): described in clause (i) involves a finding of
p.(None): compliance or noncompliance with regard to any
p.(None): requirement for nonquantitative treatment
p.(None): limitations, the example shall provide sufficient
p.(None): detail to fully explain such finding, including a
p.(None): full description of the criteria involved for
p.(None): approving medical and surgical benefits and the
p.(None): criteria involved for approving mental health and
p.(None): substance use disorder benefits.
p.(None): ``(iii) Access to additional information
p.(None): regarding compliance.--In developing and issuing
p.(None): the compliance program guidance document required
p.(None): under this paragraph, the Secretaries specified in
p.(None): subparagraph (A)--
p.(None): ``(I) shall enter into interagency
p.(None): agreements with the Inspector General of
p.(None): the Department of Health and Human
p.(None): Services, the Inspector General of the
p.(None): Department of Labor, and the Inspector
p.(None): General of the Department of the
p.(None): Treasury to share findings of compliance
p.(None): and noncompliance with this section,
p.(None): section 712 of the Employee Retirement
p.(None): Income Security Act of 1974, or section
p.(None): 9812 of the Internal Revenue Code of
p.(None): 1986, as applicable; and
p.(None): ``(II) shall seek to enter into an
p.(None): agreement with a State to share
p.(None): information on findings of compliance
p.(None): and noncompliance with this section,
p.(None): section 712 of the Employee Retirement
p.(None): Income Security Act of 1974, or section
p.(None): 9812 of the Internal Revenue Code of
p.(None): 1986, as applicable.
p.(None): ``(C) Recommendations.--The compliance program
p.(None): guidance document shall include recommendations to
p.(None): advance compliance with this section, section 712 of the
p.(None): Employee Retirement Income Security Act of 1974, or
p.(None): section 9812 of the Internal Revenue Code of 1986, as
p.(None): applicable, and encourage the development and use of
p.(None): internal controls to monitor adherence to applicable
p.(None): statutes, regulations, and program requirements. Such
p.(None): internal controls may include illustrative examples of
p.(None): nonquantitative treatment limitations on mental health
...
p.(None): benefit and a traditional covered medical and
p.(None): surgical benefit, such as residential treatment or
p.(None): hospitalizations involving voluntary or
p.(None): involuntary commitment; and
p.(None): ``(ix) additional illustrative examples of
p.(None): methods, processes, strategies, evidentiary
p.(None): standards, and other factors for which the
p.(None): Secretary determines that additional guidance is
p.(None): necessary to improve compliance with this section,
p.(None): section 712 of the Employee Retirement Income
p.(None): Security Act of 1974, or section 9812 of the
p.(None): Internal Revenue Code of 1986, as applicable.
p.(None): ``(D) Public comment.--Prior to issuing any final
p.(None): guidance under this paragraph, the Secretary shall
p.(None): provide a public comment period of not less than 60 days
p.(None): during which any member of the public may provide
p.(None): comments on a draft of the guidance.''.
p.(None):
p.(None): (c) Availability of Plan Information.--
p.(None): (1) Solicitation of public feedback.--Not later than 6
p.(None): months after the date of enactment of this Act, the Secretary of
p.(None): Health and Human Services, the Secretary of Labor, and the
p.(None): Secretary of the Treasury shall solicit feedback from the public
p.(None): on how the disclosure request process for documents containing
p.(None): information that health plans or health insurance issuers are
p.(None): required under Federal or State law to disclose to participants,
p.(None): beneficiaries, contracting providers, or authorized
p.(None): representatives to ensure compliance with existing mental health
p.(None): parity and addiction equity requirements can be improved while
p.(None): continuing to ensure consumers' rights to access all information
p.(None): required by Federal or State law to be disclosed.
p.(None): (2) Public availability.--Not later than 12 months after the
p.(None): date of the enactment of this Act, the Secretary of Health and
p.(None): Human Services, the Secretary of Labor, and the Secretary of the
p.(None): Treasury shall make such feedback publicly available.
p.(None): (3) NAIC.--The Secretary of Health and Human Services, the
p.(None): Secretary of Labor, and the Secretary of the Treasury shall
p.(None): share feedback obtained pursuant to paragraph (1) directly with
p.(None): the National Association of Insurance Commissioners to the
p.(None): extent such feedback includes recommendations for the
p.(None): development of simplified information disclosure tools to
p.(None): provide consistent information for consumers. Such feedback
p.(None):
p.(None): [[Page 130 STAT. 1283]]
p.(None):
p.(None): may be taken into consideration by the National Association of
p.(None): Insurance Commissioners and other appropriate entities for the
p.(None): voluntary development and voluntary use of common templates and
p.(None): other sample standardized forms to improve consumer access to
p.(None): plan information.
p.(None):
p.(None): (d) Improving Compliance.--
p.(None): (1) <> In general.--In the
p.(None): case that the Secretary of Health and Human Services, the
p.(None): Secretary of Labor, or the Secretary of the Treasury determines
p.(None): that a group health plan or health insurance issuer offering
p.(None): group or individual health insurance coverage has violated, at
p.(None): least 5 times, section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income
p.(None): Security Act of 1974 (29 U.S.C. 1185a), or section 9812 of the
p.(None): Internal Revenue Code of 1986, respectively, the appropriate
p.(None): Secretary shall audit plan documents for such health plan or
p.(None): issuer in the plan year following the Secretary's determination
p.(None): in order to help improve compliance with such section.
p.(None): (2) Rule of construction.--Nothing in this subsection shall
p.(None): be construed to limit the authority, as in effect on the day
p.(None): before the date of enactment of this Act, of the Secretary of
p.(None): Health and Human Services, the Secretary of Labor, or the
p.(None): Secretary of the Treasury to audit documents of health plans or
p.(None): health insurance issuers.
p.(None): SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL HEALTH
p.(None): AND SUBSTANCE USE DISORDER COVERAGE.
p.(None):
p.(None): (a) Public Meeting.--
p.(None): (1) In general.--Not later than 6 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services shall convene a public meeting of stakeholders
p.(None): described in paragraph (2) to produce an action plan for
...
p.(None): first responders to recognize individuals who have mental illness and
p.(None): how to properly intervene with individuals with mental illness,
p.(None): including strategies for verbal de-escalation of crises''.
p.(None): SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
p.(None):
p.(None): (a) In General.--Section 2201 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
...
p.(None): Judiciary and the Committee on Appropriations of the Senate and
p.(None): the Committee on the Judiciary and the Committee on
p.(None): Appropriations of the House of Representatives, an annual
p.(None): certification--
p.(None): ``(A) indicating whether--
p.(None): ``(i) all audits issued by the Office of the
p.(None): Inspector General under paragraph (1) have been
p.(None): completed and reviewed by the appropriate
p.(None): Assistant Attorney General or Director;
p.(None): ``(ii) all mandatory exclusions required under
p.(None): paragraph (1)(C) have been issued; and
p.(None): ``(iii) all reimbursements required under
p.(None): paragraph (1)(E) have been made; and
p.(None): ``(B) that includes a list of any grant recipients
p.(None): excluded under paragraph (1) from the previous year.
p.(None):
p.(None): [[Page 130 STAT. 1315]]
p.(None):
p.(None): ``(n) Preventing Duplicative Grants.--
p.(None): ``(1) In general.--Before the Attorney General awards a
p.(None): grant to an applicant under this section, the Attorney General
p.(None): shall compare potential grant awards with other grants awarded
p.(None): under this Act to determine if duplicate grant awards are
p.(None): awarded for the same purpose.
p.(None): ``(2) Report.--If the Attorney General awards duplicate
p.(None): grants to the same applicant for the same purpose the Attorney
p.(None): General shall submit to the Committee on the Judiciary of the
p.(None): Senate and the Committee on the Judiciary of the House of
p.(None): Representatives a report that includes--
p.(None): ``(A) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(B) the reason the Attorney General awarded the
p.(None): duplicate grants.''.
p.(None):
p.(None): DIVISION <Access, and Quality in Health Care
p.(None): for Americans Act.>> C--INCREASING CHOICE, ACCESS, AND QUALITY IN
p.(None): HEALTH CARE FOR AMERICANS
p.(None): SEC. 15000. <> SHORT TITLE.
p.(None):
p.(None): This division may be cited as the ``Increasing Choice, Access, and
p.(None): Quality in Health Care for Americans Act''.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG CODES
p.(None): FOR SIMILAR HOSPITAL SERVICES.
p.(None):
p.(None): Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is
p.(None): amended by adding at the end the following new subsection:
p.(None): ``(t) Relating Similar Inpatient and Outpatient Hospital Services.--
p.(None): ``(1) Development of hcpcs version of ms-drg codes.--Not
p.(None): later than January 1, 2018, the Secretary shall develop HCPCS
p.(None): versions for MS-DRGs that are similar to the ICD-10-PCS for such
p.(None): MS-DRGs such that, to the extent possible, the MS-DRG assignment
p.(None): shall be similar for a claim coded with the HCPCS version as an
p.(None): identical claim coded with a ICD-10-PCS code.
p.(None): ``(2) Coverage of surgical ms-drgs.--In carrying out
p.(None): paragraph (1), the Secretary shall develop HCPCS versions of MS-
p.(None): DRG codes for not fewer than 10 surgical MS-DRGs.
p.(None): ``(3) Publication and dissemination of the hcpcs versions of
p.(None): ms-drgs.--
p.(None): ``(A) In general.--The Secretary shall develop a
p.(None): HCPCS MS-DRG definitions manual and software that is
p.(None): similar to the definitions manual and software for ICD-
p.(None): 10-PCS codes for such MS-DRGs. The Secretary shall post
p.(None): the HCPCS MS-DRG definitions manual and software on the
p.(None): Internet website of the Centers for Medicare & Medicaid
p.(None): Services. The HCPCS MS-DRG definitions
p.(None):
p.(None): [[Page 130 STAT. 1316]]
p.(None):
p.(None): manual and software shall be in the public domain and
p.(None): available for use and redistribution without charge.
p.(None): ``(B) Use of previous analysis done by medpac.--In
...
p.(None): select for participation in the demonstration program,
p.(None): the Secretary--
p.(None): ``(i) shall give priority to rural community
p.(None): hospitals located in one of the 20 States with the
p.(None): lowest population densities (as determined by the
p.(None): Secretary using the 2015 Statistical Abstract of
p.(None): the United States); and
p.(None): ``(ii) may consider--
p.(None): ``(I) closures of hospitals located
p.(None): in rural areas in the State in which the
p.(None): rural community hospital is located
p.(None): during the 5-year period immediately
p.(None): preceding the date of the enactment of
p.(None): this paragraph; and
p.(None): ``(II) the population density of the
p.(None): State in which the rural community
p.(None): hospital is located.''.
p.(None):
p.(None): (b) Change in Timing for Report.--Subsection (e) of such section
p.(None): 410A is amended--
p.(None): (1) by striking ``Not later than 6 months after the
p.(None): completion of the demonstration program under this section'' and
p.(None): inserting ``Not later than August 1, 2018''; and
p.(None):
p.(None): [[Page 130 STAT. 1319]]
p.(None):
p.(None): (2) by striking ``such program'' and inserting ``the
p.(None): demonstration program under this section''.
p.(None): SEC. 15004. REGULATORY RELIEF FOR LTCHS.
p.(None):
p.(None): (a) Technical Change to the Medicare Long-Term Care Hospital
p.(None): Moratorium Exception.--
p.(None): (1) In general.--Section 114(d)(7) of the Medicare,
p.(None): Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww
p.(None): note), as amended by sections 3106(b) and 10312(b) of Public Law
p.(None): 111-148, section 1206(b)(2) of the Pathway for SGR Reform Act of
p.(None): 2013 (division B of Public Law 113-67), and section 112 of the
p.(None): Protecting Access to Medicare Act of 2014 (Public Law 113-93),
p.(None): is amended by striking ``The moratorium under paragraph (1)(A)''
p.(None): and inserting ``Any moratorium under paragraph (1)''.
p.(None): (2) <> Effective date.--The
p.(None): amendment made by paragraph (1) shall take effect as if included
p.(None): in the enactment of section 112 of the Protecting Access to
p.(None): Medicare Act of 2014.
p.(None):
p.(None): (b) Modification to Medicare Long-Term Care Hospital High Cost
p.(None): Outlier Payments.--Section 1886(m) of the Social Security Act (42 U.S.C.
p.(None): 1395ww(m)) is amended by adding at the end the following new paragraph:
p.(None): ``(7) Treatment of high cost outlier payments.--
p.(None): ``(A) Adjustment to the standard federal payment
p.(None): rate for estimated high cost outlier payments.--Under
p.(None): the system described in paragraph (1), for fiscal years
p.(None): beginning on or after October 1, 2017, the Secretary
p.(None): shall reduce the standard Federal payment rate as if the
p.(None): estimated aggregate amount of high cost outlier payments
p.(None): for standard Federal payment rate discharges for each
p.(None): such fiscal year would be equal to 8 percent of
p.(None): estimated aggregate payments for standard Federal
p.(None): payment rate discharges for each such fiscal year.
p.(None): ``(B) Limitation on high cost outlier payment
p.(None): amounts.--Notwithstanding subparagraph (A), the
p.(None): Secretary shall set the fixed loss amount for high cost
p.(None): outlier payments such that the estimated aggregate
p.(None): amount of high cost outlier payments made for standard
p.(None): Federal payment rate discharges for fiscal years
p.(None): beginning on or after October 1, 2017, shall be equal to
p.(None): 99.6875 percent of 8 percent of estimated aggregate
p.(None): payments for standard Federal payment rate discharges
p.(None): for each such fiscal year.
p.(None): ``(C) Waiver of budget neutrality.--Any reduction in
p.(None): payments resulting from the application of subparagraph
p.(None): (B) shall not be taken into account in applying any
p.(None): budget neutrality provision under such system.
p.(None): ``(D) No effect on site neutral high cost outlier
p.(None): payment rate.--This paragraph shall not apply with
p.(None): respect to the computation of the applicable site
p.(None): neutral payment rate under paragraph (6).''.
p.(None): SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT APPLYING
p.(None): DOCUMENTATION AND CODING ADJUSTMENTS.
p.(None):
p.(None): Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI Programs
p.(None): Extension Act of 2007 (Public Law 110-90), as amended by section 631(b)
p.(None): of the American Taxpayer Relief Act of 2012 (Public Law 112-240) and
p.(None): section 414(1)(B)(iii) of the Medicare
p.(None):
p.(None): [[Page 130 STAT. 1320]]
p.(None):
p.(None): Access and CHIP Reauthorization Act of 2015 (Public Law 114-10), is
p.(None): amended in clause (iii) by striking ``an increase of 0.5 percentage
p.(None): points for discharges occurring during each of fiscal years 2018 through
p.(None): 2023'' and inserting ``an increase of 0.4588 percentage points for
p.(None): discharges occurring during fiscal year 2018 and 0.5 percentage points
p.(None): for discharges occurring during each of fiscal years 2019 through
p.(None): 2023''.
p.(None): SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT RULES.
p.(None):
p.(None): (a) 25-Percent Patient Threshold Payment Adjustment.--Section
p.(None): 114(c)(1)(A) of the Medicare, Medicaid, and SCHIP Extension Act of 2007
p.(None): (42 U.S.C. 1395ww note), as amended by section 4302(a) of division B of
p.(None): the American Recovery and Reinvestment Act (Public Law 111-5), sections
p.(None): 3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(B) of
p.(None): the Pathway for SGR Reform Act of 2013 (division B of Public Law 113-
p.(None): 67), is amended by striking ``for a 9-year period'' and inserting
p.(None): ``through June 30, 2016, and for discharges occurring on or after
p.(None): October 1, 2016, and before October 1, 2017''.
p.(None): (b) Payment for Hospitals-Within-Hospitals.--Section 114(c)(2) of
p.(None): the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C.
p.(None): 1395ww note), as amended by section 4302(a) of division B of the
p.(None): American Recovery and Reinvestment Act (Public Law 111-5), sections
p.(None): 3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(A) of
p.(None): the Pathway for SGR Reform Act of 2013 (division B of Public Law 113-
p.(None): 67), is amended--
p.(None): (1) in subparagraph (A), by inserting ``or any similar
p.(None): provision,'' after ``Regulations,'';
p.(None): (2) in subparagraph (B)--
...
p.(None): ``(i) In general.--For a discharge occurring
p.(None): in a cost reporting period beginning during fiscal
p.(None): year 2018, subparagraph (A)(i) shall not apply
p.(None): (and payment shall be made to a long-term care
p.(None): hospital without regard to this paragraph) if such
p.(None): discharge--
p.(None): ``(I) is from a long-term care
p.(None): hospital identified by the last sentence
p.(None): of subsection (d)(1)(B);
p.(None): ``(II) is classified under MS-LTCH-
p.(None): DRG 602, 603, 539, or 540; and
p.(None): ``(III) is with respect to an
p.(None): individual treated by a long-term care
p.(None): hospital for a severe wound.
p.(None): ``(ii) Severe wound defined.--In this
p.(None): subparagraph, the term `severe wound' means a
p.(None): wound which is a stage 3 wound, stage 4 wound,
p.(None): unstageable wound, non-healing surgical wound, or
p.(None): fistula as identified in the claim from the long-
p.(None): term care hospital.
p.(None): ``(iii) Wound defined.--In this subparagraph,
p.(None): the term `wound' means an injury involving
p.(None): division of tissue or rupture of the integument or
p.(None): mucous membrane with exposure to the external
p.(None): environment.''.
p.(None):
p.(None): (c) Study and Report to Congress.--
p.(None): (1) Study.--The Comptroller General of the United States
p.(None): shall, in consultation with relevant stakeholders, conduct a
p.(None): study on the treatment needs of individuals entitled to benefits
p.(None): under part A of title XVIII of the Social Security Act or
p.(None): enrolled under part B of such title who require specialized
p.(None): wound care, and the cost, for such individuals and the Medicare
p.(None): program under such title, of treating severe wounds in rural and
p.(None): urban areas. Such study shall include an assessment of--
p.(None): (A) access of such individuals to appropriate levels
p.(None): of care for such cases;
p.(None): (B) the potential impact that section
p.(None): 1886(m)(6)(A)(i) of such Act (42 U.S.C.
p.(None): 1395ww(m)(6)(A)(i)) will have on
p.(None):
p.(None): [[Page 130 STAT. 1324]]
p.(None):
p.(None): the access, quality, and cost of care for such
p.(None): individuals; and
p.(None): (C) how to appropriately pay for such care under the
p.(None): Medicare program under such title.
p.(None): (2) Report.--Not later than October 1, 2020, the Comptroller
p.(None): General shall submit to Congress a report on the study conducted
p.(None): under paragraph (1), including recommendations for such
p.(None): legislation and administrative action as the Comptroller General
p.(None): determines appropriate.
p.(None):
p.(None): TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
p.(None):
p.(None): SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE
p.(None): PAYMENT SYSTEM FOR SERVICES FURNISHED
p.(None): BY MID-BUILD OFF-CAMPUS OUTPATIENT
p.(None): DEPARTMENTS OF PROVIDERS.
p.(None):
p.(None): (a) In General.--Section 1833(t)(21) of the Social Security Act (42
p.(None): U.S.C. 1395l(t)(21)) is amended--
p.(None): (1) in subparagraph (B)--
p.(None): (A) in clause (i), by striking ``clause (ii)'' and
p.(None): inserting ``the subsequent provisions of this
p.(None): subparagraph''; and
p.(None): (B) by adding at the end the following new clauses:
p.(None): ``(iii) Deemed treatment for 2017.--For
p.(None): purposes of applying clause (ii) with respect to
p.(None): applicable items and services furnished during
p.(None): 2017, a department of a provider (as so defined)
p.(None): not described in such clause is deemed to be
p.(None): billing under this subsection with respect to
p.(None): covered OPD services furnished prior to November
p.(None): 2, 2015, if the Secretary received from the
p.(None): provider prior to December 2, 2015, an attestation
p.(None): (pursuant to section 413.65(b)(3) of title 42 of
p.(None): the Code of Federal Regulations) that such
p.(None): department was a department of a provider (as so
p.(None): defined).
p.(None): ``(iv) Alternative exception beginning with
...
p.(None): 4(a)(7)(D)) is amended--
p.(None): [[Page 130 STAT. 1327]]
p.(None):
p.(None): (1) by striking ``hospital-based eligible professionals''
p.(None): and all that follows through ``No payment'' and inserting the
p.(None): following: ``hospital-based and ambulatory surgical center-based
p.(None): eligible professionals.--
p.(None): ``(i) Hospital-based.--No payment''; and
p.(None): (2) by adding at the end the following new clauses:
p.(None): ``(ii) Ambulatory surgical center-based.--
p.(None): Subject to clause (iv), no payment adjustment may
p.(None): be made under subparagraph (A) for 2017 and 2018
p.(None): in the case of an eligible professional with
p.(None): respect to whom substantially all of the covered
p.(None): professional services furnished by such
p.(None): professional are furnished in an ambulatory
p.(None): surgical center.
p.(None): ``(iii) Determination.--The determination of
p.(None): whether an eligible professional is an eligible
p.(None): professional described in clause (ii) may be made
p.(None): on the basis of--
p.(None): ``(I) the site of service (as
p.(None): defined by the Secretary); or
p.(None): ``(II) an attestation submitted by
p.(None): the eligible professional.
p.(None): Determinations made under subclauses (I) and (II)
p.(None): shall be made without regard to any employment or
p.(None): billing arrangement between the eligible
p.(None): professional and any other supplier or provider of
p.(None): services.
p.(None): ``(iv) Sunset.--Clause (ii) shall no longer
p.(None): apply as of the first year that begins more than 3
p.(None): years after the date on which the Secretary
p.(None): determines, through notice and comment rulemaking,
p.(None): that certified EHR technology applicable to the
p.(None): ambulatory surgical center setting is
p.(None): available.''.
p.(None): SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016.
p.(None):
p.(None): (a) Extension of Enforcement Instruction on Supervision Requirements
p.(None): for Outpatient Therapeutic Services in Critical Access and Small Rural
p.(None): Hospitals Through 2016.--Section 1 of Public Law 113-198, as amended by
p.(None): section 1 of Public Law 114-112, is amended--
p.(None): (1) in the heading, by striking ``2014 and 2015'' and
p.(None): inserting ``2016''; and
p.(None): (2) by striking ``and 2015'' and inserting ``, 2015, and
p.(None): 2016''.
p.(None):
p.(None): (b) Report.--Not later than 1 year after the date of the enactment
p.(None): of this Act, the Medicare Payment Advisory Commission (established under
p.(None): section 1805 of the Social Security Act (42 U.S.C. 1395b-6)) shall
p.(None): submit to Congress a report analyzing the effect of the extension of the
p.(None): enforcement instruction under section 1 of Public Law 113-198, as
p.(None): amended by section 1 of Public Law 114-112 and subsection (a) of this
p.(None): section, on the access to health care by Medicare beneficiaries, on the
p.(None): economic impact and the impact upon hospital staffing needs, and on the
p.(None): quality of health care furnished to such beneficiaries.
p.(None):
p.(None): [[Page 130 STAT. 1328]]
p.(None):
p.(None): SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE SCHEDULE
p.(None): ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES
p.(None): AND SEATING SYSTEMS WHEN USED IN
p.(None): CONJUNCTION WITH COMPLEX
p.(None): REHABILITATION TECHNOLOGY (CRT)
p.(None): WHEELCHAIRS.
p.(None):
p.(None): Section 2(a) of the Patient Access and Medicare Protection Act (42
p.(None): U.S.C. 1305 note) is amended by striking ``January 1, 2017'' and
p.(None): inserting ``July 1, 2017''.
p.(None): SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM TENENS
p.(None): ARRANGEMENTS UNDER MEDICARE.
p.(None):
p.(None): (a) In General.--The first sentence of section 1842(b)(6) of the
p.(None): Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by section 5012,
p.(None): is further amended--
p.(None): (1) by striking ``and'' before ``(I)''; and
p.(None): (2) by inserting before the period at the end the following:
p.(None): ``, and (J) in the case of outpatient physical therapy services
p.(None): furnished by physical therapists in a health professional
p.(None): shortage area (as defined in section 332(a)(1)(A) of the Public
p.(None): Health Service Act), a medically underserved area (as designated
p.(None): pursuant to section 330(b)(3)(A) of such Act), or a rural area
p.(None): (as defined in section 1886(d)(2)(D)), subparagraph (D) of this
p.(None): sentence shall apply to such services and therapists in the same
p.(None): manner as such subparagraph applies to physicians' services
p.(None): furnished by physicians''.
p.(None):
p.(None): (b) <> Effective Date; Implementation.--
p.(None): (1) Effective date.--The amendments made by subsection (a)
p.(None): shall apply to services furnished beginning not later than six
p.(None): months after the date of the enactment of this Act.
p.(None): (2) Implementation.--The Secretary of Health and Human
p.(None): Services may implement subparagraph (J) of section 1842(b)(6) of
p.(None): the Social Security Act (42 U.S.C. 1395u(b)(6)), as added by
p.(None): subsection (a)(2), by program instruction or otherwise.
...
p.(None): provider of services or supplier--
p.(None): ``(I) enrolls under this title on or
p.(None): after the effective date of such
p.(None): temporary moratorium; and
p.(None):
p.(None): [[Page 130 STAT. 1332]]
p.(None):
p.(None): ``(II) is within a category of
p.(None): providers of services and suppliers (as
p.(None): described in subparagraph (A)) subject
p.(None): to such temporary moratorium.
p.(None): ``(iv) Prohibition on charges for specified
p.(None): items or services.--In no case shall a provider of
p.(None): services or supplier described in clause (ii)(II)
p.(None): charge an individual or other person for an item
p.(None): or service described in clause (ii) furnished on
p.(None): or after October 1, 2017, to an individual
p.(None): entitled to benefits under part A or enrolled
p.(None): under part B or an individual under a program
p.(None): specified in subparagraph (A).''.
p.(None):
p.(None): (b) Conforming Amendments.--
p.(None): (1) Medicaid.--
p.(None): (A) In general.--Section 1903(i)(2) of the Social
p.(None): Security Act (42 U.S.C. 1396b(i)(2)), as amended by
p.(None): section 5005(a)(4), is further amended--
p.(None): (i) in subparagraph (C), by striking ``or'' at
p.(None): the end; and
p.(None): (ii) by adding at the end the following new
p.(None): subparagraph:
p.(None): ``(E) with respect to any amount expended for such
p.(None): an item or service furnished during calendar quarters
p.(None): beginning on or after October 1, 2017, subject to
p.(None): section 1902(kk)(4)(A)(ii)(II), within a geographic area
p.(None): that is subject to a moratorium imposed under section
p.(None): 1866(j)(7) by a provider or supplier that meets the
p.(None): requirements specified in subparagraph (C)(iii) of such
p.(None): section, during the period of such moratorium; or''.
p.(None): (B) Exception with respect to access.--Section
p.(None): 1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C.
p.(None): 1396a(kk)(4)(A)(ii)) is amended to read as follows:
p.(None): ``(ii) Exceptions.--
p.(None): ``(I) Compliance with moratorium.--A
p.(None): State shall not be required to comply
p.(None): with a temporary moratorium described in
p.(None): clause (i) if the State determines that
p.(None): the imposition of such temporary
p.(None): moratorium would adversely impact
p.(None): beneficiaries' access to medical
p.(None): assistance.
p.(None): ``(II) FFP available.--
p.(None): Notwithstanding section 1903(i)(2)(E),
p.(None): payment may be made to a State under
p.(None): this title with respect to amounts
p.(None): expended for items and services
p.(None): described in such section if the
p.(None): Secretary, in consultation with the
p.(None): State agency administering the State
p.(None): plan under this title (or a waiver of
p.(None): the plan), determines that denying
p.(None): payment to the State pursuant to such
p.(None): section would adversely impact
p.(None): beneficiaries' access to medical
p.(None): assistance. ''.
p.(None): (C) State plan requirement with respect to
p.(None): limitation on charges to beneficiaries.--Section
p.(None): 1902(kk)(4)(A) of the Social Security Act (42 U.S.C.
p.(None): 1396a(kk)(4)(A)) is amended by adding at the end the
p.(None): following new clause:
p.(None): ``(iii) Limitation on charges to
p.(None): beneficiaries.--With respect to any amount
p.(None): expended for items or services furnished during
p.(None): calendar quarters beginning on or after October 1,
p.(None): 2017, the State prohibits, during
p.(None):
p.(None): [[Page 130 STAT. 1333]]
p.(None):
p.(None): the period of a temporary moratorium described in
p.(None): clause (i), a provider meeting the requirements
p.(None): specified in subparagraph (C)(iii) of section
p.(None): 1866(j)(7) from charging an individual or other
p.(None): person eligible to receive medical assistance
p.(None): under the State plan under this title (or a waiver
p.(None): of the plan) for an item or service described in
p.(None): section 1903(i)(2)(E) furnished to such an
p.(None): individual.''.
p.(None): (2) Correcting amendments to related provisions.--
p.(None): (A) Section 1866(j).--Section 1866(j) of the Social
p.(None): Security Act (42 U.S.C. 1395cc(j)) is amended--
p.(None): (i) in paragraph (1)(A)--
p.(None): (I) by striking ``paragraph (4)''
p.(None): and inserting ``paragraph (5)'';
p.(None): (II) by striking ``moratoria in
p.(None): accordance with paragraph (5)'' and
p.(None): inserting ``moratoria in accordance with
p.(None): paragraph (7)''; and
p.(None): (III) by striking ``paragraph (6)''
p.(None): and inserting ``paragraph (9)''; and
p.(None): (ii) by redesignating the second paragraph (8)
p.(None): (redesignated by section 1304(1) of Public Law
p.(None): 111-152) as paragraph (9).
p.(None): (B) Section 1902(kk).--Section 1902(kk) of such Act
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p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
...
p.(None): U.S.C. 241(d)) prior to the date of enactment of this Act shall be
p.(None): subject to the requirements of such section (as amended by this Act).
p.(None): SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
p.(None):
p.(None): Section 301 of the Public Health Service Act (42 U.S.C. 241) is
p.(None): amended by adding at the end the following:
p.(None): ``(f)(1) The Secretary may exempt from disclosure under section
p.(None): 552(b)(3) of title 5, United States Code, biomedical information that is
p.(None): about an individual and that is gathered or used during the course of
p.(None): biomedical research if--
p.(None): ``(A) an individual is identified; or
p.(None): ``(B) there is at least a very small risk, as determined by
p.(None): current scientific practices or statistical methods, that some
p.(None): combination of the information, the request, and other available
p.(None): data sources could be used to deduce the identity of an
p.(None): individual.
p.(None):
p.(None): ``(2)(A) Each determination of the Secretary under paragraph (1) to
p.(None): exempt information from disclosure shall be made in writing and
p.(None): accompanied by a statement of the basis for the determination.
p.(None): ``(B) Each such determination and statement of basis shall be
p.(None): available to the public, upon request, through the Office of the Chief
p.(None): FOIA Officer of the Department of Health and Human Services.
p.(None):
p.(None): [[Page 130 STAT. 1051]]
p.(None):
p.(None): ``(3) Nothing in this subsection shall be construed to limit a
p.(None): research participant's access to information about such participant
p.(None): collected during the participant's participation in the research.''.
p.(None): SEC. 2014. DATA SHARING.
p.(None):
p.(None): (a) In General.--Section 402(b) of the Public Health Service Act (42
p.(None): U.S.C. 282(b)) is amended--
p.(None): (1) in paragraph (23), by striking ``and'' at the end;
p.(None): (2) in paragraph (24), by striking the period and inserting
p.(None): ``; and''; and
p.(None): (3) by inserting after paragraph (24) the following:
p.(None): ``(25) may require recipients of National Institutes of
p.(None): Health awards to share scientific data, to the extent feasible,
p.(None): generated from such National Institutes of Health awards in a
p.(None): manner that is consistent with all applicable Federal laws and
p.(None): regulations, including such laws and regulations for the
p.(None): protection of--
p.(None): ``(A) human research participants, including with
p.(None): respect to privacy, security, informed consent, and
p.(None): protected health information; and
p.(None): ``(B) proprietary interests, confidential commercial
p.(None): information, and the intellectual property rights of the
p.(None): funding recipient.''.
p.(None):
p.(None): (b) <> Confidentiality.--Nothing in the
p.(None): amendments made by subsection (a) authorizes the Secretary of Health and
p.(None): Human Services to disclose any information that is a trade secret, or
p.(None): other privileged or confidential information, described in section
p.(None): 552(b)(4) of title 5, United States Code, or section 1905 of title 18,
p.(None): United States Code, or be construed to require recipients of grants or
p.(None): cooperative agreements through the National Institutes of Health to
...
p.(None): provider is permitted to exchange and provide access to
p.(None): health information.''.
p.(None): ``(2) Certifying usability for patients.--In carrying out
p.(None): certification programs under section 3001(c)(5), the National
p.(None): Coordinator may require that--
p.(None): ``(A) the certification criteria support--
p.(None): ``(i) patient access to their electronic
p.(None): health information, including in a single
p.(None): longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically;
p.(None): ``(ii) the patient's ability to electronically
p.(None): communicate patient-reported information (such as
p.(None): family history and medical history); and
p.(None): ``(iii) patient access to their personal
p.(None): electronic health information for research at the
p.(None): option of the patient; and
p.(None): ``(B) the HIT Advisory Committee develop and
p.(None): prioritize standards, implementation specifications, and
p.(None): certification criteria required to help support patient
p.(None): access to electronic health information, patient
p.(None): usability, and support for technologies that offer
p.(None): patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to
p.(None): understand, secure, and may be updated automatically.''.
p.(None):
p.(None): (b) Access to Information in an Electronic Format.--Section 13405(e)
p.(None): of the Health Information Technology for Economic and Clinical Health
p.(None): Act (42 U.S.C. 17935) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (2) as paragraph (3); and
p.(None): (3) by inserting after paragraph (1), the following:
p.(None): ``(2) if the individual makes a request to a business
p.(None): associate for access to, or a copy of, protected health
p.(None): information about the individual, or if an individual makes a
p.(None): request to a business associate to grant such access to, or
p.(None): transmit such copy directly to, a person or entity designated by
p.(None): the individual, a business associate may provide the individual
p.(None): with such access or copy, which may be in an electronic form, or
p.(None): grant or transmit such access or copy to such person or entity
p.(None): designated by the individual; and''.
p.(None): SEC. 4007. GAO STUDY ON PATIENT MATCHING.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, the Comptroller General of the United States shall conduct
p.(None): a study to--
p.(None): (1) review the policies and activities of the Office of the
p.(None): National Coordinator for Health Information Technology and other
p.(None): relevant stakeholders, which may include standards development
p.(None): organizations, experts in the technical aspects of health
p.(None): information technology, health information technology
p.(None): developers, providers of health services, health care suppliers,
...
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
p.(None): the Assistant Secretary may establish a period for the
p.(None): submission of applications for evidence-based programs and
p.(None): practices to be posted publicly in accordance with subsection
p.(None): (a).
p.(None): ``(2) Notice.--In establishing the application period under
p.(None): paragraph (1), the Assistant Secretary shall provide for the
p.(None): public notice of such application period in the Federal
p.(None): Register.
p.(None):
p.(None): [[Page 130 STAT. 1223]]
p.(None):
...
p.(None): intervention services to individuals seeking help at any time,
p.(None): day or night;
p.(None): ``(2) maintaining a suicide prevention hotline to link
p.(None): callers to local emergency, mental health, and social services
p.(None): resources; and
p.(None): ``(3) consulting with the Secretary of Veterans Affairs to
p.(None): ensure that veterans calling the suicide prevention hotline have
p.(None): access to a specialized veterans' suicide prevention hotline.
p.(None):
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $7,198,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.), as amended by section 9005, is further amended
p.(None): by inserting after section 520E-3 the following:
p.(None): ``SEC. 520E-4. <> TREATMENT REFERRAL
p.(None): ROUTING SERVICE.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Assistant
p.(None): Secretary, shall maintain the National Treatment Referral Routing
p.(None): Service (referred to in this section as the `Routing Service') to assist
p.(None): individuals and families in locating mental and substance use disorders
p.(None): treatment providers.
p.(None): ``(b) Activities of the Secretary.--To maintain the Routing Service,
p.(None): the activities of the Assistant Secretary shall include administering--
p.(None): ``(1) a nationwide, telephone number providing year-round
p.(None): access to information that is updated on a regular basis
p.(None): regarding local behavioral health providers and community-based
p.(None): organizations in a manner that is confidential, without
p.(None): requiring individuals to identify themselves, is in languages
p.(None): that include at least English and Spanish, and is at no cost to
p.(None): the individual using the Routing Service; and
p.(None):
p.(None): [[Page 130 STAT. 1240]]
p.(None):
p.(None): ``(2) an Internet website to provide a searchable, online
p.(None): treatment services locator of behavioral health treatment
p.(None): providers and community-based organizations, which shall include
p.(None): information on the name, location, contact information, and
p.(None): basic services provided by such providers and organizations.
p.(None):
p.(None): ``(c) Removing Practitioner Contact Information.--In the event that
p.(None): the Internet website described in subsection (b)(2) contains information
p.(None): on any qualified practitioner that is certified to prescribe medication
p.(None): for opioid dependency under section 303(g)(2)(B) of the Controlled
p.(None): Substances Act, the Assistant Secretary--
p.(None): ``(1) shall provide an opportunity to such practitioner to
p.(None): have the contact information of the practitioner removed from
p.(None): the website at the request of the practitioner; and
p.(None): ``(2) may evaluate other methods to periodically update the
p.(None): information displayed on such website.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the Assistant Secretary from using any unobligated
p.(None): amounts otherwise made available to the Administration to maintain the
p.(None): Routing Service.''.
p.(None): SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
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p.(None): regarding objectives of the national institutes and
p.(None): national centers to ensure that future activities by
p.(None): such institutes and centers take into account women and
p.(None): minorities and are focused on reducing health
p.(None): disparities.
p.(None): ``(B) Strategic plans.--Any strategic plan issued by
p.(None): a national institute or national center shall include
p.(None): details on the objectives described in subparagraph
p.(None): (A).''.
p.(None): SEC. 2032. TRIENNIAL REPORTS.
p.(None):
p.(None): Section 403 of the Public Health Service Act (42 U.S.C. 283) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``biennial'' and
p.(None): inserting ``triennial'' ; and
p.(None): (2) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``biennial'' and inserting ``triennial'';
p.(None): (B) by amending paragraph (3) to read as follows:
p.(None): ``(3) A description of intra-National Institutes of Health
p.(None): activities, including--
p.(None): ``(A) identification of the percentage of funds made
p.(None): available by each national research institute and
p.(None): national center with respect to each applicable fiscal
p.(None): year for conducting or supporting research that involves
p.(None): collaboration between the institute or center and 1 or
p.(None): more other national research institutes or national
p.(None): centers; and
p.(None): ``(B) recommendations for promoting coordination of
p.(None): information among the centers of excellence.'';
p.(None): (C) in paragraph (4)--
p.(None): (i) in subparagraph (B), by striking
p.(None): ``demographic variables and other variables'' and
p.(None): inserting ``demographic variables, including
p.(None): biological and social variables and relevant age
p.(None): categories (such as pediatric subgroups), and
p.(None): determinants of health,''; and
p.(None): (ii) in subparagraph (C)(v)--
p.(None): (I) by striking ``demographic
p.(None): variables and such'' and inserting
p.(None): ``demographic variables, including
p.(None): relevant age categories (such as
p.(None): pediatric subgroups), information
p.(None): submitted by each
p.(None):
p.(None): [[Page 130 STAT. 1057]]
p.(None):
p.(None): national research institute and national
p.(None): center to the Director of National
p.(None): Institutes of Health under section
p.(None): 492B(f), and such''; and
p.(None): (II) by striking ``(regarding
p.(None): inclusion of women and minorities in
p.(None): clinical research)'' and inserting ``and
p.(None): other applicable requirements regarding
p.(None): inclusion of demographic groups''; and
p.(None): (D) in paragraph (6)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``the following:'' and inserting ``the
p.(None): following--'';
p.(None): (ii) in subparagraph (A)--
p.(None): (I) by striking ``An evaluation''
p.(None): and inserting ``an evaluation''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and'';
p.(None): (iii) by striking subparagraphs (B) and (D);
p.(None): (iv) by redesignating subparagraph (C) as
p.(None): subparagraph (B); and
p.(None): (v) in subparagraph (B), as redesignated by
p.(None): clause (iv), by striking ``Recommendations'' and
p.(None): inserting ``recommendations''.
p.(None): SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL INSTITUTES OF
p.(None): HEALTH.
p.(None):
p.(None): (a) Appointment and Terms of Directors of National Research
p.(None): Institutes and National Centers.--Subsection (a) of section 405 of the
p.(None): Public Health Service Act (42 U.S.C. 284) is amended to read as follows:
p.(None): ``(a) Appointment.--
p.(None): ``(1) In general.--The Director of the National Cancer
p.(None): Institute shall be appointed by the President, and the Directors
p.(None): of the other national research institutes and national centers
...
p.(None): Administration to support medical product reviews.''; and
p.(None):
p.(None): [[Page 130 STAT. 1064]]
p.(None):
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(d) Inclusion of List.--The first biennial report submitted under
p.(None): this section after the date of enactment of the 21st Century Cures Act
p.(None): shall include a complete list of all of the methods and tools, if any,
p.(None): which have been developed by research supported by the Center.
p.(None): ``(e) Rule of Construction.--Nothing in this section shall be
p.(None): construed as authorizing the Secretary to disclose any information that
p.(None): is a trade secret, or other privileged or confidential information
p.(None): subject to section 552(b)(4) of title 5, United States Code, or section
p.(None): 1905 of title 18, United States Code.''.
p.(None): SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.
p.(None):
p.(None): (a) Research Priorities; Collaborative Research Projects.--Section
p.(None): 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
p.(None): (1) by amending paragraph (4) to read as follows:
p.(None): ``(4) shall assemble accurate data to be used to assess
p.(None): research priorities, including--
p.(None): ``(A) information to better evaluate scientific
p.(None): opportunity, public health burdens, and progress in
p.(None): reducing health disparities; and
p.(None): ``(B) data on study populations of clinical
p.(None): research, funded by or conducted at each national
p.(None): research institute and national center, which--
p.(None): ``(i) specifies the inclusion of--
p.(None): ``(I) women;
p.(None): ``(II) members of minority groups;
p.(None): ``(III) relevant age categories,
p.(None): including pediatric subgroups; and
p.(None): ``(IV) other demographic variables
p.(None): as the Director of the National
p.(None): Institutes of Health determines
p.(None): appropriate;
p.(None): ``(ii) is disaggregated by research area,
p.(None): condition, and disease categories; and
p.(None): ``(iii) is to be made publicly available on
p.(None): the Internet website of the National Institutes of
p.(None): Health;''; and
p.(None): (2) in paragraph (8)--
p.(None): (A) in subparagraph (A), by striking ``and'' at the
p.(None): end; and
p.(None): (B) by adding at the end the following:
p.(None): ``(C) foster collaboration between clinical research
p.(None): projects funded by the respective national research
p.(None): institutes and national centers that--
p.(None): ``(i) conduct research involving human
p.(None): subjects; and
p.(None): ``(ii) collect similar data; and
p.(None): ``(D) encourage the collaboration described in
p.(None): subparagraph (C) to--
p.(None): ``(i) allow for an increase in the number of
p.(None): subjects studied; and
p.(None): ``(ii) utilize diverse study populations, with
p.(None): special consideration to biological, social, and
p.(None): other determinants of health that contribute to
p.(None): health disparities;''.
p.(None):
p.(None): [[Page 130 STAT. 1065]]
p.(None):
p.(None): (b) Reporting.--Section 492B(f) of the Public Health Service Act (42
p.(None): U.S.C. 289a-2(f)) is amended--
p.(None): (1) by striking ``biennial'' each place such term appears
p.(None): and inserting ``triennial'';
p.(None): (2) by striking ``The advisory council'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The advisory council''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(2) Contents.--Each triennial report prepared by an
p.(None): advisory council of each national research institute as
...
p.(None): appropriate with respect to the analysis of any sex
p.(None): differences.
p.(None):
p.(None): (h) <> Clinical Research.--
p.(None): (1) In general.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Director of the National Institutes
p.(None): of Health, in consultation with the Director of the Office of
p.(None): Research on Women's Health and the Director of the National
p.(None): Institute on Minority Health and Health Disparities, shall
p.(None): update the guidelines established under section 492B(d) of
p.(None): Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance
p.(None): with paragraph (2).
p.(None): (2) Requirements.--The updated guidelines described in
p.(None): paragraph (1) shall--
p.(None): (A) reflect the science regarding sex differences;
p.(None): (B) improve adherence to the requirements under
p.(None): section 492B of the Public Health Service Act (42 U.S.C.
p.(None): 289a-2), including the reporting requirements under
p.(None): subsection (f) of such section; and
p.(None): (C) clarify the circumstances under which studies
p.(None): should be designed to support the conduct of analyses to
p.(None): detect significant differences in the intervention
p.(None): effect due to demographic factors related to section
p.(None): 492B of the Public Health Service Act, including in the
p.(None): absence of prior studies that demonstrate a difference
p.(None): in study outcomes on the basis of such factors and
p.(None): considering the effects of the absence of such analyses
p.(None): on the availability of data related to demographic
p.(None): differences.
p.(None):
p.(None): (i) <> Appropriate Age Groupings in
p.(None): Clinical Research.--
p.(None): (1) Input from experts.--Not later than 180 days after the
p.(None): date of enactment of this Act, the Director of the National
p.(None): Institutes of Health shall convene a workshop of experts on
p.(None): pediatric and older populations to provide input on--
p.(None): (A) appropriate age groups to be included in
p.(None): research studies involving human subjects; and
p.(None): (B) acceptable justifications for excluding
p.(None): participants from a range of age groups from human
p.(None): subjects research studies.
p.(None): (2) Policy updates.--Not later than 180 days after the
p.(None): conclusion of the workshop under paragraph (1), the Director of
p.(None): the National Institutes of Health shall make a determination
p.(None): with respect to whether the policies of the National Institutes
p.(None): of Health on the inclusion of relevant age groups in clinical
p.(None): studies need to be updated, and shall update such policies as
p.(None): appropriate. In making the determination, the Director of the
p.(None): National Institutes of Health shall take into consideration
p.(None): whether such policies--
p.(None):
p.(None): [[Page 130 STAT. 1068]]
p.(None):
p.(None): (A) address the consideration of age as an inclusion
p.(None): variable in research involving human subjects; and
p.(None): (B) identify the criteria for justification for any
p.(None): age-related exclusions in such research.
p.(None): (3) Public availability of findings and conclusions.--The
p.(None): Director of the National Institutes of Health shall--
p.(None): (A) make the findings and conclusions resulting from
p.(None): the workshop under paragraph (1) and updates to policies
p.(None): in accordance with paragraph (2), as applicable,
p.(None): available to the public on the Internet website of the
p.(None): National Institutes of Health; and
p.(None): (B) ensure that age-related data reported in the
p.(None): triennial report under section 403 of the Public Health
p.(None): Service Act (42 U.S.C. 283) (as amended by section 2032)
p.(None): are made available to the public on the Internet website
p.(None): of the National Institutes of Health.
p.(None): SEC. 2039. <> ENHANCING THE RIGOR AND
p.(None): REPRODUCIBILITY OF SCIENTIFIC RESEARCH.
p.(None):
p.(None): (a) Establishment.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Secretary of Health and Human Services,
p.(None): acting through the Director of the National Institutes of Health, shall
p.(None): convene a working group under the Advisory Committee to the Director of
p.(None): the National Institutes of Health (referred to in this section as the
p.(None): ``Advisory Committee''), appointed under section 222 of the Public
p.(None): Health Service Act (42 U.S.C. 217a), to develop and issue
p.(None): recommendations through the Advisory Committee for a formal policy,
p.(None): which may incorporate or be informed by relevant existing and ongoing
p.(None): activities, to enhance rigor and reproducibility of scientific research
p.(None): funded by the National Institutes of Health.
p.(None): (b) Considerations.--In developing and issuing recommendations
p.(None): through the Advisory Committee under subsection (a), the working group
p.(None): established under such subsection shall consider, as appropriate--
p.(None): (1) preclinical experiment design, including analysis of sex
p.(None): as a biological variable;
p.(None): (2) clinical experiment design, including--
p.(None): (A) the diversity of populations studied for
p.(None): clinical research, with respect to biological, social,
p.(None): and other determinants of health that contribute to
p.(None): health disparities;
...
p.(None):
p.(None): SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE SYSTEM.
p.(None):
p.(None): Part P of title III of the Public Health Service Act (42 U.S.C. 280g
p.(None): et seq.) is amended by inserting after section 399S the following:
p.(None):
p.(None): [[Page 130 STAT. 1077]]
p.(None):
p.(None): ``SEC. 399S-1. <> SURVEILLANCE OF
p.(None): NEUROLOGICAL DISEASES.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Director of the
p.(None): Centers for Disease Control and Prevention and in coordination with
p.(None): other agencies as the Secretary determines, shall, as appropriate--
p.(None): ``(1) enhance and expand infrastructure and activities to
p.(None): track the epidemiology of neurological diseases; and
p.(None): ``(2) incorporate information obtained through such
p.(None): activities into an integrated surveillance system, which may
p.(None): consist of or include a registry, to be known as the National
p.(None): Neurological Conditions Surveillance System.
p.(None):
p.(None): ``(b) Research.--The Secretary shall ensure that the National
p.(None): Neurological Conditions Surveillance System is designed in a manner that
p.(None): facilitates further research on neurological diseases.
p.(None): ``(c) Content.--In carrying out subsection (a), the Secretary--
p.(None): ``(1) shall provide for the collection and storage of
p.(None): information on the incidence and prevalence of neurological
p.(None): diseases in the United States;
p.(None): ``(2) to the extent practicable, shall provide for the
p.(None): collection and storage of other available information on
p.(None): neurological diseases, including information related to persons
p.(None): living with neurological diseases who choose to participate,
p.(None): such as--
p.(None): ``(A) demographics, such as age, race, ethnicity,
p.(None): sex, geographic location, family history, and other
p.(None): information, as appropriate;
p.(None): ``(B) risk factors that may be associated with
p.(None): neurological diseases, such as genetic and environmental
p.(None): risk factors and other information, as appropriate; and
p.(None): ``(C) diagnosis and progression markers;
p.(None): ``(3) may provide for the collection and storage of
p.(None): information relevant to analysis on neurological diseases, such
p.(None): as information concerning--
p.(None): ``(A) the natural history of the diseases;
p.(None): ``(B) the prevention of the diseases;
p.(None): ``(C) the detection, management, and treatment
p.(None): approaches for the diseases; and
p.(None): ``(D) the development of outcomes measures;
p.(None): ``(4) may address issues identified during the consultation
p.(None): process under subsection (d); and
p.(None): ``(5) initially may address a limited number of neurological
p.(None): diseases.
p.(None):
p.(None): ``(d) Consultation.--In carrying out this section, the Secretary
p.(None): shall consult with individuals with appropriate expertise, which may
p.(None): include--
p.(None): ``(1) epidemiologists with experience in disease
p.(None): surveillance or registries;
p.(None): ``(2) representatives of national voluntary health
p.(None): associations that--
p.(None): ``(A) focus on neurological diseases; and
p.(None): ``(B) have demonstrated experience in research,
p.(None): care, or patient services;
p.(None): ``(3) health information technology experts or other
p.(None): information management specialists;
...
p.(None): that allows for the electronic access, exchange,
p.(None): and use of health information, including through
p.(None): technology that provides accurate patient
p.(None): information for the correct patient, including
p.(None): exchanging such information, and avoids the
p.(None): duplication of patient records.
p.(None): ``(ii) The promotion and protection of privacy
p.(None): and security of health information in health
p.(None): information technology, including technologies
p.(None): that allow for an accounting of disclosures and
p.(None): protections against disclosures of individually
p.(None): identifiable health information made by a covered
p.(None): entity for purposes of treatment, payment, and
p.(None): health care operations (as such terms are defined
p.(None): for purposes of the regulation promulgated under
p.(None): section 264(c) of the Health Insurance Portability
p.(None): and Accountability Act of 1996), including for the
p.(None): segmentation and protection from disclosure of
p.(None): specific and sensitive individually identifiable
p.(None): health information with the goal of minimizing the
p.(None): reluctance of patients to seek care.
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
...
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
p.(None): ``(iv) include a description of how the State
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
p.(None): providers; and
p.(None): ``(vii) as appropriate to, and reflective of,
p.(None): the uses the State proposes for the block grant
p.(None): funds, include--
p.(None): ``(I) a description of the
p.(None): activities intended to reduce
p.(None): hospitalizations and hospital stays
p.(None): using the block grant funds;
p.(None): ``(II) a description of the
p.(None): activities intended to reduce incidents
p.(None): of suicide using the block grant funds;
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
...
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
p.(None): inserting ``shall further describe''; and
p.(None): (ii) by striking ``involved.'' and inserting
p.(None): ``involved, and the manner in which the State
p.(None): intends to comply with each of the funding
p.(None): agreements in this subpart and subpart III.'';
p.(None): (10) by striking the flush matter at the end; and
p.(None): (11) by adding at the end the following:
p.(None): ``(2) Goals and objectives.--The establishment of goals and
p.(None): objectives for the period of the plan, including targets and
p.(None): milestones that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.''.
p.(None):
p.(None): [[Page 130 STAT. 1228]]
p.(None):
p.(None): (c) Early Serious Mental Illness.--Section 1920 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-9) is amended by adding at the end the
p.(None): following:
p.(None): ``(c) Early Serious Mental Illness.--
p.(None): ``(1) In general.--Except as provided in paragraph (2), a
p.(None): State shall expend not less than 10 percent of the amount the
p.(None): State receives for carrying out this section for each fiscal
p.(None): year to support evidence-based programs that address the needs
p.(None): of individuals with early serious mental illness, including
p.(None): psychotic disorders, regardless of the age of the individual at
p.(None): onset.
p.(None): ``(2) State flexibility.--In lieu of expending 10 percent of
p.(None): the amount the State receives under this section for a fiscal
p.(None): year as required under paragraph (1), a State may elect to
p.(None): expend not less than 20 percent of such amount by the end of
p.(None): such succeeding fiscal year.''.
p.(None):
p.(None): (d) Additional Provisions.--Section 1915(b) of the Public Health
p.(None): Service Act (42 U.S.C. 300x-4(b)) is amended--
p.(None): (1) in paragraph (3)--
p.(None): (A) by striking ``The Secretary'' and inserting the
p.(None): following:
p.(None): ``(A) In general.--The Secretary'';
p.(None): (B) by striking ``paragraph (1) if'' and inserting
p.(None): ``paragraph (1) in whole or in part if'';
p.(None): (C) by striking ``State justify the waiver.'' and
p.(None): inserting ``State in the fiscal year involved or in the
p.(None): previous fiscal year justify the waiver''; and
p.(None): (D) by adding at the end the following:
p.(None): ``(B) Date certain for action upon request.--The
p.(None): Secretary shall approve or deny a request for a waiver
p.(None): under this paragraph not later than 120 days after the
p.(None): date on which the request is made.
p.(None): ``(C) Applicability of waiver.--A waiver provided by
p.(None): the Secretary under this paragraph shall be applicable
p.(None): only to the fiscal year involved.''; and
p.(None): (2) in paragraph (4)--
p.(None): (A) in subparagraph (A)--
p.(None): (i) by inserting after the subparagraph
p.(None): designation the following: ``In general.--'';
p.(None): (ii) by striking ``In making a grant'' and
p.(None): inserting the following:
p.(None): ``(i) Determination.--In making a grant''; and
p.(None): (iii) by inserting at the end the following:
p.(None): ``(ii) Alternative.--A State that has failed
p.(None): to comply with paragraph (1) and would otherwise
...
p.(None): State does not receive more than 1 grant or
p.(None): cooperative agreement under this section at any 1
p.(None): time''; and
p.(None): (ii) by striking ``been awarded'' and
p.(None): inserting ``received''; and
p.(None): (B) by adding after paragraph (2) the following:
p.(None): ``(3) Consideration.--In awarding grants under this section,
p.(None): the Secretary shall take into consideration the extent of the
p.(None): need of the applicant, including the incidence and prevalence of
p.(None): suicide in the State and among the populations of focus,
p.(None): including rates of suicide determined by the Centers for Disease
p.(None): Control and Prevention for the State or population of focus.'';
p.(None): (3) in subsection (g)(2), by striking ``2 years after the
p.(None): date of enactment of this section,'' and insert ``2 years after
p.(None): the date of enactment of Helping Families in Mental Health
p.(None): Crisis Reform Act of 2016,''; and
p.(None): (4) by striking subsection (m) and inserting the following:
p.(None):
p.(None): ``(m) Authorization of Appropriations.--For the purpose of carrying
p.(None): out this section, there are authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2018 through 2022.''.
p.(None): SEC. 9009. <> ADULT SUICIDE PREVENTION.
p.(None):
p.(None): Subpart 3 of part B of title V of the Public Health Service Act (42
p.(None): U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 520L. ADULT SUICIDE PREVENTION.
p.(None):
p.(None): ``(a) Grants.--
p.(None): ``(1) In general.--The Assistant Secretary shall award
p.(None): grants to eligible entities described in paragraph (2) to
p.(None): implement suicide prevention and intervention programs, for
p.(None): individuals who are 25 years of age or older, that are designed
p.(None): to raise awareness of suicide, establish referral processes, and
p.(None): improve care and outcomes for such individuals who are at risk
p.(None): of suicide.
p.(None): ``(2) Eligible entities.--To be eligible to receive a grant
p.(None): under this section, an entity shall be a community-based primary
p.(None): care or behavioral health care setting, an emergency department,
p.(None): a State mental health agency (or State health agency with mental
p.(None): or behavioral health functions), public health agency, a
p.(None): territory of the United States, or an Indian tribe or tribal
p.(None): organization (as the terms `Indian tribe' and `tribal
p.(None): organization' are defined in section 4 of the Indian Self-
p.(None): Determination and Education Assistance Act).
p.(None): ``(3) Use of funds.--The grants awarded under paragraph (1)
p.(None): shall be used to implement programs, in accordance with such
p.(None): paragraph, that include one or more of the following components:
p.(None): ``(A) Screening for suicide risk, suicide
p.(None): intervention services, and services for referral for
p.(None): treatment for individuals at risk for suicide.
p.(None): ``(B) Implementing evidence-based practices to
p.(None): provide treatment for individuals at risk for suicide,
p.(None): including appropriate followup services.
p.(None): ``(C) Raising awareness and reducing stigma of
p.(None): suicide.
p.(None):
p.(None): [[Page 130 STAT. 1244]]
p.(None):
...
p.(None): determined by the Secretary,'' after ``emergency
p.(None): services personnel'';
p.(None): (C) in paragraph (5)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``to'' and inserting ``for evidence-
p.(None): based programs that provide training and education
p.(None): in accordance with paragraph (1) on matters
p.(None): including''; and
p.(None): (ii) by striking subparagraphs (A) through (C)
p.(None): and inserting the following:
p.(None): ``(A) recognizing the signs and symptoms of mental
p.(None): illness; and
p.(None): ``(B)(i) resources available in the community for
p.(None): individuals with a mental illness and other relevant
p.(None): resources; or
p.(None): ``(ii) safely de-escalating crisis situations
p.(None): involving individuals with a mental illness.''; and
p.(None): (D) in paragraph (7), by striking ``, $25,000,000''
p.(None): and all that follows through the period at the end and
p.(None): inserting ``$14,693,000 for each of fiscal years 2018
p.(None): through 2022.''.
p.(None): SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND
p.(None): ALASKA NATIVE YOUTH WITHIN SUICIDE
p.(None): PREVENTION PROGRAMS.
p.(None):
p.(None): (a) Findings.--The Congress finds as follows:
p.(None): (1) Suicide is the eighth leading cause of death among
p.(None): American Indians and Alaska Natives across all ages.
p.(None): (2) Among American Indians and Alaska Natives who are 10 to
p.(None): 34 years of age, suicide is the second leading cause of death.
p.(None): (3) The suicide rate among American Indian and Alaska Native
p.(None): adolescents and young adults ages 15 to 34 (17.9 per
p.(None):
p.(None): [[Page 130 STAT. 1245]]
p.(None):
p.(None): 100,000) is approximately 1.3 times higher than the national
p.(None): average for that age group (13.3 per 100,000).
p.(None):
p.(None): (b) Sense of Congress.--It is the sense of Congress that the
p.(None): Secretary of Health and Human Services, in carrying out suicide
p.(None): prevention and intervention programs, should prioritize programs and
p.(None): activities for populations with disproportionately high rates of
p.(None): suicide, such as American Indians and Alaska Natives.
p.(None): SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
p.(None):
p.(None): Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 32(e)) is amended by adding at the end the following:
p.(None): ``(3) Geriatric mental disorders.--The Secretary shall, as
p.(None): appropriate, provide technical assistance to grantees regarding
p.(None): evidence-based practices for the prevention and treatment of
p.(None): geriatric mental disorders and co-occurring mental health and
p.(None): substance use disorders among geriatric populations, as well as
p.(None): disseminate information about such evidence-based practices to
p.(None): States and nongrantees throughout the United States.''.
p.(None): SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
p.(None):
p.(None): The Secretary of Health and Human Services, acting through the
p.(None): Director of the Centers for Disease Control and Prevention, is
p.(None): encouraged to improve, particularly through the inclusion of additional
p.(None): States, the National Violent Death Reporting System as authorized by
p.(None): title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
p.(None): Participation in the system by the States shall be voluntary.
p.(None): SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
p.(None):
p.(None): Section 224 of the Protecting Access to Medicare Act of 2014 (42
p.(None): U.S.C. 290aa note) is amended--
...
p.(None): ``(2) Use of certain funds.--Of the funds appropriated to
p.(None): carry out this section in any fiscal year, not more than 5
p.(None): percent shall be available to the Assistant Secretary for
p.(None): carrying out subsection (d).''.
p.(None): SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
p.(None): REAUTHORIZATION.
p.(None):
p.(None): Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
p.(None): is amended--
p.(None): (1) in subsection (c)(3), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (2) in subsection (d)(4), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (3) in subsection (e)(1)(I), by striking ``fiscal year
p.(None): 2007'' and all that follows through the period at the end and
p.(None): inserting ``each of the fiscal years 2018 through 2022.'';
p.(None): (4) in subsection (f)(2), by striking ``$6,000,000 for
p.(None): fiscal year 2007'' and all that follows through the period at
p.(None): the end and inserting ``$3,000,000 for each of the fiscal years
p.(None): 2018 through 2022''; and
p.(None): (5) by adding at the end the following new subsection:
p.(None):
p.(None): ``(g) Reducing Underage Drinking Through Screening and Brief
p.(None): Intervention.--
p.(None):
p.(None): [[Page 130 STAT. 1247]]
p.(None):
p.(None): ``(1) Grants to pediatric health care providers to reduce
p.(None): underage drinking.--The Assistant Secretary may make grants to
p.(None): eligible entities to increase implementation of practices for
p.(None): reducing the prevalence of alcohol use among individuals under
p.(None): the age of 21, including college students.
p.(None): ``(2) Purposes.--Grants under this subsection shall be made
p.(None): to improve--
p.(None): ``(A) screening children and adolescents for alcohol
p.(None): use;
p.(None): ``(B) offering brief interventions to children and
p.(None): adolescents to discourage such use;
p.(None): ``(C) educating parents about the dangers of, and
p.(None): methods of discouraging, such use;
p.(None): ``(D) diagnosing and treating alcohol use disorders;
p.(None): and
p.(None): ``(E) referring patients, when necessary, to other
p.(None): appropriate care.
p.(None): ``(3) Use of funds.--An entity receiving a grant under this
p.(None): subsection may use such funding for the purposes identified in
p.(None): paragraph (2) by--
p.(None): ``(A) providing training to health care providers;
p.(None): ``(B) disseminating best practices, including
p.(None): culturally and linguistically appropriate best
p.(None): practices, as appropriate, and developing and
p.(None): distributing materials; and
p.(None): ``(C) supporting other activities, as determined
p.(None): appropriate by the Assistant Secretary.
p.(None): ``(4) Application.--To be eligible to receive a grant under
p.(None): this subsection, an entity shall submit an application to the
p.(None): Assistant Secretary at such time, and in such manner, and
p.(None): accompanied by such information as the Assistant Secretary may
p.(None): require. Each application shall include--
p.(None): ``(A) a description of the entity;
p.(None): ``(B) a description of activities to be completed;
p.(None): ``(C) a description of how the services specified in
p.(None): paragraphs (2) and (3) will be carried out and the
p.(None): qualifications for providing such services; and
p.(None): ``(D) a timeline for the completion of such
p.(None): activities.
p.(None): ``(5) Definitions.--For the purpose of this subsection:
p.(None): ``(A) Brief intervention.--The term `brief
p.(None): intervention' means, after screening a patient,
p.(None): providing the patient with brief advice and other brief
p.(None): motivational enhancement techniques designed to increase
p.(None): the insight of the patient regarding the patient's
p.(None): alcohol use, and any realized or potential consequences
p.(None): of such use, to effect the desired related behavioral
p.(None): change.
p.(None): ``(B) Children and adolescents.--The term `children
p.(None): and adolescents' means any person under 21 years of age.
p.(None): ``(C) Eligible entity.--The term `eligible entity'
p.(None): means an entity consisting of pediatric health care
p.(None): providers and that is qualified to support or provide
p.(None): the activities identified in paragraph (2).
p.(None): ``(D) Pediatric health care provider.--The term
p.(None): `pediatric health care provider' means a provider of
p.(None): primary health care to individuals under the age of 21
p.(None): years.
p.(None): ``(E) Screening.--The term `screening' means using
p.(None): validated patient interview techniques to identify and
p.(None): assess the existence and extent of alcohol use in a
p.(None): patient.''.
p.(None):
p.(None): [[Page 130 STAT. 1248]]
p.(None):
p.(None): SEC. 9017. CENTER AND PROGRAM REPEALS.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
p.(None): second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
p.(None): amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
p.(None): 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
p.(None): 25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
p.(None): GRANTS.
p.(None):
p.(None): Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``of higher education''; and
p.(None): (B) by striking paragraphs (1) through (4) and
p.(None): inserting the following:
p.(None): ``(1) accredited institutions of higher education or
p.(None): accredited professional training programs that are establishing
p.(None): or expanding internships or other field placement programs in
p.(None): mental health in psychiatry, psychology, school psychology,
p.(None): behavioral pediatrics, psychiatric nursing (which may include
p.(None): master's and doctoral level programs), social work, school
p.(None): social work, substance use disorder prevention and treatment,
p.(None): marriage and family therapy, occupational therapy, school
p.(None): counseling, or professional counseling, including such programs
p.(None): with a focus on child and adolescent mental health and
p.(None): transitional-age youth;
p.(None): ``(2) accredited doctoral, internship, and post-doctoral
p.(None): residency programs of health service psychology (including
p.(None): clinical psychology, counseling, and school psychology) for the
p.(None): development and implementation of interdisciplinary training of
p.(None): psychology graduate students for providing behavioral health
p.(None): services, including substance use disorder prevention and
p.(None): treatment services, as well as the development of faculty in
p.(None): health service psychology;
p.(None): ``(3) accredited master's and doctoral degree programs of
p.(None): social work for the development and implementation of
p.(None): interdisciplinary training of social work graduate students for
p.(None): providing behavioral health services, including substance use
p.(None): disorder prevention and treatment services, and the development
p.(None): of faculty in social work; and
p.(None): ``(4) State-licensed mental health nonprofit and for-profit
p.(None): organizations to enable such organizations to pay for programs
p.(None): for preservice or in-service training in a behavioral health-
p.(None): related paraprofessional field with preference for preservice or
p.(None): in-service training of paraprofessional child and adolescent
p.(None): mental health workers.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (5);
p.(None): [[Page 130 STAT. 1249]]
p.(None):
p.(None): (B) by redesignating paragraphs (1) through (4) as
p.(None): paragraphs (2) through (5), respectively;
p.(None): (C) by inserting before paragraph (2), as so
p.(None): redesignated, the following:
p.(None): ``(1) an ability to recruit and place the students described
p.(None): in subsection (a) in areas with a high need and high demand
p.(None): population;'';
p.(None): (D) in paragraph (3), as so redesignated, by
p.(None): striking ``subsection (a)'' and inserting ``paragraph
p.(None): (2), especially individuals with mental disorder
p.(None): symptoms or diagnoses, particularly children and
p.(None): adolescents, and transitional-age youth'';
p.(None): (E) in paragraph (4), as so redesignated, by
p.(None): striking ``;'' and inserting ``; and''; and
p.(None): (F) in paragraph (5), as so redesignated, by
p.(None): striking ``; and'' and inserting a period;
p.(None): (3) in subsection (c), by striking ``authorized under
p.(None): subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
p.(None): and (3) of subsection (a)'';
p.(None): (4) by amending subsection (d) to read as follows:
p.(None):
p.(None): ``(d) Priority.--In selecting grant recipients under this section,
p.(None): the Secretary shall give priority to--
p.(None): ``(1) programs that have demonstrated the ability to train
p.(None): psychology, psychiatry, and social work professionals to work in
p.(None): integrated care settings for purposes of recipients under
p.(None): paragraphs (1), (2), and (3) of subsection (a); and
p.(None): ``(2) programs for paraprofessionals that emphasize the role
p.(None): of the family and the lived experience of the consumer and
p.(None): family-paraprofessional partnerships for purposes of recipients
p.(None): under subsection (a)(4).''; and
p.(None): (5) by striking subsection (e) and inserting the following:
p.(None):
p.(None): ``(e) Report to Congress.--Not later than 4 years after the date of
p.(None): enactment of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016, the Secretary shall include in the biennial report submitted to
p.(None): Congress under section 501(m) an assessment on the effectiveness of the
p.(None): grants under this section in--
p.(None): ``(1) providing graduate students support for experiential
p.(None): training (internship or field placement);
p.(None): ``(2) recruiting students interested in behavioral health
...
p.(None): establishment of a College Campus Task Force to discuss mental and
p.(None): behavioral health concerns on campuses of institutions of higher
p.(None): education.
p.(None): (b) Establishment.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall establish a
p.(None): College Campus Task Force (referred to in this section as the ``Task
p.(None): Force'') to discuss mental and behavioral health concerns on campuses of
p.(None): institutions of higher education.
p.(None): (c) Membership.--The Task Force shall be composed of a
p.(None): representative from each Federal agency (as appointed by the head of the
p.(None): agency) that has jurisdiction over, or is affected by, mental health and
p.(None): education policies and projects, including--
p.(None): (1) the Department of Education;
p.(None): (2) the Department of Health and Human Services;
p.(None): (3) the Department of Veterans Affairs; and
p.(None): (4) such other Federal agencies as the Assistant Secretary
p.(None): for Mental Health and Substance Use, in consultation with the
p.(None): Secretary, determines to be appropriate.
p.(None):
p.(None): (d) Duties.--The Task Force shall--
p.(None): (1) serve as a centralized mechanism to coordinate a
p.(None): national effort to--
p.(None): (A) discuss and evaluate evidence and knowledge on
p.(None): mental and behavioral health services available to, and
p.(None): the prevalence of mental illness among, the age
p.(None): population of students attending institutions of higher
p.(None): education in the United States;
p.(None): (B) determine the range of effective, feasible, and
p.(None): comprehensive actions to improve mental and behavioral
p.(None): health on campuses of institutions of higher education;
p.(None):
p.(None): [[Page 130 STAT. 1260]]
p.(None):
p.(None): (C) examine and better address the needs of the age
p.(None): population of students attending institutions of higher
p.(None): education dealing with mental illness;
p.(None): (D) survey Federal agencies to determine which
p.(None): policies are effective in encouraging, and how best to
p.(None): facilitate outreach without duplicating, efforts
p.(None): relating to mental and behavioral health promotion;
p.(None): (E) establish specific goals within and across
p.(None): Federal agencies for mental health promotion, including
p.(None): determinations of accountability for reaching those
p.(None): goals;
p.(None): (F) develop a strategy for allocating
p.(None): responsibilities and ensuring participation in mental
p.(None): and behavioral health promotion, particularly in the
p.(None): case of competing agency priorities;
p.(None): (G) coordinate plans to communicate research results
p.(None): relating to mental and behavioral health amongst the age
p.(None): population of students attending institutions of higher
p.(None): education to enable reporting and outreach activities to
p.(None): produce more useful and timely information;
p.(None): (H) provide a description of evidence-based
p.(None): practices, model programs, effective guidelines, and
p.(None): other strategies for promoting mental and behavioral
p.(None): health on campuses of institutions of higher education;
p.(None): (I) make recommendations to improve Federal efforts
p.(None): relating to mental and behavioral health promotion on
p.(None): campuses of institutions of higher education and to
p.(None): ensure Federal efforts are consistent with available
p.(None): standards, evidence, and other programs in existence as
p.(None): of the date of enactment of this Act;
p.(None): (J) monitor Federal progress in meeting specific
p.(None): mental and behavioral health promotion goals as they
p.(None): relate to settings of institutions of higher education;
p.(None): and
p.(None): (K) examine and disseminate best practices related
p.(None): to intracampus sharing of treatment records;
p.(None): (2) consult with national organizations with expertise in
p.(None): mental and behavioral health, especially those organizations
p.(None): working with the age population of students attending
p.(None): institutions of higher education; and
p.(None): (3) consult with and seek input from mental health
p.(None): professionals working on campuses of institutions of higher
p.(None): education as appropriate.
p.(None):
p.(None): (e) Meetings.--
p.(None): (1) In general.--The Task Force shall meet not fewer than
p.(None): three times each year.
p.(None): (2) Annual conference.--The Secretary shall sponsor an
p.(None): annual conference on mental and behavioral health in settings of
p.(None): institutions of higher education to enhance coordination, build
p.(None): partnerships, and share best practices in mental and behavioral
p.(None): health promotion, data collection, analysis, and services.
p.(None):
p.(None): (f) Definition.--In this section, the term ``institution of higher
p.(None): education'' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): (g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None):
p.(None): [[Page 130 STAT. 1261]]
p.(None):
p.(None): SEC. 9033. <> IMPROVING MENTAL HEALTH ON
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON
p.(None): COLLEGE CAMPUSES.
p.(None):
...
p.(None): promotion of mental health, prevention of mental disorders, and
p.(None): treatment of such disorders;
p.(None): ``(3) make the connection between mental and behavioral
p.(None): health and academic success; and
p.(None): ``(4) assist the general public in identifying the early
p.(None): warning signs and reducing the stigma of mental illness.
p.(None):
p.(None): ``(c) Composition.--The working group convened under subsection (b)
p.(None): shall include--
p.(None): ``(1) mental health consumers, including students and family
p.(None): members;
p.(None): ``(2) representatives of institutions of higher education;
p.(None): ``(3) representatives of national mental and behavioral
p.(None): health associations and associations of institutions of higher
p.(None): education;
p.(None): ``(4) representatives of health promotion and prevention
p.(None): organizations at institutions of higher education;
p.(None): ``(5) representatives of mental health providers, including
p.(None): community mental health centers; and
p.(None): ``(6) representatives of private-sector and public-sector
p.(None): groups with experience in the development of effective public
p.(None): health education campaigns.
p.(None):
p.(None): ``(d) Plan.--The working group under subsection (b) shall develop a
p.(None): plan that--
p.(None): ``(1) targets promotional and educational efforts to the age
p.(None): population of students at institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
p.(None): ``(3) provides support for local efforts to reduce stigma by
p.(None): using the National Health Information Center as a primary point
p.(None): of contact for information, publications, and service program
p.(None): referrals; and
p.(None):
p.(None): [[Page 130 STAT. 1262]]
p.(None):
p.(None): ``(4) develops and proposes the implementation of a social
p.(None): marketing campaign that is targeted at the population of
p.(None): students attending institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education.
p.(None):
p.(None): ``(e) Definition.--In this section, the term `institution of higher
p.(None): education' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
p.(None): DISTURBANCE.
p.(None):
p.(None): (a) Comprehensive Community Mental Health Services for Children With
p.(None): a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
p.(None): may include efforts to identify and serve children at risk'' before the
p.(None): period.
p.(None): (b) Requirements With Respect to Carrying Out Purpose of Grants.--
p.(None): Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b))
p.(None): is amended by striking ``will not provide an individual with access to
p.(None): the system if the individual is more than 21 years of age'' and
p.(None): inserting ``will provide an individual with access to the system through
p.(None): the age of 21 years''.
p.(None): (c) Additional Provisions.--Section 564(f) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and
p.(None): provide a copy to the State involved)'' after ``to the Secretary''.
p.(None): (d) General Provisions.--Section 565 of the Public Health Service
p.(None): Act (42 U.S.C. 290ff-4) is amended--
p.(None): (1) in subsection (b)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``receiving a grant under section 561(a)'' and
p.(None): inserting ``, regardless of whether such public entity
p.(None): is receiving a grant under section 561(a)''; and
p.(None): (B) in subparagraph (B), by striking ``pursuant to''
p.(None): and inserting ``described in'';
p.(None): (2) in subsection (d)(1), by striking ``not more than 21
p.(None): years of age'' and inserting ``through the age of 21 years'';
p.(None): and
p.(None): (3) in subsection (f)(1), by striking ``$100,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$119,026,000
p.(None): for each of fiscal years 2018 through 2022''.
p.(None): SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.
p.(None):
p.(None): Title III of the Public Health Service Act is amended by inserting
p.(None): after section 330L of such Act (42 U.S.C. 254c-18) the following new
p.(None): section:
p.(None):
p.(None): [[Page 130 STAT. 1263]]
p.(None):
p.(None): ``SEC. 330M <> PEDIATRIC MENTAL HEALTH
p.(None): CARE ACCESS GRANTS.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Administrator
p.(None): of the Health Resources and Services Administration and in coordination
p.(None): with other relevant Federal agencies, shall award grants to States,
p.(None): political subdivisions of States, and Indian tribes and tribal
p.(None): organizations (for purposes of this section, as such terms are defined
p.(None): in section 4 of the Indian Self-Determination and Education Assistance
p.(None): Act (25 U.S.C. 450b)) to promote behavioral health integration in
p.(None): pediatric primary care by--
p.(None): ``(1) supporting the development of statewide or regional
p.(None): pediatric mental health care telehealth access programs; and
p.(None): ``(2) supporting the improvement of existing statewide or
...
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
p.(None): ``(B) multigenerational therapy and other services
p.(None): that support the caregiving relationship; and
p.(None): ``(2) ensure that programs funded through grants under this
p.(None): section are evidence-informed or evidence-based models,
p.(None): practices, and methods that are, as appropriate, culturally and
p.(None):
p.(None): [[Page 130 STAT. 1268]]
p.(None):
p.(None): linguistically appropriate, and can be replicated in other
p.(None): appropriate settings.
p.(None):
p.(None): ``(b) Eligible Children and Entities.--In this section:
p.(None): ``(1) Eligible child.--The term `eligible child' means a
p.(None): child from birth to not more than 12 years of age who--
p.(None): ``(A) is at risk for, shows early signs of, or has
p.(None): been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance; and
p.(None): ``(B) may benefit from infant and early childhood
p.(None): intervention or treatment programs or specialized
p.(None): preschool or elementary school programs that are
p.(None): evidence-based or that have been scientifically
p.(None): demonstrated to show promise but would benefit from
p.(None): further applied development.
p.(None): ``(2) Eligible entity.--The term `eligible entity' means a
p.(None): human services agency or nonprofit institution that--
p.(None): ``(A) employs licensed mental health professionals
p.(None): who have specialized training and experience in infant
p.(None): and early childhood mental health assessment, diagnosis,
p.(None): and treatment, or is accredited or approved by the
p.(None): appropriate State agency, as applicable, to provide for
p.(None): children from infancy to 12 years of age mental health
p.(None): promotion, intervention, or treatment services; and
p.(None): ``(B) provides services or programs described in
p.(None): subsection (a) that are evidence-based or that have been
p.(None): scientifically demonstrated to show promise but would
p.(None): benefit from further applied development.
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
p.(None): functional impairment and substantially interferes with or
p.(None): limits one or more major life activities.
p.(None): (3) In reporting on the incidence of serious mental illness,
p.(None): the Substance Abuse and Mental Health Services Administration
p.(None): includes major depression, schizophrenia, bipolar disorder, and
p.(None): other mental disorders that cause serious impairment.
p.(None): (4) Adults with a serious mental illness are at a higher
p.(None): risk for chronic physical illnesses and premature death.
p.(None): (5) According to the World Health Organization, adults with
p.(None): a serious mental illness have lifespans that are 10 to 25 years
p.(None): shorter than those without serious mental illness. The vast
p.(None): majority of these deaths are due to chronic physical medical
p.(None): conditions, such as cardiovascular, respiratory, and infectious
p.(None): diseases, as well as diabetes and hypertension.
p.(None): (6) According to the World Health Organization, the majority
p.(None): of deaths of adults with a serious mental illness that are due
p.(None): to physical medical conditions are preventable.
p.(None): (7) Supported decision making can facilitate care decisions
...
p.(None): RELATED TO MEDICAID COVERAGE OF MENTAL
p.(None): HEALTH SERVICES AND PRIMARY CARE
p.(None): SERVICES FURNISHED ON THE SAME DAY.
p.(None):
p.(None): Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.) shall be construed as prohibiting separate payment under the State
p.(None): plan under such title (or under a waiver of the plan) for the provision
p.(None): of a mental health service or primary care service under such plan, with
p.(None): respect to an individual, because such service is--
p.(None): (1) a primary care service furnished to the individual by a
p.(None): provider at a facility on the same day a mental health service
p.(None): is furnished to such individual by such provider (or another
p.(None): provider) at the facility; or
p.(None): (2) a mental health service furnished to the individual by a
p.(None): provider at a facility on the same day a primary care service is
p.(None): furnished to such individual by such provider (or another
p.(None): provider) at the facility.
p.(None): SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE
p.(None): REGULATION.
p.(None):
p.(None): (a) Study.--The Secretary of Health and Human Services, acting
p.(None): through the Administrator of the Centers for Medicare &
p.(None):
p.(None): [[Page 130 STAT. 1273]]
p.(None):
p.(None): Medicaid Services, shall conduct a study on coverage under the Medicaid
p.(None): program under title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.) of services provided through a medicaid managed care organization
p.(None): (as defined in section 1903(m) of such Act (42 U.S.C. 1396b(m)) or a
p.(None): prepaid inpatient health plan (as defined in section 438.2 of title 42,
p.(None): Code of Federal Regulations (or any successor regulation)) with respect
p.(None): to individuals over the age of 21 and under the age of 65 for the
p.(None): treatment of a mental health disorder in institutions for mental
p.(None): diseases (as defined in section 1905(i) of such Act (42 U.S.C.
p.(None): 1396d(i))). Such study shall include information on the following:
p.(None): (1) The extent to which States, including the District of
p.(None): Columbia and each territory or possession of the United States,
p.(None): are providing capitated payments to such organizations or plans
p.(None): for enrollees who are receiving services in institutions for
p.(None): mental diseases.
p.(None): (2) The number of individuals receiving medical assistance
p.(None): under a State plan under such title XIX, or a waiver of such
p.(None): plan, who receive services in institutions for mental diseases
p.(None): through such organizations and plans.
p.(None): (3) The range of and average number of months, and the
p.(None): length of stay during such months, that such individuals are
p.(None): receiving such services in such institutions.
p.(None): (4) How such organizations or plans determine when to
p.(None): provide for the furnishing of such services through an
p.(None): institution for mental diseases in lieu of other benefits
p.(None): (including the full range of community-based services) under
p.(None): their contract with the State agency administering the State
p.(None): plan under such title XIX, or a waiver of such plan, to address
p.(None): psychiatric or substance use disorder treatment.
p.(None): (5) The extent to which the provision of services within
p.(None): such institutions has affected the capitated payments for such
p.(None): organizations or plans.
p.(None):
p.(None): (b) Report.--Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary shall submit to Congress a report on the
p.(None): study conducted under subsection (a).
...
p.(None): arrangement which--
p.(None): ``(i) is described in subparagraph (B), and
p.(None): ``(ii) is provided on the same terms to all
p.(None): eligible employees of the eligible employer.
p.(None): ``(B) Arrangement described.--An arrangement is
p.(None): described in this subparagraph if--
p.(None): ``(i) such arrangement is funded solely by an
p.(None): eligible employer and no salary reduction
p.(None): contributions may be made under such arrangement,
p.(None): ``(ii) such arrangement provides, after the
p.(None): employee provides proof of coverage, for the
p.(None): payment of, or reimbursement of, an eligible
p.(None): employee for expenses for medical care (as defined
p.(None): in section 213(d)) incurred by the eligible
p.(None): employee or the eligible employee's family members
p.(None): (as determined under the terms of the
p.(None): arrangement), and
p.(None): ``(iii) the amount of payments and
p.(None): reimbursements described in clause (ii) for any
p.(None): year do not exceed $4,950 ($10,000 in the case of
p.(None): an arrangement that also provides for payments or
p.(None): reimbursements for family members of the
p.(None): employee).
p.(None): ``(C) Certain variation permitted.--For purposes of
p.(None): subparagraph (A)(ii), an arrangement shall not fail to
p.(None): be treated as provided on the same terms to each
p.(None): eligible employee merely because the employee's
p.(None): permitted benefit under such arrangement varies in
p.(None): accordance with the variation in the price of an
p.(None): insurance policy in the relevant individual health
p.(None): insurance market based on--
p.(None): ``(i) the age of the eligible employee (and,
p.(None): in the case of an arrangement which covers medical
p.(None): expenses of the eligible employee's family
p.(None): members, the age of such family members), or
p.(None): ``(ii) the number of family members of the
p.(None): eligible employee the medical expenses of which
p.(None): are covered under such arrangement.
p.(None): The variation permitted under the preceding sentence
p.(None): shall be determined by reference to the same insurance
p.(None): policy with respect to all eligible employees.
p.(None): ``(D) Rules relating to maximum dollar limitation.--
p.(None):
p.(None): [[Page 130 STAT. 1340]]
p.(None):
p.(None): ``(i) Amount prorated in certain cases.--In
p.(None): the case of an individual who is not covered by an
p.(None): arrangement for the entire year, the limitation
p.(None): under subparagraph (B)(iii) for such year shall be
p.(None): an amount which bears the same ratio to the amount
p.(None): which would (but for this clause) be in effect for
p.(None): such individual for such year under subparagraph
p.(None): (B)(iii) as the number of months for which such
p.(None): individual is covered by the arrangement for such
p.(None): year bears to 12.
p.(None): ``(ii) Inflation adjustment.--In the case of
p.(None): any year beginning after 2016, each of the dollar
p.(None): amounts in subparagraph (B)(iii) shall be
p.(None): increased by an amount equal to--
p.(None): ``(I) such dollar amount, multiplied
p.(None): by
p.(None): ``(II) the cost-of-living adjustment
p.(None): determined under section 1(f)(3) for the
p.(None): calendar year in which the taxable year
p.(None): begins, determined by substituting
p.(None): `calendar year 2015' for `calendar year
p.(None): 1992' in subparagraph (B) thereof.
p.(None): If any dollar amount increased under the preceding
p.(None): sentence is not a multiple of $50, such dollar
...
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p.(None): are from disadvantaged backgrounds; and
p.(None): ``(B) may focus on an area of emerging scientific or
p.(None): workforce need.
p.(None): ``(2) Elimination or establishment of subcategories.--The
p.(None): Director of the National Institutes of Health may eliminate one
p.(None): or more subcategories provided for in paragraph (1) due to
p.(None): changes in workforce or scientific needs related to biomedical
p.(None): research. The Director may establish other subcategory areas
p.(None): based on workforce and scientific priorities if the total number
p.(None): of subcategories does not exceed the number of subcategories
p.(None): listed in paragraph (1).
p.(None):
p.(None): ``(c) Limitation.--The Director of the National Institutes of Health
p.(None): may not enter into a contract with a health professional pursuant to
p.(None): subsection (a) unless such professional has a substantial amount of
p.(None): education loans relative to income (as determined pursuant to guidelines
p.(None): issued by the Director).''; and
p.(None): (5) by adding at the end the following:
p.(None):
p.(None): ``(e) Availability of Appropriations.--Amounts available for
p.(None): carrying out this section shall remain available until the expiration of
p.(None): the second fiscal year beginning after the fiscal year for which such
p.(None): amounts are made available.''.
p.(None): (b) Extramural Loan Repayment Program.--Section 487B of the Public
p.(None): Health Service Act (42 U.S.C. 288-2) is amended--
p.(None): (1) by amending the section heading to read as follows:
p.(None): ``extramural loan repayment program'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``The Secretary, in consultation
p.(None): with the Director of the Eunice Kennedy Shriver National
p.(None): Institute of Child Health and Human Development, shall
p.(None): establish a program'' and inserting ``In General.--The
p.(None): Director of the National Institutes of Health shall, as
p.(None): appropriate and based on workforce and scientific
p.(None): priorities, carry out a program through the
p.(None): subcategories listed in subsection (b)(1) (or modified
p.(None): subcategories as provided for in subsection (b)(2)),'';
p.(None): (B) by striking ``(including graduate students)'';
p.(None): (C) by striking ``with respect to contraception, or
p.(None): with respect to infertility,''; and
p.(None): (D) by striking ``service, not more than $35,000''
p.(None): and inserting ``research, not more than $50,000'';
p.(None): (3) by redesignating subsections (b) and (c) as subsections
p.(None): (d) and (e), respectively;
p.(None): (4) by inserting after subsection (a), the following:
p.(None):
p.(None): ``(b) Subcategories of Research.--
p.(None): ``(1) In general.--In carrying out the program under
p.(None): subsection (a), the Director of the National Institutes of
p.(None): Health--
p.(None): ``(A) shall continue to focus on--
p.(None): ``(i) contraception or infertility research;
p.(None): ``(ii) pediatric research, including pediatric
p.(None): pharmacological research;
p.(None): ``(iii) minority health disparities research;
p.(None): ``(iv) clinical research; and
p.(None):
p.(None): [[Page 130 STAT. 1054]]
p.(None):
p.(None): ``(v) clinical research conducted by
p.(None): appropriately qualified health professional who
p.(None): are from disadvantaged backgrounds; and
p.(None): ``(B) may focus on an area of emerging scientific or
p.(None): workforce need.
p.(None): ``(2) Elimination or establishment of subcategories.--The
p.(None): Director of the National Institutes of Health may eliminate one
...
p.(None): Women.--
p.(None): (1) Establishment.--Not later than 90 days after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services (referred to in this section as the ``Secretary'')
p.(None): shall establish a task force, in accordance with the Federal
p.(None): Advisory Committee Act (5 U.S.C. App.), to be known as the
p.(None): ``Task
p.(None):
p.(None): [[Page 130 STAT. 1071]]
p.(None):
p.(None): Force on Research Specific to Pregnant Women and Lactating
p.(None): Women'' (in this section referred to as the ``Task Force'').
p.(None): (2) Duties.--The Task Force shall provide advice and
p.(None): guidance to the Secretary regarding Federal activities related
p.(None): to identifying and addressing gaps in knowledge and research
p.(None): regarding safe and effective therapies for pregnant women and
p.(None): lactating women, including the development of such therapies and
p.(None): the collaboration on and coordination of such activities.
p.(None): (3) Membership.--
p.(None): (A) Federal members.--The Task Force shall be
p.(None): composed of each of the following Federal members, or
p.(None): the designees of such members:
p.(None): (i) The Director of the Centers for Disease
p.(None): Control and Prevention.
p.(None): (ii) The Director of the National Institutes
p.(None): of Health, the Director of the Eunice Kennedy
p.(None): Shriver National Institute of Child Health and
p.(None): Human Development, and the directors of such other
p.(None): appropriate national research institutes.
p.(None): (iii) The Commissioner of Food and Drugs.
p.(None): (iv) The Director of the Office on Women's
p.(None): Health.
p.(None): (v) The Director of the National Vaccine
p.(None): Program Office.
p.(None): (vi) The head of any other research-related
p.(None): agency or department not described in clauses (i)
p.(None): through (v) that the Secretary determines
p.(None): appropriate, which may include the Department of
p.(None): Veterans Affairs and the Department of Defense.
p.(None): (B) Non-federal members.--The Task Force shall be
p.(None): composed of each of the following non-Federal members,
p.(None): including--
p.(None): (i) representatives from relevant medical
p.(None): societies with subject matter expertise on
p.(None): pregnant women, lactating women, or children;
p.(None): (ii) nonprofit organizations with expertise
p.(None): related to the health of women and children;
p.(None): (iii) relevant industry representatives; and
p.(None): (iv) other representatives, as appropriate.
p.(None): (C) Limitations.--The non-Federal members described
p.(None): in subparagraph (B) shall--
p.(None): (i) compose not more than one-half, and not
p.(None): less than one-third, of the total membership of
p.(None): the Task Force; and
p.(None): (ii) be appointed by the Secretary.
...
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
p.(None): or part 164, as appropriate, of title 45, Code of Federal
p.(None): Regulations (or any successor regulation).
p.(None): (2) Part 164.--References to a specified section of ``part
p.(None): 164'', refer to such specified section of part 164 of title 45,
p.(None): Code of Federal Regulations (or any successor section).
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
p.(None):
p.(None): Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d))
p.(None): is amended--
p.(None): (1) in paragraph (1), by striking ``in consultation with the
p.(None): Director of the Eunice Kennedy Shriver National Institute of
p.(None): Child Health and Human Development and in collaboration with
p.(None): other appropriate national research institutes and national
p.(None): centers that carry out activities involving pediatric research,
p.(None): may provide for the establishment of'' and inserting ``in
p.(None): collaboration with the national research institutes and national
p.(None): centers that carry out activities involving pediatric research,
p.(None): shall support''; and
p.(None): (2) in paragraph (2)(A) and the first sentence of paragraph
p.(None): (2)(E), by striking ``may'' each place such term appears and
p.(None): inserting ``shall''.
p.(None): SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
p.(None):
p.(None): It is the sense of Congress that--
p.(None): (1) the National Institutes of Health should encourage a
p.(None): global pediatric clinical study network by providing grants,
p.(None): contracts, or cooperative agreements to support new and early
p.(None): stage investigators who participate in the global pediatric
p.(None): clinical study network;
p.(None): (2) the Secretary of Health and Human Services (referred to
p.(None): in this section as the ``Secretary'') should engage with
p.(None): clinical investigators and appropriate authorities outside of
p.(None): the United States, including authorities in the European Union,
p.(None): during the formation of the global pediatric clinical study
p.(None): network to encourage the participation of such investigator and
p.(None): authorities; and
p.(None): (3) once a global pediatric clinical study network is
p.(None): established and becomes operational, the Secretary should
p.(None): continue to encourage and facilitate the participation of
p.(None): clinical investigators and appropriate authorities outside of
...
p.(None): Department of Veterans Affairs;
p.(None): (B) academic researchers;
p.(None): (C) developers and manufacturers of vaccines;
p.(None): (D) medical and public health practitioners;
p.(None): (E) representatives of patient, policy, and advocacy
p.(None): organizations; and
p.(None):
p.(None): [[Page 130 STAT. 1152]]
p.(None):
p.(None): (F) representatives of other entities, as the
p.(None): Secretary determines appropriate.
p.(None):
p.(None): (c) Updates Related to Maternal Immunization.--
p.(None): (1) Additional vaccines.--Section 2114(e) of the Public
p.(None): Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding
p.(None): at the end the following:
p.(None): ``(3) Vaccines recommended for use in pregnant women.--The
p.(None): Secretary shall revise the Vaccine Injury Table included in
p.(None): subsection (a), through the process described in subsection (c),
p.(None): to include vaccines recommended by the Centers for Disease
p.(None): Control and Prevention for routine administration in pregnant
p.(None): women and the information described in subparagraphs (B) and (C)
p.(None): of paragraph (2) with respect to such vaccines.''.
p.(None): (2) Petition content.--Section 2111 of the Public Health
p.(None): Service Act (42 U.S.C. 300aa-11) is amended by adding at the end
p.(None): the following:
p.(None):
p.(None): ``(f) Maternal Immunization.--
p.(None): ``(1) In general.--Notwithstanding any other provision of
p.(None): law, for purposes of this subtitle, both a woman who received a
p.(None): covered vaccine while pregnant and any child who was in utero at
p.(None): the time such woman received the vaccine shall be considered
p.(None): persons to whom the covered vaccine was administered and persons
p.(None): who received the covered vaccine.
p.(None): ``(2) Definition.--As used in this subsection, the term
p.(None): `child' shall have the meaning given that term by subsections
p.(None): (a) and (b) of section 8 of title 1, United States Code, except
p.(None): that, for purposes of this subsection, such section 8 shall be
p.(None): applied as if the term `include' in subsection (a) of such
p.(None): section were replaced with the term `mean'.''.
p.(None): (3) Petitioners.--Section 2111(b)(2) of the Public Health
p.(None): Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A
p.(None): covered vaccine administered to a pregnant woman shall
p.(None): constitute more than one administration, one to the mother and
p.(None): one to each child (as such term is defined in subsection (f)(2))
p.(None): who was in utero at the time such woman was administered the
p.(None): vaccine.'' at the end.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): SEC. 3101. TECHNICAL CORRECTIONS.
p.(None):
p.(None): (a) FFDCA.--
p.(None): (1) References.--Except as otherwise expressly provided,
p.(None): whenever in this subsection an amendment is expressed in terms
p.(None): of an amendment to a section or other provision, the reference
p.(None): shall be considered to be made to that section or other
p.(None): provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 301 et seq.).
p.(None): (2) Amendments.--
p.(None): (A) Prohibited acts.--Section 301(r) (21 U.S.C.
p.(None): 331(r)) is amended by inserting ``, drug,'' after
p.(None): ``device'' each place the term appears.
p.(None): (B) New drugs.--Section 505 (21 U.S.C. 355) is
p.(None): amended--
p.(None):
p.(None): [[Page 130 STAT. 1153]]
p.(None):
p.(None): (i) in subsection (d), in the last sentence,
p.(None): by striking ``premarket approval'' and inserting
p.(None): ``marketing approval''; and
p.(None): (ii) in subsection (q)(5)(A), by striking
p.(None): ``subsection (b)(2) or (j) of the Act or 351(k)''
p.(None): and inserting ``subsection (b)(2) or (j) of this
p.(None): section or section 351(k)''.
p.(None): (C) Risk evaluation and mitigation strategies.--
p.(None): Section 505-1(h)(21 U.S.C. 355-1(h)) is amended--
p.(None): (i) in paragraph (2)(A)(iii)--
p.(None): (I) in the clause heading, by
p.(None): striking ``label'' and inserting
p.(None): ``labeling'';
p.(None): (II) by striking ``label'' each
p.(None): place the term appears and inserting
p.(None): ``labeling''; and
...
p.(None): Act (42 U.S.C. 1397gg(e)(1)) is amended--
p.(None): (A) by redesignating subparagraphs (B), (C), (D),
p.(None): (E), (F), (G), (H), (I), (J), (K), (L), (M), (N), and
p.(None): (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J),
p.(None): (K), (M), (N), (O), (P), (Q), and (R), respectively;
p.(None): (B) by inserting after subparagraph (A) the
p.(None): following new subparagraphs:
p.(None): ``(B) Section 1902(a)(39) (relating to termination
p.(None): of participation of certain providers).
p.(None): ``(C) Section 1902(a)(78) (relating to enrollment of
p.(None): providers participating in State plans providing medical
p.(None): assistance on a fee-for-service basis).'';
p.(None): (C) by inserting after subparagraph (K) (as
p.(None): redesignated by subparagraph (A)) the following new
p.(None): subparagraph:
p.(None): ``(L) Section 1903(m)(3) (relating to limitation on
p.(None): payment with respect to managed care).''; and
p.(None): (D) in subparagraph (P) (as redesignated by
p.(None): subparagraph (A)), by striking ``(a)(2)(C) and (h)'' and
p.(None): inserting ``(a)(2)(C) (relating to Indian enrollment),
p.(None): (d)(5) (relating to contract requirement for managed
p.(None): care entities), (d)(6) (relating to enrollment of
p.(None): providers participating with a managed care entity), and
p.(None): (h) (relating to special rules with respect to Indian
p.(None): enrollees, Indian health care providers, and Indian
p.(None): managed care entities)''.
p.(None): (2) Excluding from medicaid providers excluded from chip.--
p.(None): Section 1902(a)(39) of the Social Security Act (42 U.S.C.
p.(None): 1396a(a)(39)) is amended by striking ``title XVIII or any other
p.(None): State plan under this title'' and inserting ``title XVIII, any
p.(None): other State plan under this title (or waiver of the plan), or
p.(None): any State child health plan under title XXI (or waiver of the
p.(None): plan) and such termination is included by the Secretary in any
p.(None): database or similar system developed pursuant to section
p.(None): 6401(b)(2) of the Patient Protection and Affordable Care Act''.
p.(None):
p.(None): (d) <> Rule of Construction.--Nothing in
p.(None): this section shall be construed as changing or limiting the appeal
p.(None): rights of providers or the process for appeals of States under the
p.(None): Social Security Act.
p.(None):
p.(None): (e) OIG Report.--Not later than March 31, 2020, the Inspector
p.(None): General of the Department of Health and Human Services shall submit to
p.(None): Congress a report on the implementation of the amendments made by this
p.(None): section. Such report shall include the following:
p.(None): (1) An assessment of the extent to which providers who are
p.(None): included under subsection (ll) of section 1902 of the Social
p.(None): Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3))
p.(None):
p.(None): [[Page 130 STAT. 1195]]
p.(None):
p.(None): in the database or similar system referred to in such subsection
p.(None): are terminated (as described in paragraph (8) of subsection (kk)
p.(None): of such section, as added by subsection (a)(1)) from
p.(None): participation in all State plans under title XIX of such Act (or
p.(None): waivers of such plans).
p.(None): (2) Information on the amount of Federal financial
p.(None): participation paid to States under section 1903 of such Act in
p.(None): violation of the limitation on such payment specified in
p.(None): subparagraph (D) of subsection (i)(2) of such section and
p.(None): paragraph (3) of subsection (m) of such section, as added by
p.(None): subsection (a)(4).
p.(None): (3) An assessment of the extent to which contracts with
...
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
p.(None): collaboration with States, local governments,
p.(None): communities, and Indian tribes and tribal organizations
p.(None): (as such terms are defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act); and
p.(None): ``(F) specify a strategy to disseminate evidence-
p.(None): based and promising best practices related to
p.(None): prevention, diagnosis, early intervention, treatment,
p.(None): and recovery services related to mental illness,
p.(None): particularly for adults with a serious mental illness
...
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
p.(None): (H) the Secretary of Labor;
p.(None): (I) the Administrator of the Centers for Medicare &
p.(None): Medicaid Services; and
p.(None): (J) the Commissioner of Social Security.
p.(None):
p.(None): [[Page 130 STAT. 1219]]
p.(None):
p.(None): (2) Non-federal members.--The Committee shall also include
p.(None): not less than 14 non-Federal public members appointed by the
p.(None): Secretary of Health and Human Services, of which--
p.(None): (A) at least 2 members shall be an individual who
p.(None): has received treatment for a diagnosis of a serious
p.(None): mental illness;
p.(None): (B) at least 1 member shall be a parent or legal
p.(None): guardian of an adult with a history of a serious mental
p.(None): illness or a child with a history of a serious emotional
p.(None): disturbance;
p.(None): (C) at least 1 member shall be a representative of a
p.(None): leading research, advocacy, or service organization for
p.(None): adults with a serious mental illness;
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
p.(None): experience treating serious mental illnesses or
p.(None): serious emotional disturbances; or
p.(None): (iv) a licensed psychiatric nurse, nurse
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
...
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
p.(None): based system of care for individuals with mental
p.(None): illness, and describe available services and
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
p.(None): ``(iv) include a description of how the State
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
p.(None): providers; and
p.(None): ``(vii) as appropriate to, and reflective of,
...
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
p.(None): (8) in subparagraph (D) (as so redesignated), by striking
p.(None): ``plan describes'' and inserting ``plan shall describe'';
p.(None): (9) in subparagraph (E) (as so redesignated)--
p.(None): (A) in the subparagraph heading by striking
p.(None): ``systems'' and inserting ``services'';
p.(None): (B) in the first sentence, by striking ``plan
p.(None): describes'' and all that follows through ``and provides
p.(None): for'' and inserting ``plan shall describe the financial
p.(None): resources available, the existing mental health
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
p.(None): inserting ``shall further describe''; and
p.(None): (ii) by striking ``involved.'' and inserting
p.(None): ``involved, and the manner in which the State
p.(None): intends to comply with each of the funding
p.(None): agreements in this subpart and subpart III.'';
p.(None): (10) by striking the flush matter at the end; and
p.(None): (11) by adding at the end the following:
p.(None): ``(2) Goals and objectives.--The establishment of goals and
...
p.(None): et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
p.(None): second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
p.(None): amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
p.(None): 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
p.(None): 25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
p.(None): GRANTS.
p.(None):
p.(None): Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``of higher education''; and
p.(None): (B) by striking paragraphs (1) through (4) and
p.(None): inserting the following:
p.(None): ``(1) accredited institutions of higher education or
p.(None): accredited professional training programs that are establishing
p.(None): or expanding internships or other field placement programs in
p.(None): mental health in psychiatry, psychology, school psychology,
p.(None): behavioral pediatrics, psychiatric nursing (which may include
p.(None): master's and doctoral level programs), social work, school
p.(None): social work, substance use disorder prevention and treatment,
p.(None): marriage and family therapy, occupational therapy, school
p.(None): counseling, or professional counseling, including such programs
p.(None): with a focus on child and adolescent mental health and
p.(None): transitional-age youth;
p.(None): ``(2) accredited doctoral, internship, and post-doctoral
p.(None): residency programs of health service psychology (including
p.(None): clinical psychology, counseling, and school psychology) for the
p.(None): development and implementation of interdisciplinary training of
p.(None): psychology graduate students for providing behavioral health
p.(None): services, including substance use disorder prevention and
p.(None): treatment services, as well as the development of faculty in
p.(None): health service psychology;
p.(None): ``(3) accredited master's and doctoral degree programs of
p.(None): social work for the development and implementation of
p.(None): interdisciplinary training of social work graduate students for
p.(None): providing behavioral health services, including substance use
p.(None): disorder prevention and treatment services, and the development
p.(None): of faculty in social work; and
p.(None): ``(4) State-licensed mental health nonprofit and for-profit
p.(None): organizations to enable such organizations to pay for programs
p.(None): for preservice or in-service training in a behavioral health-
p.(None): related paraprofessional field with preference for preservice or
p.(None): in-service training of paraprofessional child and adolescent
p.(None): mental health workers.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (5);
p.(None): [[Page 130 STAT. 1249]]
p.(None):
p.(None): (B) by redesignating paragraphs (1) through (4) as
p.(None): paragraphs (2) through (5), respectively;
p.(None): (C) by inserting before paragraph (2), as so
p.(None): redesignated, the following:
p.(None): ``(1) an ability to recruit and place the students described
p.(None): in subsection (a) in areas with a high need and high demand
p.(None): population;'';
p.(None): (D) in paragraph (3), as so redesignated, by
p.(None): striking ``subsection (a)'' and inserting ``paragraph
p.(None): (2), especially individuals with mental disorder
p.(None): symptoms or diagnoses, particularly children and
p.(None): adolescents, and transitional-age youth'';
p.(None): (E) in paragraph (4), as so redesignated, by
p.(None): striking ``;'' and inserting ``; and''; and
p.(None): (F) in paragraph (5), as so redesignated, by
p.(None): striking ``; and'' and inserting a period;
p.(None): (3) in subsection (c), by striking ``authorized under
p.(None): subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
p.(None): and (3) of subsection (a)'';
p.(None): (4) by amending subsection (d) to read as follows:
p.(None):
p.(None): ``(d) Priority.--In selecting grant recipients under this section,
p.(None): the Secretary shall give priority to--
p.(None): ``(1) programs that have demonstrated the ability to train
p.(None): psychology, psychiatry, and social work professionals to work in
p.(None): integrated care settings for purposes of recipients under
p.(None): paragraphs (1), (2), and (3) of subsection (a); and
...
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
p.(None): ``(B) an analysis of the effect of the demonstration
p.(None): program on the prevalence of untreated mental and
p.(None): substance use disorders in the surrounding communities
p.(None): of health centers participating in the demonstration;
p.(None): and
p.(None): ``(C) recommendations on whether the demonstration
p.(None): program should be expanded.
p.(None):
p.(None): ``(g) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $10,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9023. <> CLARIFICATION ON CURRENT
p.(None): ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
p.(None):
p.(None): The Administrator of the Health Resources and Services
p.(None): Administration shall clarify the eligibility pursuant to section
p.(None): 338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
p.(None): 1(b)(1)(B)) of child and adolescent psychiatrists for the National
p.(None): Health Service Corps Loan Repayment Program under subpart III of part D
p.(None): of title III of such Act (42 U.S.C. 254l et seq.).
p.(None): SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by adding at the end the following:
p.(None):
p.(None): ``PART K--MINORITY FELLOWSHIP PROGRAM
p.(None):
p.(None): ``SEC. 597. <> FELLOWSHIPS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall maintain a program, to be
p.(None): known as the Minority Fellowship Program, under which the Secretary
p.(None): shall award fellowships, which may include stipends, for the purposes
p.(None): of--
p.(None):
p.(None): [[Page 130 STAT. 1254]]
p.(None): ``(1) increasing the knowledge of mental and substance use
p.(None): disorders practitioners on issues related to prevention,
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
...
p.(None): ``(1) In general.--A pediatric mental health care telehealth
p.(None): access program referred to in subsection (a), with respect to
p.(None): which a grant under such subsection may be used, shall--
p.(None): ``(A) be a statewide or regional network of
p.(None): pediatric mental health teams that provide support to
p.(None): pediatric primary care sites as an integrated team;
p.(None): ``(B) support and further develop organized State or
p.(None): regional networks of pediatric mental health teams to
p.(None): provide consultative support to pediatric primary care
p.(None): sites;
p.(None): ``(C) conduct an assessment of critical behavioral
p.(None): consultation needs among pediatric providers and such
p.(None): providers' preferred mechanisms for receiving
p.(None): consultation, training, and technical assistance;
p.(None): ``(D) develop an online database and communication
p.(None): mechanisms, including telehealth, to facilitate
p.(None): consultation support to pediatric practices;
p.(None): ``(E) provide rapid statewide or regional clinical
p.(None): telephone or telehealth consultations when requested
p.(None): between the pediatric mental health teams and pediatric
p.(None): primary care providers;
p.(None): ``(F) conduct training and provide technical
p.(None): assistance to pediatric primary care providers to
p.(None): support the early identification, diagnosis, treatment,
p.(None): and referral of children with behavioral health
p.(None): conditions;
p.(None): ``(G) provide information to pediatric providers
p.(None): about, and assist pediatric providers in accessing,
p.(None): pediatric mental health care providers, including child
p.(None): and adolescent psychiatrists, and licensed mental health
p.(None): professionals, such as psychologists, social workers, or
p.(None): mental health counselors and in scheduling and
p.(None): conducting technical assistance;
p.(None): ``(H) assist with referrals to specialty care and
p.(None): community or behavioral health resources; and
p.(None): ``(I) establish mechanisms for measuring and
p.(None): monitoring increased access to pediatric mental health
p.(None): care services by pediatric primary care providers and
p.(None): expanded capacity of pediatric primary care providers to
p.(None): identify, treat, and refer children with mental health
p.(None): problems.
p.(None): ``(2) Pediatric mental health teams.--In this subsection,
p.(None): the term `pediatric mental health team' means a team consisting
p.(None): of at least one case coordinator, at least one child and
p.(None): adolescent psychiatrist, and at least one licensed clinical
p.(None):
p.(None): [[Page 130 STAT. 1264]]
p.(None):
p.(None): mental health professional, such as a psychologist, social
p.(None): worker, or mental health counselor. Such a team may be
p.(None): regionally based.
p.(None):
p.(None): ``(c) Application.--A State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization seeking a grant under this section
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may require,
p.(None): including a plan for the comprehensive evaluation of activities that are
p.(None): carried out with funds received under such grant.
p.(None): ``(d) Evaluation.--A State, political subdivision of a State, Indian
p.(None): tribe, or tribal organization that receives a grant under this section
p.(None): shall prepare and submit an evaluation of activities that are carried
p.(None): out with funds received under such grant to the Secretary at such time,
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
...
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
p.(None): of the long-term consequences of child trauma, and early
p.(None): intervention services and treatment to address the long-term
p.(None): consequences of child trauma; and
p.(None): ``(2) the development of knowledge with regard to evidence-
p.(None): based practices for identifying and treating mental, behavioral,
p.(None): and biological disorders of children and youth resulting from
p.(None): witnessing or experiencing a traumatic event.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking ``subsection (a) related'' and
p.(None): inserting ``subsection (a)(2) (related'';
p.(None): (B) by striking ``treating disorders associated with
p.(None): psychological trauma'' and inserting ``treating mental,
p.(None): behavioral, and biological disorders associated with
p.(None): psychological trauma)''; and
p.(None): (C) by striking ``mental health agencies and
p.(None): programs that have established clinical and basic
p.(None): research'' and inserting ``universities, hospitals,
p.(None): mental health agencies,
p.(None):
p.(None): [[Page 130 STAT. 1266]]
p.(None):
p.(None): and other programs that have established clinical
p.(None): expertise and research'';
p.(None): (3) by redesignating subsections (c) through (g) as
p.(None): subsections (g) through (k), respectively;
p.(None): (4) by inserting after subsection (b), the following:
p.(None):
p.(None): ``(c) Child Outcome Data.--The NCTSI coordinating center described
p.(None): in subsection (a)(1) shall collect, analyze, report, and make publicly
p.(None): available, as appropriate, NCTSI-wide child treatment process and
p.(None): outcome data regarding the early identification and delivery of
p.(None): evidence-based treatment and services for children and families served
p.(None): by the NCTSI grantees.
p.(None): ``(d) Training.--The NCTSI coordinating center shall facilitate the
p.(None): coordination of training initiatives in evidence-based and trauma-
p.(None): informed treatments, interventions, and practices offered to NCTSI
p.(None): grantees, providers, and partners.
p.(None): ``(e) Dissemination and Collaboration.--The NCTSI coordinating
p.(None): center shall, as appropriate, collaborate with--
p.(None): ``(1) the Secretary, in the dissemination of evidence-based
p.(None): and trauma-informed interventions, treatments, products, and
p.(None): other resources to appropriate stakeholders; and
p.(None): ``(2) appropriate agencies that conduct or fund research
p.(None): within the Department of Health and Human Services, for purposes
p.(None): of sharing NCTSI expertise, evaluation data, and other
p.(None): activities, as appropriate.
p.(None):
p.(None): ``(f) Review.--The Secretary shall, consistent with the peer-review
p.(None): process, ensure that NCTSI applications are reviewed by appropriate
p.(None): experts in the field as part of a consensus-review process. The
p.(None): Secretary shall include review criteria related to expertise and
p.(None): experience in child trauma and evidence-based practices.'';
p.(None): (5) in subsection (g) (as so redesignated), by striking
p.(None): ``with respect to centers of excellence are distributed
p.(None): equitably among the regions of the country'' and inserting ``are
p.(None): distributed equitably among the regions of the United States'';
p.(None): (6) in subsection (i) (as so redesignated), by striking
p.(None): ``recipient may not exceed 5 years'' and inserting ``recipient
p.(None): shall not be less than 4 years, but shall not exceed 5 years'';
p.(None): and
p.(None): (7) in subsection (j) (as so redesignated), by striking
p.(None): ``$50,000,000'' and all that follows through ``2006'' and
p.(None): inserting ``$46,887,000 for each of fiscal years 2018 through
p.(None): 2022''.
p.(None): SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.(None): Part B of title III of the Public Health Service Act (42 U.S.C. 243
p.(None): et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13)
p.(None): the following:
p.(None): ``SEC. 317L-1. <> SCREENING AND TREATMENT
p.(None): FOR MATERNAL DEPRESSION.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall make grants to States to
p.(None): establish, improve, or maintain programs for screening, assessment, and
p.(None): treatment services, including culturally and linguistically appropriate
p.(None): services, as appropriate, for women who are pregnant, or who have given
p.(None): birth within the preceding 12 months, for maternal depression.
p.(None): ``(b) Application.--To seek a grant under this section, a State
p.(None): shall submit an application to the Secretary at such time, in such
...
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 399Z-2. <> INFANT AND EARLY
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
p.(None): ``(B) multigenerational therapy and other services
p.(None): that support the caregiving relationship; and
p.(None): ``(2) ensure that programs funded through grants under this
p.(None): section are evidence-informed or evidence-based models,
p.(None): practices, and methods that are, as appropriate, culturally and
p.(None):
p.(None): [[Page 130 STAT. 1268]]
p.(None):
p.(None): linguistically appropriate, and can be replicated in other
p.(None): appropriate settings.
p.(None):
p.(None): ``(b) Eligible Children and Entities.--In this section:
p.(None): ``(1) Eligible child.--The term `eligible child' means a
p.(None): child from birth to not more than 12 years of age who--
p.(None): ``(A) is at risk for, shows early signs of, or has
p.(None): been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance; and
p.(None): ``(B) may benefit from infant and early childhood
p.(None): intervention or treatment programs or specialized
p.(None): preschool or elementary school programs that are
p.(None): evidence-based or that have been scientifically
p.(None): demonstrated to show promise but would benefit from
p.(None): further applied development.
p.(None): ``(2) Eligible entity.--The term `eligible entity' means a
p.(None): human services agency or nonprofit institution that--
p.(None): ``(A) employs licensed mental health professionals
p.(None): who have specialized training and experience in infant
p.(None): and early childhood mental health assessment, diagnosis,
p.(None): and treatment, or is accredited or approved by the
p.(None): appropriate State agency, as applicable, to provide for
p.(None): children from infancy to 12 years of age mental health
p.(None): promotion, intervention, or treatment services; and
p.(None): ``(B) provides services or programs described in
p.(None): subsection (a) that are evidence-based or that have been
p.(None): scientifically demonstrated to show promise but would
p.(None): benefit from further applied development.
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
...
p.(None): medication adherence;
p.(None): (E) listening to the patient, or receiving
p.(None): information with respect to the patient from the family
p.(None): or caregiver of the patient;
p.(None): (F) communicating with family members of the
p.(None): patient, caregivers of the patient, law enforcement, or
p.(None): others when the patient presents a serious and imminent
p.(None): threat of harm to self or others; and
p.(None): (G) communicating to law enforcement and family
p.(None): members or caregivers of the patient about the admission
p.(None): of the patient to receive care at, or the release of a
p.(None): patient from, a facility for an emergency psychiatric
p.(None): hold or involuntary treatment.
p.(None): SEC. 11004. <> DEVELOPMENT AND
p.(None): DISSEMINATION OF MODEL TRAINING
p.(None): PROGRAMS.
p.(None):
p.(None): (a) Initial Programs and Materials.--Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary, in consultation with
p.(None): appropriate experts, shall identify the following model programs and
p.(None): materials, or (in the case that no such programs or materials exist)
p.(None): recognize private or public entities to develop and disseminate each of
p.(None): the following:
p.(None): (1) Model programs and materials for training health care
p.(None): providers (including physicians, emergency medical personnel,
p.(None): psychiatrists, including child and adolescent psychiatrists,
p.(None): psychologists, counselors, therapists, nurse practitioners,
p.(None): physician assistants, behavioral health facilities and clinics,
p.(None): care managers, and hospitals, including individuals such as
p.(None): general counsels or regulatory compliance staff who are
p.(None): responsible for establishing provider privacy policies)
p.(None): regarding the permitted uses and disclosures, consistent with
p.(None): the standards governing the privacy and security of individually
p.(None): identifiable health information promulgated by the Secretary
p.(None): under part C of title XI of the Social Security Act (42 U.S.C.
p.(None): 1320d et seq.) and regulations promulgated under section 264(c)
p.(None): of the Health Insurance Portability and Accountability Act of
p.(None): 1996 (42 U.S.C. 1320d-2 note) and such part C, of the protected
p.(None): health information of patients seeking or undergoing mental or
p.(None): substance use disorder treatment.
p.(None):
p.(None): [[Page 130 STAT. 1272]]
p.(None):
p.(None): (2) A model program and materials for training patients and
p.(None): their families regarding their rights to protect and obtain
p.(None): information under the standards and regulations specified in
p.(None): paragraph (1).
p.(None):
p.(None): (b) Periodic Updates.--The Secretary shall--
p.(None): (1) periodically review and update the model programs and
p.(None): materials identified or developed under subsection (a); and
p.(None): (2) disseminate the updated model programs and materials to
p.(None): the individuals described in subsection (a).
p.(None):
p.(None): (c) Coordination.--The Secretary shall carry out this section in
p.(None): coordination with the Director of the Office for Civil Rights within the
p.(None): Department of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, the Administrator of the Health
p.(None): Resources and Services Administration, and the heads of other relevant
p.(None): agencies within the Department of Health and Human Services.
p.(None): (d) Input of Certain Entities.--In identifying, reviewing, or
p.(None): updating the model programs and materials under subsections (a) and (b),
p.(None): the Secretary shall solicit the input of relevant national, State, and
p.(None): local associations; medical societies; licensing boards; providers of
p.(None): mental and substance use disorder treatment; organizations with
p.(None): expertise on domestic violence, sexual assault, elder abuse, and child
p.(None): abuse; and organizations representing patients and consumers and the
p.(None): families of patients and consumers.
p.(None): (e) Funding.--There are authorized to be appropriated to carry out
p.(None): this section--
p.(None): (1) $4,000,000 for fiscal year 2018;
p.(None): (2) $2,000,000 for each of fiscal years 2019 and 2020; and
p.(None): (3) $1,000,000 for each of fiscal years 2021 and 2022.
p.(None):
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): SEC. 12001. <> RULE OF CONSTRUCTION
p.(None): RELATED TO MEDICAID COVERAGE OF MENTAL
p.(None): HEALTH SERVICES AND PRIMARY CARE
p.(None): SERVICES FURNISHED ON THE SAME DAY.
p.(None):
p.(None): Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.) shall be construed as prohibiting separate payment under the State
p.(None): plan under such title (or under a waiver of the plan) for the provision
p.(None): of a mental health service or primary care service under such plan, with
p.(None): respect to an individual, because such service is--
p.(None): (1) a primary care service furnished to the individual by a
p.(None): provider at a facility on the same day a mental health service
p.(None): is furnished to such individual by such provider (or another
p.(None): provider) at the facility; or
p.(None): (2) a mental health service furnished to the individual by a
p.(None): provider at a facility on the same day a primary care service is
p.(None): furnished to such individual by such provider (or another
p.(None): provider) at the facility.
p.(None): SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE
p.(None): REGULATION.
p.(None):
p.(None): (a) Study.--The Secretary of Health and Human Services, acting
p.(None): through the Administrator of the Centers for Medicare &
p.(None):
...
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
p.(None): other family support services for each program
p.(None): participant who requires such services;
p.(None): (E) outpatient or inpatient mental health treatment,
p.(None): as ordered by the court, that carries with it the
p.(None): possibility of dismissal of charges or reduced
p.(None): sentencing upon successful completion of such treatment;
p.(None): (F) centralized case management, including--
p.(None): (i) the consolidation of all cases, including
p.(None): violations of probations, of the program
p.(None): participant; and
p.(None): (ii) coordination of all mental health
p.(None): treatment plans and social services, including
p.(None): life skills and vocational training, housing and
p.(None): job placement, education, health care, and relapse
p.(None): prevention for each program participant who
p.(None): requires such services; and
p.(None): (G) continuing supervision of treatment plan
p.(None): compliance by the program participant for a term not to
p.(None): exceed the maximum allowable sentence or probation
p.(None): period for the charged or relevant offense and, to the
p.(None): extent practicable, continuity of psychiatric care at
p.(None): the end of the supervised period.
p.(None):
p.(None): (d) Implementation; Duration.--The pilot program established under
p.(None): subsection (b) shall be conducted--
p.(None): (1) in not less than 1 United States judicial district,
p.(None): designated by the Attorney General in consultation with the
p.(None): Director of the Administrative Office of the United States
p.(None): Courts, as appropriate for the pilot program; and
p.(None): (2) during fiscal year 2017 through fiscal year 2021.
p.(None):
...
Searching for indicator children:
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p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
...
p.(None): lactating women, including the development of such therapies and
p.(None): the collaboration on and coordination of such activities.
p.(None): (3) Membership.--
p.(None): (A) Federal members.--The Task Force shall be
p.(None): composed of each of the following Federal members, or
p.(None): the designees of such members:
p.(None): (i) The Director of the Centers for Disease
p.(None): Control and Prevention.
p.(None): (ii) The Director of the National Institutes
p.(None): of Health, the Director of the Eunice Kennedy
p.(None): Shriver National Institute of Child Health and
p.(None): Human Development, and the directors of such other
p.(None): appropriate national research institutes.
p.(None): (iii) The Commissioner of Food and Drugs.
p.(None): (iv) The Director of the Office on Women's
p.(None): Health.
p.(None): (v) The Director of the National Vaccine
p.(None): Program Office.
p.(None): (vi) The head of any other research-related
p.(None): agency or department not described in clauses (i)
p.(None): through (v) that the Secretary determines
p.(None): appropriate, which may include the Department of
p.(None): Veterans Affairs and the Department of Defense.
p.(None): (B) Non-federal members.--The Task Force shall be
p.(None): composed of each of the following non-Federal members,
p.(None): including--
p.(None): (i) representatives from relevant medical
p.(None): societies with subject matter expertise on
p.(None): pregnant women, lactating women, or children;
p.(None): (ii) nonprofit organizations with expertise
p.(None): related to the health of women and children;
p.(None): (iii) relevant industry representatives; and
p.(None): (iv) other representatives, as appropriate.
p.(None): (C) Limitations.--The non-Federal members described
p.(None): in subparagraph (B) shall--
p.(None): (i) compose not more than one-half, and not
p.(None): less than one-third, of the total membership of
p.(None): the Task Force; and
p.(None): (ii) be appointed by the Secretary.
p.(None): (4) Termination.--
p.(None): (A) In general.--Subject to subparagraph (B), the
p.(None): Task Force shall terminate on the date that is 2 years
p.(None): after the date on which the Task Force is established
p.(None): under paragraph (1).
p.(None): (B) Extension.--The Secretary may extend the
p.(None): operation of the Task Force for one additional 2-year
p.(None): period following the 2-year period described in
p.(None): subparagraph (A), if the Secretary determines that the
p.(None): extension is appropriate for carrying out the purpose of
p.(None): this section.
p.(None): (5) Meetings.--The Task Force shall meet not less than 2
p.(None): times each year and shall convene public meetings, as
p.(None): appropriate, to fulfill its duties under paragraph (2).
p.(None):
p.(None): [[Page 130 STAT. 1072]]
p.(None):
p.(None): (6) Task force report to congress.--Not later than 18 months
p.(None): after the date on which the Task Force is established under
p.(None): paragraph (1), the Task Force shall prepare and submit to the
p.(None): Secretary, the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate, and the Committee on Energy and Commerce
p.(None): of the House of Representatives a report that includes each of
p.(None): the following:
p.(None): (A) A plan to identify and address gaps in knowledge
p.(None): and research regarding safe and effective therapies for
...
p.(None): the working group is convened under paragraph (1), the working
p.(None): group shall conduct a review and submit a report to the
p.(None): Secretary containing recommendations on whether the uses and
p.(None): disclosures of protected health information for research
p.(None): purposes should be modified to allow protected health
p.(None): information to be available, as appropriate, for research
p.(None): purposes, including studies to obtain generalizable knowledge,
p.(None): while protecting individuals' privacy rights. In conducting the
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
p.(None): policy related to protecting the privacy of
p.(None): individuals, and
p.(None): (vi) existing barriers to research related to
p.(None): the current restrictions on the uses and
p.(None): disclosures of protected health information; and
p.(None): (B) consider, at a minimum--
p.(None): (i) expectations and preferences on how an
p.(None): individual's protected health information is
p.(None): shared and used;
p.(None): (ii) issues related to specific subgroups of
p.(None): people, such as children, incarcerated
p.(None): individuals, and individuals with a cognitive or
p.(None): intellectual disability impacting capacity to
p.(None): consent;
p.(None): (iii) relevant Federal and State laws;
p.(None): (iv) models of facilitating data access and
p.(None): levels of data access, including data
p.(None): segmentation, where applicable;
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
...
p.(None): inserting after the item relating to section 13102 the
p.(None): following:
p.(None):
p.(None): ``13103. Assisting doctors and hospitals in improving the quality and
p.(None): care for patients.''.
p.(None):
p.(None): (b) Certification of Health Information Technology for Medical
p.(None): Specialties and Sites of Service.--Section 3001(c)(5) of the Public
p.(None): Health Service Act (42 U.S.C. 300jj-11(c)(5)) is amended by adding at
p.(None): the end the following:
p.(None): ``(C) Health information technology for medical
p.(None): specialties and sites of service.--
p.(None): ``(i) In general.--The National Coordinator
p.(None): shall encourage, keep, or recognize, through
p.(None): existing authorities, the voluntary certification
p.(None): of health information technology under the program
p.(None): developed under
p.(None): [[Page 130 STAT. 1159]]
p.(None):
p.(None): subparagraph (A) for use in medical specialties
p.(None): and sites of service for which no such technology
p.(None): is available or where more technological
p.(None): advancement or integration is needed.
p.(None): ``(ii) Specific medical specialties.--The
p.(None): Secretary shall accept public comment on specific
p.(None): medical specialties and sites of service, in
p.(None): addition to those described in clause (i), for the
p.(None): purpose of selecting additional specialties and
p.(None): sites of service as necessary.
p.(None): ``(iii) Health information technology for
p.(None): pediatrics.--Not later than 18 months after the
p.(None): date of enactment of the 21st Century Cures Act,
p.(None): the Secretary, in consultation with relevant
p.(None): stakeholders, shall make recommendations for the
p.(None): voluntary certification of health information
p.(None): technology for use by pediatric health providers
p.(None): to support the health care of children. Not later
p.(None): than 2 years after the date of enactment of the
p.(None): 21st Century Cures Act, the Secretary shall adopt
p.(None): certification criteria under section 3004 to
p.(None): support the voluntary certification of health
p.(None): information technology for use by pediatric health
p.(None): providers to support the health care of
p.(None): children.''.
p.(None):
p.(None): (c) Meaningful Use Statistics.--
p.(None): (1) In general.--Not later than 6 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit to the HIT Advisory Committee of the
p.(None): Office of the National Coordinator for Health Information
p.(None): Technology, a report concerning attestation statistics for the
p.(None): Medicare and Medicaid EHR Meaningful Use Incentive programs to
p.(None): assist in informing standards adoption and related practices.
p.(None): Such statistics shall include attestation information delineated
p.(None): by State, including, to the extent practicable, the number of
p.(None): providers who did not meet the minimum criteria necessary to
p.(None): attest for the Medicare and Medicaid EHR Meaningful Use
p.(None): Incentive programs for a calendar year, and shall be made
p.(None): publicly available on the Internet website of the Secretary on
p.(None): at least a quarterly basis.
p.(None): (2) Authority to alter format.--The Secretary of Health and
p.(None): Human Services may alter the format of the reports on the
p.(None): attestation of eligible health care professionals following the
p.(None): first performance year of the Merit-based Incentive Payment
p.(None): System to account for changes arising from the implementation of
p.(None): such payment system.
p.(None): SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND
p.(None): FUNCTIONALITY.
p.(None):
p.(None): (a) Enhancements to Certification.--Section 3001(c)(5) of the Public
p.(None): Health Service Act (42 U.S.C. 300jj-11), as amended by section 4001(b),
p.(None): is further amended by adding at the end the following:
p.(None): ``(D) Conditions of certification.--Not later than 1
p.(None): year after the date of enactment of the 21st Century
...
p.(None): ``(iii) The facilitation of secure access by
p.(None): an individual to such individual's protected
p.(None): health information and access to such information
p.(None): by a family member, caregiver, or guardian acting
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
...
p.(None): 1902(kk)(8)) after the date that is 60 days after the
p.(None): date on which such termination is included in the
p.(None): database or other system under section 1902(ll); or'';
p.(None): and
p.(None): (B) in subsection (m), by inserting after paragraph
p.(None): (2) the following new paragraph:
p.(None):
p.(None): ``(3) No payment shall be made under this title to a State with
p.(None): respect to expenditures incurred by the State for payment for services
p.(None): provided by a managed care entity (as defined under section 1932(a)(1))
p.(None): under the State plan under this title (or under a waiver of the plan)
p.(None): unless the State--
p.(None):
p.(None): [[Page 130 STAT. 1193]]
p.(None):
p.(None): ``(A) beginning on July 1, 2018, has a contract with such
p.(None): entity that complies with the requirement specified in section
p.(None): 1932(d)(5); and
p.(None): ``(B) beginning on January 1, 2018, complies with the
p.(None): requirement specified in section 1932(d)(6)(A).''.
p.(None): (5) <> Development of uniform
p.(None): terminology for reasons for provider termination.--Not later
p.(None): than July 1, 2017, the Secretary of Health and Human Services
p.(None): shall, in consultation with the heads of State agencies
p.(None): administering State Medicaid plans (or waivers of such plans),
p.(None): issue regulations establishing uniform terminology to be used
p.(None): with respect to specifying reasons under subparagraph (A)(v) of
p.(None): paragraph (8) of section 1902(kk) of the Social Security Act (42
p.(None): U.S.C. 1396a(kk)), as added by paragraph (1), for the
p.(None): termination (as described in such paragraph (8)) of the
p.(None): participation of certain providers in the Medicaid program under
p.(None): title XIX of such Act or the Children's Health Insurance Program
p.(None): under title XXI of such Act.
p.(None): (6) Conforming amendment.--Section 1902(a)(41) of the Social
p.(None): Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking
p.(None): ``provide that whenever'' and inserting ``provide, in accordance
p.(None): with subsection (kk)(8) (as applicable), that whenever''.
p.(None):
p.(None): (b) Increasing Availability of Medicaid Provider Information.--
p.(None): (1) FFS provider enrollment.--Section 1902(a) of the Social
p.(None): Security Act (42 U.S.C. 1396a(a)) is amended by inserting after
p.(None): paragraph (77) the following new paragraph:
p.(None): ``(78) provide that, not later than January 1, 2017, in the
p.(None): case of a State that pursuant to its State plan or waiver of the
p.(None): plan for medical assistance pays for medical assistance on a
p.(None): fee-for-service basis, the State shall require each provider
p.(None): furnishing items and services to, or ordering, prescribing,
p.(None): referring, or certifying eligibility for, services for
p.(None): individuals eligible to receive medical assistance under such
p.(None): plan to enroll with the State agency and provide to the State
p.(None): agency the provider's identifying information, including the
p.(None): name, specialty, date of birth, Social Security number, national
p.(None): provider identifier (if applicable), Federal taxpayer
p.(None): identification number, and the State license or certification
p.(None): number of the provider (if applicable);''.
p.(None): (2) Managed care provider enrollment.--Section 1932(d) of
p.(None): the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by
p.(None): subsection (a)(2), is amended by adding at the end the following
p.(None): new paragraph:
p.(None): ``(6) Enrollment of participating providers.--
p.(None): ``(A) In general.--Beginning not later than January
...
p.(None): criteria when awarding grants and the ongoing oversight
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
...
p.(None): 2018, and every 4 years thereafter, the Assistant Secretary
p.(None): shall--
p.(None): ``(A) submit the strategic plan developed under
p.(None): paragraph (1) to the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate; and
p.(None): ``(B) post such plan on the Internet website of the
p.(None): Administration.
p.(None): ``(4) Contents.--The strategic plan developed under
p.(None): paragraph (1) shall--
p.(None): ``(A) identify strategic priorities, goals, and
p.(None): measurable objectives for mental and substance use
p.(None): disorders activities and programs operated and supported
p.(None): by the Administration, including priorities to prevent
p.(None): or eliminate the burden of mental and substance use
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
p.(None): a serious mental illness or children with a
p.(None): serious emotional disturbance; and
p.(None): ``(ii) a strategy to improve the recruitment,
p.(None): training, and retention of a workforce for the
p.(None): treatment of individuals with mental or substance
p.(None): use disorders, or co-occurring disorders;
p.(None): ``(E) identify opportunities to improve
p.(None): collaboration with States, local governments,
p.(None): communities, and Indian tribes and tribal organizations
p.(None): (as such terms are defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act); and
p.(None): ``(F) specify a strategy to disseminate evidence-
p.(None): based and promising best practices related to
p.(None): prevention, diagnosis, early intervention, treatment,
p.(None): and recovery services related to mental illness,
p.(None): particularly for adults with a serious mental illness
p.(None): and children with a serious emotional disturbance, and
p.(None): for individuals with a substance use disorder.''.
p.(None): SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
p.(None):
p.(None): (a) In General.--Section 501 of the Public Health Service Act (42
p.(None): U.S.C. 290aa), as so amended, is further amended by amending subsection
p.(None): (m), as redesignated by section 6003, to read as follows:
p.(None): ``(m) Biennial Report Concerning Activities and Progress.--Not later
p.(None): than September 30, 2020, and every 2 years thereafter, the Assistant
p.(None): Secretary shall prepare and submit to the Committee on Energy and
p.(None): Commerce and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions and the Committee on Appropriations of the Senate, and post on
p.(None): the Internet website of the Administration, a report containing at a
p.(None): minimum--
p.(None): ``(1) a review of activities conducted or supported by the
p.(None): Administration, including progress toward strategic priorities,
p.(None): goals, and objectives identified in the strategic plan developed
p.(None): under subsection (l);
p.(None):
p.(None): [[Page 130 STAT. 1211]]
p.(None):
p.(None): ``(2) an assessment of programs and activities carried out
p.(None): by the Assistant Secretary, including the extent to which
p.(None): programs and activities under this title and part B of title XIX
p.(None): meet identified goals and performance measures developed for the
p.(None): respective programs and activities;
p.(None): ``(3) a description of the progress made in addressing gaps
p.(None): in mental and substance use disorders prevention, treatment, and
...
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): SEC. 6021. <> IMPROVING OVERSIGHT OF
p.(None): MENTAL AND SUBSTANCE USE DISORDERS
p.(None): PROGRAMS THROUGH THE ASSISTANT SECRETARY
p.(None): FOR PLANNING AND EVALUATION.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services, acting
p.(None): through the Assistant Secretary for Planning and Evaluation, shall
p.(None): ensure efficient and effective planning and evaluation of mental and
p.(None): substance use disorders prevention and treatment programs and related
p.(None): activities.
p.(None): (b) Evaluation Strategy.--In carrying out subsection (a), the
p.(None): Assistant Secretary for Planning and Evaluation shall, not later than
p.(None): 180 days after the date of enactment of this Act, develop a strategy for
p.(None): conducting ongoing evaluations that identifies priority programs to be
p.(None): evaluated by the Assistant Secretary for Planning and Evaluation and
p.(None): priority programs to be evaluated by other relevant offices and agencies
p.(None): within the Department of Health and Human Services. The strategy shall--
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
...
p.(None): Committee
p.(None):
p.(None): SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
p.(None): COMMITTEE.
p.(None):
p.(None): (a) Establishment.--
p.(None): (1) In general.--Not later than 3 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services, or the designee of the Secretary, shall establish a
p.(None): committee to be known as the Interdepartmental Serious Mental
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
p.(None): this section, the provisions of the Federal Advisory Committee
p.(None): Act (5 U.S.C. App.) shall apply to the Committee.
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
p.(None): services for adults with a serious mental illness or children
p.(None): with a serious emotional disturbance.
p.(None):
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
p.(None): (H) the Secretary of Labor;
p.(None): (I) the Administrator of the Centers for Medicare &
p.(None): Medicaid Services; and
p.(None): (J) the Commissioner of Social Security.
p.(None):
p.(None): [[Page 130 STAT. 1219]]
p.(None):
p.(None): (2) Non-federal members.--The Committee shall also include
p.(None): not less than 14 non-Federal public members appointed by the
p.(None): Secretary of Health and Human Services, of which--
p.(None): (A) at least 2 members shall be an individual who
p.(None): has received treatment for a diagnosis of a serious
p.(None): mental illness;
p.(None): (B) at least 1 member shall be a parent or legal
p.(None): guardian of an adult with a history of a serious mental
p.(None): illness or a child with a history of a serious emotional
p.(None): disturbance;
p.(None): (C) at least 1 member shall be a representative of a
p.(None): leading research, advocacy, or service organization for
p.(None): adults with a serious mental illness;
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
p.(None): experience treating serious mental illnesses or
p.(None): serious emotional disturbances; or
p.(None): (iv) a licensed psychiatric nurse, nurse
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
p.(None): justice or serious mental illness;
p.(None): (J) at least 1 member shall be a law enforcement
p.(None): officer or corrections officer with extensive experience
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
p.(None): (g) Sunset.--The Committee shall terminate on the date that is 6
p.(None): years after the date on which the Committee is established under
p.(None): subsection (a)(1).
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by inserting after section 501 (42 U.S.C. 290aa) the
p.(None): following:
p.(None): ``SEC. 501A. <> NATIONAL MENTAL HEALTH AND
p.(None): SUBSTANCE USE POLICY LABORATORY.
p.(None):
p.(None): ``(a) In General.--There shall be established within the
p.(None): Administration a National Mental Health and Substance Use Policy
...
p.(None): ``(5) periodically review programs and activities operated
p.(None): by the Administration relating to the diagnosis or prevention
p.(None): of, treatment for, and recovery from, mental and substance use
p.(None): disorders to--
p.(None): ``(A) identify any such programs or activities that
p.(None): are duplicative;
p.(None): ``(B) identify any such programs or activities that
p.(None): are not evidence-based, effective, or efficient; and
p.(None): ``(C) formulate recommendations for coordinating,
p.(None): eliminating, or improving programs or activities
p.(None): identified
p.(None):
p.(None): [[Page 130 STAT. 1221]]
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
...
p.(None): (B) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1225]]
p.(None):
p.(None): (i) in subparagraph (A), by striking ``; and''
p.(None): at the end and inserting ``;'';
p.(None): (ii) in subparagraph (B)--
p.(None): (I) by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and''; and
p.(None): (iii) by adding at the end the following:
p.(None): ``(C) substance use disorder prevention among high-
p.(None): risk groups.'';
p.(None): (4) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (5) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$211,148,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1911(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x(b)) is amended--
p.(None): (1) by redesignating paragraphs (1) through (3) as
p.(None): paragraphs (2) through (4), respectively; and
p.(None): (2) by inserting before paragraph (2) (as so redesignated)
p.(None): the following:
p.(None): ``(1) providing community mental health services for adults
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
p.(None): accordance with subsection (a), a State shall submit to the
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
...
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
p.(None): services to be provided by local school systems
p.(None): under the Individuals with Disabilities Education
p.(None): Act;
p.(None): ``(iv) include a description of how the State
p.(None): promotes evidence-based practices, including those
p.(None): evidence-based programs that address the needs of
p.(None): individuals with early serious mental illness
p.(None): regardless of the age of the individual at onset,
p.(None): provide comprehensive individualized treatment, or
p.(None): integrate mental and physical health services;
p.(None): ``(v) include a description of case management
p.(None): services;
p.(None): ``(vi) include a description of activities
p.(None): that seek to engage adults with a serious mental
p.(None): illness or children with a serious emotional
p.(None): disturbance and their caregivers where appropriate
p.(None): in making health care decisions, including
p.(None): activities that enhance communication among
p.(None): individuals, families, caregivers, and treatment
p.(None): providers; and
p.(None): ``(vii) as appropriate to, and reflective of,
p.(None): the uses the State proposes for the block grant
p.(None): funds, include--
p.(None): ``(I) a description of the
p.(None): activities intended to reduce
p.(None): hospitalizations and hospital stays
p.(None): using the block grant funds;
p.(None): ``(II) a description of the
p.(None): activities intended to reduce incidents
p.(None): of suicide using the block grant funds;
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
...
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
p.(None): pregnant women, women with dependent children,
p.(None): individuals with a co-occurring mental health and
p.(None): substance use disorder, persons who inject drugs,
p.(None): and persons who are experiencing homelessness;
p.(None): ``(iii) provides aggregate information on the
p.(None): number of individuals in treatment within the
p.(None): State, including the number of such individuals
p.(None): who are pregnant women, women with dependent
p.(None): children, individuals with a co-occurring mental
p.(None): health and substance use disorder, persons who
p.(None): inject drugs, and persons who are experiencing
p.(None): homelessness;
p.(None): ``(iv) provides a description of the system
p.(None): that is available to provide services by modality,
p.(None): including the provision of recovery support
p.(None): services;
p.(None): ``(v) provides a description of the State's
p.(None): comprehensive statewide prevention efforts,
p.(None): including the number of individuals being served
p.(None): in the system, target populations, and priority
p.(None): needs, and provides a description of the amount of
p.(None): funds from the prevention set-aside expended on
p.(None): primary prevention;
p.(None): ``(vi) provides a description of the financial
p.(None): resources available;
p.(None): ``(vii) describes the existing substance use
p.(None): disorders workforce and workforce trained in
p.(None): treating co-occurring substance use and mental
p.(None): disorders;
p.(None): ``(viii) includes a description of how the
p.(None): State promotes evidence-based practices; and
p.(None): ``(ix) describes how the State integrates
p.(None): substance use disorder services and primary health
p.(None): care, which in the case of those individuals with
p.(None): co-occurring mental health and substance use
p.(None): disorders may include
p.(None):
p.(None): [[Page 130 STAT. 1232]]
p.(None):
p.(None): providing both mental health and substance use
p.(None): disorder services in primary care settings or
...
p.(None): (C) by adding at the end the following:
p.(None): ``(5) develop programs to divert individuals prior to
p.(None): booking or arrest.''; and
p.(None): (7) in subsection (j), as so redesignated, by striking
p.(None): ``$10,000,000 for fiscal year 2001, and such sums as may be
p.(None): necessary for fiscal years 2002 through 2003'' and inserting
p.(None): ``$4,269,000 for each of fiscal years 2018 through 2022''.
p.(None): SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH
p.(None): CARE.
p.(None):
p.(None): Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
p.(None): AGREEMENTS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Eligible entity.--The term `eligible entity' means a
p.(None): State, or other appropriate State agency, in collaboration with
p.(None): 1 or more qualified community programs as described in section
p.(None): 1913(b)(1) or 1 or more community health centers as described in
p.(None): section 330.
p.(None): ``(2) Integrated care.--The term `integrated care' means
p.(None): collaborative models or practices offering mental and physical
p.(None): health services, which may include practices that share the same
p.(None): space in the same facility.
p.(None): ``(3) Special population.--The term `special population'
p.(None): means--
p.(None): ``(A) adults with a mental illness who have co-
p.(None): occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(B) adults with a serious mental illness who have
p.(None): co-occurring physical health conditions or chronic
p.(None): diseases;
p.(None): ``(C) children and adolescents with a serious
p.(None): emotional disturbance with co-occurring physical health
p.(None): conditions or chronic diseases; or
p.(None): ``(D) individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Grants and Cooperative Agreements.--
p.(None): ``(1) In general.--The Secretary may award grants and
p.(None): cooperative agreements to eligible entities to support the
p.(None):
p.(None): [[Page 130 STAT. 1236]]
p.(None):
p.(None): improvement of integrated care for primary care and behavioral
p.(None): health care in accordance with paragraph (2).
p.(None): ``(2) Purposes.--A grant or cooperative agreement awarded
p.(None): under this section shall be designed to--
p.(None): ``(A) promote full integration and collaboration in
p.(None): clinical practices between primary and behavioral health
p.(None): care;
p.(None): ``(B) support the improvement of integrated care
p.(None): models for primary care and behavioral health care to
p.(None): improve the overall wellness and physical health status
p.(None): of adults with a serious mental illness or children with
p.(None): a serious emotional disturbance; and
p.(None): ``(C) promote integrated care services related to
p.(None): screening, diagnosis, prevention, and treatment of
p.(None): mental and substance use disorders, and co-occurring
p.(None): physical health conditions and chronic diseases.
p.(None):
p.(None): ``(c) Applications.--
p.(None): ``(1) In general.--An eligible entity seeking a grant or
p.(None): cooperative agreement under this section shall submit an
p.(None): application to the Secretary at such time, in such manner, and
p.(None): accompanied by such information as the Secretary may require,
p.(None): including the contents described in paragraph (2).
p.(None): ``(2) Contents.--The contents described in this paragraph
p.(None): are--
p.(None): ``(A) a description of a plan to achieve fully
p.(None): collaborative agreements to provide services to special
p.(None): populations;
p.(None): ``(B) a document that summarizes the policies, if
p.(None): any, that serve as barriers to the provision of
p.(None): integrated care, and the specific steps, if applicable,
p.(None): that will be taken to address such barriers;
p.(None): ``(C) a description of partnerships or other
p.(None): arrangements with local health care providers to provide
p.(None): services to special populations;
p.(None): ``(D) an agreement and plan to report to the
p.(None): Secretary performance measures necessary to evaluate
p.(None): patient outcomes and facilitate evaluations across
p.(None): participating projects; and
p.(None): ``(E) a plan for sustainability beyond the grant or
p.(None): cooperative agreement period under subsection (e).
p.(None):
p.(None): ``(d) Grant and Cooperative Agreement Amounts.--
p.(None): ``(1) Target amount.--The target amount that an eligible
p.(None): entity may receive for a year through a grant or cooperative
...
p.(None): and the remaining amounts shall be allocated to health
p.(None): facilities that provide integrated care.
p.(None):
p.(None): ``(e) Duration.--A grant or cooperative agreement under this section
p.(None): shall be for a period not to exceed 5 years.
p.(None):
p.(None): [[Page 130 STAT. 1237]]
p.(None):
p.(None): ``(f) Report on Program Outcomes.--An eligible entity receiving a
p.(None): grant or cooperative agreement under this section shall submit an annual
p.(None): report to the Secretary that includes--
p.(None): ``(1) the progress made to reduce barriers to integrated
p.(None): care as described in the entity's application under subsection
p.(None): (c); and
p.(None): ``(2) a description of functional outcomes of special
p.(None): populations, including--
p.(None): ``(A) with respect to adults with a serious mental
p.(None): illness, participation in supportive housing or
p.(None): independent living programs, attendance in social and
p.(None): rehabilitative programs, participation in job training
p.(None): opportunities, satisfactory performance in work
p.(None): settings, attendance at scheduled medical and mental
p.(None): health appointments, and compliance with prescribed
p.(None): medication regimes;
p.(None): ``(B) with respect to individuals with co-occurring
p.(None): mental illness and physical health conditions and
p.(None): chronic diseases, attendance at scheduled medical and
p.(None): mental health appointments, compliance with prescribed
p.(None): medication regimes, and participation in learning
p.(None): opportunities related to improved health and lifestyle
p.(None): practices; and
p.(None): ``(C) with respect to children and adolescents with
p.(None): a serious emotional disturbance who have co-occurring
p.(None): physical health conditions and chronic diseases,
p.(None): attendance at scheduled medical and mental health
p.(None): appointments, compliance with prescribed medication
p.(None): regimes, and participation in learning opportunities at
p.(None): school and extracurricular activities.
p.(None):
p.(None): ``(g) Technical Assistance for Primary-Behavioral Health Care
p.(None): Integration.--
p.(None): ``(1) In general.--The Secretary may provide appropriate
p.(None): information, training, and technical assistance to eligible
p.(None): entities that receive a grant or cooperative agreement under
p.(None): this section, in order to help such entities meet the
p.(None): requirements of this section, including assistance with--
p.(None): ``(A) development and selection of integrated care
p.(None): models;
p.(None): ``(B) dissemination of evidence-based interventions
p.(None): in integrated care;
p.(None): ``(C) establishment of organizational practices to
p.(None): support operational and administrative success; and
p.(None): ``(D) other activities, as the Secretary determines
p.(None): appropriate.
p.(None): ``(2) Additional dissemination of technical information.--
p.(None): The information and resources provided by the Secretary under
p.(None): paragraph (1) shall, as appropriate, be made available to
p.(None): States, political subdivisions of States, Indian tribes or
p.(None): tribal organizations (as defined in section 4 of the Indian
p.(None): Self-Determination and Education Assistance Act), outpatient
p.(None): mental health and addiction treatment centers, community mental
...
p.(None): on any qualified practitioner that is certified to prescribe medication
p.(None): for opioid dependency under section 303(g)(2)(B) of the Controlled
p.(None): Substances Act, the Assistant Secretary--
p.(None): ``(1) shall provide an opportunity to such practitioner to
p.(None): have the contact information of the practitioner removed from
p.(None): the website at the request of the practitioner; and
p.(None): ``(2) may evaluate other methods to periodically update the
p.(None): information displayed on such website.
p.(None):
p.(None): ``(d) Rule of Construction.--Nothing in this section shall be
p.(None): construed to prevent the Assistant Secretary from using any unobligated
p.(None): amounts otherwise made available to the Administration to maintain the
p.(None): Routing Service.''.
p.(None): SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall award competitive grants to--
p.(None): ``(1) State and local governments and Indian tribes and
p.(None): tribal organizations, to enhance community-based crisis response
p.(None): systems; or
p.(None): ``(2) States to develop, maintain, or enhance a database of
p.(None): beds at inpatient psychiatric facilities, crisis stabilization
p.(None): units, and residential community mental health and residential
p.(None): substance use disorder treatment facilities, for adults with a
p.(None): serious mental illness, children with a serious emotional
p.(None): disturbance, or individuals with a substance use disorder.
p.(None):
p.(None): ``(b) Applications.--
p.(None): ``(1) In general.--To receive a grant under subsection (a),
p.(None): an entity shall submit to the Secretary an application, at such
p.(None): time, in such manner, and containing such information as the
p.(None): Secretary may require.
p.(None): ``(2) Community-based crisis response plan.--An application
p.(None): for a grant under subsection (a)(1) shall include a plan for--
p.(None): ``(A) promoting integration and coordination between
p.(None): local public and private entities engaged in crisis
p.(None): response, including first responders, emergency health
p.(None): care providers, primary care providers, law enforcement,
p.(None): court systems, health care payers, social service
p.(None): providers, and behavioral health providers;
p.(None): ``(B) developing memoranda of understanding with
p.(None): public and private entities to implement crisis response
p.(None): services;
p.(None): ``(C) addressing gaps in community resources for
p.(None): crisis intervention and prevention; and
p.(None):
p.(None): [[Page 130 STAT. 1241]]
p.(None):
p.(None): ``(D) developing models for minimizing hospital
p.(None): readmissions, including through appropriate discharge
p.(None): planning.
p.(None): ``(3) Beds database plan.--An application for a grant under
p.(None): subsection (a)(2) shall include a plan for developing,
p.(None): maintaining, or enhancing a real-time, Internet-based bed
p.(None): database to collect, aggregate, and display information about
...
p.(None): carrying out subsection (d).''.
p.(None): SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
p.(None): REAUTHORIZATION.
p.(None):
p.(None): Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
p.(None): is amended--
p.(None): (1) in subsection (c)(3), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (2) in subsection (d)(4), by striking ``fiscal year 2007''
p.(None): and all that follows through the period at the end and inserting
p.(None): ``each of the fiscal years 2018 through 2022.'';
p.(None): (3) in subsection (e)(1)(I), by striking ``fiscal year
p.(None): 2007'' and all that follows through the period at the end and
p.(None): inserting ``each of the fiscal years 2018 through 2022.'';
p.(None): (4) in subsection (f)(2), by striking ``$6,000,000 for
p.(None): fiscal year 2007'' and all that follows through the period at
p.(None): the end and inserting ``$3,000,000 for each of the fiscal years
p.(None): 2018 through 2022''; and
p.(None): (5) by adding at the end the following new subsection:
p.(None):
p.(None): ``(g) Reducing Underage Drinking Through Screening and Brief
p.(None): Intervention.--
p.(None):
p.(None): [[Page 130 STAT. 1247]]
p.(None):
p.(None): ``(1) Grants to pediatric health care providers to reduce
p.(None): underage drinking.--The Assistant Secretary may make grants to
p.(None): eligible entities to increase implementation of practices for
p.(None): reducing the prevalence of alcohol use among individuals under
p.(None): the age of 21, including college students.
p.(None): ``(2) Purposes.--Grants under this subsection shall be made
p.(None): to improve--
p.(None): ``(A) screening children and adolescents for alcohol
p.(None): use;
p.(None): ``(B) offering brief interventions to children and
p.(None): adolescents to discourage such use;
p.(None): ``(C) educating parents about the dangers of, and
p.(None): methods of discouraging, such use;
p.(None): ``(D) diagnosing and treating alcohol use disorders;
p.(None): and
p.(None): ``(E) referring patients, when necessary, to other
p.(None): appropriate care.
p.(None): ``(3) Use of funds.--An entity receiving a grant under this
p.(None): subsection may use such funding for the purposes identified in
p.(None): paragraph (2) by--
p.(None): ``(A) providing training to health care providers;
p.(None): ``(B) disseminating best practices, including
p.(None): culturally and linguistically appropriate best
p.(None): practices, as appropriate, and developing and
p.(None): distributing materials; and
p.(None): ``(C) supporting other activities, as determined
p.(None): appropriate by the Assistant Secretary.
p.(None): ``(4) Application.--To be eligible to receive a grant under
p.(None): this subsection, an entity shall submit an application to the
p.(None): Assistant Secretary at such time, and in such manner, and
p.(None): accompanied by such information as the Assistant Secretary may
p.(None): require. Each application shall include--
p.(None): ``(A) a description of the entity;
p.(None): ``(B) a description of activities to be completed;
p.(None): ``(C) a description of how the services specified in
p.(None): paragraphs (2) and (3) will be carried out and the
p.(None): qualifications for providing such services; and
p.(None): ``(D) a timeline for the completion of such
p.(None): activities.
p.(None): ``(5) Definitions.--For the purpose of this subsection:
p.(None): ``(A) Brief intervention.--The term `brief
p.(None): intervention' means, after screening a patient,
p.(None): providing the patient with brief advice and other brief
p.(None): motivational enhancement techniques designed to increase
p.(None): the insight of the patient regarding the patient's
p.(None): alcohol use, and any realized or potential consequences
p.(None): of such use, to effect the desired related behavioral
p.(None): change.
p.(None): ``(B) Children and adolescents.--The term `children
p.(None): and adolescents' means any person under 21 years of age.
p.(None): ``(C) Eligible entity.--The term `eligible entity'
p.(None): means an entity consisting of pediatric health care
p.(None): providers and that is qualified to support or provide
p.(None): the activities identified in paragraph (2).
p.(None): ``(D) Pediatric health care provider.--The term
p.(None): `pediatric health care provider' means a provider of
p.(None): primary health care to individuals under the age of 21
p.(None): years.
p.(None): ``(E) Screening.--The term `screening' means using
p.(None): validated patient interview techniques to identify and
p.(None): assess the existence and extent of alcohol use in a
p.(None): patient.''.
p.(None):
p.(None): [[Page 130 STAT. 1248]]
p.(None):
p.(None): SEC. 9017. CENTER AND PROGRAM REPEALS.
p.(None):
p.(None): Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
p.(None): et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
p.(None): second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
p.(None): amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
p.(None): 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
p.(None): 25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
p.(None): GRANTS.
p.(None):
p.(None): Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
...
p.(None): treatment services, as well as the development of faculty in
p.(None): health service psychology;
p.(None): ``(3) accredited master's and doctoral degree programs of
p.(None): social work for the development and implementation of
p.(None): interdisciplinary training of social work graduate students for
p.(None): providing behavioral health services, including substance use
p.(None): disorder prevention and treatment services, and the development
p.(None): of faculty in social work; and
p.(None): ``(4) State-licensed mental health nonprofit and for-profit
p.(None): organizations to enable such organizations to pay for programs
p.(None): for preservice or in-service training in a behavioral health-
p.(None): related paraprofessional field with preference for preservice or
p.(None): in-service training of paraprofessional child and adolescent
p.(None): mental health workers.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (5);
p.(None): [[Page 130 STAT. 1249]]
p.(None):
p.(None): (B) by redesignating paragraphs (1) through (4) as
p.(None): paragraphs (2) through (5), respectively;
p.(None): (C) by inserting before paragraph (2), as so
p.(None): redesignated, the following:
p.(None): ``(1) an ability to recruit and place the students described
p.(None): in subsection (a) in areas with a high need and high demand
p.(None): population;'';
p.(None): (D) in paragraph (3), as so redesignated, by
p.(None): striking ``subsection (a)'' and inserting ``paragraph
p.(None): (2), especially individuals with mental disorder
p.(None): symptoms or diagnoses, particularly children and
p.(None): adolescents, and transitional-age youth'';
p.(None): (E) in paragraph (4), as so redesignated, by
p.(None): striking ``;'' and inserting ``; and''; and
p.(None): (F) in paragraph (5), as so redesignated, by
p.(None): striking ``; and'' and inserting a period;
p.(None): (3) in subsection (c), by striking ``authorized under
p.(None): subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
p.(None): and (3) of subsection (a)'';
p.(None): (4) by amending subsection (d) to read as follows:
p.(None):
p.(None): ``(d) Priority.--In selecting grant recipients under this section,
p.(None): the Secretary shall give priority to--
p.(None): ``(1) programs that have demonstrated the ability to train
p.(None): psychology, psychiatry, and social work professionals to work in
p.(None): integrated care settings for purposes of recipients under
p.(None): paragraphs (1), (2), and (3) of subsection (a); and
p.(None): ``(2) programs for paraprofessionals that emphasize the role
p.(None): of the family and the lived experience of the consumer and
p.(None): family-paraprofessional partnerships for purposes of recipients
p.(None): under subsection (a)(4).''; and
p.(None): (5) by striking subsection (e) and inserting the following:
p.(None):
p.(None): ``(e) Report to Congress.--Not later than 4 years after the date of
p.(None): enactment of the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016, the Secretary shall include in the biennial report submitted to
p.(None): Congress under section 501(m) an assessment on the effectiveness of the
p.(None): grants under this section in--
p.(None): ``(1) providing graduate students support for experiential
...
p.(None): content standards.
p.(None):
p.(None): ``(b) Activities.--
p.(None): ``(1) Training for residents and fellows.--A recipient of a
p.(None): grant under subsection (a)(1)--
p.(None): ``(A) shall use the grant funds--
p.(None): ``(i)(I) to plan, develop, and operate a
p.(None): training program for medical psychiatry residents
p.(None): and fellows in addiction medicine practicing in
p.(None): eligible entities described in subsection (c)(1);
p.(None): or
p.(None): ``(II) to train new psychiatric residents and
p.(None): fellows in addiction medicine to provide and
p.(None): expand access to integrated mental and substance
p.(None): use disorders services; and
p.(None): ``(ii) to provide at least 1 training track
p.(None): that is--
p.(None): ``(I) a virtual training track that
p.(None): includes an in-person rotation at a
p.(None): teaching health center or in a
p.(None): community-based setting, followed by a
p.(None): virtual rotation in which the resident
p.(None): or fellow continues to support the care
p.(None): of patients at the teaching health
p.(None): center or in the community-based setting
p.(None): through the use of health information
p.(None): technology and, as appropriate,
p.(None): telehealth services;
p.(None): ``(II) an in-person training track
p.(None): that includes a rotation, during which
p.(None): the resident or fellow practices at a
p.(None): teaching health center or in a
p.(None): community-based setting; or
p.(None): ``(III) an in-person training track
p.(None): that includes a rotation during which
p.(None): the resident practices in a community-
p.(None): based setting that specializes in the
p.(None):
p.(None): [[Page 130 STAT. 1251]]
p.(None):
p.(None): treatment of infants, children,
p.(None): adolescents, or pregnant or postpartum
p.(None): women; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such training.
p.(None): ``(2) Training for other providers.--A recipient of a grant
p.(None): under subsection (a)(2)--
p.(None): ``(A) shall use the grant funds to plan, develop, or
p.(None): operate a training program to provide mental and
p.(None): substance use disorders services in underserved,
p.(None): community-based settings, as appropriate, that integrate
p.(None): primary care and mental and substance use disorders
p.(None): prevention and treatment services; and
p.(None): ``(B) may use the grant funds to provide additional
p.(None): support for the administration of the program or to meet
p.(None): the costs of projects to establish, maintain, or improve
p.(None): faculty development, or departments, divisions, or other
p.(None): units necessary to implement such program.
p.(None): ``(3) Academic units or programs.--A recipient of a grant
p.(None): under subsection (a)(3) shall enter into a partnership with
p.(None): organizations such as an education accrediting organization
p.(None): (such as the Liaison Committee on Medical Education, the
p.(None): Accreditation Council for Graduate Medical Education, the
...
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
...
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
p.(None): ``(3) provides support for local efforts to reduce stigma by
p.(None): using the National Health Information Center as a primary point
p.(None): of contact for information, publications, and service program
p.(None): referrals; and
p.(None):
p.(None): [[Page 130 STAT. 1262]]
p.(None):
p.(None): ``(4) develops and proposes the implementation of a social
p.(None): marketing campaign that is targeted at the population of
p.(None): students attending institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education.
p.(None):
p.(None): ``(e) Definition.--In this section, the term `institution of higher
p.(None): education' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
p.(None): DISTURBANCE.
p.(None):
p.(None): (a) Comprehensive Community Mental Health Services for Children With
p.(None): a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
p.(None): may include efforts to identify and serve children at risk'' before the
p.(None): period.
p.(None): (b) Requirements With Respect to Carrying Out Purpose of Grants.--
p.(None): Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b))
p.(None): is amended by striking ``will not provide an individual with access to
p.(None): the system if the individual is more than 21 years of age'' and
p.(None): inserting ``will provide an individual with access to the system through
p.(None): the age of 21 years''.
p.(None): (c) Additional Provisions.--Section 564(f) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and
p.(None): provide a copy to the State involved)'' after ``to the Secretary''.
p.(None): (d) General Provisions.--Section 565 of the Public Health Service
p.(None): Act (42 U.S.C. 290ff-4) is amended--
p.(None): (1) in subsection (b)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``receiving a grant under section 561(a)'' and
p.(None): inserting ``, regardless of whether such public entity
p.(None): is receiving a grant under section 561(a)''; and
p.(None): (B) in subparagraph (B), by striking ``pursuant to''
p.(None): and inserting ``described in'';
p.(None): (2) in subsection (d)(1), by striking ``not more than 21
p.(None): years of age'' and inserting ``through the age of 21 years'';
p.(None): and
p.(None): (3) in subsection (f)(1), by striking ``$100,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
...
p.(None): ``(2) supporting the improvement of existing statewide or
p.(None): regional pediatric mental health care telehealth access
p.(None): programs.
p.(None):
p.(None): ``(b) Program Requirements.--
p.(None): ``(1) In general.--A pediatric mental health care telehealth
p.(None): access program referred to in subsection (a), with respect to
p.(None): which a grant under such subsection may be used, shall--
p.(None): ``(A) be a statewide or regional network of
p.(None): pediatric mental health teams that provide support to
p.(None): pediatric primary care sites as an integrated team;
p.(None): ``(B) support and further develop organized State or
p.(None): regional networks of pediatric mental health teams to
p.(None): provide consultative support to pediatric primary care
p.(None): sites;
p.(None): ``(C) conduct an assessment of critical behavioral
p.(None): consultation needs among pediatric providers and such
p.(None): providers' preferred mechanisms for receiving
p.(None): consultation, training, and technical assistance;
p.(None): ``(D) develop an online database and communication
p.(None): mechanisms, including telehealth, to facilitate
p.(None): consultation support to pediatric practices;
p.(None): ``(E) provide rapid statewide or regional clinical
p.(None): telephone or telehealth consultations when requested
p.(None): between the pediatric mental health teams and pediatric
p.(None): primary care providers;
p.(None): ``(F) conduct training and provide technical
p.(None): assistance to pediatric primary care providers to
p.(None): support the early identification, diagnosis, treatment,
p.(None): and referral of children with behavioral health
p.(None): conditions;
p.(None): ``(G) provide information to pediatric providers
p.(None): about, and assist pediatric providers in accessing,
p.(None): pediatric mental health care providers, including child
p.(None): and adolescent psychiatrists, and licensed mental health
p.(None): professionals, such as psychologists, social workers, or
p.(None): mental health counselors and in scheduling and
p.(None): conducting technical assistance;
p.(None): ``(H) assist with referrals to specialty care and
p.(None): community or behavioral health resources; and
p.(None): ``(I) establish mechanisms for measuring and
p.(None): monitoring increased access to pediatric mental health
p.(None): care services by pediatric primary care providers and
p.(None): expanded capacity of pediatric primary care providers to
p.(None): identify, treat, and refer children with mental health
p.(None): problems.
p.(None): ``(2) Pediatric mental health teams.--In this subsection,
p.(None): the term `pediatric mental health team' means a team consisting
p.(None): of at least one case coordinator, at least one child and
p.(None): adolescent psychiatrist, and at least one licensed clinical
p.(None):
p.(None): [[Page 130 STAT. 1264]]
p.(None):
p.(None): mental health professional, such as a psychologist, social
p.(None): worker, or mental health counselor. Such a team may be
p.(None): regionally based.
p.(None):
p.(None): ``(c) Application.--A State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization seeking a grant under this section
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may require,
p.(None): including a plan for the comprehensive evaluation of activities that are
p.(None): carried out with funds received under such grant.
p.(None): ``(d) Evaluation.--A State, political subdivision of a State, Indian
p.(None): tribe, or tribal organization that receives a grant under this section
p.(None): shall prepare and submit an evaluation of activities that are carried
p.(None): out with funds received under such grant to the Secretary at such time,
p.(None): in such manner, and containing such information as the Secretary may
p.(None): reasonably require, including a process and outcome evaluation.
p.(None): ``(e) Access to Broadband.--In administering grants under this
p.(None): section, the Secretary may coordinate with other agencies to ensure that
p.(None): funding opportunities are available to support access to reliable, high-
p.(None): speed Internet for providers.
p.(None): ``(f) Matching Requirement.--The Secretary may not award a grant
p.(None): under this section unless the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization involved agrees, with respect to
p.(None): the costs to be incurred by the State, political subdivision of a State,
p.(None): Indian tribe, or tribal organization in carrying out the purpose
p.(None): described in this section, to make available non-Federal contributions
p.(None): (in cash or in kind) toward such costs in an amount that is not less
p.(None): than 20 percent of Federal funds provided in the grant.
p.(None): ``(g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated, $9,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
p.(None): INTERVENTION SERVICES FOR CHILDREN AND
p.(None): ADOLESCENTS.
p.(None):
p.(None): The first section 514 of the Public Health Service Act (42 U.S.C.
p.(None): 290bb-7), relating to substance abuse treatment services for children
p.(None): and adolescents, is amended--
p.(None): (1) in the section heading, by striking ``abuse treatment''
p.(None): and inserting ``use disorder treatment and early intervention'';
p.(None): (2) by striking subsection (a) and inserting the following:
p.(None):
p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
p.(None): of the long-term consequences of child trauma, and early
p.(None): intervention services and treatment to address the long-term
p.(None): consequences of child trauma; and
p.(None): ``(2) the development of knowledge with regard to evidence-
p.(None): based practices for identifying and treating mental, behavioral,
p.(None): and biological disorders of children and youth resulting from
p.(None): witnessing or experiencing a traumatic event.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking ``subsection (a) related'' and
p.(None): inserting ``subsection (a)(2) (related'';
p.(None): (B) by striking ``treating disorders associated with
p.(None): psychological trauma'' and inserting ``treating mental,
p.(None): behavioral, and biological disorders associated with
p.(None): psychological trauma)''; and
p.(None): (C) by striking ``mental health agencies and
p.(None): programs that have established clinical and basic
p.(None): research'' and inserting ``universities, hospitals,
p.(None): mental health agencies,
p.(None):
p.(None): [[Page 130 STAT. 1266]]
p.(None):
p.(None): and other programs that have established clinical
p.(None): expertise and research'';
p.(None): (3) by redesignating subsections (c) through (g) as
p.(None): subsections (g) through (k), respectively;
p.(None): (4) by inserting after subsection (b), the following:
p.(None):
p.(None): ``(c) Child Outcome Data.--The NCTSI coordinating center described
p.(None): in subsection (a)(1) shall collect, analyze, report, and make publicly
p.(None): available, as appropriate, NCTSI-wide child treatment process and
p.(None): outcome data regarding the early identification and delivery of
p.(None): evidence-based treatment and services for children and families served
p.(None): by the NCTSI grantees.
p.(None): ``(d) Training.--The NCTSI coordinating center shall facilitate the
p.(None): coordination of training initiatives in evidence-based and trauma-
p.(None): informed treatments, interventions, and practices offered to NCTSI
p.(None): grantees, providers, and partners.
p.(None): ``(e) Dissemination and Collaboration.--The NCTSI coordinating
p.(None): center shall, as appropriate, collaborate with--
p.(None): ``(1) the Secretary, in the dissemination of evidence-based
p.(None): and trauma-informed interventions, treatments, products, and
p.(None): other resources to appropriate stakeholders; and
p.(None): ``(2) appropriate agencies that conduct or fund research
p.(None): within the Department of Health and Human Services, for purposes
p.(None): of sharing NCTSI expertise, evaluation data, and other
p.(None): activities, as appropriate.
p.(None):
p.(None): ``(f) Review.--The Secretary shall, consistent with the peer-review
p.(None): process, ensure that NCTSI applications are reviewed by appropriate
p.(None): experts in the field as part of a consensus-review process. The
p.(None): Secretary shall include review criteria related to expertise and
p.(None): experience in child trauma and evidence-based practices.'';
p.(None): (5) in subsection (g) (as so redesignated), by striking
p.(None): ``with respect to centers of excellence are distributed
p.(None): equitably among the regions of the country'' and inserting ``are
p.(None): distributed equitably among the regions of the United States'';
p.(None): (6) in subsection (i) (as so redesignated), by striking
...
p.(None): obstetrician-gynecologists, pediatricians,
p.(None): psychiatrists, mental health care providers, and adult
p.(None): primary care clinicians) to provide or receive real-time
p.(None): psychiatric consultation (in-person or remotely) to aid
p.(None): in the treatment of pregnant and parenting women;
p.(None): ``(B) establishing linkages with and among
p.(None): community-based resources, including mental health
p.(None): resources, primary care resources, and support groups;
p.(None): and
p.(None): ``(C) utilizing telehealth services for rural areas
p.(None): and medically underserved areas (as defined in section
p.(None): 330I(a)).
p.(None):
p.(None): ``(e) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $5,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 399Z-2. <> INFANT AND EARLY
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
p.(None): ``(B) multigenerational therapy and other services
p.(None): that support the caregiving relationship; and
p.(None): ``(2) ensure that programs funded through grants under this
p.(None): section are evidence-informed or evidence-based models,
p.(None): practices, and methods that are, as appropriate, culturally and
p.(None):
p.(None): [[Page 130 STAT. 1268]]
p.(None):
p.(None): linguistically appropriate, and can be replicated in other
p.(None): appropriate settings.
p.(None):
p.(None): ``(b) Eligible Children and Entities.--In this section:
p.(None): ``(1) Eligible child.--The term `eligible child' means a
p.(None): child from birth to not more than 12 years of age who--
p.(None): ``(A) is at risk for, shows early signs of, or has
p.(None): been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance; and
p.(None): ``(B) may benefit from infant and early childhood
p.(None): intervention or treatment programs or specialized
p.(None): preschool or elementary school programs that are
p.(None): evidence-based or that have been scientifically
p.(None): demonstrated to show promise but would benefit from
p.(None): further applied development.
p.(None): ``(2) Eligible entity.--The term `eligible entity' means a
p.(None): human services agency or nonprofit institution that--
p.(None): ``(A) employs licensed mental health professionals
p.(None): who have specialized training and experience in infant
p.(None): and early childhood mental health assessment, diagnosis,
p.(None): and treatment, or is accredited or approved by the
p.(None): appropriate State agency, as applicable, to provide for
p.(None): children from infancy to 12 years of age mental health
p.(None): promotion, intervention, or treatment services; and
p.(None): ``(B) provides services or programs described in
p.(None): subsection (a) that are evidence-based or that have been
p.(None): scientifically demonstrated to show promise but would
p.(None): benefit from further applied development.
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
p.(None): illness affecting individuals 18 years of age or older as
p.(None): having, at any time in the past year, a diagnosable mental,
p.(None): behavioral, or emotional disorder that results in serious
...
p.(None): under a State plan under such title XIX, or a waiver of such
p.(None): plan, who receive services in institutions for mental diseases
p.(None): through such organizations and plans.
p.(None): (3) The range of and average number of months, and the
p.(None): length of stay during such months, that such individuals are
p.(None): receiving such services in such institutions.
p.(None): (4) How such organizations or plans determine when to
p.(None): provide for the furnishing of such services through an
p.(None): institution for mental diseases in lieu of other benefits
p.(None): (including the full range of community-based services) under
p.(None): their contract with the State agency administering the State
p.(None): plan under such title XIX, or a waiver of such plan, to address
p.(None): psychiatric or substance use disorder treatment.
p.(None): (5) The extent to which the provision of services within
p.(None): such institutions has affected the capitated payments for such
p.(None): organizations or plans.
p.(None):
p.(None): (b) Report.--Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary shall submit to Congress a report on the
p.(None): study conducted under subsection (a).
p.(None): SEC. 12003. <> GUIDANCE ON OPPORTUNITIES
p.(None): FOR INNOVATION.
p.(None):
p.(None): Not later than 1 year after the date of the enactment of this Act,
p.(None): the Administrator of the Centers for Medicare & Medicaid Services shall
p.(None): issue a State Medicaid Director letter regarding opportunities to design
p.(None): innovative service delivery systems, including systems for providing
p.(None): community-based services, for adults with a serious mental illness or
p.(None): children with a serious emotional disturbance who are receiving medical
p.(None): assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.). The letter shall include opportunities for demonstration projects
p.(None): under section 1115 of such Act (42 U.S.C. 1315) to improve care for such
p.(None): adults and children.
p.(None): SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC
p.(None): DEMONSTRATION PROJECT.
p.(None):
p.(None): (a) Collection of Information.--The Secretary of Health and Human
p.(None): Services, acting through the Administrator of the Centers for Medicare &
p.(None): Medicaid Services, shall, to the extent practical and data is available,
p.(None): with respect to each State that has participated in the demonstration
p.(None): project established under section 2707
p.(None):
p.(None): [[Page 130 STAT. 1274]]
p.(None): of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a
p.(None): note), collect from each such State information on the following:
p.(None): (1) The number of institutions for mental diseases (as
p.(None): defined in section 1905(i) of the Social Security Act (42 U.S.C.
p.(None): 1396d(i))) and beds in such institutions that received payment
p.(None): for the provision of services to individuals who receive medical
p.(None): assistance under a State plan under the Medicaid program under
p.(None): title XIX of the Social Security Act (42 U.S.C. 1396 et seq.)
p.(None): (or under a waiver of such plan) through the demonstration
p.(None): project in each such State as compared to the total number of
p.(None): institutions for mental diseases and beds in the State.
p.(None): (2) The extent to which there is a reduction in expenditures
p.(None): under the Medicaid program under title XIX of the Social
p.(None): Security Act (42 U.S.C. 1396 et seq.) or other spending on the
p.(None): full continuum of physical or mental health care for individuals
p.(None): who receive treatment in an institution for mental diseases
p.(None): under the demonstration project, including outpatient,
...
p.(None): emergency departments during the period in which the
p.(None): demonstration project was is in operation differed, with respect
p.(None): to individuals who are receiving medical assistance under a
p.(None): State plan under the Medicaid program under title XIX of the
p.(None): Social Security Act (42 U.S.C. 1396 et seq.) (or under a waiver
p.(None): of such plan), between--
p.(None):
p.(None): [[Page 130 STAT. 1275]]
p.(None):
p.(None): (A) those individuals who received treatment in an
p.(None): institution for mental diseases under the demonstration
p.(None): project;
p.(None): (B) those individuals who met the eligibility
p.(None): requirements for the demonstration project but who did
p.(None): not receive treatment in an institution for mental
p.(None): diseases under the demonstration project; and
p.(None): (C) those adults with a serious mental illness who
p.(None): did not meet such eligibility requirements and did not
p.(None): receive treatment for such illness in an institution for
p.(None): mental diseases.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall submit to
p.(None): Congress a report that summarizes and analyzes the information collected
p.(None): under subsection (a). Such report may be submitted as part of the report
p.(None): required under section 2707(f) of the Patient Protection and Affordable
p.(None): Care Act (42 U.S.C. 1396a note) or separately.
p.(None): SEC. 12005. <> PROVIDING EPSDT SERVICES
p.(None): TO CHILDREN IN IMDS.
p.(None):
p.(None): (a) In General.--Section 1905(a)(16) of the Social Security Act (42
p.(None): U.S.C. 1396d(a)(16)) is amended--
p.(None): (1) by striking ``effective January 1, 1973'' and inserting
p.(None): ``(A) effective January 1, 1973''; and
p.(None): (2) by inserting before the semicolon at the end the
p.(None): following: ``, and, (B) for individuals receiving services
p.(None): described in subparagraph (A), early and periodic screening,
p.(None): diagnostic, and treatment services (as defined in subsection
p.(None): (r)), whether or not such screening, diagnostic, and treatment
p.(None): services are furnished by the provider of the services described
p.(None): in such subparagraph''.
p.(None):
p.(None): (b) Effective Date.--The amendments made by subsection (a) shall
p.(None): apply with respect to items and services furnished in calendar quarters
p.(None): beginning on or after January 1, 2019.
p.(None): SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
p.(None): PERSONAL CARE SERVICES AND HOME HEALTH
p.(None): CARE SERVICES UNDER MEDICAID.
p.(None):
p.(None): (a) In General.--Section 1903 of the Social Security Act (42 U.S.C.
p.(None): 1396b) is amended by inserting after subsection (k) the following new
p.(None): subsection:
p.(None): ``(l)(1) Subject to paragraphs (3) and (4), with respect to any
p.(None): amount expended for personal care services or home health care services
p.(None): requiring an in-home visit by a provider that are provided under a State
p.(None): plan under this title (or under a waiver of the plan) and furnished in a
p.(None): calendar quarter beginning on or after January 1, 2019 (or, in the case
...
p.(None): monitoring of, and response to patient complaints or
p.(None): inquiries relating to mental health parity and addiction
p.(None): equity requirements, which may be through the
p.(None): development and administration of--
p.(None): (i) a single, toll-free telephone number; and
p.(None): (ii) a new parity website--
p.(None): (I) to help consumers find the
p.(None): appropriate Federal or State agency to
p.(None): assist with their parity complaints,
p.(None): appeals, and other actions; and
p.(None): (II) that takes into consideration,
p.(None): but is not duplicative of, the parity
p.(None): beta site being tested, and released for
p.(None): public comment, by the Department of
p.(None): Health and Human Services as of the date
p.(None): of the enactment of this Act;
p.(None): (C) Federal and State law enforcement agencies
p.(None): entering into memoranda of understanding to better
p.(None): coordinate enforcement responsibilities and information
p.(None): sharing--
p.(None): (i) including whether such agencies should
p.(None): make the results of enforcement actions related to
p.(None): mental health parity and addiction equity
p.(None): requirements publicly available; and
p.(None):
p.(None): [[Page 130 STAT. 1285]]
p.(None):
p.(None): (ii) which may include State Policy Academies
p.(None): on Parity Implementation for State Officials and
p.(None): other forums to bring together national experts to
p.(None): provide technical assistance to teams of State
p.(None): officials on strategies to advance compliance with
p.(None): mental health parity and addiction equity
p.(None): requirements in both the commercial market, and in
p.(None): the Medicaid program under title XIX of the Social
p.(None): Security Act and the State Children's Health
p.(None): Insurance Program under title XXI of such Act; and
p.(None): (D) recommendations to the Congress regarding the
p.(None): need for additional legal authority to improve
p.(None): enforcement of mental health parity and addiction equity
p.(None): requirements, including the need for additional legal
p.(None): authority to ensure that nonquantitative treatment
p.(None): limitations are applied, and the extent and frequency of
p.(None): the applications of such limitations, both to medical
p.(None): and surgical benefits and to mental health and substance
p.(None): use disorder benefits in a comparable manner.
p.(None): SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL
p.(None): HEALTH AND SUBSTANCE USE DISORDER
p.(None): BENEFITS.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, and annually thereafter for the subsequent 5 years, the
p.(None): Assistant Secretary of Labor of the Employee Benefits Security
p.(None): Administration, in collaboration with the Administrator of the Centers
p.(None): for Medicare & Medicaid Services and the Secretary of the Treasury,
p.(None): shall submit to the Committee on Energy and Commerce of the House of
p.(None): Representatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report summarizing the results of all closed
p.(None): Federal investigations completed during the preceding 12-month period
p.(None): with findings of any serious violation regarding compliance with mental
...
p.(None): (4) A summary of the basis of the final decision rendered
p.(None): for each closed investigation conducted during the covered
p.(None): reporting period that resulted in a finding of a serious
p.(None): violation.
p.(None):
p.(None): (c) Limitation.--Any individually identifiable information shall be
p.(None): excluded from reports under subsection (a) consistent with protections
p.(None): under the health privacy and security rules promulgated under section
p.(None): 264(c) of the Health Insurance Portability and Accountability Act of
p.(None): 1996 (42 U.S.C. 1320d-2 note).
p.(None):
p.(None): [[Page 130 STAT. 1286]]
p.(None):
p.(None): SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE
p.(None): DISORDER BENEFITS.
p.(None):
p.(None): Not later than 3 years after the date of enactment of this Act, the
p.(None): Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, the Secretary of Labor, and the
p.(None): Secretary of the Treasury, shall submit to the Committee on Energy and
p.(None): Commerce of the House of Representatives and the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate a report detailing the
p.(None): extent to which group health plans or health insurance issuers offering
p.(None): group or individual health insurance coverage that provides both medical
p.(None): and surgical benefits and mental health or substance use disorder
p.(None): benefits, medicaid managed care organizations with a contract under
p.(None): section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), and
p.(None): health plans provided under the State Children's Health Insurance
p.(None): Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et
p.(None): seq.) comply with section 2726 of the Public Health Service Act (42
p.(None): U.S.C. 300gg-26), section 712 of the Employee Retirement Income Security
p.(None): Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal Revenue
p.(None): Code of 1986, including--
p.(None): (1) how nonquantitative treatment limitations, including
p.(None): medical necessity criteria, of such plans or issuers comply with
p.(None): such sections;
p.(None): (2) how the responsible Federal departments and agencies
p.(None): ensure that such plans or issuers comply with such sections,
p.(None): including an assessment of how the Secretary of Health and Human
p.(None): Services has used its authority to conduct audits of such plans
p.(None): to ensure compliance;
p.(None): (3) a review of how the various Federal and State agencies
p.(None): responsible for enforcing mental health parity requirements have
p.(None): improved enforcement of such requirements in accordance with the
p.(None): objectives and timeline described in the action plan under
p.(None): section 13002; and
p.(None): (4) recommendations for how additional enforcement,
p.(None): education, and coordination activities by responsible Federal
p.(None): and State departments and agencies could better ensure
p.(None): compliance with such sections, including recommendations
p.(None): regarding the need for additional legal authority.
p.(None): SEC. 13005. <> INFORMATION AND AWARENESS
p.(None): ON EATING DISORDERS.
p.(None):
p.(None): (a) Information.--The Secretary of Health and Human Services, acting
...
p.(None): diagnosed with, or manifests obvious signs of,
p.(None): mental illness or a substance abuse disorder or
p.(None): co-occurring mental illness and substance abuse
p.(None): disorder;
p.(None):
p.(None): [[Page 130 STAT. 1312]]
p.(None):
p.(None): ``(ii) has been unanimously approved for
p.(None): participation in a program funded under this
p.(None): section by, when appropriate--
p.(None): ``(I) the relevant--
p.(None): ``(aa) prosecuting attorney;
p.(None): ``(bb) defense attorney;
p.(None): ``(cc) probation or
p.(None): corrections official; and
p.(None): ``(dd) judge; and
p.(None): ``(II) a representative from the
p.(None): relevant mental health agency described
p.(None): in subsection (b)(5)(B)(i);
p.(None): ``(iii) has been determined, by each person
p.(None): described in clause (ii) who is involved in
p.(None): approving the adult or juvenile for participation
p.(None): in a program funded under this section, to not
p.(None): pose a risk of violence to any person in the
p.(None): program, or the public, if selected to participate
p.(None): in the program; and
p.(None): ``(iv) has not been charged with or convicted
p.(None): of--
p.(None): ``(I) any sex offense (as defined in
p.(None): section 111 of the Sex Offender
p.(None): Registration and Notification Act (42
p.(None): U.S.C. 16911)) or any offense relating
p.(None): to the sexual exploitation of children;
p.(None): or
p.(None): ``(II) murder or assault with intent
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
p.(None): mental health or substance abuse agency representative
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
...
Social / Ethnicity
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p.(None): subsection (a) unless such professional has a substantial amount of
p.(None): education loans relative to income (as determined pursuant to guidelines
p.(None): issued by the Director).'';
p.(None): (5) in subsection (d) (as so redesignated), by striking
p.(None): ``The provisions'' and inserting ``Applicability of Certain
p.(None): Provisions Regarding Obligated Service.--The provisions''; and
p.(None): (6) in subsection (e) (as so redesignated), by striking
p.(None): ``Amounts'' and inserting ``Availability of Appropriations.--
p.(None): Amounts''.
p.(None):
p.(None): (c) Technical and Conforming Amendments.--Title IV of the Public
p.(None): Health Service Act is amended--
p.(None): (1) by striking section 464z-5 (42 U.S.C. 285t-2);
p.(None): (2) by striking section 487C (42 U.S.C. 288-3);
p.(None): (3) by striking section 487E (42 U.S.C. 288-5);
p.(None): (4) by striking section 487F (42 U.S.C. 288-5a), as added by
p.(None): section 205 of Public Law 106-505, relating to loan repayment
p.(None): for clinical researchers; and
p.(None): (5) by striking section 487F (42 U.S.C. 288-6), as added by
p.(None): section 1002(b) of Public Law 106-310 relating to pediatric
p.(None): research loan repayment.
p.(None):
p.(None): (d) GAO Report.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States
p.(None): shall submit to Congress a report on the efforts of the National
p.(None): Institutes of Health to attract, retain, and develop emerging
p.(None): scientists, including underrepresented individuals in the sciences, such
p.(None): as women, racial and ethnic minorities, and other groups. Such report
p.(None): shall include an analysis of the impact of the additional authority
p.(None): provided to the Secretary of Health and Human Services under this Act to
p.(None): address workforce shortages and gaps in priority research areas,
p.(None): including which centers and research areas offered loan repayment
p.(None): program participants the increased award amount.
p.(None):
p.(None): Subtitle D--National Institutes of Health Planning and Administration
p.(None):
p.(None): SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
p.(None):
p.(None): (a) Strategic Plan.--Section 402 of the Public Health Service Act
p.(None): (42 U.S.C. 282) is amended--
p.(None): (1) in subsection (b)(5), by inserting before the semicolon
p.(None): the following: ``, and through the development, implementation,
p.(None):
p.(None): [[Page 130 STAT. 1055]]
p.(None):
p.(None): and updating of the strategic plan developed under subsection
p.(None): (m)''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(m) National Institutes of Health Strategic Plan.--
p.(None): ``(1) In general.--Not later than 2 years after the date of
p.(None): enactment of the 21st Century Cures Act, and at least every 6
p.(None): years thereafter, the Director of the National Institutes of
p.(None): Health shall develop and submit to the appropriate committees of
p.(None): Congress and post on the Internet website of the National
p.(None): Institutes of Health, a coordinated strategy (to be known as the
p.(None): `National Institutes of Health Strategic Plan') to provide
p.(None): direction to the biomedical research investments made by the
p.(None): National Institutes of Health, to facilitate collaboration
p.(None): across the institutes and centers, to leverage scientific
...
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9023. <> CLARIFICATION ON CURRENT
p.(None): ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
p.(None):
p.(None): The Administrator of the Health Resources and Services
p.(None): Administration shall clarify the eligibility pursuant to section
p.(None): 338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
p.(None): 1(b)(1)(B)) of child and adolescent psychiatrists for the National
p.(None): Health Service Corps Loan Repayment Program under subpart III of part D
p.(None): of title III of such Act (42 U.S.C. 254l et seq.).
p.(None): SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by adding at the end the following:
p.(None):
p.(None): ``PART K--MINORITY FELLOWSHIP PROGRAM
p.(None):
p.(None): ``SEC. 597. <> FELLOWSHIPS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall maintain a program, to be
p.(None): known as the Minority Fellowship Program, under which the Secretary
p.(None): shall award fellowships, which may include stipends, for the purposes
p.(None): of--
p.(None):
p.(None): [[Page 130 STAT. 1254]]
p.(None): ``(1) increasing the knowledge of mental and substance use
p.(None): disorders practitioners on issues related to prevention,
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
...
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p.(None): [[Page 130 STAT. 1065]]
p.(None):
p.(None): (b) Reporting.--Section 492B(f) of the Public Health Service Act (42
p.(None): U.S.C. 289a-2(f)) is amended--
p.(None): (1) by striking ``biennial'' each place such term appears
p.(None): and inserting ``triennial'';
p.(None): (2) by striking ``The advisory council'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The advisory council''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(2) Contents.--Each triennial report prepared by an
p.(None): advisory council of each national research institute as
p.(None): described in paragraph (1) shall include each of the following:
p.(None): ``(A) The number of women included as subjects, and
p.(None): the proportion of subjects that are women, in any
p.(None): project of clinical research conducted during the
p.(None): applicable reporting period, disaggregated by categories
p.(None): of research area, condition, or disease, and accounting
p.(None): for single-sex studies.
p.(None): ``(B) The number of members of minority groups
p.(None): included as subjects, and the proportion of subjects
p.(None): that are members of minority groups, in any project of
p.(None): clinical research conducted during the applicable
p.(None): reporting period, disaggregated by categories of
p.(None): research area, condition, or disease and accounting for
p.(None): single-race and single-ethnicity studies.
p.(None): ``(C) For the applicable reporting period, the
p.(None): number of projects of clinical research that include
p.(None): women and members of minority groups and that--
p.(None): ``(i) have been completed during such
p.(None): reporting period; and
p.(None): ``(ii) are being carried out during such
p.(None): reporting period and have not been completed.
p.(None): ``(D) The number of studies completed during the
p.(None): applicable reporting period for which reporting has been
p.(None): submitted in accordance with subsection (c)(2)(A).''.
p.(None):
p.(None): (c) Coordination.--Section 486(c)(2) of the Public Health Service
p.(None): Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
p.(None): inserting ``senior-level staff designees''.
p.(None): (d) In General.--Part A of title IV of the Public Health Service Act
p.(None): (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended
p.(None): by adding at the end the following:
p.(None): ``SEC. 404N. <> POPULATION FOCUSED RESEARCH.
p.(None):
p.(None): ``The Director of the National Institutes of Health shall, as
p.(None): appropriate, encourage efforts to improve research related to the health
p.(None): of sexual and gender minority populations, including by--
p.(None): ``(1) facilitating increased participation of sexual and
p.(None): gender minority populations in clinical research supported by
p.(None): the National Institutes of Health, and reporting on such
p.(None): participation, as applicable;
...
p.(None): et seq.) is amended by inserting after section 399S the following:
p.(None):
p.(None): [[Page 130 STAT. 1077]]
p.(None):
p.(None): ``SEC. 399S-1. <> SURVEILLANCE OF
p.(None): NEUROLOGICAL DISEASES.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Director of the
p.(None): Centers for Disease Control and Prevention and in coordination with
p.(None): other agencies as the Secretary determines, shall, as appropriate--
p.(None): ``(1) enhance and expand infrastructure and activities to
p.(None): track the epidemiology of neurological diseases; and
p.(None): ``(2) incorporate information obtained through such
p.(None): activities into an integrated surveillance system, which may
p.(None): consist of or include a registry, to be known as the National
p.(None): Neurological Conditions Surveillance System.
p.(None):
p.(None): ``(b) Research.--The Secretary shall ensure that the National
p.(None): Neurological Conditions Surveillance System is designed in a manner that
p.(None): facilitates further research on neurological diseases.
p.(None): ``(c) Content.--In carrying out subsection (a), the Secretary--
p.(None): ``(1) shall provide for the collection and storage of
p.(None): information on the incidence and prevalence of neurological
p.(None): diseases in the United States;
p.(None): ``(2) to the extent practicable, shall provide for the
p.(None): collection and storage of other available information on
p.(None): neurological diseases, including information related to persons
p.(None): living with neurological diseases who choose to participate,
p.(None): such as--
p.(None): ``(A) demographics, such as age, race, ethnicity,
p.(None): sex, geographic location, family history, and other
p.(None): information, as appropriate;
p.(None): ``(B) risk factors that may be associated with
p.(None): neurological diseases, such as genetic and environmental
p.(None): risk factors and other information, as appropriate; and
p.(None): ``(C) diagnosis and progression markers;
p.(None): ``(3) may provide for the collection and storage of
p.(None): information relevant to analysis on neurological diseases, such
p.(None): as information concerning--
p.(None): ``(A) the natural history of the diseases;
p.(None): ``(B) the prevention of the diseases;
p.(None): ``(C) the detection, management, and treatment
p.(None): approaches for the diseases; and
p.(None): ``(D) the development of outcomes measures;
p.(None): ``(4) may address issues identified during the consultation
p.(None): process under subsection (d); and
p.(None): ``(5) initially may address a limited number of neurological
p.(None): diseases.
p.(None):
p.(None): ``(d) Consultation.--In carrying out this section, the Secretary
p.(None): shall consult with individuals with appropriate expertise, which may
p.(None): include--
p.(None): ``(1) epidemiologists with experience in disease
p.(None): surveillance or registries;
p.(None): ``(2) representatives of national voluntary health
p.(None): associations that--
p.(None): ``(A) focus on neurological diseases; and
p.(None): ``(B) have demonstrated experience in research,
p.(None): care, or patient services;
p.(None): ``(3) health information technology experts or other
p.(None): information management specialists;
p.(None): ``(4) clinicians with expertise in neurological diseases;
p.(None): and
p.(None): ``(5) research scientists with experience conducting
...
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
p.(None): subsection as a target area described in subparagraph
p.(None): (B) if--
p.(None): ``(i) the area is so identified for purposes
p.(None): of responding to new circumstances that have
p.(None): arisen in the health information technology
p.(None): community that affect the interoperability,
...
Social / Homeless Persons
Searching for indicator homeless:
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p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
...
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
...
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
p.(None): justice or serious mental illness;
p.(None): (J) at least 1 member shall be a law enforcement
p.(None): officer or corrections officer with extensive experience
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
p.(None): (g) Sunset.--The Committee shall terminate on the date that is 6
p.(None): years after the date on which the Committee is established under
p.(None): subsection (a)(1).
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by inserting after section 501 (42 U.S.C. 290aa) the
p.(None): following:
p.(None): ``SEC. 501A. <> NATIONAL MENTAL HEALTH AND
p.(None): SUBSTANCE USE POLICY LABORATORY.
p.(None):
...
p.(None): and data sources that should be used to determine the indices;
p.(None): (4) an evaluation of the variables and data sources that are
p.(None): being used for each of the indices involved, and whether such
p.(None): variables and data sources accurately represent the need for
p.(None): services, the cost of providing services, and the ability of the
p.(None): States to pay for such services;
p.(None): (5) the effect that the minimum allotment requirements for
p.(None): each such block grant have on each State's final allotment and
p.(None): the effect of such requirements, if any, on each State's
p.(None): formula-based allotment;
p.(None):
p.(None): [[Page 130 STAT. 1234]]
p.(None):
p.(None): (6) recommendations for modifications to the minimum
p.(None): allotment provisions to ensure an appropriate distribution of
p.(None): funds; and
p.(None): (7) any other information that the Secretary determines
p.(None): appropriate.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of enactment of
p.(None): this Act, the Secretary of Health and Human Services shall submit to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and
p.(None): the Committee on Energy and Commerce of the House of Representatives, a
p.(None): report containing the findings and recommendations of the study
p.(None): conducted under subsection (a) and the study conducted under section
p.(None): 9004(g).
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
p.(None): INDIVIDUALS.
p.(None):
p.(None): Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is
p.(None): amended--
p.(None): (1) in subsection (a), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraphs (1) and (3), by striking
p.(None): ``substance abuse'' each place the term appears and
p.(None): inserting ``substance use disorder''; and
p.(None): (B) in paragraph (4), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder'';
p.(None): (3) in subsection (c)--
p.(None): (A) in paragraph (1), by striking ``substance abuse
p.(None): disorder'' and inserting ``substance use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in subparagraph (A), by striking
p.(None): ``substance abuse'' and inserting ``a substance
p.(None): use disorder''; and
p.(None): (ii) in subparagraph (B), by striking
...
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
...
Social / Incarcerated
Searching for indicator incarcerated:
(return to top)
p.(None): group shall conduct a review and submit a report to the
p.(None): Secretary containing recommendations on whether the uses and
p.(None): disclosures of protected health information for research
p.(None): purposes should be modified to allow protected health
p.(None): information to be available, as appropriate, for research
p.(None): purposes, including studies to obtain generalizable knowledge,
p.(None): while protecting individuals' privacy rights. In conducting the
p.(None): review and making recommendations, the working group shall--
p.(None): (A) address, at a minimum--
p.(None): (i) the appropriate manner and timing of
p.(None): authorization, including whether additional
p.(None): notification to the individual should be required
p.(None): when the individual's protected health information
p.(None): will be used or disclosed for such research;
p.(None): (ii) opportunities for individuals to set
p.(None): preferences on the manner in which their protected
p.(None): health information is used in research;
p.(None): (iii) opportunities for patients to revoke
p.(None): authorization;
p.(None): (iv) notification to individuals of a breach
p.(None): in privacy;
p.(None): (v) existing gaps in statute, regulation, or
p.(None): policy related to protecting the privacy of
p.(None): individuals, and
p.(None): (vi) existing barriers to research related to
p.(None): the current restrictions on the uses and
p.(None): disclosures of protected health information; and
p.(None): (B) consider, at a minimum--
p.(None): (i) expectations and preferences on how an
p.(None): individual's protected health information is
p.(None): shared and used;
p.(None): (ii) issues related to specific subgroups of
p.(None): people, such as children, incarcerated
p.(None): individuals, and individuals with a cognitive or
p.(None): intellectual disability impacting capacity to
p.(None): consent;
p.(None): (iii) relevant Federal and State laws;
p.(None): (iv) models of facilitating data access and
p.(None): levels of data access, including data
p.(None): segmentation, where applicable;
p.(None): (v) potential impacts of disclosure and non-
p.(None): disclosure of protected health information on
p.(None): access to health care services; and
p.(None): (vi) the potential uses of such data.
p.(None): (4) Report submission.--The Secretary shall submit the
p.(None): report under paragraph (3) to the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Committee
p.(None): on Energy and Commerce of the House of Representatives, and
p.(None): shall post such report on the appropriate Internet website of
p.(None): the Department of Health and Human Services.
p.(None): (5) Termination.--The working group convened under paragraph
p.(None): (1) shall terminate the day after the report under paragraph (3)
p.(None): is submitted to Congress and made public in accordance with
p.(None): paragraph (4).
p.(None):
p.(None): (d) Definitions.--In this section:
p.(None):
p.(None): [[Page 130 STAT. 1083]]
p.(None):
p.(None): (1) The rule.--References to ``the Rule'' refer to part 160
p.(None): or part 164, as appropriate, of title 45, Code of Federal
p.(None): Regulations (or any successor regulation).
...
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
p.(None): and report on required performance measures; and
p.(None): ``(E) the extent to which the grantee is proposing
p.(None): to use evidence-based practices; and
p.(None): ``(25) advance, through existing programs, the use of
p.(None): performance metrics, including those based on the
p.(None): recommendations on performance metrics from the Assistant
p.(None): Secretary for Planning and Evaluation under section 6021(d) of
p.(None): the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016.''; and
p.(None): (3) in subsection (m), by adding at the end the following:
p.(None): ``(4) Emergency response.--Amounts made available for
p.(None): carrying out this subsection shall remain available through the
p.(None): end of the fiscal year following the fiscal year for which such
...
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
p.(None): services and substance abuse treatment services;
p.(None): and
p.(None): ``(iii) alternatives to solitary confinement
p.(None): and segregated housing and mental health screening
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
...
Searching for indicator jail:
(return to top)
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
...
p.(None): ``substance abuse'' each place the term appears and
p.(None): inserting ``substance use disorder''; and
p.(None): (B) in paragraph (4), by striking ``substance
p.(None): abuse'' and inserting ``a substance use disorder'';
p.(None): (3) in subsection (c)--
p.(None): (A) in paragraph (1), by striking ``substance abuse
p.(None): disorder'' and inserting ``substance use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in subparagraph (A), by striking
p.(None): ``substance abuse'' and inserting ``a substance
p.(None): use disorder''; and
p.(None): (ii) in subparagraph (B), by striking
p.(None): ``substance abuse'' and inserting ``substance use
p.(None): disorder''; and
p.(None): (4) in subsection (e), by striking ``, $50,000,000 for
p.(None): fiscal year 2001, and such sums as may be necessary for each of
p.(None): the fiscal years 2002 and 2003'' and inserting ``$41,304,000 for
p.(None): each of fiscal years 2018 through 2022''.
p.(None): SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
p.(None):
p.(None): Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38)
p.(None): is amended--
p.(None): (1) by striking ``substance abuse'' each place such term
p.(None): appears and inserting ``substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Indian tribes, and tribal
p.(None): organizations'' and inserting ``and Indian tribes and
p.(None): tribal organizations (as the terms `Indian tribes' and
p.(None): `tribal organizations' are
p.(None):
p.(None): [[Page 130 STAT. 1235]]
p.(None):
p.(None): defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act)''; and
p.(None): (B) by inserting ``or a health facility or program
p.(None): operated by or in accordance with a contract or grant
p.(None): with the Indian Health Service,'' after ``entities,'';
p.(None): (3) in subsection (c)(2)(A)(i), by striking ``the best
p.(None): known'' and inserting ``evidence-based'';
p.(None): (4) by redesignating subsections (d) through (i) as
p.(None): subsections (e) through (j), respectively;
p.(None): (5) by inserting after subsection (c) the following:
p.(None):
p.(None): ``(d) Special Consideration Regarding Veterans.--In awarding grants
p.(None): under subsection (a), the Secretary shall, as appropriate, give special
p.(None): consideration to entities proposing to use grant funding to support jail
p.(None): diversion services for veterans.'';
p.(None): (6) in subsection (e), as so redesignated--
p.(None): (A) in paragraph (3), by striking ``; and'' and
p.(None): inserting a semicolon;
p.(None): (B) in paragraph (4), by striking the period and
p.(None): inserting ``; and''; and
p.(None): (C) by adding at the end the following:
p.(None): ``(5) develop programs to divert individuals prior to
p.(None): booking or arrest.''; and
p.(None): (7) in subsection (j), as so redesignated, by striking
p.(None): ``$10,000,000 for fiscal year 2001, and such sums as may be
p.(None): necessary for fiscal years 2002 through 2003'' and inserting
p.(None): ``$4,269,000 for each of fiscal years 2018 through 2022''.
p.(None): SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH
p.(None): CARE.
p.(None):
p.(None): Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42)
p.(None): is amended to read as follows:
p.(None): ``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
p.(None): AGREEMENTS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Eligible entity.--The term `eligible entity' means a
p.(None): State, or other appropriate State agency, in collaboration with
p.(None): 1 or more qualified community programs as described in section
p.(None): 1913(b)(1) or 1 or more community health centers as described in
p.(None): section 330.
p.(None): ``(2) Integrated care.--The term `integrated care' means
p.(None): collaborative models or practices offering mental and physical
p.(None): health services, which may include practices that share the same
p.(None): space in the same facility.
p.(None): ``(3) Special population.--The term `special population'
p.(None): means--
p.(None): ``(A) adults with a mental illness who have co-
p.(None): occurring physical health conditions or chronic
p.(None): diseases;
...
p.(None): establish and operate a National Criminal Justice and Mental Health
p.(None): Training and Technical Assistance Center to--
p.(None): ``(1) provide law enforcement officer training regarding
p.(None): mental health and working with individuals with mental
p.(None): illnesses, with an emphasis on de-escalation of encounters
p.(None): between law enforcement officers and those with mental disorders
p.(None): or in crisis, which shall include support the development of in-
p.(None): person and technical information exchanges between systems and
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
p.(None): training and technical assistance for criminal justice agencies;
p.(None): ``(5) develop a receiving center system and pilot strategy
p.(None): that provides, for a jurisdiction, a single point of entry into
p.(None): the mental health and substance abuse system for assessments and
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
...
p.(None): based responses;
p.(None): ``(cc) court hearings and
p.(None): disposition alternatives;
p.(None): ``(dd) reentry from jails
p.(None): and prisons; and
p.(None): ``(ee) community
p.(None): supervision, treatment and
p.(None): support services; and
p.(None): ``(ii) may serve as a starting point for the
p.(None): development of strategic plans to achieve positive
p.(None): public health and safety outcomes; and
p.(None): ``(B) implementation, which shall--
p.(None): ``(i) be derived from the strategic plans
p.(None): described in subparagraph (A)(ii); and
p.(None): ``(ii) consist of--
p.(None): ``(I) hiring and training personnel;
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
...
p.(None): and treatment for inmates placed in solitary
p.(None): confinement or segregated housing; and
p.(None): ``(D) to train each employee of the correctional
p.(None): facility to identify and appropriately respond to
p.(None): incidents involving inmates with mental health or co-
p.(None): occurring mental health and substance abuse
p.(None): disorders.''.
p.(None): SEC. 14023. ALLOWABLE USES.
p.(None):
p.(None): Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and
p.(None): Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by
p.(None): adding at the end the following:
p.(None): ``(v) Teams addressing frequent users of
p.(None): crisis services.--Multidisciplinary teams that--
p.(None): ``(I) coordinate, implement, and
p.(None): administer community-based crisis
p.(None): responses and long-term plans for
p.(None): frequent users of crisis services;
p.(None): ``(II) provide training on how to
p.(None): respond appropriately to the unique
p.(None): issues involving frequent users of
p.(None): crisis services for public service
p.(None): personnel,
p.(None):
p.(None): [[Page 130 STAT. 1310]]
p.(None):
p.(None): including criminal justice, mental
p.(None): health, substance abuse, emergency room,
p.(None): healthcare, law enforcement,
p.(None): corrections, and housing personnel;
p.(None): ``(III) develop or support
p.(None): alternatives to hospital and jail
p.(None): admissions for frequent users of crisis
p.(None): services that provide treatment,
p.(None): stabilization, and other appropriate
p.(None): supports in the least restrictive, yet
p.(None): appropriate, environment; and
p.(None): ``(IV) develop protocols and systems
p.(None): among law enforcement, mental health,
p.(None): substance abuse, housing, corrections,
p.(None): and emergency medical service operations
p.(None): to provide coordinated assistance to
p.(None): frequent users of crisis services.''.
p.(None): SEC. 14024. LAW ENFORCEMENT TRAINING.
p.(None):
p.(None): Section 2991(h) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
...
Searching for indicator prison:
(return to top)
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
p.(None): DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
p.(None): AMERICANS
p.(None):
p.(None): Sec. 15000. Short title.
p.(None):
p.(None): TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
p.(None):
p.(None): Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
p.(None): similar hospital services.
p.(None): Sec. 15002. Establishing beneficiary equity in the Medicare hospital
p.(None): readmission program.
p.(None): Sec. 15003. Five-year extension of the rural community hospital
p.(None): demonstration program.
p.(None): Sec. 15004. Regulatory relief for LTCHs.
p.(None): Sec. 15005. Savings from IPPS MACRA pay-for through not applying
p.(None): documentation and coding adjustments.
p.(None): Sec. 15006. Extension of certain LTCH Medicare payment rules.
p.(None): Sec. 15007. Application of rules on the calculation of hospital length
p.(None): of stay to all LTCHs.
p.(None): Sec. 15008. Change in Medicare classification for certain hospitals.
p.(None): Sec. 15009. Temporary exception to the application of the Medicare LTCH
p.(None): site neutral provisions for certain spinal cord specialty
p.(None): hospitals.
p.(None): Sec. 15010. Temporary extension to the application of the Medicare LTCH
p.(None): site neutral provisions for certain discharges with severe
p.(None): wounds.
p.(None):
p.(None): TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
...
p.(None): Training and Technical Assistance Center to--
p.(None): ``(1) provide law enforcement officer training regarding
p.(None): mental health and working with individuals with mental
p.(None): illnesses, with an emphasis on de-escalation of encounters
p.(None): between law enforcement officers and those with mental disorders
p.(None): or in crisis, which shall include support the development of in-
p.(None): person and technical information exchanges between systems and
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
p.(None): training and technical assistance for criminal justice agencies;
p.(None): ``(5) develop a receiving center system and pilot strategy
p.(None): that provides, for a jurisdiction, a single point of entry into
p.(None): the mental health and substance abuse system for assessments and
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
p.(None): criminal justice agencies evaluation tools, mechanisms, and
p.(None): measures to better assess and document performance measures and
...
p.(None): Representatives a report that includes--
p.(None): ``(i) a list of all duplicate grants awarded,
p.(None): including the total dollar amount of any duplicate
p.(None): grants awarded; and
p.(None): ``(ii) the reason the Attorney General awarded
p.(None): the duplicate grants.''.
p.(None): SEC. 14015. <> IMPROVING DEPARTMENT OF
p.(None): JUSTICE DATA COLLECTION ON MENTAL
p.(None): ILLNESS INVOLVED IN CRIME.
p.(None):
p.(None): (a) In General.--Notwithstanding any other provision of law, on or
p.(None): after the date that is 90 days after the date on which the Attorney
p.(None): General promulgates regulations under subsection (b), any data prepared
p.(None): by, or submitted to, the Attorney General or the Director of the Federal
p.(None): Bureau of Investigation with respect to the incidences of homicides, law
p.(None): enforcement officers killed, seriously injured, and assaulted, or
p.(None): individuals killed or seriously injured by law enforcement officers
p.(None): shall include data with respect to the involvement of mental illness in
p.(None): such incidences, if any.
p.(None): (b) Regulations.--Not later than 90 days after the date of the
p.(None): enactment of this Act, the Attorney General shall promulgate or revise
p.(None): regulations as necessary to carry out subsection (a).
p.(None): SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
p.(None): PRISON.
p.(None):
p.(None): (a) Report on the Cost of Treating the Mentally Ill in the Criminal
p.(None): Justice System.--Not later than 12 months after the date of enactment of
p.(None): this Act, the Comptroller General of the United States shall submit to
p.(None): Congress a report detailing the cost of imprisonment for individuals who
p.(None): have serious mental illness by the Federal Government or a State or unit
p.(None): of local government, which shall include--
p.(None):
p.(None): [[Page 130 STAT. 1307]]
p.(None):
p.(None): (1) the number and type of crimes committed by individuals
p.(None): with serious mental illness each year; and
p.(None): (2) detail strategies or ideas for preventing crimes by
p.(None): those individuals with serious mental illness from occurring.
p.(None):
p.(None): (b) Definition.--For purposes of this section, the Attorney General,
p.(None): in consultation with the Assistant Secretary of Mental Health and
p.(None): Substance Use Disorders, shall define ``serious mental illness'' based
p.(None): on the ``Health Care Reform for Americans with Severe Mental Illnesses:
p.(None): Report'' of the National Advisory Mental Health Council, American
p.(None): Journal of Psychiatry 1993; 150:1447-1465.
p.(None): SEC. 14017. <> CODIFICATION OF DUE PROCESS
p.(None): FOR DETERMINATIONS BY SECRETARY OF
...
p.(None): risks and needs of individuals
p.(None): described in item (aa); and
p.(None): ``(II) developing strategies to
p.(None): address gaps in services and bring
p.(None): innovative and effective programs to
p.(None): scale along multiple intercepts,
p.(None): including--
p.(None): ``(aa) emergency and crisis
p.(None): services;
p.(None): ``(bb) specialized police-
p.(None): based responses;
p.(None): ``(cc) court hearings and
p.(None): disposition alternatives;
p.(None): ``(dd) reentry from jails
p.(None): and prisons; and
p.(None): ``(ee) community
p.(None): supervision, treatment and
p.(None): support services; and
p.(None): ``(ii) may serve as a starting point for the
p.(None): development of strategic plans to achieve positive
p.(None): public health and safety outcomes; and
p.(None): ``(B) implementation, which shall--
p.(None): ``(i) be derived from the strategic plans
p.(None): described in subparagraph (A)(ii); and
p.(None): ``(ii) consist of--
p.(None): ``(I) hiring and training personnel;
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
p.(None): facility' means a jail, prison, or other detention
p.(None): facility used to house people who have been arrested,
p.(None): detained, held, or convicted by a criminal justice
p.(None): agency or a court.
p.(None): ``(B) Eligible inmate.--The term `eligible inmate'
p.(None): means an individual who--
p.(None): ``(i) is being held, detained, or incarcerated
p.(None): in a correctional facility; and
p.(None): ``(ii) manifests obvious signs of a mental
p.(None): illness or has been diagnosed by a qualified
p.(None): mental health professional as having a mental
p.(None): illness.
p.(None): ``(2) Correctional facility grants.--The Attorney General
p.(None): may award grants to applicants to enhance the capabilities of a
p.(None): correctional facility--
p.(None): ``(A) to identify and screen for eligible inmates;
p.(None): ``(B) to plan and provide--
p.(None): ``(i) initial and periodic assessments of the
p.(None): clinical, medical, and social needs of inmates;
p.(None): and
p.(None): ``(ii) appropriate treatment and services that
p.(None): address the mental health and substance abuse
p.(None): needs of inmates;
p.(None): ``(C) to develop, implement, and enhance--
p.(None): ``(i) post-release transition plans for
p.(None): eligible inmates that, in a comprehensive manner,
p.(None): coordinate health, housing, medical, employment,
p.(None): and other appropriate services and public
p.(None): benefits;
p.(None): ``(ii) the availability of mental health care
...
Social / Infant
Searching for indicator infant:
(return to top)
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
...
p.(None):
p.(None): ``(c) Priority.--In awarding grants under this section, the
p.(None): Secretary may give priority to States proposing to improve or enhance
p.(None): access to screening services for maternal depression in primary care
p.(None): settings.
p.(None): ``(d) Use of Funds.--The activities eligible for funding through a
p.(None): grant under subsection (a)--
p.(None): ``(1) shall include--
p.(None): ``(A) providing appropriate training to health care
p.(None): providers; and
p.(None): ``(B) providing information to health care
p.(None): providers, including information on maternal depression
p.(None): screening, treatment, and followup support services, and
p.(None): linkages to community-based resources; and
p.(None): ``(2) may include--
p.(None): ``(A) enabling health care providers (including
p.(None): obstetrician-gynecologists, pediatricians,
p.(None): psychiatrists, mental health care providers, and adult
p.(None): primary care clinicians) to provide or receive real-time
p.(None): psychiatric consultation (in-person or remotely) to aid
p.(None): in the treatment of pregnant and parenting women;
p.(None): ``(B) establishing linkages with and among
p.(None): community-based resources, including mental health
p.(None): resources, primary care resources, and support groups;
p.(None): and
p.(None): ``(C) utilizing telehealth services for rural areas
p.(None): and medically underserved areas (as defined in section
p.(None): 330I(a)).
p.(None):
p.(None): ``(e) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $5,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 399Z-2. <> INFANT AND EARLY
p.(None): CHILDHOOD MENTAL HEALTH PROMOTION,
p.(None): INTERVENTION, AND TREATMENT.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall--
p.(None): ``(1) award grants to eligible entities to develop,
p.(None): maintain, or enhance infant and early childhood mental health
p.(None): promotion, intervention, and treatment programs, including--
p.(None): ``(A) programs for infants and children at
p.(None): significant risk of developing, showing early signs of,
p.(None): or having been diagnosed with mental illness, including
p.(None): a serious emotional disturbance; and
p.(None): ``(B) multigenerational therapy and other services
p.(None): that support the caregiving relationship; and
p.(None): ``(2) ensure that programs funded through grants under this
p.(None): section are evidence-informed or evidence-based models,
p.(None): practices, and methods that are, as appropriate, culturally and
p.(None):
p.(None): [[Page 130 STAT. 1268]]
p.(None):
p.(None): linguistically appropriate, and can be replicated in other
p.(None): appropriate settings.
p.(None):
p.(None): ``(b) Eligible Children and Entities.--In this section:
p.(None): ``(1) Eligible child.--The term `eligible child' means a
p.(None): child from birth to not more than 12 years of age who--
p.(None): ``(A) is at risk for, shows early signs of, or has
p.(None): been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance; and
p.(None): ``(B) may benefit from infant and early childhood
p.(None): intervention or treatment programs or specialized
p.(None): preschool or elementary school programs that are
p.(None): evidence-based or that have been scientifically
p.(None): demonstrated to show promise but would benefit from
p.(None): further applied development.
p.(None): ``(2) Eligible entity.--The term `eligible entity' means a
p.(None): human services agency or nonprofit institution that--
p.(None): ``(A) employs licensed mental health professionals
p.(None): who have specialized training and experience in infant
p.(None): and early childhood mental health assessment, diagnosis,
p.(None): and treatment, or is accredited or approved by the
p.(None): appropriate State agency, as applicable, to provide for
p.(None): children from infancy to 12 years of age mental health
p.(None): promotion, intervention, or treatment services; and
p.(None): ``(B) provides services or programs described in
p.(None): subsection (a) that are evidence-based or that have been
p.(None): scientifically demonstrated to show promise but would
p.(None): benefit from further applied development.
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
p.(None): subsection as a target area described in subparagraph
p.(None): (B) if--
p.(None): ``(i) the area is so identified for purposes
p.(None): of responding to new circumstances that have
p.(None): arisen in the health information technology
p.(None): community that affect the interoperability,
p.(None): privacy, or security of health information, or
p.(None): affect patient safety; and
...
Searching for indicator linguistic:
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p.(None): (1) in paragraph (81), by striking ``and'' at the end;
p.(None): (2) in paragraph (82), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by inserting after paragraph (82) the following new
p.(None): paragraph:
p.(None): ``(83) provide that, not later than January 1, 2017, in the
p.(None): case of a State plan (or waiver of the plan) that provides
p.(None): medical assistance on a fee-for-service basis or through a
p.(None): primary care case-management system described in section
p.(None): 1915(b)(1) (other than a primary care case management entity (as
p.(None): defined by the Secretary)), the State shall publish (and update
p.(None): on at least an annual basis) on the public website of the State
p.(None): agency administering the State plan, a directory of the
p.(None): physicians described in subsection (mm) and, at State option,
p.(None): other providers described in such subsection that--
p.(None): ``(A) includes--
p.(None): ``(i) with respect to each such physician or
p.(None): provider--
p.(None): ``(I) the name of the physician or
p.(None): provider;
p.(None): ``(II) the specialty of the
p.(None): physician or provider;
p.(None): ``(III) the address at which the
p.(None): physician or provider provides services;
p.(None): and
p.(None): ``(IV) the telephone number of the
p.(None): physician or provider; and
p.(None): ``(ii) with respect to any such physician or
p.(None): provider participating in such a primary care
p.(None): case-management system, information regarding--
p.(None): ``(I) whether the physician or
p.(None): provider is accepting as new patients
p.(None): individuals who receive medical
p.(None): assistance under this title; and
p.(None): ``(II) the physician's or provider's
p.(None): cultural and linguistic capabilities,
p.(None): including the languages spoken by the
p.(None): physician or provider or by the
p.(None):
p.(None): [[Page 130 STAT. 1196]]
p.(None):
p.(None): skilled medical interpreter providing
p.(None): interpretation services at the
p.(None): physician's or provider's office; and
p.(None): ``(B) may include, at State option, with respect to
p.(None): each such physician or provider--
p.(None): ``(i) the Internet website of such physician
p.(None): or provider; or
p.(None): ``(ii) whether the physician or provider is
p.(None): accepting as new patients individuals who receive
p.(None): medical assistance under this title.''.
p.(None):
p.(None): (b) Directory Physician or Provider Described.--Section 1902 of the
p.(None): Social Security Act (42 U.S.C. 1396a), as amended by section 5005(a)(3),
p.(None): is further amended by adding at the end the following new subsection:
p.(None): ``(mm) Directory Physician or Provider Described.--A physician or
p.(None): provider described in this subsection is--
p.(None): ``(1) in the case of a physician or provider of a provider
p.(None): type for which the State agency, as a condition on receiving
p.(None): payment for items and services furnished by the physician or
p.(None): provider to individuals eligible to receive medical assistance
p.(None): under the State plan, requires the enrollment of the physician
p.(None): or provider with the State agency, a physician or a provider
p.(None): that--
p.(None): ``(A) is enrolled with the agency as of the date on
p.(None): which the directory is published or updated (as
p.(None): applicable) under subsection (a)(83); and
p.(None): ``(B) received payment under the State plan in the
p.(None): 12-month period preceding such date; and
p.(None): ``(2) in the case of a physician or provider of a provider
p.(None): type for which the State agency does not require such
...
Social / Literacy
Searching for indicator literacy:
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p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
p.(None): ``(B) an analysis of the effect of the demonstration
p.(None): program on the prevalence of untreated mental and
p.(None): substance use disorders in the surrounding communities
p.(None): of health centers participating in the demonstration;
p.(None): and
p.(None): ``(C) recommendations on whether the demonstration
p.(None): program should be expanded.
p.(None):
p.(None): ``(g) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $10,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
...
Social / Marital Status
Searching for indicator single:
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p.(None): end; and
p.(None): (B) by adding at the end the following:
p.(None): ``(C) foster collaboration between clinical research
p.(None): projects funded by the respective national research
p.(None): institutes and national centers that--
p.(None): ``(i) conduct research involving human
p.(None): subjects; and
p.(None): ``(ii) collect similar data; and
p.(None): ``(D) encourage the collaboration described in
p.(None): subparagraph (C) to--
p.(None): ``(i) allow for an increase in the number of
p.(None): subjects studied; and
p.(None): ``(ii) utilize diverse study populations, with
p.(None): special consideration to biological, social, and
p.(None): other determinants of health that contribute to
p.(None): health disparities;''.
p.(None):
p.(None): [[Page 130 STAT. 1065]]
p.(None):
p.(None): (b) Reporting.--Section 492B(f) of the Public Health Service Act (42
p.(None): U.S.C. 289a-2(f)) is amended--
p.(None): (1) by striking ``biennial'' each place such term appears
p.(None): and inserting ``triennial'';
p.(None): (2) by striking ``The advisory council'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The advisory council''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(2) Contents.--Each triennial report prepared by an
p.(None): advisory council of each national research institute as
p.(None): described in paragraph (1) shall include each of the following:
p.(None): ``(A) The number of women included as subjects, and
p.(None): the proportion of subjects that are women, in any
p.(None): project of clinical research conducted during the
p.(None): applicable reporting period, disaggregated by categories
p.(None): of research area, condition, or disease, and accounting
p.(None): for single-sex studies.
p.(None): ``(B) The number of members of minority groups
p.(None): included as subjects, and the proportion of subjects
p.(None): that are members of minority groups, in any project of
p.(None): clinical research conducted during the applicable
p.(None): reporting period, disaggregated by categories of
p.(None): research area, condition, or disease and accounting for
p.(None): single-race and single-ethnicity studies.
p.(None): ``(C) For the applicable reporting period, the
p.(None): number of projects of clinical research that include
p.(None): women and members of minority groups and that--
p.(None): ``(i) have been completed during such
p.(None): reporting period; and
p.(None): ``(ii) are being carried out during such
p.(None): reporting period and have not been completed.
p.(None): ``(D) The number of studies completed during the
p.(None): applicable reporting period for which reporting has been
p.(None): submitted in accordance with subsection (c)(2)(A).''.
p.(None):
p.(None): (c) Coordination.--Section 486(c)(2) of the Public Health Service
p.(None): Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
p.(None): inserting ``senior-level staff designees''.
p.(None): (d) In General.--Part A of title IV of the Public Health Service Act
p.(None): (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended
p.(None): by adding at the end the following:
p.(None): ``SEC. 404N. <> POPULATION FOCUSED RESEARCH.
p.(None):
p.(None): ``The Director of the National Institutes of Health shall, as
p.(None): appropriate, encourage efforts to improve research related to the health
p.(None): of sexual and gender minority populations, including by--
p.(None): ``(1) facilitating increased participation of sexual and
p.(None): gender minority populations in clinical research supported by
p.(None): the National Institutes of Health, and reporting on such
...
p.(None): components underlying or comprising the analysis) that identifies,
p.(None): measures, or describes the economic consequences, which may be based on
p.(None): the separate or aggregated clinical consequences of the represented
p.(None): health outcomes, of the use of a drug. Such analysis may be comparative
p.(None): to the use of another drug, to another health care intervention, or to
p.(None): no intervention.
p.(None): ``(B) Such term does not include any analysis that relates only to
p.(None): an indication that is not approved under section 505 or under section
p.(None): 351 of the Public Health Service Act for such drug.''.
p.(None): SEC. 3038. COMBINATION PRODUCT INNOVATION.
p.(None):
p.(None): (a) In General.--Section 503(g) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 353(g)) is amended--
p.(None): (1) by striking paragraph (3);
p.(None): (2) by redesignating paragraph (2) as paragraph (7);
p.(None): (3) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (8) and (9), respectively;
p.(None): (4) by striking ``(g)(1)'' and all that follows through the
p.(None): end of paragraph (1) and inserting the following:
p.(None):
p.(None): [[Page 130 STAT. 1106]]
p.(None):
p.(None): ``(g)(1)(A) The Secretary shall, in accordance with this subsection,
p.(None): assign a primary agency center to regulate products that constitute a
p.(None): combination of a drug, device, or biological product.
p.(None): ``(B) The Secretary shall conduct the premarket review of any
p.(None): combination product under a single application, whenever appropriate.
p.(None): ``(C) For purposes of this subsection, the term `primary mode of
p.(None): action' means the single mode of action of a combination product
p.(None): expected to make the greatest contribution to the overall intended
p.(None): therapeutic effects of the combination product.
p.(None): ``(D) The Secretary shall determine the primary mode of action of
p.(None): the combination product. If the Secretary determines that the primary
p.(None): mode of action is that of--
p.(None): ``(i) a drug (other than a biological product), the agency
p.(None): center charged with premarket review of drugs shall have primary
p.(None): jurisdiction;
p.(None): ``(ii) a device, the agency center charged with premarket
p.(None): review of devices shall have primary jurisdiction; or
p.(None): ``(iii) a biological product, the agency center charged with
p.(None): premarket review of biological products shall have primary
p.(None): jurisdiction.
p.(None):
p.(None): ``(E) In determining the primary mode of action of a combination
p.(None): product, the Secretary shall not determine that the primary mode of
p.(None): action is that of a drug or biological product solely because the
p.(None): combination product has any chemical action within or on the human body.
p.(None): ``(F) If a sponsor of a combination product disagrees with the
p.(None): determination under subparagraph (D)--
p.(None): ``(i) such sponsor may request, and the Secretary shall
p.(None): provide, a substantive rationale to such sponsor that references
p.(None): scientific evidence provided by the sponsor and any other
p.(None): scientific evidence relied upon by the Secretary to support such
p.(None): determination; and
p.(None): ``(ii)(I) the sponsor of the combination product may propose
p.(None): one or more studies (which may be nonclinical, clinical, or
p.(None): both) to establish the relevance, if any, of the chemical action
...
p.(None): sponsor or applicant; or
p.(None): ``(II) pursuant to a decision by the director of the
p.(None): reviewing division of the primary agency center, or a person
p.(None): more senior than such director, in consultation with consulting
p.(None): centers and the Office, as appropriate, that an issue essential
p.(None): to determining whether the standard for market clearance or
p.(None): other applicable standard under this Act or the Public Health
p.(None): Service Act applicable to the combination product has been
p.(None): identified since the agreement was reached, or that deviating
p.(None): from the agreement is otherwise justifiable based on scientific
p.(None): evidence, for public health reasons.
p.(None):
p.(None): ``(3) For purposes of conducting the premarket review of a
p.(None): combination product that contains an approved constituent part described
p.(None): in paragraph (4), the Secretary may require that the sponsor of such
p.(None): combination product submit to the Secretary only data or information
p.(None): that the Secretary determines is necessary to meet the standard for
p.(None): clearance or approval, as applicable, under this Act or the Public
p.(None): Health Service Act, including any incremental risks and benefits posed
p.(None): by such combination product, using a risk-based approach and taking into
p.(None): account any prior finding of safety and effectiveness or substantial
p.(None): equivalence for the approved constituent part relied upon by the
p.(None): applicant in accordance with paragraph (5).
p.(None): ``(4) For purposes of paragraph (3), an approved constituent part
p.(None): is--
p.(None): ``(A) a drug constituent part of a combination product being
p.(None): reviewed in a single application or request under section 515,
p.(None): 510(k), or 513(f)(2) (submitted in accordance with paragraph
p.(None): (5)), that is an approved drug, provided such application or
p.(None): request complies with paragraph (5);
p.(None): ``(B) a device constituent part approved under section 515
p.(None): that is referenced by the sponsor and that is available for use
p.(None): by the Secretary under section 520(h)(4); or
p.(None): ``(C) any constituent part that was previously approved,
p.(None): cleared, or classified under section 505, 510(k), 513(f)(2), or
p.(None): 515 of this Act for which the sponsor has a right of reference
p.(None): or any constituent part that is a nonprescription drug, as
p.(None): defined in section 760(a)(2).
p.(None):
p.(None): [[Page 130 STAT. 1108]]
p.(None):
p.(None): ``(5)(A) If an application is submitted under section 515 or 510(k)
p.(None): or a request is submitted under section 513(f)(2), consistent with any
p.(None): determination made under paragraph (1)(D), for a combination product
p.(None): containing as a constituent part an approved drug--
p.(None): ``(i) the application or request shall include the
p.(None): certification or statement described in section 505(b)(2); and
p.(None): ``(ii) the applicant or requester shall provide notice as
p.(None): described in section 505(b)(3).
p.(None):
p.(None): ``(B) For purposes of this paragraph and paragraph (4), the term
p.(None): `approved drug' means an active ingredient--
p.(None): ``(i) that was in an application previously approved under
p.(None): section 505(c);
p.(None): ``(ii) where such application is relied upon by the
...
p.(None): such drug is effective in use were not conducted by or for the
p.(None): applicant submitting the application or request described in
p.(None): subparagraph (A); and
p.(None): ``(iv) for which the applicant submitting the application or
p.(None): request described in subparagraph (A) has not obtained a right
p.(None): of reference or use from the person by or for whom the
p.(None): investigations described in clause (iii) were conducted.
p.(None):
p.(None): ``(C) The following provisions shall apply with respect to an
p.(None): application or request described in subparagraph (A) to the same extent
p.(None): and in the same manner as if such application or request were an
p.(None): application described in section 505(b)(2) that referenced the approved
p.(None): drug:
p.(None): ``(i) Subparagraphs (A), (B), (C), and (D) of section
p.(None): 505(c)(3).
p.(None): ``(ii) Clauses (ii), (iii), and (iv) of section
p.(None): 505(c)(3)(E).
p.(None): ``(iii) Subsections (b) and (c) of section 505A.
p.(None): ``(iv) Section 505E(a).
p.(None): ``(v) Section 527(a).
p.(None):
p.(None): ``(D) Notwithstanding any other provision of this subsection, an
p.(None): application or request for classification for a combination product
p.(None): described in subparagraph (A) shall be considered an application
p.(None): submitted under section 505(b)(2) for purposes of section 271(e)(2)(A)
p.(None): of title 35, United States Code.
p.(None): ``(6) Nothing in this subsection shall be construed as prohibiting a
p.(None): sponsor from submitting separate applications for the constituent parts
p.(None): of a combination product, unless the Secretary determines that a single
p.(None): application is necessary.'';
p.(None): (5) in paragraph (8) (as redesignated by paragraph (3))--
p.(None): (A) in subparagraph (C)--
p.(None): (i) by amending clause (i) to read as follows:
p.(None):
p.(None): ``(i) In carrying out this subsection, the Office shall help to
p.(None): ensure timely and effective premarket review that involves more than one
p.(None): agency center by coordinating such reviews, overseeing the timeliness of
p.(None): such reviews, and overseeing the alignment of feedback regarding such
p.(None): reviews.'';
p.(None): (ii) in clause (ii), by inserting ``and
p.(None): alignment'' after ``the timeliness'' each place it
p.(None): appears; and
p.(None): (iii) by adding at the end the following new
p.(None): clauses:
p.(None):
p.(None): ``(iii) The Office shall ensure that, with respect to a combination
p.(None): product, a designated person or persons in the primary agency
p.(None):
p.(None): [[Page 130 STAT. 1109]]
p.(None):
p.(None): center is the primary point or points of contact for the sponsor of such
p.(None): combination product. The Office shall also coordinate communications to
p.(None): and from any consulting center involved in such premarket review, if
p.(None): requested by such primary agency center or any such consulting center.
p.(None): Agency communications and commitments, to the extent consistent with
p.(None): other provisions of law and the requirements of all affected agency
p.(None): centers, from the primary agency center shall be considered as
p.(None): communication from the Secretary on behalf of all agency centers
p.(None): involved in the review.
p.(None): ``(iv) The Office shall, with respect to the premarket review of a
p.(None): combination product--
p.(None): ``(I) ensure that any meeting between the Secretary and the
p.(None): sponsor of such product is attended by each agency center
...
p.(None):
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565
p.(None): the following:
p.(None):
p.(None): [[Page 130 STAT. 1145]]
p.(None):
p.(None): ``SEC. 565A. <> PRIORITY REVIEW TO
p.(None): ENCOURAGE TREATMENTS FOR AGENTS THAT
p.(None): PRESENT NATIONAL SECURITY THREATS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Human drug application.--The term `human drug
p.(None): application' has the meaning given such term in section 735(1).
p.(None): ``(2) Priority review.--The term `priority review', with
p.(None): respect to a human drug application, means review and action by
p.(None): the Secretary on such application not later than 6 months after
p.(None): receipt by the Secretary of such application, as described in
p.(None): the Manual of Policies and Procedures in the Food and Drug
p.(None): Administration and goals identified in the letters described in
p.(None): section 101(b) of the Food and Drug Administration Safety and
p.(None): Innovation Act.
p.(None): ``(3) Priority review voucher.--The term `priority review
p.(None): voucher' means a voucher issued by the Secretary to the sponsor
p.(None): of a material threat medical countermeasure application that
p.(None): entitles the holder of such voucher to priority review of a
p.(None): single human drug application submitted under section 505(b)(1)
p.(None): or section 351(a) of the Public Health Service Act after the
p.(None): date of approval of the material threat medical countermeasure
p.(None): application.
p.(None): ``(4) Material threat medical countermeasure application.--
p.(None): The term `material threat medical countermeasure application'
p.(None): means an application that--
p.(None): ``(A) is a human drug application for a drug
p.(None): intended for use--
p.(None): ``(i) to prevent, or treat harm from a
p.(None): biological, chemical, radiological, or nuclear
p.(None): agent identified as a material threat under
p.(None): section 319F-2(c)(2)(A)(ii) of the Public Health
p.(None): Service Act; or
p.(None): ``(ii) to mitigate, prevent, or treat harm
p.(None): from a condition that may result in adverse health
p.(None): consequences or death and may be caused by
p.(None): administering a drug, or biological product
p.(None): against such agent; and
p.(None): ``(B) the Secretary determines eligible for priority
p.(None): review;
p.(None): ``(C) is approved after the date of enactment of the
p.(None): 21st Century Cures Act; and
p.(None): ``(D) is for a human drug, no active ingredient
p.(None): (including any ester or salt of the active ingredient)
...
p.(None): Advisory Committee.
p.(None): ``(2) Membership.--The membership of the HIT Advisory
p.(None): Committee shall--
p.(None): ``(A) include at least 25 members, of which--
p.(None): ``(i) no fewer than 2 members are advocates
p.(None): for patients or consumers of health information
p.(None): technology;
p.(None): ``(ii) 3 members are appointed by the
p.(None): Secretary, 1 of whom shall be appointed to
p.(None): represent the Department of Health and Human
p.(None): Services and 1 of whom shall be a public health
p.(None): official;
p.(None): ``(iii) 2 members are appointed by the
p.(None): majority leader of the Senate;
p.(None): ``(iv) 2 members are appointed by the minority
p.(None): leader of the Senate;
p.(None): ``(v) 2 members are appointed by the Speaker
p.(None): of the House of Representatives;
p.(None): ``(vi) 2 members are appointed by the minority
p.(None): leader of the House of Representatives; and
p.(None): ``(vii) such other members are appointed by
p.(None): the Comptroller General of the United States; and
p.(None): ``(B) at least reflect providers, ancillary health
p.(None): care workers, consumers, purchasers, health plans,
p.(None): health information technology developers, researchers,
p.(None): patients, relevant Federal agencies, and individuals
p.(None): with technical expertise on health care quality, system
p.(None): functions, privacy, security, and on the electronic
p.(None): exchange and use of health information, including the
p.(None): use standards for such activity.
p.(None): ``(3) Participation.--The members of the HIT Advisory
p.(None): Committee shall represent a balance among various sectors of the
p.(None): health care system so that no single sector unduly influences
p.(None): the recommendations of the Committee.
p.(None): ``(4) Terms.--
p.(None): ``(A) In general.--The terms of the members of the
p.(None): HIT Advisory Committee shall be for 3 years, except that
p.(None): the Secretary shall designate staggered terms of the
p.(None): members first appointed.
p.(None): ``(B) Vacancies.--Any member appointed to fill a
p.(None): vacancy in the membership of the HIT Advisory Committee
p.(None): that occurs prior to the expiration of the term for
p.(None): which the member's predecessor was appointed shall be
p.(None): appointed only for the remainder of that term. A member
p.(None): may serve after the expiration of that member's term
p.(None): until a successor has been appointed. A vacancy in the
p.(None): HIT Advisory Committee shall be filled in the manner in
p.(None): which the original appointment was made.
p.(None): ``(C) Limits.--Members of the HIT Advisory Committee
p.(None): shall be limited to two 3-year terms, for a total of not
p.(None): to exceed 6 years of service on the Committee.
p.(None): ``(5) Outside involvement.--The HIT Advisory Committee shall
p.(None): ensure an opportunity for the participation in activities of the
p.(None): Committee of outside advisors, including individuals with
p.(None): expertise in the development of policies and standards for the
p.(None): electronic exchange and use of health information,
p.(None):
p.(None): [[Page 130 STAT. 1174]]
p.(None):
p.(None): including in the areas of health information privacy and
p.(None): security.
p.(None): ``(6) Quorum.--A majority of the members of the HIT Advisory
p.(None): Committee shall constitute a quorum for purposes of voting, but
p.(None): a lesser number of members may meet and hold hearings.
p.(None): ``(7) Consideration.--The National Coordinator shall ensure
p.(None): that the relevant and available recommendations and comments
...
p.(None): care quality, or health care outcomes.
p.(None): (2) Report.--Not later than 4 years after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives, a report
p.(None): concerning best practices and current trends voluntarily
p.(None): provided, without identifying individual providers or disclosing
p.(None): or using protected health information or individually
p.(None): identifiable information, by patient safety organizations to
p.(None): improve the integration of health information technology into
p.(None): clinical practice.
p.(None): SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS TO
p.(None): THEIR ELECTRONIC HEALTH INFORMATION.
p.(None):
p.(None): (a) Use of Health Information Exchanges for Patient Access.--Section
p.(None): 3009 of the Public Health Service Act (42 U.S.C. 300jj-19) is amended by
p.(None): adding at the end the following:
p.(None): ``(c) Promoting Patient Access to Electronic Health Information
p.(None): Through Health Information Exchanges .--
p.(None): ``(1) In general.--The Secretary shall use existing
p.(None): authorities to encourage partnerships between health information
p.(None): exchange organizations and networks and health care providers,
p.(None): health plans, and other appropriate entities with the goal of
p.(None): offering patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically.
p.(None): ``(2) Education of providers.--The Secretary, in
p.(None): coordination with the Office for Civil Rights of the Department
p.(None): of Health and Human Services, shall--
p.(None): ``(A) educate health care providers on ways of
p.(None): leveraging the capabilities of health information
p.(None): exchanges
p.(None):
p.(None): [[Page 130 STAT. 1182]]
p.(None):
p.(None): (or other relevant platforms) to provide patients with
p.(None): access to their electronic health information;
p.(None): ``(B) clarify misunderstandings by health care
p.(None): providers about using health information exchanges (or
p.(None): other relevant platforms) for patient access to
p.(None): electronic health information; and
p.(None): ``(C) to the extent practicable, educate providers
p.(None): about health information exchanges (or other relevant
p.(None): platforms) that employ some or all of the capabilities
p.(None): described in paragraph (1).
p.(None): ``(3) Requirements.--In carrying out paragraph (1), the
p.(None): Secretary, in coordination with the Office for Civil Rights,
p.(None): shall issue guidance to health information exchanges related to
p.(None): best practices to ensure that the electronic health information
p.(None): provided to patients is--
p.(None): ``(A) private and secure;
p.(None): ``(B) accurate;
p.(None): ``(C) verifiable; and
p.(None): ``(D) where a patient's authorization to exchange
p.(None): information is required by law, easily exchanged
p.(None): pursuant to such authorization.
p.(None): ``(4) Rule of construction.--Nothing in this subsection
...
p.(None): an individual has a right of access to inspect, obtain a
p.(None): copy of, and transmit to a third party a copy of such
p.(None): individual's protected health information pursuant to
p.(None): the Health Information Portability and Accountability
p.(None): Act, Privacy Rule (subpart E of part 164 of title 45,
p.(None): Code of Federal Regulations), the Director of the Office
p.(None): for Civil Rights, in consultation with the National
p.(None): Coordinator, shall assist individuals and health care
p.(None): providers in understanding a patient's rights to access
p.(None): and protect personal health information under the Health
p.(None): Insurance Portability and Accountability Act of 1996
p.(None): (Public Law 104-191), including providing best practices
p.(None):
p.(None): [[Page 130 STAT. 1183]]
p.(None):
p.(None): for requesting personal health information in a
p.(None): computable format, including using patient portals or
p.(None): third-party applications and common cases when a
p.(None): provider is permitted to exchange and provide access to
p.(None): health information.''.
p.(None): ``(2) Certifying usability for patients.--In carrying out
p.(None): certification programs under section 3001(c)(5), the National
p.(None): Coordinator may require that--
p.(None): ``(A) the certification criteria support--
p.(None): ``(i) patient access to their electronic
p.(None): health information, including in a single
p.(None): longitudinal format that is easy to understand,
p.(None): secure, and may be updated automatically;
p.(None): ``(ii) the patient's ability to electronically
p.(None): communicate patient-reported information (such as
p.(None): family history and medical history); and
p.(None): ``(iii) patient access to their personal
p.(None): electronic health information for research at the
p.(None): option of the patient; and
p.(None): ``(B) the HIT Advisory Committee develop and
p.(None): prioritize standards, implementation specifications, and
p.(None): certification criteria required to help support patient
p.(None): access to electronic health information, patient
p.(None): usability, and support for technologies that offer
p.(None): patients access to their electronic health information
p.(None): in a single, longitudinal format that is easy to
p.(None): understand, secure, and may be updated automatically.''.
p.(None):
p.(None): (b) Access to Information in an Electronic Format.--Section 13405(e)
p.(None): of the Health Information Technology for Economic and Clinical Health
p.(None): Act (42 U.S.C. 17935) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) by redesignating paragraph (2) as paragraph (3); and
p.(None): (3) by inserting after paragraph (1), the following:
p.(None): ``(2) if the individual makes a request to a business
p.(None): associate for access to, or a copy of, protected health
p.(None): information about the individual, or if an individual makes a
p.(None): request to a business associate to grant such access to, or
p.(None): transmit such copy directly to, a person or entity designated by
p.(None): the individual, a business associate may provide the individual
p.(None): with such access or copy, which may be in an electronic form, or
p.(None): grant or transmit such access or copy to such person or entity
p.(None): designated by the individual; and''.
p.(None): SEC. 4007. GAO STUDY ON PATIENT MATCHING.
p.(None):
p.(None): (a) In General.--Not later than 1 year after the date of enactment
p.(None): of this Act, the Comptroller General of the United States shall conduct
p.(None): a study to--
p.(None): (1) review the policies and activities of the Office of the
p.(None): National Coordinator for Health Information Technology and other
p.(None): relevant stakeholders, which may include standards development
...
p.(None): supplier licensed by the State in which the pharmacy, physician,
p.(None): or provider or services or supplier furnishes items or services
p.(None): and that--
p.(None): ``(I) furnishes infusion therapy to individuals with
p.(None): acute or chronic conditions requiring administration of
p.(None): home infusion drugs;
p.(None): ``(II) ensures the safe and effective provision and
p.(None): administration of home infusion therapy on a 7-day-a-
p.(None): week, 24-hour-a-day basis;
p.(None): ``(III) is accredited by an organization designated
p.(None): by the Secretary pursuant to section 1834(u)(5); and
p.(None): ``(IV) meets such other requirements as the
p.(None): Secretary determines appropriate, taking into account
p.(None): the standards of care for home infusion therapy
p.(None): established by Medicare Advantage plans under part C and
p.(None): in the private sector.
p.(None): ``(ii) A qualified home infusion therapy supplier may
p.(None): subcontract with a pharmacy, physician, provider of services, or
p.(None): supplier to meet the requirements of this subparagraph.''.
p.(None):
p.(None): (b) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by
p.(None): section 4011, is further amended by adding at the end the following new
p.(None): subsection:
p.(None): ``(u) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): ``(1) Payment.--
p.(None): ``(A) Single payment.--
p.(None): ``(i) In general.--Subject to clause (iii) and
p.(None): subparagraphs (B) and (C), the Secretary shall
p.(None): implement a payment system under which a single
p.(None): payment is made under this title to a qualified
p.(None): home infusion therapy supplier for items and
p.(None): services described in subparagraphs (A) and (B) of
p.(None): section 1861(iii)(2)) furnished by a qualified
p.(None): home infusion therapy supplier (as defined in
p.(None): section 1861(iii)(3)(D)) in coordination with the
p.(None): furnishing of home infusion drugs (as defined in
p.(None): section 1861(iii)(3)(C)) under this part.
p.(None): ``(ii) Unit of single payment.--A unit of
p.(None): single payment under the payment system
p.(None): implemented under this subparagraph is for each
p.(None): infusion drug administration calendar day in the
p.(None): individual's home. The Secretary shall, as
p.(None): appropriate, establish single
p.(None):
p.(None): [[Page 130 STAT. 1200]]
p.(None):
p.(None): payment amounts for types of infusion therapy,
p.(None): including to take into account variation in
p.(None): utilization of nursing services by therapy type.
p.(None): ``(iii) Limitation.--The single payment amount
p.(None): determined under this subparagraph after
p.(None): application of subparagraph (B) and paragraph (3)
p.(None): shall not exceed the amount determined under the
p.(None): fee schedule under section 1848 for infusion
p.(None): therapy services furnished in a calendar day if
p.(None): furnished in a physician office setting, except
p.(None): such single payment shall not reflect more than 5
p.(None): hours of infusion for a particular therapy in a
p.(None): calendar day.
p.(None): ``(B) Required adjustments.--The Secretary shall
p.(None): adjust the single payment amount determined under
p.(None): subparagraph (A) for home infusion therapy services
p.(None): under section 1861(iii)(1) to reflect other factors such
p.(None): as--
p.(None): ``(i) a geographic wage index and other costs
p.(None): that may vary by region; and
p.(None): ``(ii) patient acuity and complexity of drug
p.(None): administration.
p.(None): ``(C) Discretionary adjustments.--
p.(None): ``(i) In general.--Subject to clause (ii), the
p.(None): Secretary may adjust the single payment amount
p.(None): determined under subparagraph (A) (after
p.(None): application of subparagraph (B)) to reflect
p.(None): outlier situations and other factors as the
p.(None): Secretary determines appropriate.
p.(None): ``(ii) Requirement of budget neutrality.--Any
p.(None): adjustment under this subparagraph shall be made
p.(None): in a budget neutral manner.
p.(None): ``(2) Considerations.--In developing the payment system
p.(None): under this subsection, the Secretary may consider the costs of
p.(None): furnishing infusion therapy in the home, consult with home
p.(None): infusion therapy suppliers, consider payment amounts for similar
p.(None): items and services under this part and part A, and consider
p.(None): payment amounts established by Medicare Advantage plans under
p.(None): part C and in the private insurance market for home infusion
p.(None): therapy (including average per treatment day payment amounts by
p.(None): type of home infusion therapy).
p.(None): ``(3) Annual updates.--
p.(None): ``(A) In general.--Subject to subparagraph (B), the
p.(None): Secretary shall update the single payment amount under
p.(None): this subsection from year to year beginning in 2022 by
p.(None): increasing the single payment amount from the prior year
p.(None): by the percentage increase in the Consumer Price Index
p.(None): for all urban consumers (United States city average) for
p.(None): the 12-month period ending with June of the preceding
p.(None): year.
p.(None): ``(B) Adjustment.--For each year, the Secretary
p.(None): shall reduce the percentage increase described in
p.(None): subparagraph (A) by the productivity adjustment
p.(None): described in section 1886(b)(3)(B)(xi)(II). The
p.(None): application of the preceding sentence may result in a
p.(None): percentage being less than 0.0 for a year, and may
p.(None): result in payment being less than such payment rates for
p.(None): the preceding year.
p.(None): ``(4) Authority to apply prior authorization.--The Secretary
p.(None): may, as determined appropriate by the Secretary, apply
p.(None):
p.(None): [[Page 130 STAT. 1201]]
p.(None):
p.(None): prior authorization for home infusion therapy services under
p.(None): section 1861(iii)(1).
p.(None): ``(5) Accreditation of qualified home infusion therapy
p.(None): suppliers.--
p.(None): ``(A) Factors for designation of accreditation
p.(None): organizations.--The Secretary shall consider the
p.(None): following factors in designating accreditation
p.(None): organizations under subparagraph (B) and in reviewing
p.(None): and modifying the list of accreditation organizations
p.(None): designated pursuant to subparagraph (C):
p.(None): ``(i) The ability of the organization to
p.(None): conduct timely reviews of accreditation
p.(None): applications.
p.(None): ``(ii) The ability of the organization to take
p.(None): into account the capacities of suppliers located
...
p.(None): paragraphs (2) through (4), respectively; and
p.(None): (2) by inserting before paragraph (2) (as so redesignated)
p.(None): the following:
p.(None): ``(1) providing community mental health services for adults
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
p.(None): accordance with subsection (a), a State shall submit to the
p.(None): Secretary a plan every two years that, at a minimum, includes
p.(None): each of the following:'';
p.(None): (4) by inserting before subparagraph (A) (as so
p.(None): redesignated) the following:
p.(None): ``(1) System of care.--A description of the State's system
p.(None): of care that contains the following:'';
p.(None): (5) by striking subparagraph (A) (as so redesignated) and
p.(None): inserting the following:
p.(None): ``(A) Comprehensive community-based health
p.(None): systems.--The plan shall--
p.(None):
p.(None): [[Page 130 STAT. 1226]]
p.(None):
p.(None): ``(i) identify the single State agency to be
p.(None): responsible for the administration of the program
p.(None): under the grant, including any third party who
p.(None): administers mental health services and is
p.(None): responsible for complying with the requirements of
p.(None): this part with respect to the grant;
p.(None): ``(ii) provide for an organized community-
p.(None): based system of care for individuals with mental
p.(None): illness, and describe available services and
p.(None): resources in a comprehensive system of care,
p.(None): including services for individuals with co-
p.(None): occurring disorders;
p.(None): ``(iii) include a description of the manner in
p.(None): which the State and local entities will coordinate
p.(None): services to maximize the efficiency,
p.(None): effectiveness, quality, and cost-effectiveness of
p.(None): services and programs to produce the best possible
p.(None): outcomes (including health services,
p.(None): rehabilitation services, employment services,
p.(None): housing services, educational services, substance
p.(None): use disorder services, legal services, law
p.(None): enforcement services, social services, child
p.(None): welfare services, medical and dental care
p.(None): services, and other support services to be
p.(None): provided with Federal, State, and local public and
p.(None): private resources) with other agencies to enable
p.(None): individuals receiving services to function outside
p.(None): of inpatient or residential institutions, to the
p.(None): maximum extent of their capabilities, including
...
p.(None): the State, in lieu of having the State's allotment under section
p.(None): 1921 reduced, agree to comply with a negotiated agreement that
p.(None): is approved by the Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State fails to enter
p.(None): into or comply with a negotiated agreement, the Secretary may
p.(None): take action under this paragraph or the terms of the negotiated
p.(None): agreement.''.
p.(None):
p.(None): (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
p.(None): Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
p.(None): ``substance abuse'' and inserting ``substance use disorders''.
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
p.(None): pregnant women, women with dependent children,
p.(None): individuals with a co-occurring mental health and
p.(None): substance use disorder, persons who inject drugs,
p.(None): and persons who are experiencing homelessness;
p.(None): ``(iii) provides aggregate information on the
p.(None): number of individuals in treatment within the
p.(None): State, including the number of such individuals
p.(None): who are pregnant women, women with dependent
p.(None): children, individuals with a co-occurring mental
p.(None): health and substance use disorder, persons who
...
p.(None): the public meeting under subsection (a), the Secretary of Health and
p.(None): Human Services shall finalize the action plan described in such
p.(None): subsection and make it plainly available on the Internet website of the
p.(None): Department of Health and Human Services.
p.(None): (c) Content.--The action plan under this section shall--
p.(None): (1) take into consideration the recommendations of the
p.(None): Mental Health and Substance Use Disorder Parity Task Force in
p.(None): its final report issued in October of 2016, and any subsequent
p.(None): Federal and State actions in relation to such recommendations;
p.(None): (2) reflect the input of the stakeholders participating in
p.(None): the public meeting under subsection (a);
p.(None): (3) identify specific strategic objectives regarding how the
p.(None): various Federal and State agencies charged with enforcement of
p.(None): mental health parity and addiction equity requirements will
p.(None): collaborate to improve enforcement of such requirements;
p.(None): (4) provide a timeline for implementing the action plan; and
p.(None): (5) provide specific examples of how such objectives may be
p.(None): met, which may include--
p.(None): (A) providing common educational information and
p.(None): documents, such as the Consumer Guide to Disclosure
p.(None): Rights, to patients about their rights under mental
p.(None): health parity and addiction equity requirements;
p.(None): (B) facilitating the centralized collection of,
p.(None): monitoring of, and response to patient complaints or
p.(None): inquiries relating to mental health parity and addiction
p.(None): equity requirements, which may be through the
p.(None): development and administration of--
p.(None): (i) a single, toll-free telephone number; and
p.(None): (ii) a new parity website--
p.(None): (I) to help consumers find the
p.(None): appropriate Federal or State agency to
p.(None): assist with their parity complaints,
p.(None): appeals, and other actions; and
p.(None): (II) that takes into consideration,
p.(None): but is not duplicative of, the parity
p.(None): beta site being tested, and released for
p.(None): public comment, by the Department of
p.(None): Health and Human Services as of the date
p.(None): of the enactment of this Act;
p.(None): (C) Federal and State law enforcement agencies
p.(None): entering into memoranda of understanding to better
p.(None): coordinate enforcement responsibilities and information
p.(None): sharing--
p.(None): (i) including whether such agencies should
p.(None): make the results of enforcement actions related to
p.(None): mental health parity and addiction equity
p.(None): requirements publicly available; and
p.(None):
p.(None): [[Page 130 STAT. 1285]]
p.(None):
p.(None): (ii) which may include State Policy Academies
p.(None): on Parity Implementation for State Officials and
p.(None): other forums to bring together national experts to
p.(None): provide technical assistance to teams of State
p.(None): officials on strategies to advance compliance with
p.(None): mental health parity and addiction equity
p.(None): requirements in both the commercial market, and in
p.(None): the Medicaid program under title XIX of the Social
p.(None): Security Act and the State Children's Health
p.(None): Insurance Program under title XXI of such Act; and
p.(None): (D) recommendations to the Congress regarding the
p.(None): need for additional legal authority to improve
p.(None): enforcement of mental health parity and addiction equity
...
p.(None): disorders, mental illness, and co-occurring mental
p.(None): illness and substance use disorders;
p.(None): ``(C) prosecutor and defender based programs;
p.(None): ``(D) specialized probation;
p.(None): ``(E) treatment and rehabilitation programs; and
p.(None): ``(F) problem-solving courts, including mental
p.(None): health courts, drug courts, co-occurring mental health
p.(None): and substance abuse courts, DWI courts, and veterans
p.(None): treatment courts.
p.(None):
p.(None): ``(c) Application.--
p.(None): ``(1) In general.--An eligible entity desiring a grant under
p.(None): this section shall submit an application to the Attorney
p.(None): General--
p.(None): ``(A) that meets the criteria under paragraph (2);
p.(None): and
p.(None): ``(B) at such time, in such manner, and accompanied
p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
p.(None): 2007);
p.(None): ``(C) demonstrate that evidence-based treatment
p.(None): practices will be utilized; and
p.(None): ``(D) demonstrate that evidence-based screening and
p.(None): assessment tools will be used to place participants in
p.(None): the treatment alternative to incarceration program.
p.(None):
p.(None): ``(d) Requirements.--Each eligible entity awarded a grant for a
p.(None): treatment alternative to incarceration program under this section
p.(None): shall--
p.(None): ``(1) determine the terms and conditions of participation in
p.(None): the program by eligible participants, taking into consideration
p.(None): the collateral consequences of an arrest, prosecution or
p.(None): criminal conviction;
p.(None): ``(2) ensure that each substance abuse and mental health
p.(None): treatment component is licensed and qualified by the relevant
p.(None): jurisdiction;
p.(None): ``(3) for programs described in subsection (b)(2), organize
p.(None): an enforcement unit comprised of appropriately trained law
p.(None): enforcement professionals under the supervision of the State,
p.(None): Tribal, or local criminal justice agency involved, the duties of
p.(None): which shall include--
p.(None): ``(A) the verification of addresses and other
...
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
p.(None): training and technical assistance for criminal justice agencies;
p.(None): ``(5) develop a receiving center system and pilot strategy
p.(None): that provides, for a jurisdiction, a single point of entry into
p.(None): the mental health and substance abuse system for assessments and
p.(None): appropriate placement of individuals experiencing a crisis;
p.(None):
p.(None): [[Page 130 STAT. 1304]]
p.(None):
p.(None): ``(6) collect data and best practices in mental health and
p.(None): criminal health and criminal justice initiatives and policies
p.(None): from grantees under this part, other recipients of grants under
p.(None): this section, Federal, State, and local agencies involved in the
p.(None): provision of mental health services, and nongovernmental
p.(None): organizations involved in the provision of mental health
p.(None): services;
p.(None): ``(7) develop and disseminate to mental health providers and
p.(None): criminal justice agencies evaluation tools, mechanisms, and
p.(None): measures to better assess and document performance measures and
p.(None): outcomes relating to the provision of mental health services;
p.(None): ``(8) disseminate information to States, units of local
p.(None): government, criminal justice agencies, law enforcement agencies,
p.(None): and other relevant entities about best practices, policy
p.(None): standards, and research findings relating to the provision of
p.(None): mental health services; and
p.(None): ``(9) provide education and support to individuals with
...
Social / Mothers
Searching for indicator mothers:
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p.(None): ``(a) In General.--The Secretary shall award grants, contracts, or
p.(None): cooperative agreements to public and private nonprofit entities,
p.(None): including Indian tribes or tribal organizations (as such terms are
p.(None): defined in section 4 of the Indian Self-Determination and Education
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
...
Social / Occupation
Searching for indicator job:
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p.(None): agreement under this section shall be $2,000,000.
p.(None): ``(2) Adjustment permitted.--The Secretary, taking into
p.(None): consideration the quality of the application and the number of
p.(None): eligible entities that received grants under this section prior
p.(None): to the date of enactment of the Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016, may adjust the target amount
p.(None): that an eligible entity may receive for a year through a grant
p.(None): or cooperative agreement under this section.
p.(None): ``(3) Limitation.--An eligible entity receiving funding
p.(None): under this section may not allocate more than 10 percent of
p.(None): funds awarded under this section to administrative functions,
p.(None): and the remaining amounts shall be allocated to health
p.(None): facilities that provide integrated care.
p.(None):
p.(None): ``(e) Duration.--A grant or cooperative agreement under this section
p.(None): shall be for a period not to exceed 5 years.
p.(None):
p.(None): [[Page 130 STAT. 1237]]
p.(None):
p.(None): ``(f) Report on Program Outcomes.--An eligible entity receiving a
p.(None): grant or cooperative agreement under this section shall submit an annual
p.(None): report to the Secretary that includes--
p.(None): ``(1) the progress made to reduce barriers to integrated
p.(None): care as described in the entity's application under subsection
p.(None): (c); and
p.(None): ``(2) a description of functional outcomes of special
p.(None): populations, including--
p.(None): ``(A) with respect to adults with a serious mental
p.(None): illness, participation in supportive housing or
p.(None): independent living programs, attendance in social and
p.(None): rehabilitative programs, participation in job training
p.(None): opportunities, satisfactory performance in work
p.(None): settings, attendance at scheduled medical and mental
p.(None): health appointments, and compliance with prescribed
p.(None): medication regimes;
p.(None): ``(B) with respect to individuals with co-occurring
p.(None): mental illness and physical health conditions and
p.(None): chronic diseases, attendance at scheduled medical and
p.(None): mental health appointments, compliance with prescribed
p.(None): medication regimes, and participation in learning
p.(None): opportunities related to improved health and lifestyle
p.(None): practices; and
p.(None): ``(C) with respect to children and adolescents with
p.(None): a serious emotional disturbance who have co-occurring
p.(None): physical health conditions and chronic diseases,
p.(None): attendance at scheduled medical and mental health
p.(None): appointments, compliance with prescribed medication
p.(None): regimes, and participation in learning opportunities at
p.(None): school and extracurricular activities.
p.(None):
p.(None): ``(g) Technical Assistance for Primary-Behavioral Health Care
p.(None): Integration.--
p.(None): ``(1) In general.--The Secretary may provide appropriate
p.(None): information, training, and technical assistance to eligible
p.(None): entities that receive a grant or cooperative agreement under
p.(None): this section, in order to help such entities meet the
p.(None): requirements of this section, including assistance with--
p.(None): ``(A) development and selection of integrated care
p.(None): models;
p.(None): ``(B) dissemination of evidence-based interventions
p.(None): in integrated care;
p.(None): ``(C) establishment of organizational practices to
p.(None): support operational and administrative success; and
...
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
p.(None): problem or mental illness; and
p.(None): (2) the integrated administration of services and sanctions,
p.(None): which shall include--
p.(None): (A) mandatory periodic testing, as appropriate, for
p.(None): the use of controlled substances or other addictive
p.(None): substances during any period of supervised release or
p.(None): probation for each program participant;
p.(None): (B) substance abuse treatment for each program
p.(None): participant who requires such services;
p.(None): (C) diversion, probation, or other supervised
p.(None): release with the possibility of prosecution,
p.(None): confinement, or incarceration based on noncompliance
p.(None): with program requirements or failure to show
p.(None): satisfactory progress toward completing program
p.(None): requirements;
p.(None): (D) programmatic offender management, including case
p.(None): management, and aftercare services, such as relapse
p.(None): prevention, health care, education, vocational training,
p.(None): job placement, housing placement, and child care or
p.(None): other family support services for each program
p.(None): participant who requires such services;
p.(None): (E) outpatient or inpatient mental health treatment,
p.(None): as ordered by the court, that carries with it the
p.(None): possibility of dismissal of charges or reduced
p.(None): sentencing upon successful completion of such treatment;
p.(None): (F) centralized case management, including--
p.(None): (i) the consolidation of all cases, including
p.(None): violations of probations, of the program
p.(None): participant; and
p.(None): (ii) coordination of all mental health
p.(None): treatment plans and social services, including
p.(None): life skills and vocational training, housing and
p.(None): job placement, education, health care, and relapse
p.(None): prevention for each program participant who
p.(None): requires such services; and
p.(None): (G) continuing supervision of treatment plan
p.(None): compliance by the program participant for a term not to
p.(None): exceed the maximum allowable sentence or probation
p.(None): period for the charged or relevant offense and, to the
p.(None): extent practicable, continuity of psychiatric care at
p.(None): the end of the supervised period.
p.(None):
p.(None): (d) Implementation; Duration.--The pilot program established under
p.(None): subsection (b) shall be conducted--
p.(None): (1) in not less than 1 United States judicial district,
p.(None): designated by the Attorney General in consultation with the
p.(None): Director of the Administrative Office of the United States
p.(None): Courts, as appropriate for the pilot program; and
p.(None): (2) during fiscal year 2017 through fiscal year 2021.
p.(None):
p.(None): (e) Criteria for Designation.--Before making a designation under
p.(None): subsection (d)(1), the Attorney General shall--
p.(None):
p.(None): [[Page 130 STAT. 1291]]
p.(None):
p.(None): (1) obtain the approval, in writing, of the United States
p.(None): Attorney for the United States judicial district being
p.(None): designated;
p.(None): (2) obtain the approval, in writing, of the chief judge for
p.(None): the United States judicial district being designated; and
p.(None): (3) determine that the United States judicial district being
p.(None): designated has adequate behavioral health systems for treatment,
p.(None): including substance abuse and mental health treatment.
p.(None):
p.(None): (f) Assistance From Other Federal Entities.--The Administrative
...
p.(None): ``(C) implementing methods for identifying and
p.(None): treating individuals who are most likely to benefit from
p.(None): coordinated supervision and treatment strategies, and
p.(None): identifying individuals who can do well with fewer
p.(None): interventions; and
p.(None): ``(D) collaborative decision-making among the heads
p.(None): of criminal justice agencies, mental health systems,
p.(None): judicial systems, substance abuse systems, and other
p.(None): relevant systems or agencies for determining how
p.(None): treatment and intensive supervision services should be
p.(None): allocated in order to maximize benefits, and developing
p.(None): and utilizing capacity accordingly.
p.(None):
p.(None): ``(c) Use of Grant Funds.--A State, unit of local government,
p.(None): territory, Indian Tribe, or nonprofit agency that receives a grant under
p.(None): this section shall, in accordance with subsection (b)(2), use grant
p.(None): funds for the expenses of a treatment program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including costs relating to enforcement;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the State or Indian Tribe and licensed, if necessary, to provide
p.(None): needed treatment to program participants, including aftercare
p.(None): supervision, vocational training, education, and job placement;
p.(None): and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Indian Tribe and licensed, if
p.(None): necessary, to provide alcohol and drug addiction treatment to
p.(None): offenders participating in the program.
p.(None):
p.(None): ``(d) Supplement of Non-Federal Funds.--
p.(None): ``(1) In general.--Grants awarded under this section shall
p.(None): be used to supplement, and not supplant, non-Federal funds that
p.(None): would otherwise be available for programs described in this
p.(None): section.
p.(None): ``(2) Federal share.--The Federal share of a grant made
p.(None): under this section may not exceed 50 percent of the total costs
p.(None): of the program described in an application under subsection (e).
p.(None):
p.(None): ``(e) Applications.--To request a grant under this section, a State,
p.(None): unit of local government, territory, Indian Tribe, or nonprofit agency
p.(None): shall submit an application to the Attorney General in such form and
p.(None): containing such information as the Attorney General may reasonably
p.(None): require.
p.(None): ``(f) Geographic Distribution.--The Attorney General shall ensure
p.(None): that, to the extent practicable, the distribution of grants under this
p.(None): section is equitable and includes--
p.(None): ``(1) each State; and
p.(None):
p.(None): [[Page 130 STAT. 1293]]
p.(None):
p.(None): ``(2) a unit of local government, territory, Indian Tribe,
p.(None): or nonprofit agency--
p.(None): ``(A) in each State; and
p.(None): ``(B) in rural, suburban, Tribal, and urban
p.(None): jurisdictions.
p.(None):
p.(None): ``(g) Reports and Evaluations.--For each fiscal year, each grantee
p.(None): under this section during that fiscal year shall submit to the Attorney
...
p.(None): ``(5) submit periodic reports on the progress of treatment
p.(None): or other measured outcomes from participation in the program of
p.(None): each eligible participant in the program to the relevant State,
p.(None): Tribal, or local criminal justice agency, including mental
p.(None): health courts, drug courts, co-occurring mental health and
p.(None): substance abuse courts, DWI courts, and veterans treatment
p.(None): courts;
p.(None): ``(6) describe the evidence-based methodology and outcome
p.(None): measurements that will be used to evaluate the program, and
p.(None): specifically explain how such measurements will provide valid
p.(None): measures of the impact of the program; and
p.(None): ``(7) describe how the program could be broadly replicated
p.(None): if demonstrated to be effective.
p.(None):
p.(None): ``(e) Use of Funds.--An eligible entity shall use a grant received
p.(None): under this section for expenses of a treatment alternative to
p.(None): incarceration program, including--
p.(None): ``(1) salaries, personnel costs, equipment costs, and other
p.(None): costs directly related to the operation of the program,
p.(None): including the enforcement unit;
p.(None): ``(2) payments for treatment providers that are approved by
p.(None): the relevant State or Tribal jurisdiction and licensed, if
p.(None): necessary, to provide needed treatment to eligible offenders
p.(None): participating in the program, including aftercare supervision,
p.(None): vocational training, education, and job placement; and
p.(None): ``(3) payments to public and nonprofit private entities that
p.(None): are approved by the State or Tribal jurisdiction and licensed,
p.(None): if necessary, to provide alcohol and drug addiction treatment to
p.(None): eligible offenders participating in the program.
p.(None):
p.(None): ``(f) Supplement Not Supplant.--An eligible entity shall use Federal
p.(None): funds received under this section only to supplement the funds that
p.(None): would, in the absence of those Federal funds, be made available from
p.(None): other Federal and non-Federal sources for the activities described in
p.(None): this section, and not to supplant those funds. The Federal share of a
p.(None): grant made under this section may not exceed 50 percent of the total
p.(None): costs of the program described in an application under subsection (d).
p.(None): ``(g) Geographic Distribution.--The Attorney General shall ensure
p.(None): that, to the extent practicable, the geographical distribution of grants
p.(None): under this section is equitable and includes a grant to an eligible
p.(None): entity in--
p.(None): ``(1) each State;
p.(None): ``(2) rural, suburban, and urban areas; and
p.(None): ``(3) Tribal jurisdictions.
p.(None):
p.(None): ``(h) Reports and Evaluations.--Each fiscal year, each recipient of
p.(None): a grant under this section during that fiscal year shall submit to the
p.(None): Attorney General a report on the outcomes of activities carried out
p.(None): using that grant in such form, containing such information, and on such
p.(None): dates as the Attorney General shall specify.
p.(None): ``(i) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None):
...
Social / Police Officer
Searching for indicator officer:
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p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
...
p.(None): after the date of enactment of this Act, all persons engaged in research
p.(None): and authorized by the Secretary of Health and Human Services to protect
p.(None): information under section 301(d) of the Public Health Service Act (42
p.(None): U.S.C. 241(d)) prior to the date of enactment of this Act shall be
p.(None): subject to the requirements of such section (as amended by this Act).
p.(None): SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
p.(None):
p.(None): Section 301 of the Public Health Service Act (42 U.S.C. 241) is
p.(None): amended by adding at the end the following:
p.(None): ``(f)(1) The Secretary may exempt from disclosure under section
p.(None): 552(b)(3) of title 5, United States Code, biomedical information that is
p.(None): about an individual and that is gathered or used during the course of
p.(None): biomedical research if--
p.(None): ``(A) an individual is identified; or
p.(None): ``(B) there is at least a very small risk, as determined by
p.(None): current scientific practices or statistical methods, that some
p.(None): combination of the information, the request, and other available
p.(None): data sources could be used to deduce the identity of an
p.(None): individual.
p.(None):
p.(None): ``(2)(A) Each determination of the Secretary under paragraph (1) to
p.(None): exempt information from disclosure shall be made in writing and
p.(None): accompanied by a statement of the basis for the determination.
p.(None): ``(B) Each such determination and statement of basis shall be
p.(None): available to the public, upon request, through the Office of the Chief
p.(None): FOIA Officer of the Department of Health and Human Services.
p.(None):
p.(None): [[Page 130 STAT. 1051]]
p.(None):
p.(None): ``(3) Nothing in this subsection shall be construed to limit a
p.(None): research participant's access to information about such participant
p.(None): collected during the participant's participation in the research.''.
p.(None): SEC. 2014. DATA SHARING.
p.(None):
p.(None): (a) In General.--Section 402(b) of the Public Health Service Act (42
p.(None): U.S.C. 282(b)) is amended--
p.(None): (1) in paragraph (23), by striking ``and'' at the end;
p.(None): (2) in paragraph (24), by striking the period and inserting
p.(None): ``; and''; and
p.(None): (3) by inserting after paragraph (24) the following:
p.(None): ``(25) may require recipients of National Institutes of
p.(None): Health awards to share scientific data, to the extent feasible,
p.(None): generated from such National Institutes of Health awards in a
p.(None): manner that is consistent with all applicable Federal laws and
p.(None): regulations, including such laws and regulations for the
p.(None): protection of--
p.(None): ``(A) human research participants, including with
p.(None): respect to privacy, security, informed consent, and
p.(None): protected health information; and
p.(None): ``(B) proprietary interests, confidential commercial
p.(None): information, and the intellectual property rights of the
p.(None): funding recipient.''.
p.(None):
p.(None): (b) <> Confidentiality.--Nothing in the
p.(None): amendments made by subsection (a) authorizes the Secretary of Health and
p.(None): Human Services to disclose any information that is a trade secret, or
...
p.(None): ``(p) The provisions of subsections (c), (d), (g), and (h) shall
p.(None): apply to a civil money penalty or assessment under subsection (o) in the
p.(None): same manner as such provisions apply to a penalty, assessment, or
p.(None): proceeding under subsection (a). In applying subsection (d), each
p.(None): reference to a claim under such subsection shall be treated as including
p.(None): a reference to a specified claim (as defined in subsection (r)).
p.(None): ``(q) For purposes of this subsection and subsections (o) and (p):
p.(None): ``(1) The term `Department' means the Department of Health
p.(None): and Human Services.
p.(None): ``(2) The term `material' means having a natural tendency to
p.(None): influence, or be capable of influencing, the payment or receipt
p.(None): of money or property.
p.(None): ``(3) The term `other agreement' includes a cooperative
p.(None): agreement, scholarship, fellowship, loan, subsidy, payment for a
p.(None): specified use, donation agreement, award, or subaward
p.(None): (regardless of whether one or more of the persons entering into
p.(None): the agreement is a contractor or subcontractor).
p.(None): ``(4) The term `program beneficiary' means, in the case of a
p.(None): grant, contract, or other agreement designed to accomplish the
p.(None): objective of awarding or otherwise furnishing benefits or
p.(None): assistance to individuals and for which the Secretary provides
p.(None): funding, an individual who applies for, or who receives, such
p.(None): benefits or assistance from such grant, contract, or other
p.(None): agreement. Such term does not include, with respect to such
p.(None): grant, contract, or other agreement, an officer, employee, or
p.(None): agent of a person or entity that receives such grant or that
p.(None): enters into such contract or other agreement.
p.(None):
p.(None): [[Page 130 STAT. 1190]]
p.(None):
p.(None): ``(5) The term `recipient' includes a subrecipient or
p.(None): subcontractor.
p.(None): ``(6) The term `specified State agency' means an agency of a
p.(None): State government established or designated to administer or
p.(None): supervise the administration of a grant, contract, or other
p.(None): agreement funded in whole or in part by the Secretary.
p.(None):
p.(None): ``(r) For purposes of this section, the term `specified claim' means
p.(None): any application, request, or demand under a grant, contract, or other
p.(None): agreement for money or property, whether or not the United States or a
p.(None): specified State agency has title to the money or property, that is not a
p.(None): claim (as defined in subsection (i)(2)) and that--
p.(None): ``(1) is presented or caused to be presented to an officer,
p.(None): employee, or agent of the Department or agency thereof, or of
p.(None): any specified State agency; or
p.(None): ``(2) is made to a contractor, grantee, or any other
p.(None): recipient if the money or property is to be spent or used on the
p.(None): Department's behalf or to advance a Department program or
p.(None): interest, and if the Department--
p.(None): ``(A) provides or has provided any portion of the
p.(None): money or property requested or demanded; or
p.(None): ``(B) will reimburse such contractor, grantee, or
p.(None): other recipient for any portion of the money or property
p.(None): which is requested or demanded.
p.(None):
p.(None): ``(s) For purposes of subsection (o), the term `obligation' means an
p.(None): established duty, whether or not fixed, arising from an express or
p.(None): implied contractual, grantor-grantee, or licensor-licensee relationship,
p.(None): for a fee-based or similar relationship, from statute or regulation, or
p.(None): from the retention of any overpayment.''.
p.(None): (b) Conforming Amendments.--Section 1128A of the Social Security Act
p.(None): (42 U.S.C. 1320a-7a) is amended--
p.(None): (1) in subsection (e), by inserting ``or specified claim''
p.(None): after ``claim'' in the first sentence; and
p.(None): (2) in subsection (f)--
p.(None): (A) in the matter preceding paragraph (1)--
p.(None): (i) by inserting ``or specified claim (as
p.(None): defined in subsection (r))'' after ``district
p.(None): where the claim''; and
p.(None): (ii) by inserting ``(or, with respect to a
p.(None): person described in subsection (o), the person)''
p.(None): after ``claimant''; and
p.(None): (B) in the matter following paragraph (4), by
...
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
p.(None): ``(B) requirements for the description of the
p.(None): program implementation approach;
p.(None): ``(C) the extent to which the grant plan submitted
p.(None): by the grantee as part of its application must explain
p.(None): how the grantee will reach the population of focus and
p.(None): provide a statement of need, which may include
p.(None): information on how the grantee will increase access to
p.(None): services and a description of measurable objectives for
p.(None): improving outcomes;
p.(None): ``(D) the extent to which the grantee must collect
p.(None): and report on required performance measures; and
p.(None): ``(E) the extent to which the grantee is proposing
p.(None): to use evidence-based practices; and
p.(None): ``(25) advance, through existing programs, the use of
p.(None): performance metrics, including those based on the
p.(None): recommendations on performance metrics from the Assistant
p.(None): Secretary for Planning and Evaluation under section 6021(d) of
p.(None): the Helping Families in Mental Health Crisis Reform Act of
p.(None): 2016.''; and
p.(None): (3) in subsection (m), by adding at the end the following:
p.(None): ``(4) Emergency response.--Amounts made available for
p.(None): carrying out this subsection shall remain available through the
p.(None): end of the fiscal year following the fiscal year for which such
p.(None): amounts are appropriated.''.
p.(None): SEC. 6003. CHIEF MEDICAL OFFICER.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 and 6002, is further amended--
p.(None):
p.(None): [[Page 130 STAT. 1207]]
p.(None):
p.(None): (1) by redesignating subsections (g) through (j) and
p.(None): subsections (k) through (o) as subsections (h) through (k) and
p.(None): subsections (m) through (q), respectively;
p.(None): (2) in subsection (e)(3)(C), by striking ``subsection (k)''
p.(None): and inserting ``subsection (m)'';
p.(None): (3) in subsection (f)(2)(C)(iii), by striking ``subsection
p.(None): (k)'' and inserting ``subsection (m)''; and
p.(None): (4) by inserting after subsection (f) the following:
p.(None):
p.(None): ``(g) Chief Medical Officer.--
p.(None): ``(1) In general.--The Assistant Secretary, with the
p.(None): approval of the Secretary, shall appoint a Chief Medical Officer
p.(None): to serve within the Administration.
p.(None): ``(2) Eligible candidates.--The Assistant Secretary shall
p.(None): select the Chief Medical Officer from among individuals who--
p.(None): ``(A) have a doctoral degree in medicine or
p.(None): osteopathic medicine;
p.(None): ``(B) have experience in the provision of mental or
p.(None): substance use disorder services;
p.(None): ``(C) have experience working with mental or
p.(None): substance use disorder programs;
p.(None): ``(D) have an understanding of biological,
p.(None): psychosocial, and pharmaceutical treatments of mental or
p.(None): substance use disorders; and
p.(None): ``(E) are licensed to practice medicine in one or
p.(None): more States.
p.(None): ``(3) Duties.--The Chief Medical Officer shall--
p.(None): ``(A) serve as a liaison between the Administration
p.(None): and providers of mental and substance use disorders
p.(None): prevention, treatment, and recovery services;
p.(None): ``(B) assist the Assistant Secretary in the
p.(None): evaluation, organization, integration, and coordination
p.(None): of programs operated by the Administration;
p.(None): ``(C) promote evidence-based and promising best
p.(None): practices, including culturally and linguistically
p.(None): appropriate practices, as appropriate, for the
p.(None): prevention and treatment of, and recovery from, mental
p.(None): and substance use disorders, including serious mental
p.(None): illness and serious emotional disturbances;
p.(None): ``(D) participate in regular strategic planning with
p.(None): the Administration;
p.(None): ``(E) coordinate with the Assistant Secretary for
p.(None): Planning and Evaluation to assess the use of performance
p.(None): metrics to evaluate activities within the Administration
p.(None): related to mental and substance use disorders; and
p.(None): ``(F) coordinate with the Assistant Secretary to
p.(None): ensure mental and substance use disorders grant programs
p.(None): within the Administration consistently utilize
p.(None): appropriate performance metrics and evaluation
p.(None): designs.''.
p.(None): SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
p.(None):
p.(None): Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), as
p.(None): amended by section 6001(c), is amended--
...
p.(None): QUALITY.'';
p.(None): (2) by redesignating subsections (a) through (d) as
p.(None): subsections (b) through (e), respectively;
p.(None): (3) before subsection (b), as redesignated by paragraph (2),
p.(None): by inserting the following:
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall maintain within the
p.(None): Administration a Center for Behavioral Health Statistics and Quality (in
p.(None): this section referred to as the `Center'). The Center shall be headed by
p.(None): a Director (in this section referred to as the `Director') appointed by
p.(None): the Secretary from among individuals with extensive experience and
p.(None): academic qualifications in research and analysis in behavioral health
p.(None): care or related fields.'';
p.(None): (4) in subsection (b), as redesignated by paragraph (2)--
p.(None): (A) by redesignating paragraphs (1) and (2) as
p.(None): subparagraphs (A) and (B), respectively;
p.(None): (B) by striking ``The Secretary, acting'' and all
p.(None): that follows through ``year on--'' and inserting ``The
p.(None): Director shall--
p.(None): ``(1) coordinate the Administration's integrated data
p.(None): strategy, including by collecting data each year on--'';
p.(None): (C) in the subparagraph (B), as redesignated by
p.(None): subparagraph (A), by striking ``Assistant Secretary''
p.(None): and inserting ``Director''; and
p.(None): (D) by adding at the end the following new
p.(None): paragraphs:
p.(None): ``(2) provide statistical and analytical support for
p.(None): activities of the Administration;
p.(None): ``(3) recommend a core set of performance metrics to
p.(None): evaluate activities supported by the Administration; and
p.(None): ``(4) coordinate with the Assistant Secretary, the Assistant
p.(None): Secretary for Planning and Evaluation, and the Chief Medical
p.(None): Officer appointed under section 501(g), as appropriate, to
p.(None): improve the quality of services provided by programs of the
p.(None): Administration and the evaluation of activities carried out by
p.(None): the Administration.''.
p.(None): (5) in subsection (c), as so redesignated--
p.(None): (A) by striking ``With respect to the activities''
p.(None): and inserting ``Mental Health.--With respect to the
p.(None): activities'';
p.(None): (B) by striking ``Assistant Secretary'' each place
p.(None): it appears and inserting ``Director''; and
p.(None): (C) by striking ``subsection (a)'' and inserting
p.(None): ``subsection (b)(1)'';
p.(None): (6) in subsection (d), as so redesignated--
p.(None): (A) by striking the subsection designation and all
p.(None): that follows through ``With respect to the activities''
p.(None): and inserting the following:
p.(None):
p.(None): ``(d) Substance Abuse.--
p.(None): ``(1) In general.--With respect to the activities'';
p.(None): (B) in paragraph (1)--
p.(None): (i) in the matter before subparagraph (A)--
p.(None): (I) by striking ``subsection (a)''
p.(None): and inserting ``subsection (b)(1)''; and
p.(None): (II) by striking ``Assistant
p.(None): Secretary'' each place it appears and
p.(None): inserting ``Director''; and
p.(None):
p.(None): [[Page 130 STAT. 1209]]
p.(None):
p.(None): (ii) in subparagraph (B), by inserting ``in
p.(None): coordination with the Centers for Disease Control
p.(None): and Prevention'' before the semicolon at the end;
p.(None): and
p.(None): (C) in paragraph (2), by striking ``Annual surveys''
p.(None): and inserting ``Annual surveys; public availability of
p.(None): data.--Annual surveys''; and
p.(None): (7) in subsection (e), as so redesignated--
p.(None): (A) by striking ``After consultation'' and inserting
...
p.(None): response to such recommendations to improve programs within the
p.(None): Administration.
p.(None):
p.(None): The Assistant Secretary may meet reporting requirements established
p.(None): under this title by providing the contents of such reports as an
p.(None): addendum to the biennial report established under this subsection,
p.(None): notwithstanding the timeline of other reporting requirements in this
p.(None): title. Nothing in this subsection shall be construed to alter the
p.(None): content requirements of such reports or authorize the Assistant
p.(None): Secretary to alter the timeline of any such reports
p.(None):
p.(None): [[Page 130 STAT. 1212]]
p.(None):
p.(None): to be less frequent than biennially, unless as specified in this
p.(None): title.''.
p.(None): (b) Conforming Amendment.--Section 508(p) of the Public Health
p.(None): Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
p.(None): 501(k)'' and inserting ``section 501(m)''.
p.(None): SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
p.(None): SUBSTANCE ABUSE PREVENTION, AND
p.(None): SUBSTANCE ABUSE TREATMENT.
p.(None):
p.(None): (a) Center for Mental Health Services.--Section 520(b) of the Public
p.(None): Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
p.(None): (1) by redesignating paragraphs (3) through (15) as
p.(None): paragraphs (4) through (16), respectively;
p.(None): (2) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute of Mental Health and the Chief Medical Officer,
p.(None): appointed under section 501(g), to ensure that, as appropriate,
p.(None): programs related to the prevention and treatment of mental
p.(None): illness and the promotion of mental health and recovery support
p.(None): are carried out in a manner that reflects the best available
p.(None): science and evidence-based practices, including culturally and
p.(None): linguistically appropriate services, as appropriate;'';
p.(None): (3) in paragraph (5), as so redesignated, by inserting ``,
p.(None): including through programs that reduce risk and promote
p.(None): resiliency'' before the semicolon;
p.(None): (4) in paragraph (6), as so redesignated, by inserting ``in
p.(None): collaboration with the Director of the National Institute of
p.(None): Mental Health,'' before ``develop'';
p.(None): (5) in paragraph (8), as so redesignated, by inserting ``,
p.(None): increase meaningful participation of individuals with mental
p.(None): illness in programs and activities of the Administration,''
p.(None): before ``and protect the legal'';
p.(None): (6) in paragraph (10), as so redesignated, by striking
p.(None): ``professional and paraprofessional personnel pursuant to
p.(None): section 303'' and inserting ``health paraprofessional personnel
p.(None): and health professionals'';
p.(None): (7) in paragraph (11), as so redesignated, by inserting
p.(None): ``and tele-mental health'' after ``rural mental health'';
p.(None): (8) in paragraph (12), as so redesignated, by striking
p.(None): ``establish a clearinghouse for mental health information to
p.(None): assure the widespread dissemination of such information'' and
...
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (B) in paragraph (3), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (C) in paragraph (4), by striking ``individuals who
p.(None): abuse drugs'' and inserting ``individuals who illicitly
p.(None): use drugs'';
p.(None): (D) in paragraph (9), by striking ``carried out by
p.(None): the Director'';
p.(None): (E) by striking paragraph (10);
p.(None): (F) by redesignating paragraphs (11) through (14) as
p.(None): paragraphs (10) through (13), respectively;
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 1(b)) is amended--
p.(None): (1) in paragraph (2)--
p.(None): (A) in subparagraph (E), by striking ``and'' after
p.(None): the semicolon;
p.(None): (B) by redesignating subparagraph (F) as
p.(None): subparagraph (J); and
p.(None): (C) by inserting after subparagraph (E), the
p.(None): following:
p.(None): ``(F) the Chief Medical Officer, appointed under
p.(None): section 501(g);
p.(None): ``(G) the Director of the National Institute of
p.(None): Mental Health for the advisory councils appointed under
p.(None): subsections (a)(1)(A) and (a)(1)(D);
p.(None): ``(H) the Director of the National Institute on Drug
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
...
p.(None): within the Department of Health and Human Services. The strategy shall--
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
p.(None): the Secretary of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, and the Congress on improving the
p.(None): quality of prevention and treatment programs and activities related to
p.(None): mental and substance use disorders, including recommendations for the
p.(None): use of performance metrics. The Assistant Secretary for Mental Health
p.(None): and Substance Use shall include such recommendations in the biennial
p.(None): report required by subsection 501(m) of the Public Health Service Act,
p.(None): as redesignated by section 6003 of this Act.
p.(None): SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
p.(None):
p.(None): (a) Public Availability of Reports.--Section 105(a)(7) of the
p.(None): Protection and Advocacy for Individuals with Mental Illness Act (42
...
p.(None): (D) at least 2 members shall be--
p.(None): (i) a licensed psychiatrist with experience in
p.(None): treating serious mental illnesses;
p.(None): (ii) a licensed psychologist with experience
p.(None): in treating serious mental illnesses or serious
p.(None): emotional disturbances;
p.(None): (iii) a licensed clinical social worker with
p.(None): experience treating serious mental illnesses or
p.(None): serious emotional disturbances; or
p.(None): (iv) a licensed psychiatric nurse, nurse
p.(None): practitioner, or physician assistant with
p.(None): experience in treating serious mental illnesses or
p.(None): serious emotional disturbances;
p.(None): (E) at least 1 member shall be a licensed mental
p.(None): health professional with a specialty in treating
p.(None): children and adolescents with a serious emotional
p.(None): disturbance;
p.(None): (F) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with minorities;
p.(None): (G) at least 1 member shall be a mental health
p.(None): professional who has research or clinical mental health
p.(None): experience in working with medically underserved
p.(None): populations;
p.(None): (H) at least 1 member shall be a State certified
p.(None): mental health peer support specialist;
p.(None): (I) at least 1 member shall be a judge with
p.(None): experience in adjudicating cases related to criminal
p.(None): justice or serious mental illness;
p.(None): (J) at least 1 member shall be a law enforcement
p.(None): officer or corrections officer with extensive experience
p.(None): in interfacing with adults with a serious mental
p.(None): illness, children with a serious emotional disturbance,
p.(None): or individuals in a mental health crisis; and
p.(None): (K) at least 1 member shall have experience
p.(None): providing services for homeless individuals and working
p.(None): with adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, or individuals in a
p.(None): mental health crisis.
p.(None): (3) Terms.--A member of the Committee appointed under
p.(None): subsection (e)(2) shall serve for a term of 3 years, and may be
p.(None): reappointed for 1 or more additional 3-year terms. Any member
p.(None): appointed to fill a vacancy for an unexpired term shall be
p.(None): appointed for the remainder of such term. A member may serve
p.(None): after the expiration of the member's term until a successor has
p.(None): been appointed.
p.(None):
p.(None): [[Page 130 STAT. 1220]]
p.(None):
p.(None): (f) Working Groups.--In carrying out its functions, the Committee
p.(None): may establish working groups. Such working groups shall be composed of
p.(None): Committee members, or their designees, and may hold such meetings as are
p.(None): necessary.
p.(None): (g) Sunset.--The Committee shall terminate on the date that is 6
p.(None): years after the date on which the Committee is established under
p.(None): subsection (a)(1).
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
...
p.(None): are not evidence-based, effective, or efficient; and
p.(None): ``(C) formulate recommendations for coordinating,
p.(None): eliminating, or improving programs or activities
p.(None): identified
p.(None):
p.(None): [[Page 130 STAT. 1221]]
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
p.(None): [[Page 130 STAT. 1222]]
p.(None):
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
p.(None): mental illness, serious emotional disturbances,
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
...
p.(None): compensation for the service from the individual, the entity
p.(None): described in subsection (g)(4), or any third-party payer
p.(None): (including reimbursement under any insurance policy or health
p.(None): plan, or under any Federal or State health benefits program),
p.(None): except that the health care practitioner may receive repayment
p.(None): from the entity described in subsection (g)(4) for reasonable
p.(None): expenses incurred by the health care practitioner in the
p.(None): provision of the service to the individual, which may include
p.(None): travel expenses to or from the site of services.
p.(None): ``(D) Before the service is provided, the health care
p.(None): practitioner or the entity described in subsection (g)(4) posts
p.(None): a clear
p.(None):
p.(None): [[Page 130 STAT. 1255]]
p.(None):
p.(None): and conspicuous notice at the site where the service is provided
p.(None): of the extent to which the legal liability of the health care
p.(None): practitioner is limited pursuant to this subsection.
p.(None): ``(E) At the time the service is provided, the health care
p.(None): practitioner is licensed or certified in accordance with
p.(None): applicable Federal and State laws regarding the provision of the
p.(None): service.
p.(None): ``(F) At the time the service is provided, the entity
p.(None): described in subsection (g)(4) maintains relevant documentation
p.(None): certifying that the health care practitioner meets the
p.(None): requirements of this subsection.
p.(None):
p.(None): ``(3) Subsection (g) (other than paragraphs (3) and (5)) and
p.(None): subsections (h), (i), and (l) apply to a health care practitioner for
p.(None): purposes of this subsection to the same extent and in the same manner as
p.(None): such subsections apply to an officer, governing board member, employee,
p.(None): or contractor of an entity described in subsection (g)(4), subject to
p.(None): paragraph (4), and subject to the following:
p.(None): ``(A) The first sentence of paragraph (1) applies in lieu of
p.(None): the first sentence of subsection (g)(1)(A).
p.(None): ``(B) With respect to an entity described in subsection
p.(None): (g)(4), a health care practitioner is not a health professional
p.(None): volunteer at such entity unless the entity sponsors the health
p.(None): care practitioner. For purposes of this subsection, the entity
p.(None): shall be considered to be sponsoring the health care
p.(None): practitioner if--
p.(None): ``(i) with respect to the health care practitioner,
p.(None): the entity submits to the Secretary an application
p.(None): meeting the requirements of subsection (g)(1)(D); and
p.(None): ``(ii) the Secretary, pursuant to subsection
p.(None): (g)(1)(E), determines that the health care practitioner
p.(None): is deemed to be an employee of the Public Health
p.(None): Service.
p.(None): ``(C) In the case of a health care practitioner who is
p.(None): determined by the Secretary pursuant to subsection (g)(1)(E) to
p.(None): be a health professional volunteer at such entity, this
p.(None): subsection applies to the health care practitioner (with respect
p.(None): to services performed on behalf of the entity sponsoring the
p.(None): health care practitioner pursuant to subparagraph (B)) for any
p.(None): cause of action arising from an act or omission of the health
p.(None): care practitioner occurring on or after the date on which the
p.(None): Secretary makes such determination.
p.(None): ``(D) Subsection (g)(1)(F) applies to a health care
p.(None): practitioner for purposes of this subsection only to the extent
...
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
p.(None):
p.(None): The Attorney General, as part of the Preventing Violence Against Law
p.(None): Enforcement and Ensuring Officer Resilience and Survivability Initiative
p.(None): (VALOR) of the Department of Justice, may provide safety training and
p.(None): technical assistance to local law enforcement agencies, including
p.(None): active-shooter response training.
p.(None): SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN RESIDENTIAL SUBSTANCE
p.(None): ABUSE TREATMENT PROGRAMS.
p.(None):
p.(None): Section 1901(a) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
...
p.(None): ``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING
p.(None): AND TECHNICAL ASSISTANCE.
p.(None):
p.(None): ``(a) Authority.--The Attorney General may make grants to eligible
p.(None): organizations to provide for the establishment of a National Criminal
p.(None): Justice and Mental Health Training and Technical Assistance Center.
p.(None): ``(b) Eligible Organization.--For purposes of subsection (a), the
p.(None): term `eligible organization' means a national nonprofit organization
p.(None): that provides technical assistance and training to, and has special
p.(None): expertise and broad, national-level experience in, mental health, crisis
p.(None): intervention, criminal justice systems, law enforcement, translating
p.(None): evidence into practice, training, and research, and education and
p.(None): support of people with mental illness and the families of such
p.(None): individuals.
p.(None): ``(c) Use of Funds.--Any organization that receives a grant under
p.(None): subsection (a) shall collaborate with other grant recipients to
p.(None): establish and operate a National Criminal Justice and Mental Health
p.(None): Training and Technical Assistance Center to--
p.(None): ``(1) provide law enforcement officer training regarding
p.(None): mental health and working with individuals with mental
p.(None): illnesses, with an emphasis on de-escalation of encounters
p.(None): between law enforcement officers and those with mental disorders
p.(None): or in crisis, which shall include support the development of in-
p.(None): person and technical information exchanges between systems and
p.(None): the individuals working in those systems in support of the
p.(None): concepts identified in the training;
p.(None): ``(2) provide education, training, and technical assistance
p.(None): for States, Indian tribes, territories, units of local
p.(None): government, service providers, nonprofit organizations,
p.(None): probation or parole officers, prosecutors, defense attorneys,
p.(None): emergency response providers, and corrections institutions to
p.(None): advance practice and knowledge relating to mental health crisis
p.(None): and approaches to mental health and criminal justice across
p.(None): systems;
p.(None): ``(3) provide training and best practices to mental health
p.(None): providers and criminal justice agencies relating to diversion
p.(None): initiatives, jail and prison strategies, reentry of individuals
p.(None): with mental illnesses into the community, and dispatch protocols
p.(None): and triage capabilities, including the establishment of learning
p.(None): sites;
p.(None): ``(4) develop suicide prevention and crisis intervention
...
p.(None): crisis services for public service
p.(None): personnel,
p.(None):
p.(None): [[Page 130 STAT. 1310]]
p.(None):
p.(None): including criminal justice, mental
p.(None): health, substance abuse, emergency room,
p.(None): healthcare, law enforcement,
p.(None): corrections, and housing personnel;
p.(None): ``(III) develop or support
p.(None): alternatives to hospital and jail
p.(None): admissions for frequent users of crisis
p.(None): services that provide treatment,
p.(None): stabilization, and other appropriate
p.(None): supports in the least restrictive, yet
p.(None): appropriate, environment; and
p.(None): ``(IV) develop protocols and systems
p.(None): among law enforcement, mental health,
p.(None): substance abuse, housing, corrections,
p.(None): and emergency medical service operations
p.(None): to provide coordinated assistance to
p.(None): frequent users of crisis services.''.
p.(None): SEC. 14024. LAW ENFORCEMENT TRAINING.
p.(None):
p.(None): Section 2991(h) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
p.(None): (1) in paragraph (1), by adding at the end the following:
p.(None): ``(F) Academy training.--To provide support for
p.(None): academy curricula, law enforcement officer orientation
p.(None): programs, continuing education training, and other
p.(None): programs that teach law enforcement personnel how to
p.(None): identify and respond to incidents involving persons with
p.(None): mental health disorders or co-occurring mental health
p.(None): and substance abuse disorders.''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(4) Priority consideration.--The Attorney General, in
p.(None): awarding grants under this subsection, shall give priority to
p.(None): programs that law enforcement personnel and members of the
p.(None): mental health and substance abuse professions develop and
p.(None): administer cooperatively.''.
p.(None): SEC. 14025. <> FEDERAL LAW
p.(None): ENFORCEMENT TRAINING.
p.(None):
p.(None): Not later than 1 year after the date of enactment of this Act, the
p.(None): Attorney General shall provide direction and guidance for the following:
p.(None): (1) Training programs.--Programs that offer specialized and
p.(None): comprehensive training, in procedures to identify and
p.(None): appropriately respond to incidents in which the unique needs of
p.(None): individuals who have a mental illness are involved, to first
p.(None): responders and tactical units of--
p.(None): (A) Federal law enforcement agencies; and
p.(None): (B) other Federal criminal justice agencies such as
p.(None): the Bureau of Prisons, the Administrative Office of the
...
p.(None): billing under this subsection with respect to
p.(None): covered OPD services furnished prior to November
p.(None): 2, 2015, if the Secretary received from the
p.(None): provider prior to December 2, 2015, an attestation
p.(None): (pursuant to section 413.65(b)(3) of title 42 of
p.(None): the Code of Federal Regulations) that such
p.(None): department was a department of a provider (as so
p.(None): defined).
p.(None): ``(iv) Alternative exception beginning with
p.(None): 2018.--For purposes of paragraph (1)(B)(v) and
p.(None): this paragraph with respect to applicable items
p.(None): and services furnished during 2018 or a subsequent
p.(None): year, the term `off-campus outpatient department
p.(None): of a provider' also shall not include a department
p.(None): of a provider (as so defined) that is not
p.(None): described in clause (ii) if--
p.(None): ``(I) the Secretary receives from
p.(None): the provider an attestation (pursuant to
p.(None): such section 413.65(b)(3)) not later
p.(None): than December 31, 2016 (or, if later, 60
p.(None): days after the date of the enactment of
p.(None): this clause), that such department met
p.(None): the requirements of a department of a
p.(None): provider specified in section 413.65 of
p.(None): title 42 of the Code of Federal
p.(None): Regulations;
p.(None): ``(II) the provider includes such
p.(None): department as part of the provider on
p.(None): its enrollment form in accordance with
p.(None): the enrollment process under section
p.(None): 1866(j); and
p.(None): ``(III) the department met the mid-
p.(None): build requirement of clause (v) and the
p.(None): Secretary receives, not later than 60
p.(None): days after the date
p.(None):
p.(None): [[Page 130 STAT. 1325]]
p.(None):
p.(None): of the enactment of this clause, from
p.(None): the chief executive officer or chief
p.(None): operating officer of the provider a
p.(None): written certification that the
p.(None): department met such requirement.
p.(None): ``(v) Mid-build requirement described.--The
p.(None): mid-build requirement of this clause is, with
p.(None): respect to a department of a provider, that before
p.(None): November 2, 2015, the provider had a binding
p.(None): written agreement with an outside unrelated party
p.(None): for the actual construction of such department.
p.(None): ``(vii) Audit.--Not later than December 31,
p.(None): 2018, the Secretary shall audit the compliance
p.(None): with requirements of clause (iv) with respect to
p.(None): each department of a provider to which such clause
p.(None): applies. If the Secretary finds as a result of an
p.(None): audit under this clause that the applicable
p.(None): requirements were not met with respect to such
p.(None): department, the department shall not be excluded
p.(None): from the term `off-campus outpatient department of
p.(None): a provider' under such clause.
p.(None): ``(viii) Implementation.--For purposes of
p.(None): implementing clauses (iii) through (vii):
p.(None): ``(I) Notwithstanding any other
p.(None): provision of law, the Secretary may
p.(None): implement such clauses by program
p.(None): instruction or otherwise.
p.(None): ``(II) Subchapter I of chapter 35 of
p.(None): title 44, United States Code, shall not
p.(None): apply.
p.(None): ``(III) For purposes of carrying out
p.(None): this subparagraph with respect to
p.(None): clauses (iii) and (iv) (and clause (vii)
p.(None): insofar as it relates to clause (iv)),
p.(None): $10,000,000 shall be available from the
p.(None): Federal Supplementary Medical Insurance
p.(None): Trust Fund under section 1841, to remain
p.(None): available until December 31, 2018.'';
p.(None): and
p.(None): (2) in subparagraph (E), by adding at the end the following
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p.(None): ``(k) Sequential Intercept Grants.--
p.(None): ``(1) Definition.--In this subsection, the term `eligible
p.(None): entity' means a State, unit of local government, Indian tribe,
p.(None): or tribal organization.
p.(None): ``(2) Authorization.--The Attorney General may make grants
p.(None): under this subsection to an eligible entity for sequential
p.(None): intercept mapping and implementation in accordance with
p.(None): paragraph (3).
p.(None): ``(3) Sequential intercept mapping; implementation.--An
p.(None): eligible entity that receives a grant under this subsection may
p.(None): use funds for--
p.(None): ``(A) sequential intercept mapping, which--
p.(None): ``(i) shall consist of--
p.(None): ``(I) convening mental health and
p.(None): criminal justice stakeholders to--
p.(None): ``(aa) develop a shared
p.(None): understanding of the flow of
p.(None): justice-involved individuals
p.(None): with mental illnesses through
p.(None): the criminal justice system; and
p.(None): ``(bb) identify
p.(None): opportunities for improved
p.(None): collaborative responses to the
p.(None): risks and needs of individuals
p.(None): described in item (aa); and
p.(None): ``(II) developing strategies to
p.(None): address gaps in services and bring
p.(None): innovative and effective programs to
p.(None): scale along multiple intercepts,
p.(None): including--
p.(None): ``(aa) emergency and crisis
p.(None): services;
p.(None): ``(bb) specialized police-
p.(None): based responses;
p.(None): ``(cc) court hearings and
p.(None): disposition alternatives;
p.(None): ``(dd) reentry from jails
p.(None): and prisons; and
p.(None): ``(ee) community
p.(None): supervision, treatment and
p.(None): support services; and
p.(None): ``(ii) may serve as a starting point for the
p.(None): development of strategic plans to achieve positive
p.(None): public health and safety outcomes; and
p.(None): ``(B) implementation, which shall--
p.(None): ``(i) be derived from the strategic plans
p.(None): described in subparagraph (A)(ii); and
p.(None): ``(ii) consist of--
p.(None): ``(I) hiring and training personnel;
p.(None): ``(II) identifying the eligible
p.(None): entity's target population;
p.(None): ``(III) providing services and
p.(None): supports to reduce unnecessary
p.(None): penetration into the criminal justice
p.(None): system;
p.(None): ``(IV) reducing recidivism;
p.(None): ``(V) evaluating the impact of the
p.(None): eligible entity's approach; and
p.(None):
p.(None): [[Page 130 STAT. 1309]]
p.(None):
p.(None): ``(VI) planning for the
p.(None): sustainability of effective
p.(None): interventions.''.
p.(None): SEC. 14022. PRISON AND JAILS.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (k), as added by section 14021, the following:
p.(None): ``(l) Correctional Facilities.--
p.(None): ``(1) Definitions.--
p.(None): ``(A) Correctional facility.--The term `correctional
...
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p.(None): functionality.
p.(None): Sec. 4003. Interoperability.
p.(None): Sec. 4004. Information blocking.
p.(None): Sec. 4005. Leveraging electronic health records to improve patient care.
p.(None): Sec. 4006. Empowering patients and improving patient access to their
p.(None): electronic health information.
p.(None): Sec. 4007. GAO study on patient matching.
p.(None): Sec. 4008. GAO study on patient access to health information.
p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
...
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
...
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
p.(None): subsection as a target area described in subparagraph
p.(None): (B) if--
p.(None): ``(i) the area is so identified for purposes
p.(None): of responding to new circumstances that have
p.(None): arisen in the health information technology
p.(None): community that affect the interoperability,
p.(None): privacy, or security of health information, or
p.(None): affect patient safety; and
p.(None): ``(ii) at least 30 days prior to treating such
p.(None): area as if it were a target area described in
p.(None): subparagraph (B), the National Coordinator
p.(None): provides adequate notice to Congress of the intent
...
p.(None): (A) 10,000,000 barrels of crude oil during fiscal
p.(None): year 2017;
p.(None): (B) 9,000,000 barrels of crude oil during fiscal
p.(None): year 2018; and
p.(None): (C) 6,000,000 barrels of crude oil during fiscal
p.(None): year 2019.
p.(None):
p.(None): [[Page 130 STAT. 1198]]
p.(None):
p.(None): (2) Deposit of amounts received from sale.--Amounts received
p.(None): from a sale under paragraph (1) shall be deposited in the
p.(None): general fund of the Treasury during the fiscal year in which the
p.(None): sale occurs.
p.(None):
p.(None): (b) <> Emergency Protection.--The
p.(None): Secretary shall not draw down and sell crude oil under this section in
p.(None): quantities that would limit the authority to sell petroleum products
p.(None): under section 161(h) of the Energy Policy and Conservation Act (42
p.(None): U.S.C. 6241(h)) in the full quantity authorized by that subsection.
p.(None):
p.(None): (c) Strategic Petroleum Drawdown Limitations.--Subparagraphs (C) and
p.(None): (D) of section 161(h)(2) of the Energy Policy and Conservation Act (42
p.(None): U.S.C. 6241(h)(2)(C) and (D)) are both amended by striking
p.(None): ``500,000,000'' and inserting ``450,000,000''.
p.(None): SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.
p.(None):
p.(None): Of the unobligated amounts available under section 1323(c)(1) of the
p.(None): Patient Protection and Affordable Care Act (42 U.S.C. 18043(c)(1)),
p.(None): $464,000,000 is rescinded immediately upon the date of the enactment of
p.(None): this Act.
p.(None): SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
p.(None):
p.(None): (a) In General.--Section 1861 of the Social Security Act (42 U.S.C.
p.(None): 1395x) is amended--
p.(None): (1) in subsection (s)(2)--
p.(None): (A) by striking ``and'' at the end of subparagraph
p.(None): (EE);
p.(None): (B) by inserting ``and'' at the end of subparagraph
p.(None): (FF); and
p.(None): (C) by inserting at the end the following new
p.(None): subparagraph:
p.(None): ``(GG) home infusion therapy (as defined in subsection
p.(None): (iii)(1));''; and
p.(None): (2) by adding at the end the following new subsection:
p.(None):
p.(None): ``(iii) Home Infusion Therapy.--(1) The term `home infusion therapy'
p.(None): means the items and services described in paragraph (2) furnished by a
p.(None): qualified home infusion therapy supplier (as defined in paragraph
p.(None): (3)(D)) which are furnished in the individual's home (as defined in
p.(None): paragraph (3)(B)) to an individual--
p.(None): ``(A) who is under the care of an applicable provider (as
p.(None): defined in paragraph (3)(A)); and
p.(None): ``(B) with respect to whom a plan prescribing the type,
p.(None): amount, and duration of infusion therapy services that are to be
p.(None): furnished such individual has been established by a physician
p.(None): (as defined in subsection (r)(1)) and is periodically reviewed
...
p.(None): week, 24-hour-a-day basis;
p.(None): ``(III) is accredited by an organization designated
p.(None): by the Secretary pursuant to section 1834(u)(5); and
p.(None): ``(IV) meets such other requirements as the
p.(None): Secretary determines appropriate, taking into account
p.(None): the standards of care for home infusion therapy
p.(None): established by Medicare Advantage plans under part C and
p.(None): in the private sector.
p.(None): ``(ii) A qualified home infusion therapy supplier may
p.(None): subcontract with a pharmacy, physician, provider of services, or
p.(None): supplier to meet the requirements of this subparagraph.''.
p.(None):
p.(None): (b) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by
p.(None): section 4011, is further amended by adding at the end the following new
p.(None): subsection:
p.(None): ``(u) Payment and Related Requirements for Home Infusion Therapy.--
p.(None): ``(1) Payment.--
p.(None): ``(A) Single payment.--
p.(None): ``(i) In general.--Subject to clause (iii) and
p.(None): subparagraphs (B) and (C), the Secretary shall
p.(None): implement a payment system under which a single
p.(None): payment is made under this title to a qualified
p.(None): home infusion therapy supplier for items and
p.(None): services described in subparagraphs (A) and (B) of
p.(None): section 1861(iii)(2)) furnished by a qualified
p.(None): home infusion therapy supplier (as defined in
p.(None): section 1861(iii)(3)(D)) in coordination with the
p.(None): furnishing of home infusion drugs (as defined in
p.(None): section 1861(iii)(3)(C)) under this part.
p.(None): ``(ii) Unit of single payment.--A unit of
p.(None): single payment under the payment system
p.(None): implemented under this subparagraph is for each
p.(None): infusion drug administration calendar day in the
p.(None): individual's home. The Secretary shall, as
p.(None): appropriate, establish single
p.(None):
p.(None): [[Page 130 STAT. 1200]]
p.(None):
p.(None): payment amounts for types of infusion therapy,
p.(None): including to take into account variation in
p.(None): utilization of nursing services by therapy type.
p.(None): ``(iii) Limitation.--The single payment amount
p.(None): determined under this subparagraph after
p.(None): application of subparagraph (B) and paragraph (3)
p.(None): shall not exceed the amount determined under the
p.(None): fee schedule under section 1848 for infusion
p.(None): therapy services furnished in a calendar day if
p.(None): furnished in a physician office setting, except
p.(None): such single payment shall not reflect more than 5
p.(None): hours of infusion for a particular therapy in a
p.(None): calendar day.
p.(None): ``(B) Required adjustments.--The Secretary shall
p.(None): adjust the single payment amount determined under
p.(None): subparagraph (A) for home infusion therapy services
p.(None): under section 1861(iii)(1) to reflect other factors such
p.(None): as--
p.(None): ``(i) a geographic wage index and other costs
p.(None): that may vary by region; and
p.(None): ``(ii) patient acuity and complexity of drug
p.(None): administration.
p.(None): ``(C) Discretionary adjustments.--
p.(None): ``(i) In general.--Subject to clause (ii), the
p.(None): Secretary may adjust the single payment amount
p.(None): determined under subparagraph (A) (after
p.(None): application of subparagraph (B)) to reflect
p.(None): outlier situations and other factors as the
p.(None): Secretary determines appropriate.
p.(None): ``(ii) Requirement of budget neutrality.--Any
p.(None): adjustment under this subparagraph shall be made
p.(None): in a budget neutral manner.
p.(None): ``(2) Considerations.--In developing the payment system
p.(None): under this subsection, the Secretary may consider the costs of
p.(None): furnishing infusion therapy in the home, consult with home
p.(None): infusion therapy suppliers, consider payment amounts for similar
p.(None): items and services under this part and part A, and consider
p.(None): payment amounts established by Medicare Advantage plans under
p.(None): part C and in the private insurance market for home infusion
p.(None): therapy (including average per treatment day payment amounts by
p.(None): type of home infusion therapy).
p.(None): ``(3) Annual updates.--
p.(None): ``(A) In general.--Subject to subparagraph (B), the
p.(None): Secretary shall update the single payment amount under
p.(None): this subsection from year to year beginning in 2022 by
p.(None): increasing the single payment amount from the prior year
p.(None): by the percentage increase in the Consumer Price Index
p.(None): for all urban consumers (United States city average) for
p.(None): the 12-month period ending with June of the preceding
p.(None): year.
p.(None): ``(B) Adjustment.--For each year, the Secretary
p.(None): shall reduce the percentage increase described in
p.(None): subparagraph (A) by the productivity adjustment
p.(None): described in section 1886(b)(3)(B)(xi)(II). The
p.(None): application of the preceding sentence may result in a
p.(None): percentage being less than 0.0 for a year, and may
p.(None): result in payment being less than such payment rates for
p.(None): the preceding year.
p.(None): ``(4) Authority to apply prior authorization.--The Secretary
p.(None): may, as determined appropriate by the Secretary, apply
p.(None):
p.(None): [[Page 130 STAT. 1201]]
p.(None):
p.(None): prior authorization for home infusion therapy services under
p.(None): section 1861(iii)(1).
p.(None): ``(5) Accreditation of qualified home infusion therapy
p.(None): suppliers.--
p.(None): ``(A) Factors for designation of accreditation
p.(None): organizations.--The Secretary shall consider the
p.(None): following factors in designating accreditation
p.(None): organizations under subparagraph (B) and in reviewing
p.(None): and modifying the list of accreditation organizations
p.(None): designated pursuant to subparagraph (C):
p.(None): ``(i) The ability of the organization to
p.(None): conduct timely reviews of accreditation
p.(None): applications.
p.(None): ``(ii) The ability of the organization to take
p.(None): into account the capacities of suppliers located
p.(None): in a rural area (as defined in section
p.(None): 1886(d)(2)(D)).
p.(None): ``(iii) Whether the organization has
p.(None): established reasonable fees to be charged to
p.(None): suppliers applying for accreditation.
p.(None): ``(iv) Such other factors as the Secretary
p.(None): determines appropriate.
p.(None): ``(B) Designation.--Not later than January 1, 2021,
p.(None): the Secretary shall designate organizations to accredit
p.(None): suppliers furnishing home infusion therapy. The list of
p.(None): accreditation organizations so designated may be
p.(None): modified pursuant to subparagraph (C).
p.(None): ``(C) Review and modification of list of
p.(None): accreditation organizations.--
p.(None): ``(i) In general.--The Secretary shall review
p.(None): the list of accreditation organizations designated
p.(None): under subparagraph (B) taking into account the
p.(None): factors under subparagraph (A). Taking into
p.(None): account the results of such review, the Secretary
p.(None): may, by regulation, modify the list of
p.(None): accreditation organizations designated under
p.(None): subparagraph (B).
p.(None): ``(ii) Special rule for accreditations done
p.(None): prior to removal from list of designated
p.(None): accreditation organizations.--In the case where
p.(None): the Secretary removes an organization from the
p.(None): list of accreditation organizations designated
p.(None): under subparagraph (B), any supplier that is
p.(None): accredited by the organization during the period
p.(None): beginning on the date on which the organization is
p.(None): designated as an accreditation organization under
p.(None): subparagraph (B) and ending on the date on which
p.(None): the organization is removed from such list shall
p.(None): be considered to have been accredited by an
p.(None): organization designated by the Secretary under
p.(None): subparagraph (B) for the remaining period such
p.(None): accreditation is in effect.
p.(None): ``(D) Rule for accreditations made prior to
p.(None): designation.--In the case of a supplier that is
p.(None): accredited before January 1, 2021, by an accreditation
p.(None): organization designated by the Secretary under
p.(None): subparagraph (B) as of January 1, 2019, such supplier
p.(None): shall be considered to have been accredited by an
p.(None): organization designated by the Secretary under such
p.(None): paragraph as of January 1, 2023, for the remaining
p.(None): period such accreditation is in effect.
p.(None):
p.(None): [[Page 130 STAT. 1202]]
p.(None):
p.(None): ``(6) Notification of infusion therapy options available
p.(None): prior to furnishing home infusion therapy.--Prior to the
p.(None): furnishing of home infusion therapy to an individual, the
p.(None): physician who establishes the plan described in section
p.(None): 1861(iii)(1) for the individual shall provide notification (in a
p.(None): form, manner, and frequency determined appropriate by the
p.(None): Secretary) of the options available (such as home, physician's
p.(None): office, hospital outpatient department) for the furnishing of
p.(None): infusion therapy under this part.''.
p.(None):
p.(None): (c) Conforming Amendments.--
p.(None): (1) Payment reference.--Section 1833(a)(1) of the Social
p.(None): Security Act (42 U.S.C. 1395l(a)(1)) is amended--
p.(None): (A) by striking ``and'' before ``(AA)''; and
p.(None): (B) by inserting before the semicolon at the end the
p.(None): following: ``, and (BB) with respect to home infusion
p.(None): therapy, the amount paid shall be an amount equal to 80
p.(None): percent of the lesser of the actual charge for the
p.(None): services or the amount determined under section
p.(None): 1834(u)''.
p.(None): (2) Direct payment.--The first sentence of section
p.(None): 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is
p.(None): amended--
p.(None): (A) by striking ``and'' before ``(H)''; and
p.(None): (B) by inserting before the period at the end the
p.(None): following: ``, and (I) in the case of home infusion
p.(None): therapy, payment shall be made to the qualified home
p.(None): infusion therapy supplier''.
p.(None): (3) Exclusion from home health services.--Section 1861(m) of
p.(None): the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the
p.(None): first sentence, by inserting the following before the period at
p.(None): the end: ``and home infusion therapy (as defined in subsection
p.(None): (iii)(i))''.
p.(None):
p.(None): (d) <> Effective Date.--The amendments
p.(None): made by this section shall apply to items and services furnished on or
p.(None): after January 1, 2021.
p.(None):
p.(None): DIVISION <p.(None): 2016.>> B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None): SEC. 6000. <> SHORT TITLE.
p.(None):
p.(None): This division may be cited as the ``Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016''.
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE
p.(None): USE.
p.(None):
p.(None): (a) Assistant Secretary.--Section 501(c) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
p.(None): ``(c) Assistant Secretary and Deputy Assistant Secretary.--
p.(None):
p.(None): [[Page 130 STAT. 1203]]
p.(None):
p.(None): ``(1) Assistant secretary.--The Administration shall be
p.(None): headed by an official to be known as the Assistant Secretary for
p.(None): Mental Health and Substance Use (hereinafter in this title
p.(None): referred to as the `Assistant Secretary') who shall be appointed
p.(None): by the President, by and with the advice and consent of the
p.(None): Senate.
p.(None): ``(2) Deputy assistant secretary.--The Assistant Secretary,
p.(None): with the approval of the Secretary, may appoint a Deputy
p.(None): Assistant Secretary and may employ and prescribe the functions
...
p.(None): Assistance Act), or health facilities or programs operated by or in
p.(None): accordance with a contract or grant with the Indian Health Service, for
p.(None): the purpose of--
p.(None): ``(1) providing early identification and services to meet
p.(None): the needs of children and adolescents who are at risk of
p.(None): substance use disorders;
p.(None): ``(2) providing substance use disorder treatment services
p.(None): for children, including children and adolescents with co-
p.(None): occurring mental illness and substance use disorders; and
p.(None):
p.(None): [[Page 130 STAT. 1265]]
p.(None):
p.(None): ``(3) providing assistance to pregnant women, and parenting
p.(None): women, with substance use disorders, in obtaining treatment
p.(None): services, linking mothers to community resources to support
p.(None): independent family lives, and staying in recovery so that
p.(None): children are in safe, stable home environments and receive
p.(None): appropriate health care services.'';
p.(None): (3) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
...
p.(None):
p.(None): ``(c) Application.--An eligible entity seeking a grant under
p.(None): subsection (a) shall submit to the Secretary an application at such
p.(None): time, in such manner, and containing such information as the Secretary
p.(None): may require.
p.(None): ``(d) Use of Funds for Early Intervention and Treatment Programs.--
p.(None): An eligible entity may use amounts awarded under a grant under
p.(None): subsection (a)(1) to carry out the following:
p.(None): ``(1) Provide age-appropriate mental health promotion and
p.(None): early intervention services or mental illness treatment
p.(None): services, which may include specialized programs, for eligible
p.(None): children at significant risk of developing, showing early signs
p.(None): of, or having been diagnosed with a mental illness, including a
p.(None): serious emotional disturbance. Such services may include social
p.(None): and behavioral services as well as multigenerational therapy and
p.(None): other services that support the caregiving relationship.
p.(None): ``(2) Provide training for health care professionals with
p.(None): expertise in infant and early childhood mental health care with
p.(None): respect to appropriate and relevant integration with other
p.(None): disciplines such as primary care clinicians, early intervention
p.(None): specialists, child welfare staff, home visitors, early care and
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
...
p.(None): receive treatment for such illness in an institution for
p.(None): mental diseases.
p.(None):
p.(None): (b) Report.--Not later than 2 years after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall submit to
p.(None): Congress a report that summarizes and analyzes the information collected
p.(None): under subsection (a). Such report may be submitted as part of the report
p.(None): required under section 2707(f) of the Patient Protection and Affordable
p.(None): Care Act (42 U.S.C. 1396a note) or separately.
p.(None): SEC. 12005. <> PROVIDING EPSDT SERVICES
p.(None): TO CHILDREN IN IMDS.
p.(None):
p.(None): (a) In General.--Section 1905(a)(16) of the Social Security Act (42
p.(None): U.S.C. 1396d(a)(16)) is amended--
p.(None): (1) by striking ``effective January 1, 1973'' and inserting
p.(None): ``(A) effective January 1, 1973''; and
p.(None): (2) by inserting before the semicolon at the end the
p.(None): following: ``, and, (B) for individuals receiving services
p.(None): described in subparagraph (A), early and periodic screening,
p.(None): diagnostic, and treatment services (as defined in subsection
p.(None): (r)), whether or not such screening, diagnostic, and treatment
p.(None): services are furnished by the provider of the services described
p.(None): in such subparagraph''.
p.(None):
p.(None): (b) Effective Date.--The amendments made by subsection (a) shall
p.(None): apply with respect to items and services furnished in calendar quarters
p.(None): beginning on or after January 1, 2019.
p.(None): SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
p.(None): PERSONAL CARE SERVICES AND HOME HEALTH
p.(None): CARE SERVICES UNDER MEDICAID.
p.(None):
p.(None): (a) In General.--Section 1903 of the Social Security Act (42 U.S.C.
p.(None): 1396b) is amended by inserting after subsection (k) the following new
p.(None): subsection:
p.(None): ``(l)(1) Subject to paragraphs (3) and (4), with respect to any
p.(None): amount expended for personal care services or home health care services
p.(None): requiring an in-home visit by a provider that are provided under a State
p.(None): plan under this title (or under a waiver of the plan) and furnished in a
p.(None): calendar quarter beginning on or after January 1, 2019 (or, in the case
p.(None): of home health care services, on or after January 1, 2023), unless a
p.(None): State requires the use of an electronic visit verification system for
p.(None): such services furnished in such quarter under the plan or such waiver,
p.(None): the Federal medical assistance percentage shall be reduced--
p.(None): ``(A) in the case of personal care services--
p.(None): ``(i) for calendar quarters in 2019 and 2020, by .25
p.(None): percentage points;
p.(None): ``(ii) for calendar quarters in 2021, by .5
p.(None): percentage points;
p.(None): ``(iii) for calendar quarters in 2022, by .75
p.(None): percentage points; and
p.(None):
p.(None): [[Page 130 STAT. 1276]]
p.(None):
p.(None): ``(iv) for calendar quarters in 2023 and each year
p.(None): thereafter, by 1 percentage point; and
p.(None): ``(B) in the case of home health care services--
p.(None): ``(i) for calendar quarters in 2023 and 2024, by .25
p.(None): percentage points;
p.(None): ``(ii) for calendar quarters in 2025, by .5
p.(None): percentage points;
p.(None): ``(iii) for calendar quarters in 2026, by .75
p.(None): percentage points; and
p.(None): ``(iv) for calendar quarters in 2027 and each year
p.(None): thereafter, by 1 percentage point.
p.(None):
p.(None): ``(2) Subject to paragraphs (3) and (4), in implementing the
p.(None): requirement for the use of an electronic visit verification system under
p.(None): paragraph (1), a State shall--
p.(None): ``(A) consult with agencies and entities that provide
p.(None): personal care services, home health care services, or both under
p.(None): the State plan (or under a waiver of the plan) to ensure that
p.(None): such system--
p.(None): ``(i) is minimally burdensome;
p.(None): ``(ii) takes into account existing best practices
p.(None): and electronic visit verification systems in use in the
p.(None): State; and
p.(None): ``(iii) is conducted in accordance with the
p.(None): requirements of HIPAA privacy and security law (as
p.(None): defined in section 3009 of the Public Health Service
p.(None): Act);
p.(None): ``(B) take into account a stakeholder process that includes
p.(None): input from beneficiaries, family caregivers, individuals who
p.(None): furnish personal care services or home health care services, and
p.(None): other stakeholders, as determined by the State in accordance
p.(None): with guidance from the Secretary; and
p.(None): ``(C) ensure that individuals who furnish personal care
p.(None): services, home health care services, or both under the State
p.(None): plan (or under a waiver of the plan) are provided the
p.(None): opportunity for training on the use of such system.
p.(None):
p.(None): ``(3) Paragraphs (1) and (2) shall not apply in the case of a State
p.(None): that, as of the date of the enactment of this subsection, requires the
p.(None): use of any system for the electronic verification of visits conducted as
p.(None): part of both personal care services and home health care services, so
p.(None): long as the State continues to require the use of such system with
p.(None): respect to the electronic verification of such visits.
p.(None): ``(4)(A) In the case of a State described in subparagraph (B), the
p.(None): reduction under paragraph (1) shall not apply--
p.(None): ``(i) in the case of personal care services, for calendar
p.(None): quarters in 2019; and
p.(None): ``(ii) in the case of home health care services, for
p.(None): calendar quarters in 2023.
p.(None):
p.(None): ``(B) For purposes of subparagraph (A), a State described in this
p.(None): subparagraph is a State that demonstrates to the Secretary that the
p.(None): State--
p.(None): ``(i) has made a good faith effort to comply with the
p.(None): requirements of paragraphs (1) and (2) (including by taking
p.(None): steps to adopt the technology used for an electronic visit
p.(None): verification system); and
p.(None): ``(ii) in implementing such a system, has encountered
p.(None): unavoidable system delays.
p.(None):
p.(None): ``(5) In this subsection:
p.(None):
p.(None): [[Page 130 STAT. 1277]]
p.(None):
p.(None): ``(A) The term `electronic visit verification system' means,
p.(None): with respect to personal care services or home health care
p.(None): services, a system under which visits conducted as part of such
p.(None): services are electronically verified with respect to--
p.(None): ``(i) the type of service performed;
p.(None): ``(ii) the individual receiving the service;
p.(None): ``(iii) the date of the service;
p.(None): ``(iv) the location of service delivery;
p.(None): ``(v) the individual providing the service; and
p.(None): ``(vi) the time the service begins and ends.
p.(None): ``(B) The term `home health care services' means services
p.(None): described in section 1905(a)(7) provided under a State plan
p.(None): under this title (or under a waiver of the plan).
p.(None): ``(C) The term `personal care services' means personal care
p.(None): services provided under a State plan under this title (or under
p.(None): a waiver of the plan), including services provided under section
p.(None): 1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a
p.(None): wavier under section 1115.
p.(None):
p.(None): ``(6)(A) In the case in which a State requires personal care service
p.(None): and home health care service providers to utilize an electronic visit
p.(None): verification system operated by the State or a contractor on behalf of
p.(None): the State, the Secretary shall pay to the State, for each quarter, an
p.(None): amount equal to 90 per centum of so much of the sums expended during
p.(None): such quarter as are attributable to the design, development, or
p.(None): installation of such system, and 75 per centum of so much of the sums
p.(None): for the operation and maintenance of such system.
p.(None): ``(B) Subparagraph (A) shall not apply in the case in which a State
p.(None): requires personal care service and home health care service providers to
p.(None): utilize an electronic visit verification system that is not operated by
p.(None): the State or a contractor on behalf of the State.''.
p.(None): (b) <> Collection and Dissemination of
p.(None): Best Practices.--Not later than January 1, 2018, the Secretary of Health
p.(None): and Human Services shall, with respect to electronic visit verification
p.(None): systems (as defined in subsection (l)(5) of section 1903 of the Social
p.(None): Security Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect
p.(None): and disseminate best practices to State Medicaid Directors with respect
p.(None): to--
p.(None): (1) training individuals who furnish personal care services,
p.(None): home health care services, or both under the State plan under
p.(None): title XIX of such Act (or under a waiver of the plan) on such
p.(None): systems and the operation of such systems and the prevention of
p.(None): fraud with respect to the provision of personal care services or
p.(None): home health care services (as defined in such subsection
p.(None): (l)(5)); and
p.(None): (2) the provision of notice and educational materials to
p.(None): family caregivers and beneficiaries with respect to the use of
p.(None): such electronic visit verification systems and other means to
p.(None): prevent such fraud.
p.(None):
p.(None): (c) <> Rules of Construction.--
p.(None): (1) No employer-employee relationship established.--Nothing
p.(None): in the amendment made by this section may be construed as
p.(None): establishing an employer-employee relationship between the
p.(None): agency or entity that provides for personal care services or
p.(None): home health care services and the individuals who, under a
p.(None): contract with such an agency or entity, furnish such
p.(None):
p.(None): [[Page 130 STAT. 1278]]
p.(None):
p.(None): services for purposes of part 552 of title 29, Code of Federal
p.(None): Regulations (or any successor regulations).
p.(None): (2) No particular or uniform electronic visit verification
p.(None): system required.--Nothing in the amendment made by this section
p.(None): shall be construed to require the use of a particular or uniform
p.(None): electronic visit verification system (as defined in subsection
p.(None): (l)(5) of section 1903 of the Social Security Act (42 U.S.C.
p.(None): 1396b), as inserted by subsection (a)) by all agencies or
p.(None): entities that provide personal care services or home health care
p.(None): under a State plan under title XIX of the Social Security Act
p.(None): (or under a waiver of the plan) (42 U.S.C. 1396 et seq.).
p.(None): (3) No limits on provision of care.--Nothing in the
p.(None): amendment made by this section may be construed to limit, with
p.(None): respect to personal care services or home health care services
p.(None): provided under a State plan under title XIX of the Social
p.(None): Security Act (or under a waiver of the plan) (42 U.S.C. 1396 et
p.(None): seq.), provider selection, constrain beneficiaries' selection of
p.(None): a caregiver, or impede the manner in which care is delivered.
p.(None): (4) No prohibition on state quality measures requirements.--
p.(None): Nothing in the amendment made by this section shall be construed
p.(None): as prohibiting a State, in implementing an electronic visit
p.(None): verification system (as defined in subsection (l)(5) of section
p.(None): 1903 of the Social Security Act (42 U.S.C. 1396b), as inserted
p.(None): by subsection (a)), from establishing requirements related to
p.(None): quality measures for such system.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE
p.(None): USE DISORDER COVERAGE REQUIREMENTS.
p.(None):
p.(None): (a) Compliance Program Guidance Document.--Section 2726(a) of the
p.(None): Public Health Service Act (42 U.S.C. 300gg-26(a)) is amended by adding
p.(None): at the end the following:
p.(None): ``(6) Compliance program guidance document.--
p.(None): ``(A) In general.--Not later than 12 months after
p.(None): the date of enactment of the Helping Families in Mental
p.(None): Health Crisis Reform Act of 2016, the Secretary, the
p.(None): Secretary of Labor, and the Secretary of the Treasury,
p.(None): in consultation with the Inspector General of the
p.(None): Department of Health and Human Services, the Inspector
p.(None): General of the Department of Labor, and the Inspector
p.(None): General of the Department of the Treasury, shall issue a
p.(None): compliance program guidance document to help improve
p.(None): compliance with this section, section 712 of the
...
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p.(None): accompanied by a statement of the basis for the determination.
p.(None): ``(B) Each such determination and statement of basis shall be
p.(None): available to the public, upon request, through the Office of the Chief
p.(None): FOIA Officer of the Department of Health and Human Services.
p.(None):
p.(None): [[Page 130 STAT. 1051]]
p.(None):
p.(None): ``(3) Nothing in this subsection shall be construed to limit a
p.(None): research participant's access to information about such participant
p.(None): collected during the participant's participation in the research.''.
p.(None): SEC. 2014. DATA SHARING.
p.(None):
p.(None): (a) In General.--Section 402(b) of the Public Health Service Act (42
p.(None): U.S.C. 282(b)) is amended--
p.(None): (1) in paragraph (23), by striking ``and'' at the end;
p.(None): (2) in paragraph (24), by striking the period and inserting
p.(None): ``; and''; and
p.(None): (3) by inserting after paragraph (24) the following:
p.(None): ``(25) may require recipients of National Institutes of
p.(None): Health awards to share scientific data, to the extent feasible,
p.(None): generated from such National Institutes of Health awards in a
p.(None): manner that is consistent with all applicable Federal laws and
p.(None): regulations, including such laws and regulations for the
p.(None): protection of--
p.(None): ``(A) human research participants, including with
p.(None): respect to privacy, security, informed consent, and
p.(None): protected health information; and
p.(None): ``(B) proprietary interests, confidential commercial
p.(None): information, and the intellectual property rights of the
p.(None): funding recipient.''.
p.(None):
p.(None): (b) <> Confidentiality.--Nothing in the
p.(None): amendments made by subsection (a) authorizes the Secretary of Health and
p.(None): Human Services to disclose any information that is a trade secret, or
p.(None): other privileged or confidential information, described in section
p.(None): 552(b)(4) of title 5, United States Code, or section 1905 of title 18,
p.(None): United States Code, or be construed to require recipients of grants or
p.(None): cooperative agreements through the National Institutes of Health to
p.(None): share such information.
p.(None):
p.(None): Subtitle C--Supporting Young Emerging Scientists
p.(None): SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.
p.(None):
p.(None): (a) In General.--Part A of title IV of the Public Health Service Act
p.(None): (42 U.S.C. 281 et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 404M. <> NEXT GENERATION OF
p.(None): RESEARCHERS.
p.(None):
p.(None): ``(a) Next Generation of Researchers Initiative.--There shall be
p.(None): established within the Office of the Director of the National Institutes
p.(None): of Health, the Next Generation of Researchers Initiative (referred to in
p.(None): this section as the `Initiative'), through which the Director shall
p.(None): coordinate all policies and programs within the National Institutes of
p.(None): Health that are focused on promoting and providing opportunities for new
p.(None): researchers and earlier research independence.
p.(None): ``(b) Activities.--The Director of the National Institutes of
p.(None): Health, through the Initiative shall--
p.(None): ``(1) promote policies and programs within the National
p.(None): Institutes of Health that are focused on improving opportunities
p.(None): for new researchers and promoting earlier research independence,
...
p.(None): for such exchange to occur; and
p.(None): ``(IV) a process for filing and
p.(None): adjudicating noncompliance with the
p.(None): terms of the common agreement.
p.(None): ``(ii) Technical assistance.--The National
p.(None): Coordinator, in collaboration with the National
p.(None): Institute of Standards and Technology, shall
p.(None): provide technical assistance on how to implement
p.(None): the trusted exchange framework and common
p.(None): agreement under this paragraph.
p.(None): ``(iii) Pilot testing.--The National
p.(None): Coordinator, in consultation with the National
p.(None): Institute of Standards and Technology, shall
p.(None): provide for the pilot testing of the trusted
p.(None): exchange framework and common agreement
p.(None): established or supported under this subsection (as
p.(None): authorized under section 13201 of the Health
p.(None): Information Technology for Economic and Clinical
p.(None): Health Act). The National Coordinator, in
p.(None): consultation with the National Institute of
p.(None): Standards and Technology, may delegate pilot
p.(None): testing activities under this clause to
p.(None): independent entities with appropriate expertise.
p.(None): ``(C) Publication of a trusted exchange framework
p.(None): and common agreement.--Not later than 1 year after
p.(None): convening stakeholders under subparagraph (A), the
p.(None): National Coordinator shall publish on its public
p.(None): Internet website, and in the Federal register, the
p.(None): trusted exchange framework and common agreement
p.(None): developed or supported under subparagraph (B). Such
p.(None): trusted exchange framework and common agreement shall be
p.(None): published in a manner that protects proprietary and
p.(None): security information, including trade secrets and any
p.(None): other protected intellectual property.
p.(None): ``(D) Directory of participating health information
p.(None): networks.--
p.(None): ``(i) In general.--Not later than 2 years
p.(None): after convening stakeholders under subparagraph
p.(None): (A), and annually thereafter, the National
p.(None): Coordinator shall publish on its public Internet
p.(None): website a list of the health information networks
p.(None): that have adopted the common agreement and are
p.(None): capable of trusted exchange pursuant to the common
p.(None): agreement developed or supported under paragraph
p.(None): (B).
p.(None): ``(ii) Process.--The Secretary shall, through
p.(None): notice and comment rulemaking, establish a process
p.(None): for health information networks that voluntarily
p.(None): elect to adopt the trusted exchange framework and
p.(None): common agreement to attest to such adoption of the
p.(None): framework and agreement.
p.(None): ``(E) Application of the trusted exchange framework
p.(None): and common agreement.--As appropriate, Federal agencies
p.(None): contracting or entering into agreements with
p.(None):
p.(None): [[Page 130 STAT. 1167]]
p.(None):
p.(None): health information exchange networks may require that as
p.(None): each such network upgrades health information technology
p.(None): or trust and operational practices, such network may
p.(None): adopt, where available, the trusted exchange framework
p.(None): and common agreement published under subparagraph (C).
p.(None): ``(F) Rule of construction.--
p.(None): ``(i) General adoption.--Nothing in this
p.(None): paragraph shall be construed to require a health
p.(None): information network to adopt the trusted exchange
p.(None): framework or common agreement.
p.(None): ``(ii) Adoption when exchange of information
p.(None): is within network.--Nothing in this paragraph
p.(None): shall be construed to require a health information
...
p.(None):
p.(None): Section 1903(i)(27) of the Social Security Act (42 U.S.C.
p.(None): 1396b(i)(27)) is amended by striking ``January 1, 2019'' and inserting
p.(None): ``January 1, 2018''.
p.(None): SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND
p.(None): OTHER AGREEMENTS.
p.(None):
p.(None): (a) In General.--Section 1128A of the Social Security Act (42 U.S.C.
p.(None): 1320a-7a) is amended by adding at the end the following new subsections:
p.(None): ``(o) Any person (including an organization, agency, or other
p.(None): entity, but excluding a program beneficiary, as defined in subsection
p.(None): (q)(4)) that, with respect to a grant, contract, or other agreement for
p.(None): which the Secretary provides funding--
p.(None): ``(1) knowingly presents or causes to be presented a
p.(None): specified claim (as defined in subsection (r)) under such grant,
p.(None): contract, or other agreement that the person knows or should
p.(None): know is false or fraudulent;
p.(None): ``(2) knowingly makes, uses, or causes to be made or used
p.(None): any false statement, omission, or misrepresentation of a
p.(None): material fact in any application, proposal, bid, progress
p.(None): report, or other document that is required to be submitted in
p.(None): order to directly or indirectly receive or retain funds provided
p.(None): in whole or in part by such Secretary pursuant to such grant,
p.(None): contract, or other agreement;
p.(None): ``(3) knowingly makes, uses, or causes to be made or used, a
p.(None): false record or statement material to a false or fraudulent
p.(None): specified claim under such grant, contract, or other agreement;
p.(None): ``(4) knowingly makes, uses, or causes to be made or used, a
p.(None): false record or statement material to an obligation (as defined
p.(None): in subsection (s)) to pay or transmit funds or property to such
p.(None): Secretary with respect to such grant, contract, or other
p.(None): agreement, or knowingly conceals or knowingly and improperly
p.(None): avoids or decreases an obligation to pay or transmit funds or
p.(None): property to such Secretary with respect to such grant, contract,
p.(None): or other agreement; or
p.(None): ``(5) fails to grant timely access, upon reasonable request
p.(None): (as defined by such Secretary in regulations), to the Inspector
p.(None): General of the Department, for the purpose of audits,
p.(None): investigations, evaluations, or other statutory functions of
p.(None): such Inspector General in matters involving such grants,
p.(None): contracts, or other agreements;
p.(None):
p.(None): [[Page 130 STAT. 1189]]
p.(None):
p.(None): shall be subject, in addition to any other penalties that may be
p.(None): prescribed by law, to a civil money penalty in cases under paragraph
p.(None): (1), of not more than $10,000 for each specified claim; in cases under
p.(None): paragraph (2), not more than $50,000 for each false statement, omission,
p.(None): or misrepresentation of a material fact; in cases under paragraph (3),
p.(None): not more than $50,000 for each false record or statement; in cases under
p.(None): paragraph (4), not more than $50,000 for each false record or statement
p.(None): or $10,000 for each day that the person knowingly conceals or knowingly
p.(None): and improperly avoids or decreases an obligation to pay; or in cases
p.(None): under paragraph (5), not more than $15,000 for each day of the failure
p.(None): described in such paragraph. In addition, in cases under paragraphs (1)
p.(None): and (3), such a person shall be subject to an assessment of not more
p.(None): than 3 times the amount claimed in the specified claim described in such
p.(None): paragraph in lieu of damages sustained by the United States or a
p.(None): specified State agency because of such specified claim, and in cases
p.(None): under paragraphs (2) and (4), such a person shall be subject to an
p.(None): assessment of not more than 3 times the total amount of the funds
p.(None): described in paragraph (2) or (4), respectively (or, in the case of an
p.(None): obligation to transmit property to the Secretary described in paragraph
p.(None): (4), of the value of the property described in such paragraph) in lieu
p.(None): of damages sustained by the United States or a specified State agency
p.(None): because of such case. In addition, the Secretary may make a
p.(None): determination in the same proceeding to exclude the person from
p.(None): participation in the Federal health care programs (as defined in section
p.(None): 1128B(f)(1)) and to direct the appropriate State agency to exclude the
p.(None): person from participation in any State health care program.
p.(None): ``(p) The provisions of subsections (c), (d), (g), and (h) shall
p.(None): apply to a civil money penalty or assessment under subsection (o) in the
p.(None): same manner as such provisions apply to a penalty, assessment, or
p.(None): proceeding under subsection (a). In applying subsection (d), each
p.(None): reference to a claim under such subsection shall be treated as including
p.(None): a reference to a specified claim (as defined in subsection (r)).
p.(None): ``(q) For purposes of this subsection and subsections (o) and (p):
p.(None): ``(1) The term `Department' means the Department of Health
p.(None): and Human Services.
p.(None): ``(2) The term `material' means having a natural tendency to
p.(None): influence, or be capable of influencing, the payment or receipt
p.(None): of money or property.
p.(None): ``(3) The term `other agreement' includes a cooperative
p.(None): agreement, scholarship, fellowship, loan, subsidy, payment for a
p.(None): specified use, donation agreement, award, or subaward
p.(None): (regardless of whether one or more of the persons entering into
p.(None): the agreement is a contractor or subcontractor).
p.(None): ``(4) The term `program beneficiary' means, in the case of a
p.(None): grant, contract, or other agreement designed to accomplish the
p.(None): objective of awarding or otherwise furnishing benefits or
p.(None): assistance to individuals and for which the Secretary provides
p.(None): funding, an individual who applies for, or who receives, such
p.(None): benefits or assistance from such grant, contract, or other
p.(None): agreement. Such term does not include, with respect to such
p.(None): grant, contract, or other agreement, an officer, employee, or
p.(None): agent of a person or entity that receives such grant or that
p.(None): enters into such contract or other agreement.
p.(None):
p.(None): [[Page 130 STAT. 1190]]
p.(None):
p.(None): ``(5) The term `recipient' includes a subrecipient or
p.(None): subcontractor.
p.(None): ``(6) The term `specified State agency' means an agency of a
p.(None): State government established or designated to administer or
p.(None): supervise the administration of a grant, contract, or other
p.(None): agreement funded in whole or in part by the Secretary.
p.(None):
p.(None): ``(r) For purposes of this section, the term `specified claim' means
p.(None): any application, request, or demand under a grant, contract, or other
p.(None): agreement for money or property, whether or not the United States or a
p.(None): specified State agency has title to the money or property, that is not a
p.(None): claim (as defined in subsection (i)(2)) and that--
p.(None): ``(1) is presented or caused to be presented to an officer,
p.(None): employee, or agent of the Department or agency thereof, or of
p.(None): any specified State agency; or
p.(None): ``(2) is made to a contractor, grantee, or any other
p.(None): recipient if the money or property is to be spent or used on the
p.(None): Department's behalf or to advance a Department program or
p.(None): interest, and if the Department--
p.(None): ``(A) provides or has provided any portion of the
p.(None): money or property requested or demanded; or
p.(None): ``(B) will reimburse such contractor, grantee, or
p.(None): other recipient for any portion of the money or property
p.(None): which is requested or demanded.
p.(None):
p.(None): ``(s) For purposes of subsection (o), the term `obligation' means an
p.(None): established duty, whether or not fixed, arising from an express or
p.(None): implied contractual, grantor-grantee, or licensor-licensee relationship,
p.(None): for a fee-based or similar relationship, from statute or regulation, or
p.(None): from the retention of any overpayment.''.
p.(None): (b) Conforming Amendments.--Section 1128A of the Social Security Act
p.(None): (42 U.S.C. 1320a-7a) is amended--
p.(None): (1) in subsection (e), by inserting ``or specified claim''
p.(None): after ``claim'' in the first sentence; and
p.(None): (2) in subsection (f)--
p.(None): (A) in the matter preceding paragraph (1)--
p.(None): (i) by inserting ``or specified claim (as
p.(None): defined in subsection (r))'' after ``district
p.(None): where the claim''; and
p.(None): (ii) by inserting ``(or, with respect to a
p.(None): person described in subsection (o), the person)''
p.(None): after ``claimant''; and
p.(None): (B) in the matter following paragraph (4), by
p.(None): inserting ``(or, in the case of a penalty or assessment
p.(None): under subsection (o), by a specified State agency (as
p.(None): defined in subsection (q)(6)),'' after ``or a State
p.(None): agency''.
p.(None): SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
p.(None):
p.(None): (a) Treatment of Infusion Drugs Furnished Through Durable Medical
p.(None): Equipment.--Section 1842(o)(1) of the Social Security Act (42 U.S.C.
p.(None): 1395u(o)(1)) is amended--
p.(None): (1) in subparagraph (C), by inserting ``(and including a
p.(None): drug or biological described in subparagraph (D)(i) furnished on
p.(None): or after January 1, 2017)'' after ``2005''; and
p.(None): (2) in subparagraph (D)--
p.(None): (A) by striking ``infusion drugs'' and inserting
...
p.(None): including strategies for verbal de-escalation of crises''.
p.(None): SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
p.(None):
p.(None): (a) In General.--Section 2201 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
p.(None): paragraph (2)(B), by inserting before the semicolon the following: ``,
p.(None): or court-ordered assisted outpatient treatment when the court has
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
...
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
p.(None): or property of another may be used in the course of
p.(None): committing the offense.''.
p.(None): SEC. 14029. GRANT ACCOUNTABILITY.
p.(None):
p.(None): Section 2991 of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
p.(None): subsection (l), as added by section 14022, the following:
p.(None): ``(m) Accountability.--All grants awarded by the Attorney General
p.(None): under this section shall be subject to the following accountability
p.(None): provisions:
p.(None): ``(1) Audit requirement.--
p.(None): ``(A) Definition.--In this paragraph, the term
p.(None): `unresolved audit finding' means a finding in the final
p.(None): audit report of the Inspector General of the Department
p.(None): of Justice that the audited grantee has utilized grant
p.(None): funds for an unauthorized expenditure or otherwise
p.(None): unallowable cost that is not closed or resolved within
p.(None): 12 months from the date when the final audit report is
p.(None): issued.
p.(None): ``(B) Audits.--Beginning in the first fiscal year
p.(None): beginning after the date of enactment of this
p.(None): subsection, and in each fiscal year thereafter, the
p.(None): Inspector General of the Department of Justice shall
p.(None): conduct audits of recipients of grants under this
p.(None): section to prevent waste, fraud, and abuse of funds by
p.(None): grantees. The Inspector General shall determine the
p.(None): appropriate number of grantees to be audited each year.
p.(None): ``(C) Mandatory exclusion.--A recipient of grant
p.(None): funds under this section that is found to have an
p.(None): unresolved audit finding shall not be eligible to
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
p.(None): Sec. 9021. Mental and behavioral health education and training grants.
p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
...
p.(None): amounts are made available.''.
p.(None): (b) Extramural Loan Repayment Program.--Section 487B of the Public
p.(None): Health Service Act (42 U.S.C. 288-2) is amended--
p.(None): (1) by amending the section heading to read as follows:
p.(None): ``extramural loan repayment program'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``The Secretary, in consultation
p.(None): with the Director of the Eunice Kennedy Shriver National
p.(None): Institute of Child Health and Human Development, shall
p.(None): establish a program'' and inserting ``In General.--The
p.(None): Director of the National Institutes of Health shall, as
p.(None): appropriate and based on workforce and scientific
p.(None): priorities, carry out a program through the
p.(None): subcategories listed in subsection (b)(1) (or modified
p.(None): subcategories as provided for in subsection (b)(2)),'';
p.(None): (B) by striking ``(including graduate students)'';
p.(None): (C) by striking ``with respect to contraception, or
p.(None): with respect to infertility,''; and
p.(None): (D) by striking ``service, not more than $35,000''
p.(None): and inserting ``research, not more than $50,000'';
p.(None): (3) by redesignating subsections (b) and (c) as subsections
p.(None): (d) and (e), respectively;
p.(None): (4) by inserting after subsection (a), the following:
p.(None):
p.(None): ``(b) Subcategories of Research.--
p.(None): ``(1) In general.--In carrying out the program under
p.(None): subsection (a), the Director of the National Institutes of
p.(None): Health--
p.(None): ``(A) shall continue to focus on--
p.(None): ``(i) contraception or infertility research;
p.(None): ``(ii) pediatric research, including pediatric
p.(None): pharmacological research;
p.(None): ``(iii) minority health disparities research;
p.(None): ``(iv) clinical research; and
p.(None):
p.(None): [[Page 130 STAT. 1054]]
p.(None):
p.(None): ``(v) clinical research conducted by
p.(None): appropriately qualified health professional who
p.(None): are from disadvantaged backgrounds; and
p.(None): ``(B) may focus on an area of emerging scientific or
p.(None): workforce need.
p.(None): ``(2) Elimination or establishment of subcategories.--The
p.(None): Director of the National Institutes of Health may eliminate one
p.(None): or more subcategories provided for in paragraph (1) due to
p.(None): changes in workforce or scientific needs related to biomedical
p.(None): research. The Director may establish other subcategory areas
p.(None): based on workforce and scientific priorities if the total number
p.(None): of subcategories does not exceed the number of subcategories
p.(None): listed in paragraph (1).
p.(None):
p.(None): ``(c) Limitation.--The Director of the National Institutes of Health
p.(None): may not enter into a contract with a health professional pursuant to
p.(None): subsection (a) unless such professional has a substantial amount of
p.(None): education loans relative to income (as determined pursuant to guidelines
p.(None): issued by the Director).'';
p.(None): (5) in subsection (d) (as so redesignated), by striking
p.(None): ``The provisions'' and inserting ``Applicability of Certain
p.(None): Provisions Regarding Obligated Service.--The provisions''; and
p.(None): (6) in subsection (e) (as so redesignated), by striking
p.(None): ``Amounts'' and inserting ``Availability of Appropriations.--
p.(None): Amounts''.
p.(None):
p.(None): (c) Technical and Conforming Amendments.--Title IV of the Public
p.(None): Health Service Act is amended--
p.(None): (1) by striking section 464z-5 (42 U.S.C. 285t-2);
...
p.(None): proposed and ongoing activities related to training and
p.(None): the biomedical workforce; and
p.(None): ``(F) describe opportunities for collaboration with
p.(None): other agencies and departments, as appropriate.
p.(None): ``(3) Use of plans.--Strategic plans developed and updated
p.(None): by the national research institutes and national centers of the
p.(None): National Institutes of Health shall be prepared regularly and in
p.(None): such a manner that such plans will be informed by the strategic
p.(None): plans developed and updated under this subsection. Such plans
p.(None): developed by and updated by the national research institutes and
p.(None): national centers shall have a common template.
p.(None):
p.(None): [[Page 130 STAT. 1056]]
p.(None):
p.(None): ``(4) Consultation.--The Director of National Institutes of
p.(None): Health shall develop the strategic plan under paragraph (1) in
p.(None): consultation with the directors of the national research
p.(None): institutes and national centers, researchers, patient advocacy
p.(None): groups, and industry leaders.''.
p.(None):
p.(None): (b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public
p.(None): Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking
p.(None): ``Not later than June 1, 2007, and every 2 years thereafter,'' and
p.(None): inserting ``As part of the National Institutes of Health Strategic Plan
p.(None): required under section 402(m),''.
p.(None): (c) Strategic Plan.--Section 492B(a) of the Public Health Service
p.(None): Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the following:
p.(None): ``(3) Strategic planning.--
p.(None): ``(A) In general.--The directors of the national
p.(None): institutes and national centers shall consult at least
p.(None): once annually with the Director of the National
p.(None): Institute on Minority Health and Health Disparities and
p.(None): the Director of the Office of Research on Women's Health
p.(None): regarding objectives of the national institutes and
p.(None): national centers to ensure that future activities by
p.(None): such institutes and centers take into account women and
p.(None): minorities and are focused on reducing health
p.(None): disparities.
p.(None): ``(B) Strategic plans.--Any strategic plan issued by
p.(None): a national institute or national center shall include
p.(None): details on the objectives described in subparagraph
p.(None): (A).''.
p.(None): SEC. 2032. TRIENNIAL REPORTS.
p.(None):
p.(None): Section 403 of the Public Health Service Act (42 U.S.C. 283) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``biennial'' and
p.(None): inserting ``triennial'' ; and
p.(None): (2) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``biennial'' and inserting ``triennial'';
p.(None): (B) by amending paragraph (3) to read as follows:
p.(None): ``(3) A description of intra-National Institutes of Health
p.(None): activities, including--
p.(None): ``(A) identification of the percentage of funds made
p.(None): available by each national research institute and
p.(None): national center with respect to each applicable fiscal
p.(None): year for conducting or supporting research that involves
p.(None): collaboration between the institute or center and 1 or
p.(None): more other national research institutes or national
p.(None): centers; and
p.(None): ``(B) recommendations for promoting coordination of
p.(None): information among the centers of excellence.'';
p.(None): (C) in paragraph (4)--
p.(None): (i) in subparagraph (B), by striking
p.(None): ``demographic variables and other variables'' and
...
p.(None): Administration to support medical product reviews.''; and
p.(None):
p.(None): [[Page 130 STAT. 1064]]
p.(None):
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(d) Inclusion of List.--The first biennial report submitted under
p.(None): this section after the date of enactment of the 21st Century Cures Act
p.(None): shall include a complete list of all of the methods and tools, if any,
p.(None): which have been developed by research supported by the Center.
p.(None): ``(e) Rule of Construction.--Nothing in this section shall be
p.(None): construed as authorizing the Secretary to disclose any information that
p.(None): is a trade secret, or other privileged or confidential information
p.(None): subject to section 552(b)(4) of title 5, United States Code, or section
p.(None): 1905 of title 18, United States Code.''.
p.(None): SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.
p.(None):
p.(None): (a) Research Priorities; Collaborative Research Projects.--Section
p.(None): 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
p.(None): (1) by amending paragraph (4) to read as follows:
p.(None): ``(4) shall assemble accurate data to be used to assess
p.(None): research priorities, including--
p.(None): ``(A) information to better evaluate scientific
p.(None): opportunity, public health burdens, and progress in
p.(None): reducing health disparities; and
p.(None): ``(B) data on study populations of clinical
p.(None): research, funded by or conducted at each national
p.(None): research institute and national center, which--
p.(None): ``(i) specifies the inclusion of--
p.(None): ``(I) women;
p.(None): ``(II) members of minority groups;
p.(None): ``(III) relevant age categories,
p.(None): including pediatric subgroups; and
p.(None): ``(IV) other demographic variables
p.(None): as the Director of the National
p.(None): Institutes of Health determines
p.(None): appropriate;
p.(None): ``(ii) is disaggregated by research area,
p.(None): condition, and disease categories; and
p.(None): ``(iii) is to be made publicly available on
p.(None): the Internet website of the National Institutes of
p.(None): Health;''; and
p.(None): (2) in paragraph (8)--
p.(None): (A) in subparagraph (A), by striking ``and'' at the
p.(None): end; and
p.(None): (B) by adding at the end the following:
p.(None): ``(C) foster collaboration between clinical research
p.(None): projects funded by the respective national research
p.(None): institutes and national centers that--
p.(None): ``(i) conduct research involving human
p.(None): subjects; and
p.(None): ``(ii) collect similar data; and
p.(None): ``(D) encourage the collaboration described in
p.(None): subparagraph (C) to--
p.(None): ``(i) allow for an increase in the number of
p.(None): subjects studied; and
p.(None): ``(ii) utilize diverse study populations, with
p.(None): special consideration to biological, social, and
p.(None): other determinants of health that contribute to
p.(None): health disparities;''.
p.(None):
p.(None): [[Page 130 STAT. 1065]]
p.(None):
p.(None): (b) Reporting.--Section 492B(f) of the Public Health Service Act (42
p.(None): U.S.C. 289a-2(f)) is amended--
p.(None): (1) by striking ``biennial'' each place such term appears
p.(None): and inserting ``triennial'';
p.(None): (2) by striking ``The advisory council'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The advisory council''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(2) Contents.--Each triennial report prepared by an
p.(None): advisory council of each national research institute as
p.(None): described in paragraph (1) shall include each of the following:
p.(None): ``(A) The number of women included as subjects, and
p.(None): the proportion of subjects that are women, in any
p.(None): project of clinical research conducted during the
p.(None): applicable reporting period, disaggregated by categories
p.(None): of research area, condition, or disease, and accounting
p.(None): for single-sex studies.
p.(None): ``(B) The number of members of minority groups
p.(None): included as subjects, and the proportion of subjects
p.(None): that are members of minority groups, in any project of
p.(None): clinical research conducted during the applicable
p.(None): reporting period, disaggregated by categories of
p.(None): research area, condition, or disease and accounting for
p.(None): single-race and single-ethnicity studies.
p.(None): ``(C) For the applicable reporting period, the
p.(None): number of projects of clinical research that include
p.(None): women and members of minority groups and that--
p.(None): ``(i) have been completed during such
p.(None): reporting period; and
p.(None): ``(ii) are being carried out during such
p.(None): reporting period and have not been completed.
p.(None): ``(D) The number of studies completed during the
p.(None): applicable reporting period for which reporting has been
p.(None): submitted in accordance with subsection (c)(2)(A).''.
p.(None):
p.(None): (c) Coordination.--Section 486(c)(2) of the Public Health Service
p.(None): Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
p.(None): inserting ``senior-level staff designees''.
p.(None): (d) In General.--Part A of title IV of the Public Health Service Act
p.(None): (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended
p.(None): by adding at the end the following:
p.(None): ``SEC. 404N. <> POPULATION FOCUSED RESEARCH.
p.(None):
p.(None): ``The Director of the National Institutes of Health shall, as
p.(None): appropriate, encourage efforts to improve research related to the health
p.(None): of sexual and gender minority populations, including by--
p.(None): ``(1) facilitating increased participation of sexual and
p.(None): gender minority populations in clinical research supported by
p.(None): the National Institutes of Health, and reporting on such
p.(None): participation, as applicable;
p.(None): ``(2) facilitating the development of valid and reliable
p.(None): methods for research relevant to sexual and gender minority
p.(None): populations; and
p.(None): ``(3) addressing methodological challenges.''.
p.(None):
p.(None): (e) <> Reporting.--
p.(None): (1) In general.--The Secretary, in collaboration with the
p.(None): Director of the National Institutes of Health, shall as
p.(None): appropriate--
p.(None): [[Page 130 STAT. 1066]]
p.(None):
p.(None): (A) continue to support research for the development
p.(None): of appropriate measures related to reporting health
p.(None): information about sexual and gender minority
p.(None): populations; and
p.(None): (B) not later than 2 years after the date of
p.(None): enactment of this Act, disseminate and make public such
p.(None): measures.
p.(None): (2) National academy of medicine recommendations.--In
p.(None): developing the measures described in paragraph (1)(A), the
p.(None): Secretary shall take into account recommendations made by the
p.(None): National Academy of Medicine.
p.(None):
p.(None): (f) Improving Coordination Related to Minority Health and Health
p.(None): Disparities.--Section 464z-3 of the Public Health Service Act (42 U.S.C.
p.(None): 285t) is amended--
p.(None): (1) by redesignating subsection (h), relating to interagency
p.(None): coordination, that follows subsection (j) as subsection (k); and
p.(None): (2) in subsection (k) (as so redesignated)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Interagency'' and inserting ``Intra-National
p.(None): Institutes of Health'';
p.(None): (B) by striking ``as the primary Federal officials''
p.(None): and inserting ``as the primary Federal official'';
p.(None): (C) by inserting a comma after ``review'';
p.(None): (D) by striking ``Institutes and Centers of the
p.(None): National Institutes of Health'' and inserting ``national
p.(None): research institutes and national centers''; and
p.(None): (E) by adding at the end the following: ``The
p.(None): Director of the Institute may foster partnerships
p.(None): between the national research institutes and national
p.(None): centers and may encourage the funding of collaborative
p.(None): research projects to achieve the goals of the National
p.(None): Institutes of Health that are related to minority health
p.(None): and health disparities.''.
p.(None):
p.(None): (g) <> Basic Research.--
p.(None): (1) Developing policies.--Not later than 2 years after the
p.(None): date of enactment of this Act, the Director of the National
p.(None): Institutes of Health (referred to in this section as the
p.(None): ``Director of the National Institutes of Health''), taking into
p.(None): consideration the recommendations developed under section 2039,
p.(None): shall develop policies for projects of basic research funded by
p.(None): National Institutes of Health to assess--
p.(None): (A) relevant biological variables including sex, as
p.(None): appropriate; and
p.(None): (B) how differences between male and female cells,
p.(None): tissues, or animals may be examined and analyzed.
p.(None): (2) Revising policies.--The Director of the National
p.(None): Institutes of Health may update or revise the policies developed
p.(None): under paragraph (1) as appropriate.
p.(None): (3) Consultation and outreach.--In developing, updating, or
p.(None): revising the policies under this section, the Director of the
p.(None): National Institutes of Health shall--
p.(None): (A) consult with--
p.(None): (i) the Office of Research on Women's Health;
p.(None): (ii) the Office of Laboratory Animal Welfare;
p.(None): and
p.(None): (iii) appropriate members of the scientific
p.(None): and academic communities; and
p.(None): (B) conduct outreach to solicit feedback from
p.(None): members of the scientific and academic communities on
p.(None): the influence of sex as a variable in basic research,
p.(None): including feedback
p.(None):
p.(None): [[Page 130 STAT. 1067]]
p.(None):
p.(None): on when it is appropriate for projects of basic research
p.(None): involving cells, tissues, or animals to include both
p.(None): male and female cells, tissues, or animals.
p.(None): (4) Additional requirements.--The Director of the National
p.(None): Institutes of Health shall--
p.(None): (A) ensure that projects of basic research funded by
p.(None): the National Institutes of Health are conducted in
p.(None): accordance with the policies developed, updated, or
p.(None): revised under this section, as applicable; and
p.(None): (B) encourage that the results of such research,
p.(None): when published or reported, be disaggregated as
p.(None): appropriate with respect to the analysis of any sex
p.(None): differences.
p.(None):
p.(None): (h) <> Clinical Research.--
p.(None): (1) In general.--Not later than 1 year after the date of
p.(None): enactment of this Act, the Director of the National Institutes
p.(None): of Health, in consultation with the Director of the Office of
p.(None): Research on Women's Health and the Director of the National
p.(None): Institute on Minority Health and Health Disparities, shall
p.(None): update the guidelines established under section 492B(d) of
p.(None): Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance
p.(None): with paragraph (2).
p.(None): (2) Requirements.--The updated guidelines described in
p.(None): paragraph (1) shall--
p.(None): (A) reflect the science regarding sex differences;
p.(None): (B) improve adherence to the requirements under
p.(None): section 492B of the Public Health Service Act (42 U.S.C.
p.(None): 289a-2), including the reporting requirements under
p.(None): subsection (f) of such section; and
p.(None): (C) clarify the circumstances under which studies
p.(None): should be designed to support the conduct of analyses to
p.(None): detect significant differences in the intervention
p.(None): effect due to demographic factors related to section
p.(None): 492B of the Public Health Service Act, including in the
p.(None): absence of prior studies that demonstrate a difference
p.(None): in study outcomes on the basis of such factors and
p.(None): considering the effects of the absence of such analyses
p.(None): on the availability of data related to demographic
p.(None): differences.
p.(None):
p.(None): (i) <> Appropriate Age Groupings in
p.(None): Clinical Research.--
p.(None): (1) Input from experts.--Not later than 180 days after the
p.(None): date of enactment of this Act, the Director of the National
p.(None): Institutes of Health shall convene a workshop of experts on
p.(None): pediatric and older populations to provide input on--
p.(None): (A) appropriate age groups to be included in
p.(None): research studies involving human subjects; and
p.(None): (B) acceptable justifications for excluding
...
p.(None): Health Service Act (42 U.S.C. 285q-2(g)) is amended by striking
p.(None): ``biennial report made under section 464Y,'' and inserting
p.(None): ``triennial report made under section 403''.
p.(None):
p.(None): [[Page 130 STAT. 1074]]
p.(None):
p.(None): SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING
p.(None): ORGANISMS.
p.(None):
p.(None): Section 301 of the Public Health Service Act (42 U.S.C. 241), as
p.(None): amended by section 2035, is further amended--
p.(None): (1) in the flush matter at the end of subsection (a)--
p.(None): (A) by redesignating such matter as subsection
p.(None): (h)(1); and
p.(None): (B) by moving such matter so as to appear at the end
p.(None): of such section; and
p.(None): (2) in subsection (h) (as so redesignated), by adding at the
p.(None): end the following:
p.(None):
p.(None): ``(2) Where research substances and living organisms are made
p.(None): available under paragraph (1) through contractors, the Secretary may
p.(None): direct such contractors to collect payments on behalf of the Secretary
p.(None): for the costs incurred to make available such substances and organisms
p.(None): and to forward amounts so collected to the Secretary, in the time and
p.(None): manner specified by the Secretary.
p.(None): ``(3) Amounts collected under paragraph (2) shall be credited to the
p.(None): appropriations accounts that incurred the costs to make available the
p.(None): research substances and living organisms involved, and shall remain
p.(None): available until expended for carrying out activities under such
p.(None): accounts.''.
p.(None): SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF
p.(None): UNDERREPRESENTED POPULATIONS IN CLINICAL
p.(None): TRIALS.
p.(None):
p.(None): It is the sense of Congress that the National Institute on Minority
p.(None): Health and Health Disparities should include within its strategic plan
p.(None): under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m))
p.(None): ways to increase representation of underrepresented populations in
p.(None): clinical trials.
p.(None):
p.(None): Subtitle E--Advancement of the National Institutes of Health Research
p.(None): and Data Access
p.(None):
p.(None): SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
p.(None):
p.(None): Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
p.(None): 282(j)(2)(D)) is amended--
p.(None): (1) in clause (ii)(I), by inserting before the semicolon ``,
p.(None): unless the responsible party affirmatively requests that the
p.(None): Director of the National Institutes of Health publicly post such
p.(None): clinical trial information for an applicable device clinical
p.(None): trial prior to such date of clearance or approval''; and
p.(None): (2) by adding at the end the following:
p.(None): ``(iii) Option to make certain clinical trial
p.(None): information available earlier.--The Director of
p.(None): the National Institutes of Health shall inform
p.(None): responsible parties of the option to request that
p.(None): clinical trial information for an applicable
p.(None): device clinical trial be publicly posted prior to
p.(None): the date of clearance or approval, in accordance
p.(None): with clause (ii)(I).
p.(None): ``(iv) Combination products.--An applicable
p.(None): clinical trial for a product that is a combination
p.(None): of drug, device, or biological product shall be
p.(None): considered--
p.(None):
p.(None): [[Page 130 STAT. 1075]]
p.(None):
...
p.(None): identified in clause (iii); and
p.(None): ``(vi) a description of additional initiatives
p.(None): as the HIT Advisory Committee and National
p.(None): Coordinator determine appropriate.
p.(None): ``(3) Significant advancement determination.--The Secretary
p.(None): shall periodically, based on the reports submitted under this
p.(None): subsection, review the target areas described in subsection
p.(None): (b)(2)(B), and, based on the objectives and benchmarks
p.(None): established under paragraph (1), the Secretary shall determine
p.(None): if significant advancement has been achieved with respect to
p.(None): such an area. Such determination shall be taken into
p.(None): consideration by the HIT Advisory Committee when determining to
p.(None): what extent the Committee makes recommendations for an area
p.(None): other than an area described in subsection (b)(2)(B).
p.(None):
p.(None): ``(d) Membership and Operations.--
p.(None):
p.(None): [[Page 130 STAT. 1173]]
p.(None):
p.(None): ``(1) In general.--The National Coordinator shall take a
p.(None): leading position in the establishment and operations of the HIT
p.(None): Advisory Committee.
p.(None): ``(2) Membership.--The membership of the HIT Advisory
p.(None): Committee shall--
p.(None): ``(A) include at least 25 members, of which--
p.(None): ``(i) no fewer than 2 members are advocates
p.(None): for patients or consumers of health information
p.(None): technology;
p.(None): ``(ii) 3 members are appointed by the
p.(None): Secretary, 1 of whom shall be appointed to
p.(None): represent the Department of Health and Human
p.(None): Services and 1 of whom shall be a public health
p.(None): official;
p.(None): ``(iii) 2 members are appointed by the
p.(None): majority leader of the Senate;
p.(None): ``(iv) 2 members are appointed by the minority
p.(None): leader of the Senate;
p.(None): ``(v) 2 members are appointed by the Speaker
p.(None): of the House of Representatives;
p.(None): ``(vi) 2 members are appointed by the minority
p.(None): leader of the House of Representatives; and
p.(None): ``(vii) such other members are appointed by
p.(None): the Comptroller General of the United States; and
p.(None): ``(B) at least reflect providers, ancillary health
p.(None): care workers, consumers, purchasers, health plans,
p.(None): health information technology developers, researchers,
p.(None): patients, relevant Federal agencies, and individuals
p.(None): with technical expertise on health care quality, system
p.(None): functions, privacy, security, and on the electronic
p.(None): exchange and use of health information, including the
p.(None): use standards for such activity.
p.(None): ``(3) Participation.--The members of the HIT Advisory
p.(None): Committee shall represent a balance among various sectors of the
p.(None): health care system so that no single sector unduly influences
p.(None): the recommendations of the Committee.
p.(None): ``(4) Terms.--
p.(None): ``(A) In general.--The terms of the members of the
p.(None): HIT Advisory Committee shall be for 3 years, except that
p.(None): the Secretary shall designate staggered terms of the
p.(None): members first appointed.
p.(None): ``(B) Vacancies.--Any member appointed to fill a
p.(None): vacancy in the membership of the HIT Advisory Committee
p.(None): that occurs prior to the expiration of the term for
p.(None): which the member's predecessor was appointed shall be
p.(None): appointed only for the remainder of that term. A member
p.(None): may serve after the expiration of that member's term
p.(None): until a successor has been appointed. A vacancy in the
p.(None): HIT Advisory Committee shall be filled in the manner in
p.(None): which the original appointment was made.
p.(None): ``(C) Limits.--Members of the HIT Advisory Committee
p.(None): shall be limited to two 3-year terms, for a total of not
...
p.(None): with primary care in community-based settings;
p.(None): ``(C) demonstrate experience in using health
p.(None): information technology and, as appropriate, telehealth
p.(None): to support--
p.(None): ``(i) the delivery of mental and substance use
p.(None): disorders services at the eligible entities
p.(None): described in subsections (c)(1) and (c)(2); and
p.(None): ``(ii) community health centers in integrating
p.(None): primary care and mental and substance use
p.(None): disorders treatment; or
p.(None): ``(D) have the capacity to expand access to mental
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
...
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
p.(None): ``(B) an analysis of the effect of the demonstration
p.(None): program on the prevalence of untreated mental and
p.(None): substance use disorders in the surrounding communities
p.(None): of health centers participating in the demonstration;
p.(None): and
p.(None): ``(C) recommendations on whether the demonstration
p.(None): program should be expanded.
p.(None):
p.(None): ``(g) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $10,000,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9023. <> CLARIFICATION ON CURRENT
p.(None): ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
p.(None):
p.(None): The Administrator of the Health Resources and Services
p.(None): Administration shall clarify the eligibility pursuant to section
p.(None): 338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
p.(None): 1(b)(1)(B)) of child and adolescent psychiatrists for the National
p.(None): Health Service Corps Loan Repayment Program under subpart III of part D
p.(None): of title III of such Act (42 U.S.C. 254l et seq.).
p.(None): SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by adding at the end the following:
p.(None):
p.(None): ``PART K--MINORITY FELLOWSHIP PROGRAM
p.(None):
p.(None): ``SEC. 597. <> FELLOWSHIPS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall maintain a program, to be
p.(None): known as the Minority Fellowship Program, under which the Secretary
p.(None): shall award fellowships, which may include stipends, for the purposes
p.(None): of--
p.(None):
p.(None): [[Page 130 STAT. 1254]]
p.(None): ``(1) increasing the knowledge of mental and substance use
p.(None): disorders practitioners on issues related to prevention,
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
p.(None): is subject to the provisions of this subsection.
p.(None): ``(2) In providing a health service to an individual, a health care
p.(None): practitioner shall for purposes of this subsection be considered to be a
...
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p.(None):
p.(None): [[Page 130 STAT. 1065]]
p.(None):
p.(None): (b) Reporting.--Section 492B(f) of the Public Health Service Act (42
p.(None): U.S.C. 289a-2(f)) is amended--
p.(None): (1) by striking ``biennial'' each place such term appears
p.(None): and inserting ``triennial'';
p.(None): (2) by striking ``The advisory council'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The advisory council''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(2) Contents.--Each triennial report prepared by an
p.(None): advisory council of each national research institute as
p.(None): described in paragraph (1) shall include each of the following:
p.(None): ``(A) The number of women included as subjects, and
p.(None): the proportion of subjects that are women, in any
p.(None): project of clinical research conducted during the
p.(None): applicable reporting period, disaggregated by categories
p.(None): of research area, condition, or disease, and accounting
p.(None): for single-sex studies.
p.(None): ``(B) The number of members of minority groups
p.(None): included as subjects, and the proportion of subjects
p.(None): that are members of minority groups, in any project of
p.(None): clinical research conducted during the applicable
p.(None): reporting period, disaggregated by categories of
p.(None): research area, condition, or disease and accounting for
p.(None): single-race and single-ethnicity studies.
p.(None): ``(C) For the applicable reporting period, the
p.(None): number of projects of clinical research that include
p.(None): women and members of minority groups and that--
p.(None): ``(i) have been completed during such
p.(None): reporting period; and
p.(None): ``(ii) are being carried out during such
p.(None): reporting period and have not been completed.
p.(None): ``(D) The number of studies completed during the
p.(None): applicable reporting period for which reporting has been
p.(None): submitted in accordance with subsection (c)(2)(A).''.
p.(None):
p.(None): (c) Coordination.--Section 486(c)(2) of the Public Health Service
p.(None): Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
p.(None): inserting ``senior-level staff designees''.
p.(None): (d) In General.--Part A of title IV of the Public Health Service Act
p.(None): (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended
p.(None): by adding at the end the following:
p.(None): ``SEC. 404N. <> POPULATION FOCUSED RESEARCH.
p.(None):
p.(None): ``The Director of the National Institutes of Health shall, as
p.(None): appropriate, encourage efforts to improve research related to the health
p.(None): of sexual and gender minority populations, including by--
p.(None): ``(1) facilitating increased participation of sexual and
...
p.(None):
p.(None): Part P of title III of the Public Health Service Act (42 U.S.C. 280g
p.(None): et seq.) is amended by inserting after section 399S the following:
p.(None):
p.(None): [[Page 130 STAT. 1077]]
p.(None):
p.(None): ``SEC. 399S-1. <> SURVEILLANCE OF
p.(None): NEUROLOGICAL DISEASES.
p.(None):
p.(None): ``(a) In General.--The Secretary, acting through the Director of the
p.(None): Centers for Disease Control and Prevention and in coordination with
p.(None): other agencies as the Secretary determines, shall, as appropriate--
p.(None): ``(1) enhance and expand infrastructure and activities to
p.(None): track the epidemiology of neurological diseases; and
p.(None): ``(2) incorporate information obtained through such
p.(None): activities into an integrated surveillance system, which may
p.(None): consist of or include a registry, to be known as the National
p.(None): Neurological Conditions Surveillance System.
p.(None):
p.(None): ``(b) Research.--The Secretary shall ensure that the National
p.(None): Neurological Conditions Surveillance System is designed in a manner that
p.(None): facilitates further research on neurological diseases.
p.(None): ``(c) Content.--In carrying out subsection (a), the Secretary--
p.(None): ``(1) shall provide for the collection and storage of
p.(None): information on the incidence and prevalence of neurological
p.(None): diseases in the United States;
p.(None): ``(2) to the extent practicable, shall provide for the
p.(None): collection and storage of other available information on
p.(None): neurological diseases, including information related to persons
p.(None): living with neurological diseases who choose to participate,
p.(None): such as--
p.(None): ``(A) demographics, such as age, race, ethnicity,
p.(None): sex, geographic location, family history, and other
p.(None): information, as appropriate;
p.(None): ``(B) risk factors that may be associated with
p.(None): neurological diseases, such as genetic and environmental
p.(None): risk factors and other information, as appropriate; and
p.(None): ``(C) diagnosis and progression markers;
p.(None): ``(3) may provide for the collection and storage of
p.(None): information relevant to analysis on neurological diseases, such
p.(None): as information concerning--
p.(None): ``(A) the natural history of the diseases;
p.(None): ``(B) the prevention of the diseases;
p.(None): ``(C) the detection, management, and treatment
p.(None): approaches for the diseases; and
p.(None): ``(D) the development of outcomes measures;
p.(None): ``(4) may address issues identified during the consultation
p.(None): process under subsection (d); and
p.(None): ``(5) initially may address a limited number of neurological
p.(None): diseases.
p.(None):
p.(None): ``(d) Consultation.--In carrying out this section, the Secretary
p.(None): shall consult with individuals with appropriate expertise, which may
p.(None): include--
p.(None): ``(1) epidemiologists with experience in disease
p.(None): surveillance or registries;
p.(None): ``(2) representatives of national voluntary health
p.(None): associations that--
p.(None): ``(A) focus on neurological diseases; and
p.(None): ``(B) have demonstrated experience in research,
p.(None): care, or patient services;
p.(None): ``(3) health information technology experts or other
p.(None): information management specialists;
p.(None): ``(4) clinicians with expertise in neurological diseases;
p.(None): and
...
p.(None): on behalf of a patient, including due to age-
p.(None): related and other disability, cognitive
p.(None): impairment, or dementia.
p.(None): ``(iv) Subject to subparagraph (D), any other
p.(None): target area that the HIT Advisory Committee
p.(None): identifies as an appropriate target area to be
p.(None): considered under this subparagraph.
p.(None): ``(C) Additional target areas.--For purposes of this
p.(None): section, the HIT Advisory Committee may make
p.(None): recommendations under subparagraph (A), in addition to
p.(None): areas described in subparagraph (B), with respect to any
p.(None): of the following areas:
p.(None): ``(i) The use of health information technology
p.(None): to improve the quality of health care, such as by
p.(None): promoting the coordination of health care and
p.(None): improving continuity of health care among health
p.(None): care providers, reducing medical errors, improving
p.(None): population health,
p.(None):
p.(None): [[Page 130 STAT. 1170]]
p.(None):
p.(None): reducing chronic disease, and advancing research
p.(None): and education.
p.(None): ``(ii) The use of technologies that address
p.(None): the needs of children and other vulnerable
p.(None): populations.
p.(None): ``(iii) The use of electronic systems to
p.(None): ensure the comprehensive collection of patient
p.(None): demographic data, including at a minimum, race,
p.(None): ethnicity, primary language, and gender
p.(None): information.
p.(None): ``(iv) The use of self-service, telemedicine,
p.(None): home health care, and remote monitoring
p.(None): technologies.
p.(None): ``(v) The use of technologies that meet the
p.(None): needs of diverse populations.
p.(None): ``(vi) The use of technologies that support--
p.(None): ``(I) data for use in quality and
p.(None): public reporting programs;
p.(None): ``(II) public health; or
p.(None): ``(III) drug safety.
p.(None): ``(vii) The use of technologies that allow
p.(None): individually identifiable health information to be
p.(None): rendered unusable, unreadable, or indecipherable
p.(None): to unauthorized individuals when such information
p.(None): is transmitted in a health information network or
p.(None): transported outside of the secure facilities or
p.(None): systems where the disclosing covered entity is
p.(None): responsible for security conditions.
p.(None): ``(viii) The use of a certified health
p.(None): information technology for each individual in the
p.(None): United States.
p.(None): ``(D) Authority for temporary additional priority
p.(None): target areas.--For purposes of subparagraph (B)(iv), the
p.(None): HIT Advisory Committee may identify an area to be
p.(None): considered for purposes of recommendations under this
p.(None): subsection as a target area described in subparagraph
p.(None): (B) if--
p.(None): ``(i) the area is so identified for purposes
p.(None): of responding to new circumstances that have
p.(None): arisen in the health information technology
...
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p.(None): may not enter into a contract with a health professional pursuant to
p.(None): subsection (a) unless such professional has a substantial amount of
p.(None): education loans relative to income (as determined pursuant to guidelines
p.(None): issued by the Director).'';
p.(None): (5) in subsection (d) (as so redesignated), by striking
p.(None): ``The provisions'' and inserting ``Applicability of Certain
p.(None): Provisions Regarding Obligated Service.--The provisions''; and
p.(None): (6) in subsection (e) (as so redesignated), by striking
p.(None): ``Amounts'' and inserting ``Availability of Appropriations.--
p.(None): Amounts''.
p.(None):
p.(None): (c) Technical and Conforming Amendments.--Title IV of the Public
p.(None): Health Service Act is amended--
p.(None): (1) by striking section 464z-5 (42 U.S.C. 285t-2);
p.(None): (2) by striking section 487C (42 U.S.C. 288-3);
p.(None): (3) by striking section 487E (42 U.S.C. 288-5);
p.(None): (4) by striking section 487F (42 U.S.C. 288-5a), as added by
p.(None): section 205 of Public Law 106-505, relating to loan repayment
p.(None): for clinical researchers; and
p.(None): (5) by striking section 487F (42 U.S.C. 288-6), as added by
p.(None): section 1002(b) of Public Law 106-310 relating to pediatric
p.(None): research loan repayment.
p.(None):
p.(None): (d) GAO Report.--Not later than 18 months after the date of
p.(None): enactment of this Act, the Comptroller General of the United States
p.(None): shall submit to Congress a report on the efforts of the National
p.(None): Institutes of Health to attract, retain, and develop emerging
p.(None): scientists, including underrepresented individuals in the sciences, such
p.(None): as women, racial and ethnic minorities, and other groups. Such report
p.(None): shall include an analysis of the impact of the additional authority
p.(None): provided to the Secretary of Health and Human Services under this Act to
p.(None): address workforce shortages and gaps in priority research areas,
p.(None): including which centers and research areas offered loan repayment
p.(None): program participants the increased award amount.
p.(None):
p.(None): Subtitle D--National Institutes of Health Planning and Administration
p.(None):
p.(None): SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
p.(None):
p.(None): (a) Strategic Plan.--Section 402 of the Public Health Service Act
p.(None): (42 U.S.C. 282) is amended--
p.(None): (1) in subsection (b)(5), by inserting before the semicolon
p.(None): the following: ``, and through the development, implementation,
p.(None):
p.(None): [[Page 130 STAT. 1055]]
p.(None):
p.(None): and updating of the strategic plan developed under subsection
p.(None): (m)''; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None): ``(m) National Institutes of Health Strategic Plan.--
p.(None): ``(1) In general.--Not later than 2 years after the date of
p.(None): enactment of the 21st Century Cures Act, and at least every 6
p.(None): years thereafter, the Director of the National Institutes of
p.(None): Health shall develop and submit to the appropriate committees of
p.(None): Congress and post on the Internet website of the National
p.(None): Institutes of Health, a coordinated strategy (to be known as the
p.(None): `National Institutes of Health Strategic Plan') to provide
p.(None): direction to the biomedical research investments made by the
p.(None): National Institutes of Health, to facilitate collaboration
...
p.(None): SEC. 9023. <> CLARIFICATION ON CURRENT
p.(None): ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
p.(None):
p.(None): The Administrator of the Health Resources and Services
p.(None): Administration shall clarify the eligibility pursuant to section
p.(None): 338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
p.(None): 1(b)(1)(B)) of child and adolescent psychiatrists for the National
p.(None): Health Service Corps Loan Repayment Program under subpart III of part D
p.(None): of title III of such Act (42 U.S.C. 254l et seq.).
p.(None): SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
p.(None):
p.(None): Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
p.(None): is amended by adding at the end the following:
p.(None):
p.(None): ``PART K--MINORITY FELLOWSHIP PROGRAM
p.(None):
p.(None): ``SEC. 597. <> FELLOWSHIPS.
p.(None):
p.(None): ``(a) In General.--The Secretary shall maintain a program, to be
p.(None): known as the Minority Fellowship Program, under which the Secretary
p.(None): shall award fellowships, which may include stipends, for the purposes
p.(None): of--
p.(None):
p.(None): [[Page 130 STAT. 1254]]
p.(None): ``(1) increasing the knowledge of mental and substance use
p.(None): disorders practitioners on issues related to prevention,
p.(None): treatment, and recovery support for individuals who are from
p.(None): racial and ethnic minority populations and who have a mental or
p.(None): substance use disorder;
p.(None): ``(2) improving the quality of mental and substance use
p.(None): disorder prevention and treatment services delivered to racial
p.(None): and ethnic minority populations; and
p.(None): ``(3) increasing the number of culturally competent mental
p.(None): and substance use disorders professionals who teach, administer
p.(None): services, conduct research, and provide direct mental or
p.(None): substance use disorder services to racial and ethnic minority
p.(None): populations.
p.(None):
p.(None): ``(b) Training Covered.--The fellowships awarded under subsection
p.(None): (a) shall be for postbaccalaureate training (including for master's and
p.(None): doctoral degrees) for mental and substance use disorder treatment
p.(None): professionals, including in the fields of psychiatry, nursing, social
p.(None): work, psychology, marriage and family therapy, mental health counseling,
p.(None): and substance use disorder and addiction counseling.
p.(None): ``(c) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $12,669,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
p.(None): VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
p.(None):
p.(None): Section 224 of the Public Health Service Act (42 U.S.C. 233) is
p.(None): amended by adding at the end the following:
p.(None): ``(q)(1) For purposes of this section, a health professional
p.(None): volunteer at a deemed entity described in subsection (g)(4) shall, in
p.(None): providing a health professional service eligible for funding under
p.(None): section 330 to an individual, be deemed to be an employee of the Public
p.(None): Health Service for a calendar year that begins during a fiscal year for
p.(None): which a transfer was made under paragraph (4)(C). The preceding sentence
...
Social / Religion
Searching for indicator faith:
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p.(None): reserves to account for variance in annual amounts
p.(None): recovered under this paragraph. There is
p.(None): authorized to be appropriated for purposes of
p.(None): carrying out this section an amount equal to the
p.(None): amount specified in such estimate for the fiscal
p.(None): year.
p.(None): ``(ii) Application to other programs.--The
p.(None): amounts recovered under this paragraph and
p.(None): remaining after amounts are made available under
p.(None): clause (i) shall be transferred to the Federal
p.(None): Hospital Insurance Trust Fund under section 1817
p.(None): of the Social Security Act and the Federal
p.(None): Supplementary Medical Insurance Trust Fund under
p.(None): section 1841 of such Act, in such proportion as
p.(None): the Secretary determines appropriate.
p.(None): ``(E) Authorization of appropriations.--There is
p.(None): authorized to be appropriated to the Office of the
p.(None): Inspector General to carry out this section $10,000,000,
p.(None): to remain available until expended.
p.(None): ``(3) Resolution of claims.--
p.(None):
p.(None): [[Page 130 STAT. 1179]]
p.(None):
p.(None): ``(A) In general.--The Office of the Inspector
p.(None): General, if such Office determines that a consultation
p.(None): regarding the health privacy and security rules
p.(None): promulgated under section 264(c) of the Health Insurance
p.(None): Portability and Accountability Act of 1996 (42 U.S.C.
p.(None): 1320d-2 note) will resolve an information blocking
p.(None): claim, may refer such instances of information blocking
p.(None): to the Office for Civil Rights of the Department of
p.(None): Health and Human Services for resolution.
p.(None): ``(B) Limitation on liability.--If a health care
p.(None): provider or health information technology developer
p.(None): makes information available based on a good faith
p.(None): reliance on consultations with the Office for Civil
p.(None): Rights of the Department of Health and Human Services
p.(None): pursuant to a referral under subparagraph (A), with
p.(None): respect to such information, the health care provider or
p.(None): developer shall not be liable for such disclosure or
p.(None): disclosures made pursuant to subparagraph (A).
p.(None):
p.(None): ``(c) Identifying Barriers To Exchange of Certified Health
p.(None): Information Technology.--
p.(None): ``(1) Trusted exchange defined.--In this section, the term
p.(None): `trusted exchange' with respect to certified electronic health
p.(None): records means that the certified electronic health record
p.(None): technology has the technical capability to enable secure health
p.(None): information exchange between users and multiple certified
p.(None): electronic health record technology systems.
p.(None): ``(2) Guidance.--The National Coordinator, in consultation
p.(None): with the Office for Civil Rights of the Department of Health and
p.(None): Human Services, shall issue guidance on common legal,
p.(None): governance, and security barriers that prevent the trusted
p.(None): exchange of electronic health information.
p.(None): ``(3) Referral.--The National Coordinator and the Office for
p.(None): Civil Rights of the Department of Health and Human Services may
p.(None): refer to the Inspector General instances or patterns of refusal
p.(None): to exchange health information with an individual or entity
p.(None): using certified electronic health record technology that is
p.(None): technically capable of trusted exchange and under conditions
p.(None): when exchange is legally permissible.
p.(None):
p.(None): ``(d) Additional Provisions.--
p.(None): ``(1) Information sharing provisions.--The National
p.(None): Coordinator may serve as a technical consultant to the Inspector
...
p.(None): input from beneficiaries, family caregivers, individuals who
p.(None): furnish personal care services or home health care services, and
p.(None): other stakeholders, as determined by the State in accordance
p.(None): with guidance from the Secretary; and
p.(None): ``(C) ensure that individuals who furnish personal care
p.(None): services, home health care services, or both under the State
p.(None): plan (or under a waiver of the plan) are provided the
p.(None): opportunity for training on the use of such system.
p.(None):
p.(None): ``(3) Paragraphs (1) and (2) shall not apply in the case of a State
p.(None): that, as of the date of the enactment of this subsection, requires the
p.(None): use of any system for the electronic verification of visits conducted as
p.(None): part of both personal care services and home health care services, so
p.(None): long as the State continues to require the use of such system with
p.(None): respect to the electronic verification of such visits.
p.(None): ``(4)(A) In the case of a State described in subparagraph (B), the
p.(None): reduction under paragraph (1) shall not apply--
p.(None): ``(i) in the case of personal care services, for calendar
p.(None): quarters in 2019; and
p.(None): ``(ii) in the case of home health care services, for
p.(None): calendar quarters in 2023.
p.(None):
p.(None): ``(B) For purposes of subparagraph (A), a State described in this
p.(None): subparagraph is a State that demonstrates to the Secretary that the
p.(None): State--
p.(None): ``(i) has made a good faith effort to comply with the
p.(None): requirements of paragraphs (1) and (2) (including by taking
p.(None): steps to adopt the technology used for an electronic visit
p.(None): verification system); and
p.(None): ``(ii) in implementing such a system, has encountered
p.(None): unavoidable system delays.
p.(None):
p.(None): ``(5) In this subsection:
p.(None):
p.(None): [[Page 130 STAT. 1277]]
p.(None):
p.(None): ``(A) The term `electronic visit verification system' means,
p.(None): with respect to personal care services or home health care
p.(None): services, a system under which visits conducted as part of such
p.(None): services are electronically verified with respect to--
p.(None): ``(i) the type of service performed;
p.(None): ``(ii) the individual receiving the service;
p.(None): ``(iii) the date of the service;
p.(None): ``(iv) the location of service delivery;
p.(None): ``(v) the individual providing the service; and
p.(None): ``(vi) the time the service begins and ends.
p.(None): ``(B) The term `home health care services' means services
p.(None): described in section 1905(a)(7) provided under a State plan
p.(None): under this title (or under a waiver of the plan).
p.(None): ``(C) The term `personal care services' means personal care
p.(None): services provided under a State plan under this title (or under
p.(None): a waiver of the plan), including services provided under section
p.(None): 1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a
p.(None): wavier under section 1115.
p.(None):
p.(None): ``(6)(A) In the case in which a State requires personal care service
p.(None): and home health care service providers to utilize an electronic visit
...
Searching for indicator conviction:
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p.(None): by such information as the Attorney General may require.
p.(None): ``(2) Criteria.--An eligible entity, in submitting an
p.(None): application under paragraph (1), shall--
p.(None): ``(A) provide extensive evidence of collaboration
p.(None): with State and local government agencies overseeing
p.(None): health, community corrections, courts, prosecution,
p.(None): substance abuse, mental health, victims services, and
p.(None): employment services, and with local law enforcement
p.(None): agencies;
p.(None): ``(B) demonstrate consultation with the Single State
p.(None): Authority for Substance Abuse of the State (as that term
p.(None): is defined in section 201(e) of the Second Chance Act of
p.(None): 2007);
p.(None): ``(C) demonstrate that evidence-based treatment
p.(None): practices will be utilized; and
p.(None): ``(D) demonstrate that evidence-based screening and
p.(None): assessment tools will be used to place participants in
p.(None): the treatment alternative to incarceration program.
p.(None):
p.(None): ``(d) Requirements.--Each eligible entity awarded a grant for a
p.(None): treatment alternative to incarceration program under this section
p.(None): shall--
p.(None): ``(1) determine the terms and conditions of participation in
p.(None): the program by eligible participants, taking into consideration
p.(None): the collateral consequences of an arrest, prosecution or
p.(None): criminal conviction;
p.(None): ``(2) ensure that each substance abuse and mental health
p.(None): treatment component is licensed and qualified by the relevant
p.(None): jurisdiction;
p.(None): ``(3) for programs described in subsection (b)(2), organize
p.(None): an enforcement unit comprised of appropriately trained law
p.(None): enforcement professionals under the supervision of the State,
p.(None): Tribal, or local criminal justice agency involved, the duties of
p.(None): which shall include--
p.(None): ``(A) the verification of addresses and other
p.(None): contact information of each eligible participant who
p.(None): participates or desires to participate in the program;
p.(None): and
p.(None): ``(B) if necessary, the location, apprehension,
p.(None): arrest, and return to custody of an eligible participant
p.(None): in the program who has absconded from the facility of a
p.(None): treatment provider or has otherwise significantly
p.(None): violated the terms and conditions of the program,
p.(None): consistent with Federal and State confidentiality
p.(None): requirements;
p.(None):
p.(None): [[Page 130 STAT. 1300]]
p.(None):
p.(None): ``(4) notify the relevant criminal justice entity if any
p.(None): eligible participant in the program absconds from the facility
p.(None): of the treatment provider or otherwise violates the terms and
p.(None): conditions of the program, consistent with Federal and State
p.(None): confidentiality requirements;
p.(None): ``(5) submit periodic reports on the progress of treatment
p.(None): or other measured outcomes from participation in the program of
...
Social / Soldier
Searching for indicator armedXforces:
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p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
p.(None): nongovernmental experts to improve mental and substance use
p.(None): disorders services for chronically homeless individuals,
p.(None): including by designing strategies to provide such services in
p.(None): supportive housing;
p.(None): ``(22) work with States and other stakeholders to develop
p.(None): and support activities to recruit and retain a workforce
p.(None): addressing mental and substance use disorders;
p.(None): ``(23) collaborate with the Attorney General and
p.(None): representatives of the criminal justice system to improve mental
p.(None): and substance use disorders services for individuals who have
p.(None): been arrested or incarcerated;
p.(None): ``(24) after providing an opportunity for public input, set
p.(None): standards for grant programs under this title for mental and
p.(None): substance use disorders services and prevention programs, which
p.(None): standards may address--
p.(None): ``(A) the capacity of the grantee to implement the
p.(None): award;
...
Social / Student
Searching for indicator student:
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p.(None): ``(2) The operation of hotlines.
p.(None): ``(3) Preparing informational material.
p.(None): ``(4) Providing outreach services to notify students about
p.(None): available mental and substance use disorder services.
p.(None): ``(5) Administering voluntary mental and substance use
p.(None): disorder screenings and assessments.
p.(None):
p.(None): [[Page 130 STAT. 1258]]
p.(None):
p.(None): ``(6) Supporting the training of students, faculty, and
p.(None): staff to respond effectively to students with mental and
p.(None): substance use disorders.
p.(None): ``(7) Creating a network infrastructure to link institutions
p.(None): of higher education with health care providers who treat mental
p.(None): and substance use disorders.
p.(None): ``(8) Providing mental and substance use disorders
p.(None): prevention and treatment services to students, which may include
p.(None): recovery support services and programming and early
p.(None): intervention, treatment, and management, including through the
p.(None): use of telehealth services.
p.(None): ``(9) Conducting research through a counseling or health
p.(None): center at the institution of higher education involved regarding
p.(None): improving the behavioral health of students through clinical
p.(None): services, outreach, prevention, or academic success, in a manner
p.(None): that is in compliance with all applicable personal privacy laws.
p.(None): ``(10) Supporting student groups on campus, including
p.(None): athletic teams, that engage in activities to educate students,
p.(None): including activities to reduce stigma surrounding mental and
p.(None): behavioral disorders, and promote mental health.
p.(None): ``(11) Employing appropriately trained staff.
p.(None): ``(12) Developing and supporting evidence-based and emerging
p.(None): best practices, including a focus on culturally and
p.(None): linguistically appropriate best practices.'';
p.(None): (4) in subsection (c)(5), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (5) in subsection (d)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``An institution of higher education desiring a
p.(None): grant under this section'' and inserting ``To be
p.(None): eligible to receive a grant under this section, an
p.(None): institution of higher education'';
p.(None): (B) by striking paragraph (1) and inserting--
p.(None): ``(1) A description of the population to be targeted by the
p.(None): program carried out under the grant, including veterans whenever
p.(None): possible and appropriate, and of identified mental and substance
p.(None): use disorder needs of students at the institution of higher
p.(None): education.'';
p.(None): (C) in paragraph (2), by inserting ``, which may
...
Social / Threat of Stigma
Searching for indicator stigma:
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p.(None): individuals who are 25 years of age or older, that are designed
p.(None): to raise awareness of suicide, establish referral processes, and
p.(None): improve care and outcomes for such individuals who are at risk
p.(None): of suicide.
p.(None): ``(2) Eligible entities.--To be eligible to receive a grant
p.(None): under this section, an entity shall be a community-based primary
p.(None): care or behavioral health care setting, an emergency department,
p.(None): a State mental health agency (or State health agency with mental
p.(None): or behavioral health functions), public health agency, a
p.(None): territory of the United States, or an Indian tribe or tribal
p.(None): organization (as the terms `Indian tribe' and `tribal
p.(None): organization' are defined in section 4 of the Indian Self-
p.(None): Determination and Education Assistance Act).
p.(None): ``(3) Use of funds.--The grants awarded under paragraph (1)
p.(None): shall be used to implement programs, in accordance with such
p.(None): paragraph, that include one or more of the following components:
p.(None): ``(A) Screening for suicide risk, suicide
p.(None): intervention services, and services for referral for
p.(None): treatment for individuals at risk for suicide.
p.(None): ``(B) Implementing evidence-based practices to
p.(None): provide treatment for individuals at risk for suicide,
p.(None): including appropriate followup services.
p.(None): ``(C) Raising awareness and reducing stigma of
p.(None): suicide.
p.(None):
p.(None): [[Page 130 STAT. 1244]]
p.(None):
p.(None): ``(b) Evaluations and Technical Assistance.--The Assistant Secretary
p.(None): shall--
p.(None): ``(1) evaluate the activities supported by grants awarded
p.(None): under subsection (a), and disseminate, as appropriate, the
p.(None): findings from the evaluation; and
p.(None): ``(2) provide appropriate information, training, and
p.(None): technical assistance, as appropriate, to eligible entities that
p.(None): receive a grant under this section, in order to help such
p.(None): entities to meet the requirements of this section, including
p.(None): assistance with selection and implementation of evidence-based
p.(None): interventions and frameworks to prevent suicide.
p.(None):
p.(None): ``(c) Duration.--A grant under this section shall be for a period of
p.(None): not more than 5 years.
p.(None): ``(d) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $30,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None): SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.(None):
p.(None): Section 520J of the Public Health Service Act (42 U.S.C. 290bb-41)
p.(None): is amended--
p.(None): (1) in the section heading, by inserting ``mental health
p.(None): awareness'' before ``training''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Illness'' and inserting ``Health'';
p.(None): (B) in paragraph (1), by inserting ``veterans, law
p.(None): enforcement, and other categories of individuals, as
p.(None): determined by the Secretary,'' after ``emergency
p.(None): services personnel'';
p.(None): (C) in paragraph (5)--
p.(None): (i) in the matter preceding subparagraph (A),
...
p.(None): (E) requirements for continuing education.
p.(None): (3) Report.--Not later than 2 years after the date of
p.(None): enactment of this Act, the Comptroller General of the United
p.(None): States shall submit to the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on Energy
p.(None): and Commerce of the House of Representatives a report on the
p.(None): study conducted under paragraph (1).
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON
p.(None): CAMPUS.
p.(None):
p.(None): Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
p.(None): 36b) is amended--
p.(None): (1) in the section heading, by striking ``and behavioral
p.(None): health'' and inserting ``health and substance use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``Services,'' and inserting
p.(None): ``Services and'';
p.(None): (B) by striking ``and behavioral health problems''
p.(None): and inserting ``health or substance use disorders'';
p.(None): (C) by striking ``substance abuse'' and inserting
p.(None): ``substance use disorders''; and
p.(None): (D) by adding after, ``suicide attempts,'' the
p.(None): following: ``prevent mental and substance use disorders,
p.(None): reduce stigma, and improve the identification and
p.(None): treatment for students at risk,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``for--'' and inserting ``for one or more of
p.(None): the following:''; and
p.(None): (B) by striking paragraphs (1) through (6) and
p.(None): inserting the following:
p.(None): ``(1) Educating students, families, faculty, and staff to
p.(None): increase awareness of mental and substance use disorders.
p.(None): ``(2) The operation of hotlines.
p.(None): ``(3) Preparing informational material.
p.(None): ``(4) Providing outreach services to notify students about
p.(None): available mental and substance use disorder services.
p.(None): ``(5) Administering voluntary mental and substance use
p.(None): disorder screenings and assessments.
p.(None):
p.(None): [[Page 130 STAT. 1258]]
p.(None):
p.(None): ``(6) Supporting the training of students, faculty, and
p.(None): staff to respond effectively to students with mental and
p.(None): substance use disorders.
p.(None): ``(7) Creating a network infrastructure to link institutions
p.(None): of higher education with health care providers who treat mental
p.(None): and substance use disorders.
p.(None): ``(8) Providing mental and substance use disorders
p.(None): prevention and treatment services to students, which may include
p.(None): recovery support services and programming and early
p.(None): intervention, treatment, and management, including through the
p.(None): use of telehealth services.
p.(None): ``(9) Conducting research through a counseling or health
p.(None): center at the institution of higher education involved regarding
p.(None): improving the behavioral health of students through clinical
p.(None): services, outreach, prevention, or academic success, in a manner
p.(None): that is in compliance with all applicable personal privacy laws.
p.(None): ``(10) Supporting student groups on campus, including
p.(None): athletic teams, that engage in activities to educate students,
p.(None): including activities to reduce stigma surrounding mental and
p.(None): behavioral disorders, and promote mental health.
p.(None): ``(11) Employing appropriately trained staff.
p.(None): ``(12) Developing and supporting evidence-based and emerging
p.(None): best practices, including a focus on culturally and
p.(None): linguistically appropriate best practices.'';
p.(None): (4) in subsection (c)(5), by striking ``substance abuse''
p.(None): and inserting ``substance use disorder'';
p.(None): (5) in subsection (d)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``An institution of higher education desiring a
p.(None): grant under this section'' and inserting ``To be
p.(None): eligible to receive a grant under this section, an
p.(None): institution of higher education'';
p.(None): (B) by striking paragraph (1) and inserting--
p.(None): ``(1) A description of the population to be targeted by the
p.(None): program carried out under the grant, including veterans whenever
p.(None): possible and appropriate, and of identified mental and substance
p.(None): use disorder needs of students at the institution of higher
p.(None): education.'';
p.(None): (C) in paragraph (2), by inserting ``, which may
p.(None): include, as appropriate and in accordance with
p.(None): subsection (b)(7), a plan to seek input from relevant
p.(None): stakeholders in the community, including appropriate
...
p.(None): education as appropriate.
p.(None):
p.(None): (e) Meetings.--
p.(None): (1) In general.--The Task Force shall meet not fewer than
p.(None): three times each year.
p.(None): (2) Annual conference.--The Secretary shall sponsor an
p.(None): annual conference on mental and behavioral health in settings of
p.(None): institutions of higher education to enhance coordination, build
p.(None): partnerships, and share best practices in mental and behavioral
p.(None): health promotion, data collection, analysis, and services.
p.(None):
p.(None): (f) Definition.--In this section, the term ``institution of higher
p.(None): education'' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): (g) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.
p.(None):
p.(None): [[Page 130 STAT. 1261]]
p.(None):
p.(None): SEC. 9033. <> IMPROVING MENTAL HEALTH ON
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by adding at the end the following:
p.(None): ``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON
p.(None): COLLEGE CAMPUSES.
p.(None):
p.(None): ``(a) Purpose.--It is the purpose of this section to increase access
p.(None): to, and reduce the stigma associated with, mental health services to
p.(None): ensure that students at institutions of higher education have the
p.(None): support necessary to successfully complete their studies.
p.(None): ``(b) National Public Education Campaign.--The Secretary, acting
p.(None): through the Assistant Secretary and in collaboration with the Director
p.(None): of the Centers for Disease Control and Prevention, shall convene an
p.(None): interagency, public-private sector working group to plan, establish, and
p.(None): begin coordinating and evaluating a targeted public education campaign
p.(None): that is designed to focus on mental and behavioral health on the
p.(None): campuses of institutions of higher education. Such campaign shall be
p.(None): designed to--
p.(None): ``(1) improve the general understanding of mental health and
p.(None): mental disorders;
p.(None): ``(2) encourage help-seeking behaviors relating to the
p.(None): promotion of mental health, prevention of mental disorders, and
p.(None): treatment of such disorders;
p.(None): ``(3) make the connection between mental and behavioral
p.(None): health and academic success; and
p.(None): ``(4) assist the general public in identifying the early
p.(None): warning signs and reducing the stigma of mental illness.
p.(None):
p.(None): ``(c) Composition.--The working group convened under subsection (b)
p.(None): shall include--
p.(None): ``(1) mental health consumers, including students and family
p.(None): members;
p.(None): ``(2) representatives of institutions of higher education;
p.(None): ``(3) representatives of national mental and behavioral
p.(None): health associations and associations of institutions of higher
p.(None): education;
p.(None): ``(4) representatives of health promotion and prevention
p.(None): organizations at institutions of higher education;
p.(None): ``(5) representatives of mental health providers, including
p.(None): community mental health centers; and
p.(None): ``(6) representatives of private-sector and public-sector
p.(None): groups with experience in the development of effective public
p.(None): health education campaigns.
p.(None):
p.(None): ``(d) Plan.--The working group under subsection (b) shall develop a
p.(None): plan that--
p.(None): ``(1) targets promotional and educational efforts to the age
p.(None): population of students at institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education, including through the use of roundtables;
p.(None): ``(2) develops and proposes the implementation of research-
p.(None): based public health messages and activities;
p.(None): ``(3) provides support for local efforts to reduce stigma by
p.(None): using the National Health Information Center as a primary point
p.(None): of contact for information, publications, and service program
p.(None): referrals; and
p.(None):
p.(None): [[Page 130 STAT. 1262]]
p.(None):
p.(None): ``(4) develops and proposes the implementation of a social
p.(None): marketing campaign that is targeted at the population of
p.(None): students attending institutions of higher education and
p.(None): individuals who are employed in settings of institutions of
p.(None): higher education.
p.(None):
p.(None): ``(e) Definition.--In this section, the term `institution of higher
p.(None): education' has the meaning given such term in section 101 of the Higher
p.(None): Education Act of 1965 (20 U.S.C. 1001).
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $1,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
p.(None): DISTURBANCE.
p.(None):
p.(None): (a) Comprehensive Community Mental Health Services for Children With
p.(None): a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
p.(None): Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
...
Searching for indicator threat:
(return to top)
p.(None): Sec. 3053. Recognition of standards.
p.(None): Sec. 3054. Certain class I and class II devices.
p.(None):
p.(None): [[Page 130 STAT. 1035]]
p.(None):
p.(None): Sec. 3055. Classification panels.
p.(None): Sec. 3056. Institutional review board flexibility.
p.(None): Sec. 3057. CLIA waiver improvements.
p.(None): Sec. 3058. Least burdensome device review.
p.(None): Sec. 3059. Cleaning instructions and validation data requirement.
p.(None): Sec. 3060. Clarifying medical software regulation.
p.(None):
p.(None): Subtitle G--Improving Scientific Expertise and Outreach at FDA
p.(None):
p.(None): Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical
p.(None): Product Assessment Service.
p.(None): Sec. 3072. Hiring authority for scientific, technical, and professional
p.(None): personnel.
p.(None): Sec. 3073. Establishment of Food and Drug Administration Intercenter
p.(None): Institutes.
p.(None): Sec. 3074. Scientific engagement.
p.(None): Sec. 3075. Drug surveillance.
p.(None): Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
p.(None):
p.(None): Subtitle H--Medical Countermeasures Innovation
p.(None):
p.(None): Sec. 3081. Medical countermeasure guidelines.
p.(None): Sec. 3082. Clarifying BARDA contracting authority.
p.(None): Sec. 3083. Countermeasure budget plan.
p.(None): Sec. 3084. Medical countermeasures innovation.
p.(None): Sec. 3085. Streamlining Project BioShield procurement.
p.(None): Sec. 3086. Encouraging treatments for agents that present a national
p.(None): security threat.
p.(None): Sec. 3087. Paperwork Reduction Act waiver during a public health
p.(None): emergency.
p.(None): Sec. 3088. Clarifying Food and Drug Administration emergency use
p.(None): authorization.
p.(None):
p.(None): Subtitle I--Vaccine Access, Certainty, and Innovation
p.(None):
p.(None): Sec. 3091. Predictable review timelines of vaccines by the Advisory
p.(None): Committee on Immunization Practices.
p.(None): Sec. 3092. Review of processes and consistency of Advisory Committee on
p.(None): Immunization Practices recommendations.
p.(None): Sec. 3093. Encouraging vaccine innovation.
p.(None):
p.(None): Subtitle J--Technical Corrections
p.(None):
p.(None): Sec. 3101. Technical corrections.
p.(None): Sec. 3102. Completed studies.
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): Sec. 4001. Assisting doctors and hospitals in improving quality of care
p.(None): for patients.
p.(None): Sec. 4002. Transparent reporting on usability, security, and
p.(None): functionality.
p.(None): Sec. 4003. Interoperability.
p.(None): Sec. 4004. Information blocking.
p.(None): Sec. 4005. Leveraging electronic health records to improve patient care.
p.(None): Sec. 4006. Empowering patients and improving patient access to their
p.(None): electronic health information.
p.(None): Sec. 4007. GAO study on patient matching.
p.(None): Sec. 4008. GAO study on patient access to health information.
p.(None): Sec. 4009. Improving Medicare local coverage determinations.
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
...
p.(None): of the study under subsection (a).
p.(None): (c) Contents of Reports.--The report submitted under subsection (b)
p.(None): shall address--
p.(None): (1) for each drug for which a priority review voucher has
p.(None): been awarded as of initiation of the study--
p.(None): (A) the indications for which the drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262(a));
p.(None): (B) whether, and to what extent, the voucher
p.(None): impacted the sponsor's decision to develop the drug; and
p.(None): (C) whether, and to what extent, the approval or
p.(None): licensure of the drug, as applicable and appropriate--
p.(None): (i) addressed a global unmet need related to
p.(None): the treatment or prevention of a neglected
p.(None): tropical disease, including whether the sponsor of
p.(None): a drug coordinated with international development
p.(None): organizations;
p.(None):
p.(None): [[Page 130 STAT. 1094]]
p.(None):
p.(None): (ii) addressed an unmet need related to the
p.(None): treatment of a rare pediatric disease; or
p.(None): (iii) affected the Nation's preparedness
p.(None): against a chemical, biological, radiological, or
p.(None): nuclear threat, including naturally occurring
p.(None): threats;
p.(None): (2) for each drug for which a priority review voucher has
p.(None): been used--
p.(None): (A) the indications for which such drug is approved
p.(None): under section 505(c) of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
p.(None): application under section 505(b)(1) of such Act, or
p.(None): licensed under section 351(a) of the Public Health
p.(None): Service Act (42 U.S.C. 262);
p.(None): (B) the value of the voucher, if transferred; and
p.(None): (C) the length of time between the date on which the
p.(None): voucher was awarded and the date on which the voucher
p.(None): was used; and
p.(None): (3) an analysis of the priority review voucher programs
p.(None): described in subsection (a), including--
p.(None): (A) the resources used by the Food and Drug
p.(None): Administration in reviewing drugs for which vouchers
p.(None): were used, including the effect of the programs on the
p.(None): Food and Drug Administration's review of drugs for which
p.(None): priority review vouchers were not awarded or used;
p.(None): (B) whether any improvements to such programs are
p.(None): necessary to appropriately target incentives for the
p.(None): development of drugs that would likely not otherwise be
p.(None): developed, or developed in as timely a manner, and, as
p.(None): applicable and appropriate--
p.(None): (i) address global unmet needs related to the
p.(None): treatment or prevention of neglected tropical
p.(None): diseases, including in countries in which
p.(None): neglected tropical diseases are endemic; or
...
p.(None):
p.(None): (a) In General.--Section 319F-2(g) of the Public Health Service Act
p.(None): (42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
p.(None):
p.(None): [[Page 130 STAT. 1141]]
p.(None):
p.(None): ``(5) Clarification on contracting authority.--The
p.(None): Secretary, acting through the Director of the Biomedical
p.(None): Advanced Research and Development Authority, shall carry out the
p.(None): programs funded by the special reserve fund (for the procurement
p.(None): of security countermeasures under subsection (c) and for
p.(None): carrying out section 319L), including the execution of
p.(None): procurement contracts, grants, and cooperative agreements
p.(None): pursuant to this section and section 319L.''.
p.(None):
p.(None): (b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public
p.(None): Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``,
p.(None): including the execution of procurement contracts, grants, and
p.(None): cooperative agreements pursuant to this section'' before the period.
p.(None): SEC. 3083. COUNTERMEASURE BUDGET PLAN.
p.(None):
p.(None): Section 2811(b)(7) of the Public Health Service Act (42 U.S.C.
p.(None): 300hh-10(b)(7)) is amended--
p.(None): (1) in the matter preceding subparagraph (A), by striking
p.(None): the first sentence and inserting ``Develop, and update not later
p.(None): than March 1 of each year, a coordinated 5-year budget plan
p.(None): based on the medical countermeasure priorities described in
p.(None): subsection (d), including with respect to chemical, biological,
p.(None): radiological, and nuclear agent or agents that may present a
p.(None): threat to the Nation, including such agents that are novel or
p.(None): emerging infectious diseases, and the corresponding efforts to
p.(None): develop qualified countermeasures (as defined in section 319F-
p.(None): 1), security countermeasures (as defined in section 319F-2), and
p.(None): qualified pandemic or epidemic products (as defined in section
p.(None): 319F-3) for each such threat.'';
p.(None): (2) in subparagraph (C), by striking ``; and'' and inserting
p.(None): a semicolon;
p.(None): (3) in subparagraph (D), by striking ``to the appropriate
p.(None): committees of Congress upon request.'' and inserting ``, not
p.(None): later than March 15 of each year, to the Committee on
p.(None): Appropriations and the Committee on Health, Education, Labor,
p.(None): and Pensions of the Senate and the Committee on Appropriations
p.(None): and the Committee on Energy and Commerce of the House of
p.(None): Representatives; and''; and
p.(None): (4) by adding at the end the following:
p.(None): ``(E) not later than March 15 of each year, be made
p.(None): publicly available in a manner that does not compromise
p.(None): national security.''.
p.(None): SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
p.(None):
p.(None): Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
p.(None): 7e(c)(4)) is amended by adding at the end the following:
p.(None): ``(E) Medical countermeasures innovation partner.--
p.(None): ``(i) In general.--To support the purposes
p.(None): described in paragraph (2), the Secretary, acting
p.(None): through the Director of BARDA, may enter into an
p.(None): agreement (including through the use of grants,
p.(None): contracts, cooperative agreements, or other
p.(None): transactions as described in paragraph (5)) with
p.(None): an independent, nonprofit entity to--
p.(None): ``(I) foster and accelerate the
p.(None): development and innovation of medical
p.(None): countermeasures and technologies that
p.(None): may assist advanced research and
p.(None):
p.(None): [[Page 130 STAT. 1142]]
p.(None):
p.(None): the development of qualified
p.(None): countermeasures and qualified pandemic
p.(None): or epidemic products, including through
p.(None): the use of strategic venture capital
...
p.(None): (C) by amending subparagraph (A), as so
p.(None): redesignated, to read as follows:
p.(None): ``(A) Notice to appropriate congressional
p.(None): committees.--The Secretary shall notify the Committee on
p.(None): Appropriations and the Committee on Health, Education,
p.(None): Labor, and Pensions of the Senate and the Committee on
p.(None): Appropriations and the Committee on Energy and Commerce
p.(None): of the House of Representatives of each decision to make
p.(None): available the special reserve fund as defined in
p.(None): subsection (h) for procurement of a security
p.(None): countermeasure, including, where available, the number
p.(None): of, the nature of, and other information concerning
p.(None): potential suppliers of such countermeasure, and whether
p.(None): other potential suppliers of the same or similar
p.(None): countermeasures were considered and rejected for
p.(None): procurement under this section and the reasons for each
p.(None): such rejection.''; and
p.(None): (D) in the heading, by striking ``Recommendation for
p.(None): president's approval'' and inserting ``Recommendations
p.(None): for procurement''; and
p.(None): (3) in paragraph (7)--
p.(None): (A) by striking subparagraphs (A) and (B) and
p.(None): inserting the following:
p.(None): ``(A) Payments from special reserve fund.--The
p.(None): special reserve fund as defined in subsection (h) shall
p.(None): be available for payments made by the Secretary to a
p.(None): vendor for procurement of a security countermeasure in
p.(None): accordance with the provisions of this paragraph.''; and
p.(None): (B) by redesignating subparagraph (C) as
p.(None): subparagraph (B).
p.(None): SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A
p.(None): NATIONAL SECURITY THREAT.
p.(None):
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565
p.(None): the following:
p.(None):
p.(None): [[Page 130 STAT. 1145]]
p.(None):
p.(None): ``SEC. 565A. <> PRIORITY REVIEW TO
p.(None): ENCOURAGE TREATMENTS FOR AGENTS THAT
p.(None): PRESENT NATIONAL SECURITY THREATS.
p.(None):
p.(None): ``(a) Definitions.--In this section:
p.(None): ``(1) Human drug application.--The term `human drug
p.(None): application' has the meaning given such term in section 735(1).
p.(None): ``(2) Priority review.--The term `priority review', with
p.(None): respect to a human drug application, means review and action by
p.(None): the Secretary on such application not later than 6 months after
p.(None): receipt by the Secretary of such application, as described in
p.(None): the Manual of Policies and Procedures in the Food and Drug
p.(None): Administration and goals identified in the letters described in
p.(None): section 101(b) of the Food and Drug Administration Safety and
p.(None): Innovation Act.
p.(None): ``(3) Priority review voucher.--The term `priority review
p.(None): voucher' means a voucher issued by the Secretary to the sponsor
p.(None): of a material threat medical countermeasure application that
p.(None): entitles the holder of such voucher to priority review of a
p.(None): single human drug application submitted under section 505(b)(1)
p.(None): or section 351(a) of the Public Health Service Act after the
p.(None): date of approval of the material threat medical countermeasure
p.(None): application.
p.(None): ``(4) Material threat medical countermeasure application.--
p.(None): The term `material threat medical countermeasure application'
p.(None): means an application that--
p.(None): ``(A) is a human drug application for a drug
p.(None): intended for use--
p.(None): ``(i) to prevent, or treat harm from a
p.(None): biological, chemical, radiological, or nuclear
p.(None): agent identified as a material threat under
p.(None): section 319F-2(c)(2)(A)(ii) of the Public Health
p.(None): Service Act; or
p.(None): ``(ii) to mitigate, prevent, or treat harm
p.(None): from a condition that may result in adverse health
p.(None): consequences or death and may be caused by
p.(None): administering a drug, or biological product
p.(None): against such agent; and
p.(None): ``(B) the Secretary determines eligible for priority
p.(None): review;
p.(None): ``(C) is approved after the date of enactment of the
p.(None): 21st Century Cures Act; and
p.(None): ``(D) is for a human drug, no active ingredient
p.(None): (including any ester or salt of the active ingredient)
p.(None): of which has been approved in any other application
p.(None): under section 505(b)(1) or section 351(a) of the Public
p.(None): Health Service Act.
p.(None):
p.(None): ``(b) Priority Review Voucher.--
p.(None): ``(1) In general.--The Secretary shall award a priority
p.(None): review voucher to the sponsor of a material threat medical
p.(None): countermeasure application upon approval by the Secretary of
p.(None): such material threat medical countermeasure application.
p.(None): ``(2) Transferability.--The sponsor of a material threat
p.(None): medical countermeasure application that receives a priority
p.(None): review voucher under this section may transfer (including by
p.(None): sale) the entitlement to such voucher to a sponsor of a human
p.(None): drug for which an application under section 505(b)(1) or section
p.(None): 351(a) of the Public Health Service Act will be submitted after
p.(None): the date of the approval of the material threat medical
p.(None): countermeasure application. There is no limit on the number of
p.(None): times
p.(None):
p.(None): [[Page 130 STAT. 1146]]
p.(None):
p.(None): a priority review voucher may be transferred before such voucher
p.(None): is used.
p.(None): ``(3) Notification.--
p.(None): ``(A) In general.--The sponsor of a human drug
p.(None): application shall notify the Secretary not later than 90
p.(None): calendar days prior to submission of the human drug
p.(None): application that is the subject of a priority review
p.(None): voucher of an intent to submit the human drug
p.(None): application, including the date on which the sponsor
p.(None): intends to submit the application. Such notification
p.(None): shall be a legally binding commitment to pay for the
p.(None): user fee to be assessed in accordance with this section.
p.(None): ``(B) Transfer after notice.--The sponsor of a human
p.(None): drug application that provides notification of the
p.(None): intent of such sponsor to use the voucher for the human
p.(None): drug application under subparagraph (A) may transfer the
p.(None): voucher after such notification is provided, if such
p.(None): sponsor has not yet submitted the human drug application
p.(None): described in the notification.
p.(None): ``(c) Priority Review User Fee.--
p.(None): ``(1) In general.--The Secretary shall establish a user fee
p.(None): program under which a sponsor of a human drug application that
p.(None): is the subject of a priority review voucher shall pay to the
...
p.(None): refunds.--The Secretary may not grant a waiver,
p.(None): exemption, reduction, or refund of any fees due and
p.(None): payable under this section.
p.(None): ``(5) Offsetting collections.--Fees collected pursuant to
p.(None): this subsection for any fiscal year--
p.(None): ``(A) shall be deposited and credited as offsetting
p.(None): collections to the account providing appropriations to
p.(None): the Food and Drug Administration; and
p.(None):
p.(None): [[Page 130 STAT. 1147]]
p.(None):
p.(None): ``(6) shall not be collected for any fiscal year except to
p.(None): the extent provided in advance in appropriation Acts.
p.(None):
p.(None): ``(d) Notice of Issuance of Voucher and Approval of Products Under
p.(None): Voucher.--The Secretary shall publish a notice in the Federal Register
p.(None): and on the Internet website of the Food and Drug Administration not
p.(None): later than 30 calendar days after the occurrence of each of the
p.(None): following:
p.(None): ``(1) The Secretary issues a priority review voucher under
p.(None): this section.
p.(None): ``(2) The Secretary approves a drug pursuant to an
p.(None): application submitted under section 505(b) of this Act or
p.(None): section 351(a) of the Public Health Service Act for which the
p.(None): sponsor of the application used a priority review voucher issued
p.(None): under this section.
p.(None):
p.(None): ``(e) Eligibility for Other Programs.--Nothing in this section
p.(None): precludes a sponsor who seeks a priority review voucher under this
p.(None): section from participating in any other incentive program, including
p.(None): under this Act, except that no sponsor of a material threat medical
p.(None): countermeasure application may receive more than one priority review
p.(None): voucher issued under any section of this Act with respect to such drug.
p.(None): ``(f) Relation to Other Provisions.--The provisions of this section
p.(None): shall supplement, not supplant, any other provisions of this Act or the
p.(None): Public Health Service Act that encourage the development of medical
p.(None): countermeasures.
p.(None): ``(g) Sunset.--The Secretary may not award any priority review
p.(None): vouchers under subsection (b) after October 1, 2023.''.
p.(None): SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH
p.(None): EMERGENCY.
p.(None):
p.(None): Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
p.(None): amended by adding at the end the following:
p.(None): ``(f) Determination With Respect to Paperwork Reduction Act Waiver
p.(None): During a Public Health Emergency.--
p.(None): ``(1) Determination.--If the Secretary determines, after
p.(None): consultation with such public health officials as may be
p.(None): necessary, that--
p.(None): ``(A)(i) the criteria set forth for a public health
p.(None): emergency under paragraph (1) or (2) of subsection (a)
p.(None): has been met; or
p.(None): ``(ii) a disease or disorder, including a novel and
p.(None): emerging public health threat, is significantly likely
p.(None): to become a public health emergency; and
p.(None): ``(B) the circumstances of such public health
p.(None): emergency, or potential for such significantly likely
p.(None): public health emergency, including the specific
p.(None): preparation for and response to such public health
p.(None): emergency or threat, necessitate a waiver from the
p.(None): requirements of subchapter I of chapter 35 of title 44,
p.(None): United States Code (commonly referred to as the
p.(None): Paperwork Reduction Act),
p.(None): then the requirements of such subchapter I with respect to
p.(None): voluntary collection of information shall not be applicable
p.(None): during the immediate investigation of, and response to, such
p.(None): public health emergency during the period of such public health
p.(None): emergency or the period of time necessary to determine if a
p.(None): disease or disorder, including a novel and emerging public
p.(None):
p.(None): [[Page 130 STAT. 1148]]
p.(None):
p.(None): health threat, will become a public health emergency as provided
p.(None): for in this paragraph. The requirements of such subchapter I
p.(None): with respect to voluntary collection of information shall not be
p.(None): applicable during the immediate postresponse review regarding
p.(None): such public health emergency if such immediate postresponse
p.(None): review does not exceed a reasonable length of time.
p.(None): ``(2) Transparency.--If the Secretary determines that a
p.(None): waiver is necessary under paragraph (1), the Secretary shall
p.(None): promptly post on the Internet website of the Department of
p.(None): Health and Human Services a brief justification for such waiver,
p.(None): the anticipated period of time such waiver will be in effect,
p.(None): and the agencies and offices within the Department of Health and
p.(None): Human Services to which such waiver shall apply, and update such
p.(None): information posted on the Internet website of the Department of
p.(None): Health and Human Services, as applicable.
p.(None): ``(3) Effectiveness of waiver.--Any waiver under this
p.(None): subsection shall take effect on the date on which the Secretary
p.(None): posts information on the Internet website as provided for in
p.(None): this subsection.
p.(None): ``(4) Termination of waiver.--Upon determining that the
p.(None): circumstances necessitating a waiver under paragraph (1) no
p.(None): longer exist, the Secretary shall promptly update the Internet
p.(None): website of the Department of Health and Human Services to
p.(None): reflect the termination of such waiver.
p.(None): ``(5) Limitations.--
p.(None): ``(A) Period of waiver.--The period of a waiver
p.(None): under paragraph (1) shall not exceed the period of time
...
p.(None): addressing the circumstances described in paragraph (2), the
p.(None): guidance issued under this section shall clarify permitted uses
p.(None): or disclosures of protected health information for purposes of--
p.(None): (A) communicating with a family member of the
p.(None): patient, caregiver of the patient, or other individual,
p.(None): to the extent that such family member, caregiver, or
p.(None): individual is involved in the care of the patient;
p.(None): (B) in the case that the patient is an adult,
p.(None): communicating with a family member of the patient,
p.(None): caregiver of the patient, or other individual involved
p.(None): in the care of the patient;
p.(None): (C) in the case that the patient is a minor,
p.(None): communicating with the parent or caregiver of the
p.(None): patient;
p.(None): (D) involving the family members or caregivers of
p.(None): the patient, or others involved in the patient's care or
p.(None): care plan, including facilitating treatment and
p.(None): medication adherence;
p.(None): (E) listening to the patient, or receiving
p.(None): information with respect to the patient from the family
p.(None): or caregiver of the patient;
p.(None): (F) communicating with family members of the
p.(None): patient, caregivers of the patient, law enforcement, or
p.(None): others when the patient presents a serious and imminent
p.(None): threat of harm to self or others; and
p.(None): (G) communicating to law enforcement and family
p.(None): members or caregivers of the patient about the admission
p.(None): of the patient to receive care at, or the release of a
p.(None): patient from, a facility for an emergency psychiatric
p.(None): hold or involuntary treatment.
p.(None): SEC. 11004. <> DEVELOPMENT AND
p.(None): DISSEMINATION OF MODEL TRAINING
p.(None): PROGRAMS.
p.(None):
p.(None): (a) Initial Programs and Materials.--Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary, in consultation with
p.(None): appropriate experts, shall identify the following model programs and
p.(None): materials, or (in the case that no such programs or materials exist)
p.(None): recognize private or public entities to develop and disseminate each of
p.(None): the following:
p.(None): (1) Model programs and materials for training health care
p.(None): providers (including physicians, emergency medical personnel,
p.(None): psychiatrists, including child and adolescent psychiatrists,
p.(None): psychologists, counselors, therapists, nurse practitioners,
p.(None): physician assistants, behavioral health facilities and clinics,
p.(None): care managers, and hospitals, including individuals such as
p.(None): general counsels or regulatory compliance staff who are
p.(None): responsible for establishing provider privacy policies)
p.(None): regarding the permitted uses and disclosures, consistent with
p.(None): the standards governing the privacy and security of individually
...
Social / Threat of Violence
Searching for indicator violence:
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p.(None): of the Assistant Secretary for Planning and Evaluation under
p.(None): section 6021(d) of the Helping Families in Mental Health Crisis
p.(None): Reform Act of 2016 and the report of the Interdepartmental
p.(None): Serious Mental Illness Coordinating Committee under section 6031
p.(None): of such Act.
p.(None): ``(3) Publication of plan.--Not later than September 30,
p.(None): 2018, and every 4 years thereafter, the Assistant Secretary
p.(None): shall--
p.(None): ``(A) submit the strategic plan developed under
p.(None): paragraph (1) to the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives and the Committee on Health, Education,
p.(None): Labor, and Pensions and the Committee on Appropriations
p.(None): of the Senate; and
p.(None): ``(B) post such plan on the Internet website of the
p.(None): Administration.
p.(None): ``(4) Contents.--The strategic plan developed under
p.(None): paragraph (1) shall--
p.(None): ``(A) identify strategic priorities, goals, and
p.(None): measurable objectives for mental and substance use
p.(None): disorders activities and programs operated and supported
p.(None): by the Administration, including priorities to prevent
p.(None): or eliminate the burden of mental and substance use
p.(None): disorders;
p.(None): ``(B) identify ways to improve the quality of
p.(None): services for individuals with mental and substance use
p.(None): disorders, and to reduce homelessness, arrest,
p.(None): incarceration, violence, including self-directed
p.(None): violence, and unnecessary hospitalization of individuals
p.(None): with a mental or substance use disorder, including
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None):
p.(None): [[Page 130 STAT. 1210]]
p.(None):
p.(None): ``(C) ensure that programs provide, as appropriate,
p.(None): access to effective and evidence-based prevention,
p.(None): diagnosis, intervention, treatment, and recovery
p.(None): services, including culturally and linguistically
p.(None): appropriate services, as appropriate, for individuals
p.(None): with a mental or substance use disorder;
p.(None): ``(D) identify opportunities to collaborate with the
p.(None): Health Resources and Services Administration to develop
p.(None): or improve--
p.(None): ``(i) initiatives to encourage individuals to
p.(None): pursue careers (especially in rural and
p.(None): underserved areas and with rural and underserved
p.(None): populations) as psychiatrists, including child and
p.(None): adolescent psychiatrists, psychologists,
p.(None): psychiatric nurse practitioners, physician
p.(None): assistants, clinical social workers, certified
p.(None): peer support specialists, licensed professional
p.(None): counselors, or other licensed or certified mental
p.(None): health or substance use disorder professionals,
p.(None): including such professionals specializing in the
p.(None): diagnosis, evaluation, or treatment of adults with
...
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
p.(None): of the long-term consequences of child trauma, and early
p.(None): intervention services and treatment to address the long-term
p.(None): consequences of child trauma; and
p.(None): ``(2) the development of knowledge with regard to evidence-
p.(None): based practices for identifying and treating mental, behavioral,
p.(None): and biological disorders of children and youth resulting from
p.(None): witnessing or experiencing a traumatic event.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking ``subsection (a) related'' and
p.(None): inserting ``subsection (a)(2) (related'';
p.(None): (B) by striking ``treating disorders associated with
...
p.(None): health information of patients seeking or undergoing mental or
p.(None): substance use disorder treatment.
p.(None):
p.(None): [[Page 130 STAT. 1272]]
p.(None):
p.(None): (2) A model program and materials for training patients and
p.(None): their families regarding their rights to protect and obtain
p.(None): information under the standards and regulations specified in
p.(None): paragraph (1).
p.(None):
p.(None): (b) Periodic Updates.--The Secretary shall--
p.(None): (1) periodically review and update the model programs and
p.(None): materials identified or developed under subsection (a); and
p.(None): (2) disseminate the updated model programs and materials to
p.(None): the individuals described in subsection (a).
p.(None):
p.(None): (c) Coordination.--The Secretary shall carry out this section in
p.(None): coordination with the Director of the Office for Civil Rights within the
p.(None): Department of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, the Administrator of the Health
p.(None): Resources and Services Administration, and the heads of other relevant
p.(None): agencies within the Department of Health and Human Services.
p.(None): (d) Input of Certain Entities.--In identifying, reviewing, or
p.(None): updating the model programs and materials under subsections (a) and (b),
p.(None): the Secretary shall solicit the input of relevant national, State, and
p.(None): local associations; medical societies; licensing boards; providers of
p.(None): mental and substance use disorder treatment; organizations with
p.(None): expertise on domestic violence, sexual assault, elder abuse, and child
p.(None): abuse; and organizations representing patients and consumers and the
p.(None): families of patients and consumers.
p.(None): (e) Funding.--There are authorized to be appropriated to carry out
p.(None): this section--
p.(None): (1) $4,000,000 for fiscal year 2018;
p.(None): (2) $2,000,000 for each of fiscal years 2019 and 2020; and
p.(None): (3) $1,000,000 for each of fiscal years 2021 and 2022.
p.(None):
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): SEC. 12001. <> RULE OF CONSTRUCTION
p.(None): RELATED TO MEDICAID COVERAGE OF MENTAL
p.(None): HEALTH SERVICES AND PRIMARY CARE
p.(None): SERVICES FURNISHED ON THE SAME DAY.
p.(None):
p.(None): Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et
p.(None): seq.) shall be construed as prohibiting separate payment under the State
p.(None): plan under such title (or under a waiver of the plan) for the provision
p.(None): of a mental health service or primary care service under such plan, with
p.(None): respect to an individual, because such service is--
p.(None): (1) a primary care service furnished to the individual by a
p.(None): provider at a facility on the same day a mental health service
p.(None): is furnished to such individual by such provider (or another
p.(None): provider) at the facility; or
p.(None): (2) a mental health service furnished to the individual by a
p.(None): provider at a facility on the same day a primary care service is
p.(None): furnished to such individual by such provider (or another
p.(None): provider) at the facility.
p.(None): SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE
p.(None): REGULATION.
p.(None):
...
p.(None): determined such treatment to be necessary''.
p.(None): (b) Definitions.--Section 2202 of title I of the Omnibus Crime
p.(None): Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting a semicolon; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) the term `court-ordered assisted outpatient treatment'
p.(None): means a program through which a court may order a treatment plan
p.(None): for an eligible patient that--
p.(None): ``(A) requires such patient to obtain outpatient
p.(None): mental health treatment while the patient is not
p.(None): currently residing in a correctional facility or
p.(None): inpatient treatment facility; and
p.(None):
p.(None): [[Page 130 STAT. 1289]]
p.(None):
p.(None): ``(B) is designed to improve access and adherence by
p.(None): such patient to intensive behavioral health services in
p.(None): order to--
p.(None): ``(i) avert relapse, repeated
p.(None): hospitalizations, arrest, incarceration, suicide,
p.(None): property destruction, and violent behavior; and
p.(None): ``(ii) provide such patient with the
p.(None): opportunity to live in a less restrictive
p.(None): alternative to incarceration or involuntary
p.(None): hospitalization; and
p.(None): ``(4) the term `eligible patient' means an adult, mentally
p.(None): ill person who, as determined by a court--
p.(None): ``(A) has a history of violence, incarceration, or
p.(None): medically unnecessary hospitalizations;
p.(None): ``(B) without supervision and treatment, may be a
p.(None): danger to self or others in the community;
p.(None): ``(C) is substantially unlikely to voluntarily
p.(None): participate in treatment;
p.(None): ``(D) may be unable, for reasons other than
p.(None): indigence, to provide for any of his or her basic needs,
p.(None): such as food, clothing, shelter, health, or safety;
p.(None): ``(E) has a history of mental illness or a condition
p.(None): that is likely to substantially deteriorate if the
p.(None): person is not provided with timely treatment; or
p.(None): ``(F) due to mental illness, lacks capacity to fully
p.(None): understand or lacks judgment to make informed decisions
p.(None): regarding his or her need for treatment, care, or
p.(None): supervision.''.
p.(None): SEC. 14003. <> FEDERAL DRUG AND MENTAL
p.(None): HEALTH COURTS.
p.(None):
p.(None): (a) Definitions.--In this section--
p.(None): (1) the term ``eligible offender'' means a person who--
p.(None): (A)(i) previously or currently has been diagnosed by
p.(None): a qualified mental health professional as having a
p.(None): mental illness, mental retardation, or co-occurring
p.(None): mental illness and substance abuse disorders; or
p.(None): (ii) manifests obvious signs of mental illness,
p.(None): mental retardation, or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or confinement
p.(None): or before any court;
p.(None): (B) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): (i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): (ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code; and
p.(None): (C) is determined by a judge to be eligible; and
p.(None): (2) the term ``mental illness'' means a diagnosable mental,
p.(None): behavioral, or emotional disorder--
p.(None): (A) of sufficient duration to meet diagnostic
p.(None): criteria within the most recent edition of the
p.(None): Diagnostic and Statistical Manual of Mental Disorders
p.(None): published by the American Psychiatric Association; and
p.(None): (B) that has resulted in functional impairment that
p.(None): substantially interferes with or limits 1 or more major
p.(None): life activities.
p.(None):
p.(None): [[Page 130 STAT. 1290]]
p.(None):
p.(None): (b) Establishment of Program.--Not later than 1 year after the date
p.(None): of enactment of this Act, the Attorney General shall establish a pilot
p.(None): program to determine the effectiveness of diverting eligible offenders
p.(None): from Federal prosecution, Federal probation, or a Bureau of Prisons
p.(None): facility, and placing such eligible offenders in drug or mental health
p.(None): courts.
p.(None): (c) Program Specifications.--The pilot program established under
p.(None): subsection (b) shall involve--
p.(None): (1) continuing judicial supervision, including periodic
p.(None): review, of program participants who have a substance abuse
...
p.(None): ``(8) target offenders with histories of homelessness,
p.(None): substance abuse, or mental illness, including a prerelease
p.(None): assessment of the housing status of the offender and behavioral
p.(None): health needs of the offender with clear coordination with mental
p.(None): health, substance abuse, and homelessness services systems to
p.(None): achieve stable and permanent housing outcomes with appropriate
p.(None): support service.''.
p.(None):
p.(None): (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
p.(None): 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
p.(None): mental health care'' after ``community''.
p.(None): SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
p.(None):
p.(None): Section 2701(b) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
p.(None): (1) by redesignating paragraphs (4) and (5) as paragraphs
p.(None): (5) and (6), respectively; and
p.(None): (2) by inserting after paragraph (3) the following:
p.(None): ``(4) The development and operation of crisis intervention
p.(None): teams that may include coordination with law enforcement
p.(None): agencies and specialized training for school officials in
p.(None): responding to mental health crises.''.
p.(None): SEC. 14011. <> ACTIVE-SHOOTER TRAINING
p.(None): FOR LAW ENFORCEMENT.
p.(None):
p.(None): The Attorney General, as part of the Preventing Violence Against Law
p.(None): Enforcement and Ensuring Officer Resilience and Survivability Initiative
p.(None): (VALOR) of the Department of Justice, may provide safety training and
p.(None): technical assistance to local law enforcement agencies, including
p.(None): active-shooter response training.
p.(None): SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
p.(None): CHALLENGES IN RESIDENTIAL SUBSTANCE
p.(None): ABUSE TREATMENT PROGRAMS.
p.(None):
p.(None): Section 1901(a) of title I of the Omnibus Crime Control and Safe
p.(None): Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``and'' at the end;
p.(None): (2) in paragraph (2), by striking the period at the end and
p.(None): inserting ``; and''; and
p.(None): (3) by adding at the end the following:
p.(None): ``(3) developing and implementing specialized residential
p.(None): substance abuse treatment programs that identify and provide
p.(None): appropriate treatment to inmates with co-occurring mental health
p.(None): and substance abuse disorders or challenges.''.
p.(None):
p.(None): [[Page 130 STAT. 1298]]
p.(None):
p.(None): SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS.
p.(None):
p.(None): Title I of the Omnibus Crime Control and Safe Streets Act of 1968
p.(None): (42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
p.(None): the following:
p.(None):
p.(None): ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
p.(None): INCARCERATION PROGRAMS
p.(None):
p.(None): ``SEC. 2901. <> MENTAL HEALTH AND DRUG
p.(None): TREATMENT ALTERNATIVES TO INCARCERATION
p.(None): PROGRAMS.
p.(None):
p.(None): ``(a) Definitions.--In this section--
p.(None): ``(1) the term `eligible entity' means a State, unit of
p.(None): local government, Indian tribe, or nonprofit organization; and
p.(None): ``(2) the term `eligible participant' means an individual
p.(None): who--
p.(None): ``(A) comes into contact with the criminal justice
p.(None): system or is arrested or charged with an offense that is
p.(None): not--
p.(None): ``(i) a crime of violence, as defined under
p.(None): applicable State law or in section 3156 of title
p.(None): 18, United States Code; or
p.(None): ``(ii) a serious drug offense, as defined in
p.(None): section 924(e)(2)(A) of title 18, United States
p.(None): Code;
p.(None): ``(B) has a history of, or a current--
p.(None): ``(i) substance use disorder;
p.(None): ``(ii) mental illness; or
p.(None): ``(iii) co-occurring mental illness and
p.(None): substance use disorder; and
p.(None): ``(C) has been approved for participation in a
p.(None): program funded under this section by the relevant law
p.(None): enforcement agency, prosecuting attorney, defense
p.(None): attorney, probation official, corrections official,
p.(None): judge, representative of a mental health agency, or
p.(None): representative of a substance abuse agency, as required
p.(None): by law.
p.(None):
p.(None): ``(b) Program Authorized.--The Attorney General may make grants to
p.(None): eligible entities to develop, implement, or expand a treatment
p.(None): alternative to incarceration program for eligible participants,
p.(None): including--
p.(None): ``(1) pre-booking treatment alternative to incarceration
p.(None): programs, including--
p.(None): ``(A) law enforcement training on substance use
p.(None): disorders, mental illness, and co-occurring mental
...
p.(None): illness or co-occurring mental illness and
p.(None): substance abuse disorders during arrest or
p.(None): confinement or before any court; or
p.(None): ``(III) in the case of a veterans treatment
p.(None): court provided under subsection (i), has been
p.(None): diagnosed with, or manifests obvious signs of,
p.(None): mental illness or a substance abuse disorder or
p.(None): co-occurring mental illness and substance abuse
p.(None): disorder;
p.(None):
p.(None): [[Page 130 STAT. 1312]]
p.(None):
p.(None): ``(ii) has been unanimously approved for
p.(None): participation in a program funded under this
p.(None): section by, when appropriate--
p.(None): ``(I) the relevant--
p.(None): ``(aa) prosecuting attorney;
p.(None): ``(bb) defense attorney;
p.(None): ``(cc) probation or
p.(None): corrections official; and
p.(None): ``(dd) judge; and
p.(None): ``(II) a representative from the
p.(None): relevant mental health agency described
p.(None): in subsection (b)(5)(B)(i);
p.(None): ``(iii) has been determined, by each person
p.(None): described in clause (ii) who is involved in
p.(None): approving the adult or juvenile for participation
p.(None): in a program funded under this section, to not
p.(None): pose a risk of violence to any person in the
p.(None): program, or the public, if selected to participate
p.(None): in the program; and
p.(None): ``(iv) has not been charged with or convicted
p.(None): of--
p.(None): ``(I) any sex offense (as defined in
p.(None): section 111 of the Sex Offender
p.(None): Registration and Notification Act (42
p.(None): U.S.C. 16911)) or any offense relating
p.(None): to the sexual exploitation of children;
p.(None): or
p.(None): ``(II) murder or assault with intent
p.(None): to commit murder.
p.(None): ``(B) Determination.--In determining whether to
p.(None): designate a defendant as a preliminarily qualified
p.(None): offender, the relevant prosecuting attorney, defense
p.(None): attorney, probation or corrections official, judge, and
p.(None): mental health or substance abuse agency representative
p.(None): shall take into account--
p.(None): ``(i) whether the participation of the
p.(None): defendant in the program would pose a substantial
p.(None): risk of violence to the community;
p.(None): ``(ii) the criminal history of the defendant
p.(None): and the nature and severity of the offense for
p.(None): which the defendant is charged;
p.(None): ``(iii) the views of any relevant victims to
p.(None): the offense;
p.(None): ``(iv) the extent to which the defendant would
p.(None): benefit from participation in the program;
p.(None): ``(v) the extent to which the community would
p.(None): realize cost savings because of the defendant's
p.(None): participation in the program; and
p.(None): ``(vi) whether the defendant satisfies the
p.(None): eligibility criteria for program participation
p.(None): unanimously established by the relevant
p.(None): prosecuting attorney, defense attorney, probation
p.(None): or corrections official, judge and mental health
p.(None): or substance abuse agency representative.''.
p.(None):
p.(None): (b) Technical and Conforming Amendment.--Section 2927(2) of title I
p.(None): of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
p.(None): 3797s-6(2)) is amended by striking ``has the meaning given that term in
p.(None): section 2991(a).'' and inserting ``means an offense that--
p.(None): ``(A) does not have as an element the use, attempted
p.(None): use, or threatened use of physical force against the
p.(None): person or property of another; or
p.(None):
p.(None): [[Page 130 STAT. 1313]]
p.(None):
p.(None): ``(B) is not a felony that by its nature involves a
p.(None): substantial risk that physical force against the person
...
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p.(None): Code of Federal Regulations (or any successor section).
p.(None):
p.(None): Subtitle G--Promoting Pediatric Research
p.(None):
p.(None): SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
p.(None):
p.(None): Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d))
p.(None): is amended--
p.(None): (1) in paragraph (1), by striking ``in consultation with the
p.(None): Director of the Eunice Kennedy Shriver National Institute of
p.(None): Child Health and Human Development and in collaboration with
p.(None): other appropriate national research institutes and national
p.(None): centers that carry out activities involving pediatric research,
p.(None): may provide for the establishment of'' and inserting ``in
p.(None): collaboration with the national research institutes and national
p.(None): centers that carry out activities involving pediatric research,
p.(None): shall support''; and
p.(None): (2) in paragraph (2)(A) and the first sentence of paragraph
p.(None): (2)(E), by striking ``may'' each place such term appears and
p.(None): inserting ``shall''.
p.(None): SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
p.(None):
p.(None): It is the sense of Congress that--
p.(None): (1) the National Institutes of Health should encourage a
p.(None): global pediatric clinical study network by providing grants,
p.(None): contracts, or cooperative agreements to support new and early
p.(None): stage investigators who participate in the global pediatric
p.(None): clinical study network;
p.(None): (2) the Secretary of Health and Human Services (referred to
p.(None): in this section as the ``Secretary'') should engage with
p.(None): clinical investigators and appropriate authorities outside of
p.(None): the United States, including authorities in the European Union,
p.(None): during the formation of the global pediatric clinical study
p.(None): network to encourage the participation of such investigator and
p.(None): authorities; and
p.(None): (3) once a global pediatric clinical study network is
p.(None): established and becomes operational, the Secretary should
p.(None): continue to encourage and facilitate the participation of
p.(None): clinical investigators and appropriate authorities outside of
p.(None): the United States, including in the European Union, to
p.(None): participate in the network with the goal of enhancing the global
p.(None): reach of the network.
p.(None):
p.(None): TITLE III--DEVELOPMENT
p.(None):
p.(None): Subtitle A--Patient-Focused Drug Development
p.(None):
p.(None): SEC. 3001. PATIENT EXPERIENCE DATA.
p.(None):
p.(None): Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 360bbb-8c) is amended--
p.(None): [[Page 130 STAT. 1084]]
p.(None):
p.(None): (1) in subsection (a)--
p.(None): (A) in the subsection heading, by striking ``In
p.(None): General'' and inserting ``Patient Engagement in Drugs
p.(None): and Devices'';
p.(None): (B) by redesignating paragraphs (1) and (2) as
p.(None): subparagraphs (A) and (B), respectively, and moving such
p.(None): subparagraphs 2 ems to the right; and
p.(None): (C) by striking ``The Secretary'' and inserting the
p.(None): following:
p.(None): ``(1) In general.--The Secretary'';
p.(None): (2) by redesignating subsections (b) through (e) as
p.(None): paragraphs (2) through (5), respectively, and moving such
p.(None): paragraphs 2 ems to the right; and
p.(None): (3) by adding at the end the following:
p.(None):
p.(None): ``(b) Statement of Patient Experience.--
p.(None): ``(1) In general.--Following the approval of an application
p.(None): that was submitted under section 505(b) of this Act or section
p.(None): 351(a) of the Public Health Service Act at least 180 days after
p.(None): the date of enactment of the 21st Century Cures Act, the
p.(None): Secretary shall make public a brief statement regarding the
p.(None): patient experience data and related information, if any,
p.(None): submitted and reviewed as part of such application.
p.(None): ``(2) Data and information.--The data and information
p.(None): referred to in paragraph (1) are--
...
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p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
p.(None): (1) a summary of advances in serious mental illness and
p.(None): serious emotional disturbance research related to the prevention
p.(None): of, diagnosis of, intervention in, and treatment and recovery of
p.(None): serious mental illnesses, serious emotional disturbances, and
p.(None): advances in access to services and support for adults with a
p.(None): serious mental illness or children with a serious emotional
p.(None): disturbance;
p.(None): (2) an evaluation of the effect Federal programs related to
p.(None): serious mental illness have on public health, including public
p.(None): health outcomes such as--
p.(None): (A) rates of suicide, suicide attempts, incidence
p.(None): and prevalence of serious mental illnesses, serious
p.(None): emotional disturbances, and substance use disorders,
p.(None): overdose, overdose deaths, emergency hospitalizations,
p.(None): emergency room boarding, preventable emergency room
p.(None): visits, interaction with the criminal justice system,
p.(None): homelessness, and unemployment;
p.(None): (B) increased rates of employment and enrollment in
p.(None): educational and vocational programs;
p.(None): (C) quality of mental and substance use disorders
p.(None): treatment services; or
p.(None): (D) any other criteria as may be determined by the
p.(None): Secretary; and
p.(None): (3) specific recommendations for actions that agencies can
p.(None): take to better coordinate the administration of mental health
p.(None): services for adults with a serious mental illness or children
p.(None): with a serious emotional disturbance.
p.(None):
p.(None): (d) Committee Extension.--Upon the submission of the second report
p.(None): under subsection (c), the Secretary shall submit a recommendation to
p.(None): Congress on whether to extend the operation of the Committee.
p.(None): (e) Membership.--
p.(None): (1) Federal members.--The Committee shall be composed of the
p.(None): following Federal representatives, or the designees of such
p.(None): representatives--
p.(None): (A) the Secretary of Health and Human Services, who
p.(None): shall serve as the Chair of the Committee;
p.(None): (B) the Assistant Secretary for Mental Health and
p.(None): Substance Use;
p.(None): (C) the Attorney General;
p.(None): (D) the Secretary of Veterans Affairs;
p.(None): (E) the Secretary of Defense;
p.(None): (F) the Secretary of Housing and Urban Development;
p.(None): (G) the Secretary of Education;
p.(None): (H) the Secretary of Labor;
p.(None): (I) the Administrator of the Centers for Medicare &
p.(None): Medicaid Services; and
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p.(None):
p.(None): [[Page 130 STAT. 1037]]
p.(None):
p.(None): Sec. 9022. Strengthening the mental and substance use disorders
p.(None): workforce.
p.(None): Sec. 9023. Clarification on current eligibility for loan repayment
p.(None): programs.
p.(None): Sec. 9024. Minority fellowship program.
p.(None): Sec. 9025. Liability protections for health professional volunteers at
p.(None): community health centers.
p.(None): Sec. 9026. Reports.
p.(None):
p.(None): Subtitle C--Mental Health on Campus Improvement
p.(None):
p.(None): Sec. 9031. Mental health and substance use disorder services on campus.
p.(None): Sec. 9032. Interagency Working Group on College Mental Health.
p.(None): Sec. 9033. Improving mental health on college campuses.
p.(None):
p.(None): TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
p.(None): CHILDREN AND ADOLESCENTS
p.(None):
p.(None): Sec. 10001. Programs for children with a serious emotional disturbance.
p.(None): Sec. 10002. Increasing access to pediatric mental health care.
p.(None): Sec. 10003. Substance use disorder treatment and early intervention
p.(None): services for children and adolescents.
p.(None): Sec. 10004. Children's recovery from trauma.
p.(None): Sec. 10005. Screening and treatment for maternal depression.
p.(None): Sec. 10006. Infant and early childhood mental health promotion,
p.(None): intervention, and treatment.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): Sec. 11001. Sense of Congress.
p.(None): Sec. 11002. Confidentiality of records.
p.(None): Sec. 11003. Clarification on permitted uses and disclosures of protected
p.(None): health information.
p.(None): Sec. 11004. Development and dissemination of model training programs.
p.(None): TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
p.(None):
p.(None): Sec. 12001. Rule of construction related to Medicaid coverage of mental
p.(None): health services and primary care services furnished on the
p.(None): same day.
p.(None): Sec. 12002. Study and report related to Medicaid managed care
p.(None): regulation.
p.(None): Sec. 12003. Guidance on opportunities for innovation.
p.(None): Sec. 12004. Study and report on Medicaid emergency psychiatric
p.(None): demonstration project.
p.(None): Sec. 12005. Providing EPSDT services to children in IMDs.
p.(None): Sec. 12006. Electronic visit verification system required for personal
p.(None): care services and home health care services under Medicaid.
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
...
p.(None): and substance use disorders services in areas with
p.(None): demonstrated need, as determined by the Secretary, such
p.(None): as tribal, rural, or other underserved communities.
p.(None): ``(2) Academic units or programs.--In awarding grants under
p.(None): subsection (a)(3), the Secretary shall give priority to eligible
p.(None): entities that--
p.(None): ``(A) have a record of training the greatest
p.(None): percentage of mental and substance use disorders
p.(None): providers who enter and remain in these fields or who
p.(None): enter and remain in settings with integrated primary
p.(None): care and mental and substance use disorder prevention
p.(None): and treatment services;
p.(None): ``(B) have a record of training individuals who are
p.(None): from underrepresented minority groups, including native
p.(None): populations, or from a rural or disadvantaged
p.(None): background;
p.(None): ``(C) provide training in the care of vulnerable
p.(None): populations such as infants, children, adolescents,
p.(None): pregnant and
p.(None):
p.(None): [[Page 130 STAT. 1253]]
p.(None):
p.(None): postpartum women, older adults, homeless individuals,
p.(None): victims of abuse or trauma, individuals with
p.(None): disabilities, and other groups as defined by the
p.(None): Secretary;
p.(None): ``(D) teach trainees the skills to provide
p.(None): interprofessional, integrated care through collaboration
p.(None): among health professionals; or
p.(None): ``(E) provide training in cultural competency and
p.(None): health literacy.
p.(None):
p.(None): ``(e) Duration.--Grants awarded under this section shall be for a
p.(None): minimum of 5 years.
p.(None): ``(f) Study and Report.--
p.(None): ``(1) Study.--
p.(None): ``(A) In general.--The Secretary, acting through the
p.(None): Administrator of the Health Resources and Services
p.(None): Administration, shall conduct a study on the results of
p.(None): the demonstration program under this section.
p.(None): ``(B) Data submission.--Not later than 90 days after
p.(None): the completion of the first year of the training program
p.(None): and each subsequent year that the program is in effect,
p.(None): each recipient of a grant under subsection (a) shall
p.(None): submit to the Secretary such data as the Secretary may
p.(None): require for analysis for the report described in
p.(None): paragraph (2).
p.(None): ``(2) Report to congress.--Not later than 1 year after
p.(None): receipt of the data described in paragraph (1)(B), the Secretary
p.(None): shall submit to Congress a report that includes--
p.(None): ``(A) an analysis of the effect of the demonstration
p.(None): program under this section on the quality, quantity, and
p.(None): distribution of mental and substance use disorders
p.(None): services;
p.(None): ``(B) an analysis of the effect of the demonstration
p.(None): program on the prevalence of untreated mental and
...
p.(None): ``(1) apply evidence-based and cost-effective methods;'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``treatment''; and
p.(None): (ii) by inserting ``substance abuse,'' after
p.(None): ``child welfare,'';
p.(None): (C) in paragraph (3), by striking ``substance abuse
p.(None): disorders'' and inserting ``substance use disorders,
p.(None): including children and adolescents with co-occurring
p.(None): mental illness and substance use disorders,'';
p.(None): (D) in paragraph (5), by striking ``treatment;'' and
p.(None): inserting ``services; and'';
p.(None): (E) in paragraph (6), by striking ``substance abuse
p.(None): treatment; and'' and inserting ``treatment.''; and
p.(None): (F) by striking paragraph (7); and
p.(None): (4) in subsection (f), by striking ``$40,000,000'' and all
p.(None): that follows through the period and inserting ``$29,605,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
p.(None):
p.(None): The first section 582 of the Public Health Service Act (42 U.S.C.
p.(None): 290hh-1; relating to grants to address the problems of persons who
p.(None): experience violence related stress) is amended--
p.(None): (1) in subsection (a), by striking ``developing programs''
p.(None): and all that follows through the period at the end and inserting
p.(None): the following: ``developing and maintaining programs that
p.(None): provide for--
p.(None): ``(1) the continued operation of the National Child
p.(None): Traumatic Stress Initiative (referred to in this section as the
p.(None): `NCTSI'), which includes a cooperative agreement with a
p.(None): coordinating center, that focuses on the mental, behavioral, and
p.(None): biological aspects of psychological trauma response, prevention
p.(None): of the long-term consequences of child trauma, and early
p.(None): intervention services and treatment to address the long-term
p.(None): consequences of child trauma; and
p.(None): ``(2) the development of knowledge with regard to evidence-
p.(None): based practices for identifying and treating mental, behavioral,
p.(None): and biological disorders of children and youth resulting from
p.(None): witnessing or experiencing a traumatic event.'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking ``subsection (a) related'' and
p.(None): inserting ``subsection (a)(2) (related'';
p.(None): (B) by striking ``treating disorders associated with
p.(None): psychological trauma'' and inserting ``treating mental,
p.(None): behavioral, and biological disorders associated with
p.(None): psychological trauma)''; and
p.(None): (C) by striking ``mental health agencies and
p.(None): programs that have established clinical and basic
p.(None): research'' and inserting ``universities, hospitals,
p.(None): mental health agencies,
p.(None):
p.(None): [[Page 130 STAT. 1266]]
p.(None):
p.(None): and other programs that have established clinical
p.(None): expertise and research'';
p.(None): (3) by redesignating subsections (c) through (g) as
p.(None): subsections (g) through (k), respectively;
p.(None): (4) by inserting after subsection (b), the following:
p.(None):
p.(None): ``(c) Child Outcome Data.--The NCTSI coordinating center described
p.(None): in subsection (a)(1) shall collect, analyze, report, and make publicly
p.(None): available, as appropriate, NCTSI-wide child treatment process and
p.(None): outcome data regarding the early identification and delivery of
p.(None): evidence-based treatment and services for children and families served
p.(None): by the NCTSI grantees.
p.(None): ``(d) Training.--The NCTSI coordinating center shall facilitate the
p.(None): coordination of training initiatives in evidence-based and trauma-
p.(None): informed treatments, interventions, and practices offered to NCTSI
p.(None): grantees, providers, and partners.
p.(None): ``(e) Dissemination and Collaboration.--The NCTSI coordinating
p.(None): center shall, as appropriate, collaborate with--
p.(None): ``(1) the Secretary, in the dissemination of evidence-based
p.(None): and trauma-informed interventions, treatments, products, and
p.(None): other resources to appropriate stakeholders; and
p.(None): ``(2) appropriate agencies that conduct or fund research
p.(None): within the Department of Health and Human Services, for purposes
p.(None): of sharing NCTSI expertise, evaluation data, and other
p.(None): activities, as appropriate.
p.(None):
p.(None): ``(f) Review.--The Secretary shall, consistent with the peer-review
p.(None): process, ensure that NCTSI applications are reviewed by appropriate
p.(None): experts in the field as part of a consensus-review process. The
p.(None): Secretary shall include review criteria related to expertise and
p.(None): experience in child trauma and evidence-based practices.'';
p.(None): (5) in subsection (g) (as so redesignated), by striking
p.(None): ``with respect to centers of excellence are distributed
p.(None): equitably among the regions of the country'' and inserting ``are
p.(None): distributed equitably among the regions of the United States'';
p.(None): (6) in subsection (i) (as so redesignated), by striking
p.(None): ``recipient may not exceed 5 years'' and inserting ``recipient
p.(None): shall not be less than 4 years, but shall not exceed 5 years'';
p.(None): and
p.(None): (7) in subsection (j) (as so redesignated), by striking
p.(None): ``$50,000,000'' and all that follows through ``2006'' and
p.(None): inserting ``$46,887,000 for each of fiscal years 2018 through
p.(None): 2022''.
p.(None): SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.(None): Part B of title III of the Public Health Service Act (42 U.S.C. 243
p.(None): et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13)
p.(None): the following:
p.(None): ``SEC. 317L-1. <> SCREENING AND TREATMENT
p.(None): FOR MATERNAL DEPRESSION.
p.(None):
p.(None): ``(a) Grants.--The Secretary shall make grants to States to
p.(None): establish, improve, or maintain programs for screening, assessment, and
p.(None): treatment services, including culturally and linguistically appropriate
p.(None): services, as appropriate, for women who are pregnant, or who have given
p.(None): birth within the preceding 12 months, for maternal depression.
p.(None): ``(b) Application.--To seek a grant under this section, a State
p.(None): shall submit an application to the Secretary at such time, in such
p.(None): manner, and containing such information as the Secretary may
p.(None):
...
p.(None): education providers, and others who work with young children and
p.(None): families.
p.(None): ``(3) Provide mental health consultation to personnel of
p.(None): early care and education programs (including licensed or
p.(None): regulated center-based and home-based child care, home visiting,
p.(None): preschool special education, and early intervention programs)
p.(None): who work with children and families.
p.(None): ``(4) Provide training for mental health clinicians in
p.(None): infant and early childhood in promising and evidence-based
p.(None): practices and models for infant and early childhood mental
p.(None): health treatment and early intervention, including with regard
p.(None): to practices
p.(None):
p.(None): [[Page 130 STAT. 1269]]
p.(None):
p.(None): for identifying and treating mental illness and behavioral
p.(None): disorders of infants and children resulting from exposure or
p.(None): repeated exposure to adverse childhood experiences or childhood
p.(None): trauma.
p.(None): ``(5) Provide age-appropriate assessment, diagnostic, and
p.(None): intervention services for eligible children, including early
p.(None): mental health promotion, intervention, and treatment services.
p.(None):
p.(None): ``(e) Matching Funds.--The Secretary may not award a grant under
p.(None): this section to an eligible entity unless the eligible entity agrees,
p.(None): with respect to the costs to be incurred by the eligible entity in
p.(None): carrying out the activities described in subsection (d), to make
p.(None): available non-Federal contributions (in cash or in kind) toward such
p.(None): costs in an amount that is not less than 10 percent of the total amount
p.(None): of Federal funds provided in the grant.
p.(None): ``(f) Authorization of Appropriations.--To carry out this section,
p.(None): there are authorized to be appropriated $20,000,000 for the period of
p.(None): fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
p.(None):
p.(None): SEC. 11001. SENSE OF CONGRESS.
p.(None):
p.(None): (a) Findings.--Congress finds the following:
p.(None): (1) According to the National Survey on Drug Use and Health,
p.(None): in 2015, there were approximately 9,800,000 adults in the United
p.(None): States with serious mental illness.
p.(None): (2) The Substance Abuse and Mental Health Services
p.(None): Administration defines the term ``serious mental illness'' as an
...
p.(None): further amended by adding at the end the following new subparagraph:
p.(None): ``(E) Changes in risk adjustment.--
p.(None): ``(i) Consideration of recommendations in
p.(None): impact reports.--The Secretary may take into
p.(None): account the studies conducted and the
p.(None): recommendations made by the Secretary under
p.(None): section 2(d)(1) of the IMPACT Act of 2014 (Public
p.(None): Law 113-185; 42 U.S.C. 1395lll note) with respect
p.(None): to the application under this subsection of risk
p.(None): adjustment methodologies. Nothing in this clause
p.(None): shall be construed as precluding consideration of
p.(None): the use of groupings of hospitals.
p.(None): ``(ii) Consideration of exclusion of patient
p.(None): cases based on v or other appropriate codes.--In
p.(None): promulgating regulations to carry out this
p.(None): subsection with respect to discharges occurring
p.(None): after fiscal year 2018, the Secretary may consider
p.(None): the use of V or other ICD-related codes for
p.(None): removal of a readmission. The Secretary may
p.(None): consider modifying measures under this subsection
p.(None): to incorporate V or other ICD-related codes at the
p.(None): same time as other changes are being made under
p.(None): this subparagraph.
p.(None): ``(iii) Removal of certain readmissions.--In
p.(None): promulgating regulations to carry out this
p.(None): subsection, with respect to discharges occurring
p.(None): after fiscal year 2018, the Secretary may consider
p.(None): removal as a readmission of an admission that is
p.(None): classified within one or more of the following:
p.(None): transplants, end-stage renal disease, burns,
p.(None): trauma, psychosis, or substance abuse. The
p.(None): Secretary may consider modifying measures under
p.(None): this subsection to remove readmissions at the same
p.(None): time as other changes are being made under this
p.(None): subparagraph.''.
p.(None):
p.(None): (c) MedPAC Study on Readmissions Program.--The Medicare Payment
p.(None): Advisory Commission shall conduct a study to review overall hospital
p.(None): readmissions described in section 1886(q)(5)(E) of the Social Security
p.(None): Act (42 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions are
p.(None): related to any changes in outpatient and emergency services furnished.
p.(None): The Commission shall submit to Congress a report on such study in its
p.(None): report to Congress in June 2018.
p.(None): SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL
p.(None): DEMONSTRATION PROGRAM.
p.(None):
p.(None): (a) Extension.--Section 410A of the Medicare Prescription Drug,
p.(None): Improvement, and Modernization Act of 2003 (Public Law 108-173; 42
p.(None): U.S.C. 1395ww note) is amended--
p.(None):
p.(None): [[Page 130 STAT. 1318]]
p.(None):
p.(None): (1) in subsection (a)(5), by striking ``5-year extension
p.(None): period'' and inserting ``10-year extension period''; and
p.(None): (2) in subsection (g)--
p.(None): (A) in the subsection heading, by striking ``Five-
p.(None): Year'' and inserting ``Ten-Year'';
p.(None): (B) in paragraph (1), by striking ``additional 5-
p.(None): year'' and inserting ``additional 10-year'';
p.(None): (C) by striking ``5-year extension period'' and
p.(None): inserting ``10-year extension period'' each place it
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p.(None):
p.(None):
p.(None): Text: H.R.34 — 114th Congress (2015-2016)
p.(None): All Information (Except Text)
p.(None):
p.(None): Listen to this page
p.(None):
p.(None):
p.(None): There are 8 versions: Public Law (12/13/2016)
p.(None):
p.(None): Text available
p.(None): as:
p.(None): TXT
p.(None): PDF
p.(None):
p.(None):
p.(None): Shown Here:
p.(None): Public Law No: 114-255 (12/13/2016)
p.(None):
p.(None):
p.(None): [114th Congress Public Law 255]
p.(None): [From the U.S. Government Publishing Office]
p.(None):
p.(None):
p.(None):
p.(None): [[Page 130 STAT. 1033]]
p.(None):
p.(None): Public Law 114-255
p.(None): 114th Congress
p.(None):
p.(None): An Act
p.(None):
p.(None):
p.(None):
p.(None): To accelerate the discovery, development, and delivery of 21st century
p.(None): cures, and for other purposes. <>
p.(None):
p.(None): Be it enacted by the Senate and House of Representatives of the
p.(None): United States of America in Congress assembled, <p.(None): Cures Act. 42 USC 201 note.>>
p.(None): SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
p.(None):
p.(None): (a) Short Title.--This Act may be cited as the ``21st Century Cures
p.(None): Act''.
p.(None): (b) Table of Contents.--The table of contents for this Act is as
p.(None): follows:
p.(None):
p.(None): Sec. 1. Short title; table of contents.
p.(None):
p.(None): DIVISION A--21ST CENTURY CURES
p.(None):
p.(None): Sec. 1000. Short title.
p.(None):
p.(None): TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
p.(None): Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.
p.(None): Sec. 1002. FDA innovation projects.
p.(None): Sec. 1003. Account for the state response to the opioid abuse crisis.
p.(None): Sec. 1004. Budgetary treatment.
p.(None):
p.(None): TITLE II--DISCOVERY
p.(None):
p.(None): Subtitle A--National Institutes of Health Reauthorization
p.(None):
p.(None): Sec. 2001. National Institutes of Health Reauthorization.
p.(None): Sec. 2002. EUREKA prize competitions.
p.(None):
p.(None): Subtitle B--Advancing Precision Medicine
p.(None):
p.(None): Sec. 2011. Precision Medicine Initiative.
p.(None): Sec. 2012. Privacy protection for human research subjects.
p.(None): Sec. 2013. Protection of identifiable and sensitive information.
p.(None): Sec. 2014. Data sharing.
p.(None):
p.(None): Subtitle C--Supporting Young Emerging Scientists
p.(None):
p.(None): Sec. 2021. Investing in the next generation of researchers.
p.(None): Sec. 2022. Improvement of loan repayment program.
p.(None):
p.(None): Subtitle D--National Institutes of Health Planning and Administration
p.(None):
p.(None): Sec. 2031. National Institutes of Health strategic plan.
p.(None): Sec. 2032. Triennial reports.
p.(None): Sec. 2033. Increasing accountability at the National Institutes of
p.(None): Health.
p.(None): Sec. 2034. Reducing administrative burden for researchers.
p.(None): Sec. 2035. Exemption for the National Institutes of Health from the
p.(None): Paperwork Reduction Act requirements.
p.(None): Sec. 2036. High-risk, high-reward research.
p.(None): Sec. 2037. National Center for Advancing Translational Sciences.
p.(None): Sec. 2038. Collaboration and coordination to enhance research.
p.(None): Sec. 2039. Enhancing the rigor and reproducibility of scientific
p.(None): research.
p.(None): Sec. 2040. Improving medical rehabilitation research at the National
...
p.(None): Sec. 4010. Medicare pharmaceutical and technology ombudsman.
p.(None): Sec. 4011. Medicare site-of-service price transparency.
p.(None): Sec. 4012. Telehealth services in Medicare.
p.(None):
p.(None): TITLE V--SAVINGS
p.(None):
p.(None): Sec. 5001. Savings in the Medicare Improvement Fund.
p.(None): Sec. 5002. Medicaid reimbursement to States for durable medical
p.(None): equipment.
p.(None): Sec. 5003. Penalties for violations of grants, contracts, and other
p.(None): agreements.
p.(None): Sec. 5004. Reducing overpayments of infusion drugs.
p.(None): Sec. 5005. Increasing oversight of termination of Medicaid providers.
p.(None): Sec. 5006. Requiring publication of fee-for-service provider directory.
p.(None): Sec. 5007. Fairness in Medicaid supplemental needs trusts.
p.(None): Sec. 5008. Eliminating Federal financial participation with respect to
p.(None): expenditures under Medicaid for agents used for cosmetic
p.(None): purposes or hair growth.
p.(None): Sec. 5009. Amendment to the Prevention and Public Health Fund.
p.(None): Sec. 5010. Strategic Petroleum Reserve drawdown.
p.(None): Sec. 5011. Rescission of portion of ACA territory funding.
p.(None): Sec. 5012. Medicare coverage of home infusion therapy.
p.(None):
p.(None): DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
p.(None):
p.(None): Sec. 6000. Short title.
p.(None):
p.(None): [[Page 130 STAT. 1036]]
p.(None):
p.(None): TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
p.(None):
p.(None): Subtitle A--Leadership
p.(None):
p.(None): Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
p.(None): Sec. 6002. Strengthening the leadership of the Substance Abuse and
p.(None): Mental Health Services Administration.
p.(None): Sec. 6003. Chief Medical Officer.
p.(None): Sec. 6004. Improving the quality of behavioral health programs.
p.(None): Sec. 6005. Strategic plan.
p.(None): Sec. 6006. Biennial report concerning activities and progress.
p.(None): Sec. 6007. Authorities of centers for mental health services, substance
p.(None): abuse prevention, and substance abuse treatment.
p.(None): Sec. 6008. Advisory councils.
p.(None): Sec. 6009. Peer review.
p.(None):
p.(None): Subtitle B--Oversight and Accountability
p.(None):
p.(None): Sec. 6021. Improving oversight of mental and substance use disorders
p.(None): programs through the Assistant Secretary for Planning and
p.(None): Evaluation.
p.(None): Sec. 6022. Reporting for protection and advocacy organizations.
p.(None): Sec. 6023. GAO study.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee.
p.(None):
p.(None): TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
p.(None): TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
p.(None):
p.(None): Sec. 7001. Encouraging innovation and evidence-based programs.
p.(None): Sec. 7002. Promoting access to information on evidence-based programs
p.(None): and practices.
p.(None): Sec. 7003. Priority mental health needs of regional and national
p.(None): significance.
p.(None): Sec. 7004. Priority substance use disorder treatment needs of regional
p.(None): and national significance.
p.(None): Sec. 7005. Priority substance use disorder prevention needs of regional
p.(None): and national significance.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): Sec. 8001. Community mental health services block grant.
p.(None): Sec. 8002. Substance abuse prevention and treatment block grant.
p.(None): Sec. 8003. Additional provisions related to the block grants.
p.(None): Sec. 8004. Study of distribution of funds under the substance abuse
p.(None): prevention and treatment block grant and the community mental
p.(None): health services block grant.
p.(None):
p.(None): TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
p.(None): CARE
p.(None):
p.(None): Subtitle A--Helping Individuals and Families
p.(None):
p.(None): Sec. 9001. Grants for treatment and recovery for homeless individuals.
p.(None): Sec. 9002. Grants for jail diversion programs.
p.(None): Sec. 9003. Promoting integration of primary and behavioral health care.
p.(None): Sec. 9004. Projects for assistance in transition from homelessness.
p.(None): Sec. 9005. National Suicide Prevention Lifeline Program.
p.(None): Sec. 9006. Connecting individuals and families with care.
p.(None): Sec. 9007. Strengthening community crisis response systems.
p.(None): Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
p.(None): Sec. 9009. Adult suicide prevention.
p.(None): Sec. 9010. Mental health awareness training grants.
p.(None): Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
p.(None): Native youth within suicide prevention programs.
p.(None): Sec. 9012. Evidence-based practices for older adults.
p.(None): Sec. 9013. National violent death reporting system.
p.(None): Sec. 9014. Assisted outpatient treatment.
p.(None): Sec. 9015. Assertive community treatment grant program.
p.(None): Sec. 9016. Sober truth on preventing underage drinking reauthorization.
p.(None): Sec. 9017. Center and program repeals.
p.(None):
p.(None): Subtitle B--Strengthening the Health Care Workforce
p.(None):
...
p.(None):
p.(None): TITLE XIII--MENTAL HEALTH PARITY
p.(None):
p.(None): Sec. 13001. Enhanced compliance with mental health and substance use
p.(None): disorder coverage requirements.
p.(None): Sec. 13002. Action plan for enhanced enforcement of mental health and
p.(None): substance use disorder coverage.
p.(None): Sec. 13003. Report on investigations regarding parity in mental health
p.(None): and substance use disorder benefits.
p.(None): Sec. 13004. GAO study on parity in mental health and substance use
p.(None): disorder benefits.
p.(None): Sec. 13005. Information and awareness on eating disorders.
p.(None): Sec. 13006. Education and training on eating disorders.
p.(None): Sec. 13007. Clarification of existing parity rules.
p.(None):
p.(None): TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
p.(None):
p.(None): Subtitle A--Mental Health and Safe Communities
p.(None):
p.(None): Sec. 14001. Law enforcement grants for crisis intervention teams, mental
p.(None): health purposes.
p.(None): Sec. 14002. Assisted outpatient treatment programs.
p.(None): Sec. 14003. Federal drug and mental health courts.
p.(None): Sec. 14004. Mental health in the judicial system.
p.(None): Sec. 14005. Forensic assertive community treatment initiatives.
p.(None): Sec. 14006. Assistance for individuals transitioning out of systems.
p.(None): Sec. 14007. Co-occurring substance abuse and mental health challenges in
p.(None): drug courts.
p.(None): Sec. 14008. Mental health training for Federal uniformed services.
p.(None): Sec. 14009. Advancing mental health as part of offender reentry.
p.(None): Sec. 14010. School mental health crisis intervention teams.
p.(None): Sec. 14011. Active-shooter training for law enforcement.
p.(None):
p.(None): [[Page 130 STAT. 1038]]
p.(None):
p.(None): Sec. 14012. Co-occurring substance abuse and mental health challenges in
p.(None): residential substance abuse treatment programs.
p.(None): Sec. 14013. Mental health and drug treatment alternatives to
p.(None): incarceration programs.
p.(None): Sec. 14014. National criminal justice and mental health training and
p.(None): technical assistance.
p.(None): Sec. 14015. Improving Department of Justice data collection on mental
p.(None): illness involved in crime.
p.(None): Sec. 14016. Reports on the number of mentally ill offenders in prison.
p.(None): Sec. 14017. Codification of due process for determinations by secretary
p.(None): of veterans affairs of mental capacity of beneficiaries.
p.(None): Sec. 14018. Reauthorization of appropriations.
p.(None):
p.(None): Subtitle B--Comprehensive Justice and Mental Health
p.(None):
p.(None): Sec. 14021. Sequential intercept model.
p.(None): Sec. 14022. Prison and jails.
p.(None): Sec. 14023. Allowable uses.
p.(None): Sec. 14024. Law enforcement training.
p.(None): Sec. 14025. Federal law enforcement training.
p.(None): Sec. 14026. GAO report.
p.(None): Sec. 14027. Evidence based practices.
p.(None): Sec. 14028. Transparency, program accountability, and enhancement of
p.(None): local authority.
p.(None): Sec. 14029. Grant accountability.
p.(None):
...
p.(None): Sec. 16006. Allowing physical therapists to utilize locum tenens
p.(None): arrangements under Medicare.
p.(None): Sec. 16007. Extension of the transition to new payment rates for durable
p.(None): medical equipment under the Medicare program.
p.(None): Sec. 16008. Requirements in determining adjustments using information
p.(None): from competitive bidding programs.
p.(None):
p.(None): TITLE XVII--OTHER MEDICARE PROVISIONS
p.(None):
p.(None): Sec. 17001. Delay in authority to terminate contracts for Medicare
p.(None): Advantage plans failing to achieve minimum quality ratings.
p.(None):
p.(None): [[Page 130 STAT. 1039]]
p.(None):
p.(None): Sec. 17002. Requirement for enrollment data reporting for Medicare.
p.(None): Sec. 17003. Updating the Welcome to Medicare package.
p.(None): Sec. 17004. No payment for items and services furnished by newly
p.(None): enrolled providers or suppliers within a temporary moratorium
p.(None): area.
p.(None): Sec. 17005. Preservation of Medicare beneficiary choice under Medicare
p.(None): Advantage.
p.(None): Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a
p.(None): Medicare Advantage plan.
p.(None): Sec. 17007. Improvements to the assignment of beneficiaries under the
p.(None): Medicare Shared Savings Program.
p.(None):
p.(None): TITLE XVIII--OTHER PROVISIONS
p.(None):
p.(None): Sec. 18001. Exception from group health plan requirements for qualified
p.(None): small employer health reimbursement arrangements.
p.(None):
p.(None): DIVISION <> A--21ST CENTURY CURES
p.(None): SEC. 1000. <> SHORT TITLE.
p.(None):
p.(None): This Division may be cited as the ``21st Century Cures Act''.
p.(None):
p.(None): TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
p.(None):
p.(None): SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION PROJECTS.
p.(None):
p.(None): (a) In General.--The Director of the National Institutes of Health
p.(None): (referred to in this section as the ``Director of NIH'') shall use any
p.(None): funds appropriated pursuant to the authorization of appropriations in
p.(None): subsection (b)(3) to carry out the National Institutes of Health
p.(None): innovation projects described in subsection (b)(4) (referred to in this
p.(None): section as the ``NIH Innovation Projects'').
p.(None): (b) National Institutes of Health Innovation Account.--
p.(None): (1) Establishment of nih innovation account.--There is
p.(None): established in the Treasury an account, to be known as the ``NIH
p.(None): Innovation Account'' (referred to in this subsection as the
p.(None): ``Account''), for purposes of carrying out the NIH Innovation
p.(None): Projects described in paragraph (4).
p.(None): (2) Transfer of direct spending savings.--
p.(None): (A) In general.--The following amounts shall be
p.(None): transferred to the Account from the general fund of the
p.(None): Treasury:
p.(None): (i) For fiscal year 2017, $352,000,000.
p.(None): (ii) For fiscal year 2018, $496,000,000.
p.(None): (iii) For fiscal year 2019, $711,000,000.
p.(None): (iv) For fiscal year 2020, $492,000,000.
p.(None): (v) For fiscal year 2021, $404,000,000.
p.(None): (vi) For fiscal year 2022, $496,000,000.
p.(None): (vii) For fiscal year 2023, $1,085,000,000.
p.(None): (viii) For fiscal year 2024, $407,000,000.
p.(None): (ix) For fiscal year 2025, $127,000,000.
p.(None): (x) For fiscal year 2026, $226,000,000.
p.(None): (B) Amounts deposited.--Any amounts transferred
p.(None): under subparagraph (A) shall remain unavailable in the
p.(None): Account until such amounts are appropriated pursuant to
p.(None): paragraph (3).
p.(None): (3) Appropriations.--
...
p.(None): of the Senate and the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of
p.(None): Representatives, a report including--
p.(None): (i) the amount of money obligated or expended
p.(None): in the prior fiscal year for each activity
p.(None): described in subsection (b)(4);
p.(None): (ii) a description of all such activities
p.(None): using funds provided pursuant to the authorization
p.(None): of appropriations under subsection (b)(3); and
p.(None): (iii) how the activities are advancing public
p.(None): health.
p.(None): (B) Additional reports.--At the request of the
p.(None): Committee on Health, Education, Labor, and Pensions or
p.(None): the Committee on Appropriations of the Senate, or the
p.(None): Committee on Energy and Commerce or the Committee on
p.(None): Appropriations of the House of Representatives, the
p.(None): Commissioner shall provide an update in the form of
p.(None): testimony and any additional reports to the respective
p.(None): congressional committee regarding the allocation of
p.(None): funding under this section or the description of the
p.(None): activities undertaken with such funding.
p.(None):
p.(None): (d) Limitations.--Notwithstanding any transfer authority authorized
p.(None): by this Act or any appropriations Act, any funds made available pursuant
p.(None): to the authorization of appropriations in subsection (b)(3) shall not be
p.(None): used for any purpose other than an activity described in subsection
p.(None): (b)(4).
p.(None): (e) Sunset.--This section shall expire on September 30, 2025.
p.(None): SEC. 1003. <> ACCOUNT FOR THE STATE
p.(None): RESPONSE TO THE OPIOID ABUSE CRISIS.
p.(None):
p.(None): (a) In General.--The Secretary of Health and Human Services
p.(None): (referred to in this section as the ``Secretary'') shall use any funds
p.(None): appropriated pursuant to the authorization of appropriations under
p.(None): subsection (b) to carry out the grant program described in subsection
p.(None): (c) for purposes of addressing the opioid abuse crisis within the
p.(None): States.
p.(None):
p.(None): [[Page 130 STAT. 1045]]
p.(None):
p.(None): (b) Account for the State Response to the Opioid Abuse Crisis.--
p.(None): (1) Establishment.--There is established in the Treasury an
p.(None): account, to be known as the ``Account For the State Response to
p.(None): the Opioid Abuse Crisis'' (referred to in this subsection as the
p.(None): ``Account''), to carry out the opioid grant program described in
p.(None): subsection (c).
p.(None): (2) Transfer of direct spending savings.--
p.(None): (A) In general.--The following amounts shall be
p.(None): transferred to the Account from the general fund of the
p.(None): Treasury:
p.(None): (i) For fiscal year 2017, $500,000,000.
p.(None): (ii) For fiscal year 2018, $500,000,000.
p.(None): (B) Amounts deposited.--Any amounts transferred
p.(None): under subparagraph (A) shall remain unavailable in the
p.(None): Account until such amounts are appropriated pursuant to
p.(None): paragraph (3).
p.(None): (3) Appropriations.--
p.(None): (A) Authorization of appropriations.--In each of the
p.(None): fiscal years 2017 and 2018, there is authorized to be
p.(None): appropriated from the Account to the Secretary, for the
p.(None): grant program described in subsection (c), an amount not
p.(None): to exceed the total amount transferred to the Account
p.(None): under paragraph (2)(A), to remain available until
p.(None): expended.
p.(None): (B) Offsetting future appropriations.--In each of
p.(None): fiscal years 2017 and 2018, for any discretionary
p.(None): appropriation under the heading ``Account For the State
p.(None): Response to the Opioid Abuse Crisis'' for the grant
p.(None): program described in subsection (c), the total amount of
p.(None): such appropriations in the applicable fiscal year (not
p.(None): to exceed the total amount remaining in the Account)
p.(None): shall be subtracted from the estimate of discretionary
p.(None): budget authority and the resulting outlays for any
p.(None): estimate under the Congressional Budget and Impoundment
p.(None): Control Act of 1974 or the Balanced Budget and Emergency
p.(None): Deficit Control Act of 1985, and the amount transferred
p.(None): to the Account shall be reduced by the same amount.
p.(None):
p.(None): (c) Opioid Grant Program.--
p.(None): (1) State response to the opioid abuse crisis.--Subject to
p.(None): the availability of appropriations, the Secretary shall award
p.(None): grants to States for the purpose of addressing the opioid abuse
p.(None): crisis within such States, in accordance with subparagraph (B).
p.(None): In awarding such grants, the Secretary shall give preference to
p.(None): States with an incidence or prevalence of opioid use disorders
p.(None): that is substantially higher relative to other States.
p.(None): (2) Opioid grants.--Grants awarded to a State under this
p.(None): subsection shall be used for carrying out activities that
p.(None): supplement activities pertaining to opioids undertaken by the
p.(None): State agency responsible for administering the substance abuse
p.(None): prevention and treatment block grant under subpart II of part B
p.(None): of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
p.(None): et seq.), which may include public health-related activities
p.(None): such as the following:
p.(None): (A) Improving State prescription drug monitoring
p.(None): programs.
p.(None):
p.(None): [[Page 130 STAT. 1046]]
p.(None): (B) Implementing prevention activities, and
p.(None): evaluating such activities to identify effective
p.(None): strategies to prevent opioid abuse.
p.(None): (C) Training for health care practitioners, such as
p.(None): best practices for prescribing opioids, pain management,
p.(None): recognizing potential cases of substance abuse, referral
p.(None): of patients to treatment programs, and overdose
p.(None): prevention.
p.(None): (D) Supporting access to health care services,
p.(None): including those services provided by Federally certified
p.(None): opioid treatment programs or other appropriate health
p.(None): care providers to treat substance use disorders.
p.(None): (E) Other public health-related activities, as the
p.(None): State determines appropriate, related to addressing the
p.(None): opioid abuse crisis within the State.
p.(None):
p.(None): (d) Accountability and Oversight.--A State receiving a grant under
p.(None): subsection (c) shall include in a report related to substance abuse
p.(None): submitted to the Secretary pursuant to section 1942 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-52), a description of--
p.(None): (1) the purposes for which the grant funds received by the
p.(None): State under such subsection for the preceding fiscal year were
p.(None): expended and a description of the activities of the State under
p.(None): the program; and
p.(None): (2) the ultimate recipients of amounts provided to the State
p.(None): in the grant.
p.(None):
p.(None): (e) Limitations.--Any funds made available pursuant to the
p.(None): authorization of appropriations under subsection (b)--
p.(None): (1) notwithstanding any transfer authority in any
p.(None): appropriations Act, shall not be used for any purpose other than
p.(None): the grant program in subsection (c); and
p.(None): (2) shall be subject to the same requirements as substance
p.(None): abuse prevention and treatment programs under titles V and XIX
p.(None): of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w
p.(None): et seq.).
p.(None):
p.(None): (f) Sunset.--This section shall expire on September 30, 2026.
p.(None): SEC. 1004. BUDGETARY TREATMENT.
p.(None):
p.(None): (a) Statutory Paygo Scorecards.--The budgetary effects of division A
p.(None): of this Act shall not be entered on either PAYGO scorecard maintained
p.(None): pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
p.(None): (b) Senate Paygo Scorecards.--The budgetary effects of division A of
p.(None): this Act shall not be entered on any PAYGO scorecard maintained for
p.(None): purposes of section 201 of S. Con. Res. 21 (110th Congress).
p.(None): (c) Reservation of Savings.--None of the funds in the NIH Innovation
p.(None): Account, the FDA Innovation Account, or the Account For the State
p.(None): Response to the Opioid Abuse Crisis established by this title shall be
p.(None): made available except to the extent provided in advance in
p.(None): appropriations Acts, and legislation or an Act that rescinds or reduces
p.(None): amounts in such accounts shall not be estimated as a reduction in direct
p.(None): spending under the Congressional Budget and Impoundment Control Act of
p.(None): 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985.
p.(None):
p.(None): [[Page 130 STAT. 1047]]
p.(None):
p.(None): TITLE II--DISCOVERY
p.(None):
p.(None): Subtitle A--National Institutes of Health Reauthorization
p.(None):
p.(None): SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
p.(None):
p.(None): Section 402A(a)(1) of the Public Health Service Act (42 U.S.C.
p.(None): 282a(a)(1)) is amended--
p.(None): (1) in subparagraph (B), by striking ``and'' at the end;
p.(None): (2) in subparagraph (C), by striking the period at the end
p.(None): and inserting a semicolon; and
p.(None): (3) by adding at the end the following new subparagraphs:
p.(None): ``(D) $34,851,000,000 for fiscal year 2018;
p.(None): ``(E) $35,585,871,000 for fiscal year 2019; and
p.(None): ``(F) $36,472,442,775 for fiscal year 2020.''.
p.(None): SEC. 2002. <> EUREKA PRIZE COMPETITIONS.
p.(None):
p.(None): (a) In General.--Pursuant to the authorities and processes
p.(None): established under section 24 of the Stevenson-Wydler Technology
p.(None): Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National
p.(None): Institutes of Health shall support prize competitions for one or both of
p.(None): the following goals:
p.(None): (1) Identifying and funding areas of biomedical science that
p.(None): could realize significant advancements through a prize
p.(None): competition.
p.(None): (2) Improving health outcomes, particularly with respect to
...
p.(None): updating any regulations or guidance described in paragraph (1),
p.(None): the Secretary shall consider any appropriate criteria to be used
p.(None): by institutional review boards and individuals reviewing grant
p.(None): proposals for excluding pregnant women or lactating women as a
p.(None): study population requiring additional protections from
p.(None): participating in human subject research.
p.(None):
p.(None): [[Page 130 STAT. 1073]]
p.(None):
p.(None): SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH REPORTING
p.(None): REQUIREMENTS.
p.(None):
p.(None): (a) Trans-National Institutes of Health Research Reporting.--Section
p.(None): 402A(c)(2) of the Public Health Service Act (42 U.S.C. 282a(c)(2)) is
p.(None): amended--
p.(None): (1) by amending subparagraph (B) to read as follows:
p.(None): ``(B) Reporting.--Not later than 2 years after the
p.(None): date of enactment of 21st Century Cures Act, the head of
p.(None): each national research institute or national center
p.(None): shall submit to the Director of the National Institutes
p.(None): of Health a report, to be included in the triennial
p.(None): report under section 403, on the amount made available
p.(None): by the institute or center for conducting or supporting
p.(None): research that involves collaboration between the
p.(None): institute or center and 1 or more other national
p.(None): research institutes or national centers.''; and
p.(None): (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' each
p.(None): place it appears and inserting ``(B)''.
p.(None):
p.(None): (b) Fraud and Abuse Reporting.--Section 403B of the Public Health
p.(None): Service Act (42 U.S.C. 283a-1) is amended--
p.(None): (1) by striking subsection (b);
p.(None): (2) by redesignating subsection (c) as subsection (b); and
p.(None): (3) in subsection (b) (as so redesignated), by striking
p.(None): ``subsections (a) and (b)'' and inserting ``subsection (a)''.
p.(None):
p.(None): (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public
p.(None): Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking
p.(None): ``(not including any leaves of absence)''.
p.(None): (d) Vaccine Reporting.--Section 404B of the Public Health Service
p.(None): Act (42 U.S.C. 283d) is amended--
p.(None): (1) by striking subsection (b); and
p.(None): (2) by striking ``(a) Development of New Vaccines.--The
p.(None): Secretary'' and inserting ``The Secretary''.
p.(None):
p.(None): (e) National Center for Advancing Translational Sciences.--Section
p.(None): 479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
p.(None): (1) in the subsection heading, by striking ``Annual'' and
p.(None): inserting ``Biennial''; and
p.(None): (2) in the matter preceding paragraph (1), by striking ``an
p.(None): annual report'' and inserting ``a report on a biennial basis''.
p.(None):
p.(None): (f) Review of Centers of Excellence.--
p.(None): (1) Repeal.--Section 404H of the Public Health Service Act
p.(None): (42 U.S.C. 283j) is repealed.
p.(None): (2) Conforming amendment.--Section 399EE(c) of the Public
p.(None): Health Service Act (42 U.S.C. 280-4(c)) is amended by striking
p.(None): ``399CC, 404H,'' and inserting ``399CC''.
p.(None):
p.(None): (g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE
p.(None): Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
p.(None): (1) by striking paragraph (2); and
...
p.(None): the level of risk posed by the imported product.''.
p.(None): (ii) Conforming amendment.--Section 714 of the
p.(None): Food and Drug Administration Safety and Innovation
p.(None): Act (Public Law 112-144; 126 Stat. 1074) is
p.(None): amended by striking subsection (d).
p.(None): (X) Recognition of foreign government inspections.--
p.(None): Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by
p.(None): striking ``conduction'' and inserting ``conducting''.
p.(None):
p.(None): (b) FDASIA.--
p.(None): (1) Findings relating to drug approval.--Section
p.(None): 901(a)(1)(A) of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is
p.(None): amended by striking ``serious and life-threatening diseases''
p.(None): and inserting ``serious or life-threatening diseases''.
p.(None): (2) Reporting of inclusion of demographic subgroups.--
p.(None): Section 907 of the Food and Drug Administration Safety and
p.(None): Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is
p.(None): amended--
p.(None): (A) in the section heading, by striking
p.(None): ``biologics'' in the heading and inserting ``biological
p.(None): products''; and
p.(None): (B) in subsection (a)(2)(B), by striking
p.(None): ``applications for new drug applications'' and inserting
p.(None): ``new drug applications''.
p.(None): (3) Combating prescription drug abuse.--Section 1122 of the
p.(None): Food and Drug Administration Safety and Innovation Act (Public
p.(None): Law 112-144; 126 Stat. 1112, 1113) is amended--
p.(None): (A) in subsection (a)(2), by striking ``dependance''
p.(None): and inserting ``dependence''; and
p.(None): (B) in subsection (c), by striking ``promulgate''
p.(None): and inserting ``issue''.
p.(None): SEC. 3102. COMPLETED STUDIES.
p.(None):
p.(None): The Federal Food, Drug, and Cosmetic Act is amended--
p.(None): (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
p.(None): (A) in subparagraph (A), by inserting ``and'' after
p.(None): the semicolon;
p.(None): (B) by striking subparagraph (B); and
p.(None): (C) by redesignating subparagraph (C) as
p.(None): subparagraph (B);
p.(None): (2) in section 505A (21 U.S.C. 355a), by striking subsection
p.(None): (p);
p.(None): (3) in section 505B (21 U.S.C. 355c)--
p.(None): (A) by striking subsection (l); and
p.(None): (B) by redesignating subsection (m) as subsection
p.(None): (l); and
p.(None): (4) in section 523 (21 U.S.C. 360m), by striking subsection
p.(None): (d).
p.(None):
p.(None): [[Page 130 STAT. 1157]]
p.(None):
p.(None): TITLE IV--DELIVERY
p.(None):
p.(None): SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
p.(None):
p.(None): (a) In General.--The Health Information Technology for Economic and
p.(None): Clinical Health Act (title XIII of division A of Public Law 111-5) is
p.(None): amended--
p.(None): (1) by adding at the end of part 1 of subtitle A the
p.(None): following:
p.(None): ``SEC. 13103. <> ASSISTING DOCTORS
p.(None): AND HOSPITALS IN IMPROVING QUALITY OF
p.(None): CARE FOR PATIENTS.
...
p.(None): that such practice is likely to interfere with, prevent,
p.(None): or materially discourage the access, exchange, or use of
p.(None): electronic health information; or
p.(None): ``(ii) if conducted by a health care provider, such
p.(None): provider knows that such practice is unreasonable and is
p.(None):
p.(None): [[Page 130 STAT. 1177]]
p.(None):
p.(None): likely to interfere with, prevent, or materially
p.(None): discourage access, exchange, or use of electronic health
p.(None): information.
p.(None): ``(2) Practices described.--The information blocking
p.(None): practices described in paragraph (1) may include--
p.(None): ``(A) practices that restrict authorized access,
p.(None): exchange, or use under applicable State or Federal law
p.(None): of such information for treatment and other permitted
p.(None): purposes under such applicable law, including
p.(None): transitions between certified health information
p.(None): technologies;
p.(None): ``(B) implementing health information technology in
p.(None): nonstandard ways that are likely to substantially
p.(None): increase the complexity or burden of accessing,
p.(None): exchanging, or using electronic health information; and
p.(None): ``(C) implementing health information technology in
p.(None): ways that are likely to--
p.(None): ``(i) restrict the access, exchange, or use of
p.(None): electronic health information with respect to
p.(None): exporting complete information sets or in
p.(None): transitioning between health information
p.(None): technology systems; or
p.(None): ``(ii) lead to fraud, waste, or abuse, or
p.(None): impede innovations and advancements in health
p.(None): information access, exchange, and use, including
p.(None): care delivery enabled by health information
p.(None): technology.
p.(None): ``(3) Rulemaking.--The Secretary, through rulemaking, shall
p.(None): identify reasonable and necessary activities that do not
p.(None): constitute information blocking for purposes of paragraph (1).
p.(None): ``(4) No enforcement before exception identified.--The term
p.(None): `information blocking' does not include any practice or conduct
p.(None): occurring prior to the date that is 30 days after the date of
p.(None): enactment of the 21st Century Cures Act.
p.(None): ``(5) Consultation.--The Secretary may consult with the
p.(None): Federal Trade Commission in promulgating regulations under this
p.(None): subsection, to the extent that such regulations define practices
p.(None): that are necessary to promote competition and consumer welfare.
p.(None): ``(6) Application.--The term `information blocking', with
p.(None): respect to an individual or entity, shall not include an act or
p.(None): practice other than an act or practice committed by such
p.(None): individual or entity.
p.(None): ``(7) Clarification.--In carrying out this section, the
p.(None): Secretary shall ensure that health care providers are not
p.(None): penalized for the failure of developers of health information
p.(None): technology or other entities offering health information
p.(None): technology to such providers to ensure that such technology
p.(None): meets the requirements to be certified under this title.
p.(None):
p.(None): ``(b) Inspector General Authority.--
p.(None): ``(1) In general.--The inspector general of the Department
...
p.(None):
p.(None): SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE
p.(None): USE.
p.(None):
p.(None): (a) Assistant Secretary.--Section 501(c) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
p.(None): ``(c) Assistant Secretary and Deputy Assistant Secretary.--
p.(None):
p.(None): [[Page 130 STAT. 1203]]
p.(None):
p.(None): ``(1) Assistant secretary.--The Administration shall be
p.(None): headed by an official to be known as the Assistant Secretary for
p.(None): Mental Health and Substance Use (hereinafter in this title
p.(None): referred to as the `Assistant Secretary') who shall be appointed
p.(None): by the President, by and with the advice and consent of the
p.(None): Senate.
p.(None): ``(2) Deputy assistant secretary.--The Assistant Secretary,
p.(None): with the approval of the Secretary, may appoint a Deputy
p.(None): Assistant Secretary and may employ and prescribe the functions
p.(None): of such officers and employees, including attorneys, as are
p.(None): necessary to administer the activities to be carried out through
p.(None): the Administration.''.
p.(None):
p.(None): (b) <> Transfer of Authorities.--The
p.(None): Secretary of Health and Human Services shall delegate to the Assistant
p.(None): Secretary for Mental Health and Substance Use all duties and authorities
p.(None): that--
p.(None): (1) as of the day before the date of enactment of this Act,
p.(None): were vested in the Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration; and
p.(None): (2) are not terminated by this Act.
p.(None):
p.(None): (c) Conforming Amendments.--Title V of the Public Health Service Act
p.(None): (42 U.S.C. 290aa et seq.), as amended by the previous provisions of this
p.(None): section, is further amended--
p.(None): (1) by striking ``Administrator of the Substance Abuse and
p.(None): Mental Health Services Administration'' each place it appears
p.(None): and inserting ``Assistant Secretary for Mental Health and
p.(None): Substance Use''; and
p.(None): (2) by striking ``Administrator'' or ``Administrator'' each
p.(None): place it appears (including in any headings) and inserting
p.(None): ``Assistant Secretary'' or ``Assistant Secretary'',
p.(None): respectively, except where the term ``Administrator'' appears--
p.(None): (A) in each of subsections (e) and (f) of section
p.(None): 501 of such Act (42 U.S.C. 290aa), including the
p.(None): headings of such subsections, within the term
p.(None): ``Associate Administrator'';
p.(None): (B) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Health Resources and Services Administration'';
p.(None): (C) in section 507(b)(6) of such Act (42 U.S.C.
p.(None): 290bb(b)(6)), within the term ``Administrator of the
p.(None): Centers for Medicare & Medicaid Services'';
p.(None): (D) in section 519B(c)(1)(B) of such Act (42 U.S.C.
p.(None): 290bb-25b(c)(1)(B)), within the term ``Administrator of
p.(None): the National Highway Traffic Safety Administration''; or
p.(None): (E) in each of sections 519B(c)(1)(B), 520C(a), and
p.(None): 520D(a) of such Act (42 U.S.C. 290bb-25b(c)(1)(B),
p.(None): 290bb-34(a), 290bb-35(a)), within the term
p.(None): ``Administrator of the Office of Juvenile Justice and
p.(None): Delinquency Prevention''.
p.(None):
p.(None): (d) <> References.--After executing
p.(None): subsections (a), (b), and (c), any reference in statute, regulation, or
p.(None): guidance to the Administrator of the Substance Abuse and Mental Health
p.(None): Services Administration shall be construed to be a reference to the
p.(None): Assistant Secretary for Mental Health and Substance Use.
p.(None):
p.(None): [[Page 130 STAT. 1204]]
p.(None):
p.(None): SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND
p.(None): MENTAL HEALTH SERVICES ADMINISTRATION.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by section 6001, is further amended--
p.(None): (1) in subsection (b)--
p.(None): (A) in the subsection heading, by striking
p.(None): ``Agencies'' and inserting ``Centers''; and
p.(None): (B) in the matter preceding paragraph (1), by
p.(None): striking ``entities'' and inserting ``Centers'';
p.(None): (2) in subsection (d)--
p.(None): (A) in paragraph (1)--
p.(None): (i) by striking ``agencies'' each place the
p.(None): term appears and inserting ``Centers''; and
p.(None): (ii) by striking ``such agency'' and inserting
p.(None): ``such Center'';
p.(None): (B) in paragraph (2)--
p.(None): (i) by striking ``agencies'' and inserting
p.(None): ``Centers'';
p.(None): (ii) by striking ``with respect to substance
p.(None): abuse'' and inserting ``with respect to substance
p.(None): use disorders''; and
p.(None): (iii) by striking ``and individuals who are
p.(None): substance abusers'' and inserting ``and
p.(None): individuals with substance use disorders'';
p.(None): (C) in paragraph (5), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorder'';
p.(None): (D) in paragraph (6)--
p.(None): (i) by striking ``the Centers for Disease
p.(None): Control'' and inserting ``the Centers for Disease
p.(None): Control and Prevention,'';
p.(None): (ii) by striking ``Administration develop''
p.(None): and inserting ``Administration, develop'';
p.(None): (iii) by striking ``HIV or tuberculosis among
p.(None): substance abusers and individuals with mental
p.(None): illness'' and inserting ``HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases
p.(None): among individuals with mental or substance use
p.(None): disorders,''; and
p.(None): (iv) by striking ``illnesses'' at the end and
p.(None): inserting ``diseases or disorders'';
p.(None): (E) in paragraph (7), by striking ``abuse utilizing
p.(None): anti-addiction medications, including methadone'' and
p.(None): inserting ``use disorders, including services that
p.(None): utilize drugs or devices approved or cleared by the Food
p.(None): and Drug Administration for the treatment of substance
p.(None): use disorders'';
p.(None): (F) in paragraph (8)--
p.(None): (i) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None): (ii) by striking ``treatment and prevention''
p.(None): and inserting ``prevention and treatment'';
p.(None): (G) in paragraph (9)--
p.(None): (i) by inserting ``and maintenance'' after
p.(None): ``development'';
p.(None): (ii) by striking ``Agency for Health Care
p.(None): Policy Research'' and inserting ``Agency for
p.(None): Healthcare Research and Quality''; and
p.(None):
p.(None): [[Page 130 STAT. 1205]]
p.(None):
p.(None): (iii) by striking ``treatment and prevention
p.(None): services'' and inserting ``prevention, treatment,
p.(None): and recovery support services and are
p.(None): appropriately incorporated into programs carried
p.(None): out by the Administration'';
p.(None): (H) in paragraph (10), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (I) by striking paragraph (11) and inserting the
p.(None): following:
p.(None): ``(11) work with relevant agencies of the Department of
p.(None): Health and Human Services on integrating mental health promotion
p.(None): and substance use disorder prevention with general health
p.(None): promotion and disease prevention and integrating mental and
p.(None): substance use disorders treatment services with physical health
p.(None): treatment services;'';
p.(None): (J) in paragraph (13)--
p.(None): (i) in the matter preceding subparagraph (A),
p.(None): by striking ``this title, assure that'' and
p.(None): inserting ``this title or part B of title XIX, or
p.(None): grant programs otherwise funded by the
p.(None): Administration'';
p.(None): (ii) in subparagraph (A)--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) by striking ``and'' at the end;
p.(None): (iii) by redesignating subparagraph (B) as
p.(None): subparagraph (C);
p.(None): (iv) by inserting after subparagraph (A) the
p.(None): following:
p.(None): ``(B) ensure that the director of each Center of the
p.(None): Administration consistently documents the application of
p.(None): criteria when awarding grants and the ongoing oversight
p.(None): of grantees after such grants are awarded;'';
p.(None): (v) in subparagraph (C), as so redesignated--
p.(None): (I) by inserting ``require that''
p.(None): before ``all grants''; and
p.(None): (II) in clause (ii), by inserting
p.(None): ``and'' after the semicolon at the end;
p.(None): and
p.(None): (vi) by adding at the end the following:
p.(None): ``(D) inform a State when any funds are awarded
p.(None): through such a grant to any entity within such State;'';
p.(None): (K) in paragraph (16), by striking ``abuse and
p.(None): mental health information'' and inserting ``use disorder
p.(None): information, including evidence-based and promising best
p.(None): practices for prevention, treatment, and recovery
p.(None): support services for individuals with mental and
p.(None): substance use disorders,'';
p.(None): (L) in paragraph (17)--
p.(None): (i) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorder''; and
p.(None): (ii) by striking ``and'' at the end;
p.(None): (M) in paragraph (18), by striking the period and
p.(None): inserting a semicolon; and
p.(None): (N) by adding at the end the following:
p.(None): ``(19) consult with State, local, and tribal governments,
p.(None): nongovernmental entities, and individuals with mental illness,
p.(None): particularly adults with a serious mental illness, children with
p.(None): a serious emotional disturbance, and the family members of
p.(None):
p.(None): [[Page 130 STAT. 1206]]
p.(None):
p.(None): such adults and children, with respect to improving community-
p.(None): based and other mental health services;
p.(None): ``(20) collaborate with the Secretary of Defense and the
p.(None): Secretary of Veterans Affairs to improve the provision of mental
p.(None): and substance use disorder services provided by the Department
p.(None): of Defense and the Department of Veterans Affairs to members of
p.(None): the Armed Forces, veterans, and the family members of such
p.(None): members and veterans, including through the provision of
p.(None): services using the telehealth capabilities of the Department of
p.(None): Defense and the Department of Veterans Affairs;
p.(None): ``(21) collaborate with the heads of relevant Federal
p.(None): agencies and departments, States, communities, and
...
p.(None): that follows through ``year on--'' and inserting ``The
p.(None): Director shall--
p.(None): ``(1) coordinate the Administration's integrated data
p.(None): strategy, including by collecting data each year on--'';
p.(None): (C) in the subparagraph (B), as redesignated by
p.(None): subparagraph (A), by striking ``Assistant Secretary''
p.(None): and inserting ``Director''; and
p.(None): (D) by adding at the end the following new
p.(None): paragraphs:
p.(None): ``(2) provide statistical and analytical support for
p.(None): activities of the Administration;
p.(None): ``(3) recommend a core set of performance metrics to
p.(None): evaluate activities supported by the Administration; and
p.(None): ``(4) coordinate with the Assistant Secretary, the Assistant
p.(None): Secretary for Planning and Evaluation, and the Chief Medical
p.(None): Officer appointed under section 501(g), as appropriate, to
p.(None): improve the quality of services provided by programs of the
p.(None): Administration and the evaluation of activities carried out by
p.(None): the Administration.''.
p.(None): (5) in subsection (c), as so redesignated--
p.(None): (A) by striking ``With respect to the activities''
p.(None): and inserting ``Mental Health.--With respect to the
p.(None): activities'';
p.(None): (B) by striking ``Assistant Secretary'' each place
p.(None): it appears and inserting ``Director''; and
p.(None): (C) by striking ``subsection (a)'' and inserting
p.(None): ``subsection (b)(1)'';
p.(None): (6) in subsection (d), as so redesignated--
p.(None): (A) by striking the subsection designation and all
p.(None): that follows through ``With respect to the activities''
p.(None): and inserting the following:
p.(None):
p.(None): ``(d) Substance Abuse.--
p.(None): ``(1) In general.--With respect to the activities'';
p.(None): (B) in paragraph (1)--
p.(None): (i) in the matter before subparagraph (A)--
p.(None): (I) by striking ``subsection (a)''
p.(None): and inserting ``subsection (b)(1)''; and
p.(None): (II) by striking ``Assistant
p.(None): Secretary'' each place it appears and
p.(None): inserting ``Director''; and
p.(None):
p.(None): [[Page 130 STAT. 1209]]
p.(None):
p.(None): (ii) in subparagraph (B), by inserting ``in
p.(None): coordination with the Centers for Disease Control
p.(None): and Prevention'' before the semicolon at the end;
p.(None): and
p.(None): (C) in paragraph (2), by striking ``Annual surveys''
p.(None): and inserting ``Annual surveys; public availability of
p.(None): data.--Annual surveys''; and
p.(None): (7) in subsection (e), as so redesignated--
p.(None): (A) by striking ``After consultation'' and inserting
p.(None): ``Consultation.--After consultation''; and
p.(None): (B) by striking ``Assistant Secretary shall
p.(None): develop'' and inserting ``Assistant Secretary shall use
p.(None): existing standards and best practices to develop''.
p.(None): SEC. 6005. STRATEGIC PLAN.
p.(None):
p.(None): Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
p.(None): amended by sections 6001 through 6003, is further amended by inserting
p.(None): after subsection (k), as redesignated by section 6003, the following:
p.(None): ``(l) Strategic Plan.--
p.(None): ``(1) In general.--Not later than September 30, 2018, and
p.(None): every 4 years thereafter, the Assistant Secretary shall develop
p.(None): and carry out a strategic plan in accordance with this
p.(None): subsection for the planning and operation of activities carried
p.(None): out by the Administration, including evidence-based programs.
p.(None): ``(2) Coordination.--In developing and carrying out the
...
p.(None): ``(A) the implementation and dissemination of
p.(None): research findings into improved programs, including with
p.(None): respect to how advances in serious mental illness and
p.(None): serious emotional disturbance research have been
p.(None): incorporated into programs;
p.(None): ``(B) the recruitment, training, and retention of a
p.(None): mental and substance use disorders workforce;
p.(None): ``(C) the integration of mental disorder services,
p.(None): substance use disorder services, and physical health
p.(None): services;
p.(None): ``(D) homelessness; and
p.(None): ``(E) veterans;
p.(None): ``(5) a description of the manner in which the
p.(None): Administration promotes coordination by grantees under this
p.(None): title, and part B of title XIX, with State or local agencies;
p.(None): and
p.(None): ``(6) a description of the activities carried out under
p.(None): section 501A(e), with respect to mental and substance use
p.(None): disorders, including--
p.(None): ``(A) the number and a description of grants
p.(None): awarded;
p.(None): ``(B) the total amount of funding for grants
p.(None): awarded;
p.(None): ``(C) a description of the activities supported
p.(None): through such grants, including outcomes of programs
p.(None): supported; and
p.(None): ``(D) information on how the National Mental Health
p.(None): and Substance Use Policy Laboratory is consulting with
p.(None): the Assistant Secretary for Planning and Evaluation and
p.(None): collaborating with the Center for Substance Abuse
p.(None): Treatment, the Center for Substance Abuse Prevention,
p.(None): the Center for Behavioral Health Statistics and Quality,
p.(None): and the Center for Mental Health Services to carry out
p.(None): such activities; and
p.(None): ``(7) recommendations made by the Assistant Secretary for
p.(None): Planning and Evaluation under section 6021 of the Helping
p.(None): Families in Mental Health Crisis Reform Act of 2016 to improve
p.(None): programs within the Administration, and actions taken in
p.(None): response to such recommendations to improve programs within the
p.(None): Administration.
p.(None):
p.(None): The Assistant Secretary may meet reporting requirements established
p.(None): under this title by providing the contents of such reports as an
p.(None): addendum to the biennial report established under this subsection,
p.(None): notwithstanding the timeline of other reporting requirements in this
p.(None): title. Nothing in this subsection shall be construed to alter the
p.(None): content requirements of such reports or authorize the Assistant
p.(None): Secretary to alter the timeline of any such reports
p.(None):
p.(None): [[Page 130 STAT. 1212]]
p.(None):
p.(None): to be less frequent than biennially, unless as specified in this
p.(None): title.''.
p.(None): (b) Conforming Amendment.--Section 508(p) of the Public Health
p.(None): Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
p.(None): 501(k)'' and inserting ``section 501(m)''.
p.(None): SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
p.(None): SUBSTANCE ABUSE PREVENTION, AND
p.(None): SUBSTANCE ABUSE TREATMENT.
p.(None):
p.(None): (a) Center for Mental Health Services.--Section 520(b) of the Public
p.(None): Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
p.(None): (1) by redesignating paragraphs (3) through (15) as
p.(None): paragraphs (4) through (16), respectively;
p.(None): (2) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute of Mental Health and the Chief Medical Officer,
p.(None): appointed under section 501(g), to ensure that, as appropriate,
p.(None): programs related to the prevention and treatment of mental
p.(None): illness and the promotion of mental health and recovery support
p.(None): are carried out in a manner that reflects the best available
p.(None): science and evidence-based practices, including culturally and
p.(None): linguistically appropriate services, as appropriate;'';
p.(None): (3) in paragraph (5), as so redesignated, by inserting ``,
p.(None): including through programs that reduce risk and promote
p.(None): resiliency'' before the semicolon;
p.(None): (4) in paragraph (6), as so redesignated, by inserting ``in
p.(None): collaboration with the Director of the National Institute of
p.(None): Mental Health,'' before ``develop'';
p.(None): (5) in paragraph (8), as so redesignated, by inserting ``,
p.(None): increase meaningful participation of individuals with mental
p.(None): illness in programs and activities of the Administration,''
p.(None): before ``and protect the legal'';
p.(None): (6) in paragraph (10), as so redesignated, by striking
p.(None): ``professional and paraprofessional personnel pursuant to
p.(None): section 303'' and inserting ``health paraprofessional personnel
p.(None): and health professionals'';
p.(None): (7) in paragraph (11), as so redesignated, by inserting
p.(None): ``and tele-mental health'' after ``rural mental health'';
p.(None): (8) in paragraph (12), as so redesignated, by striking
p.(None): ``establish a clearinghouse for mental health information to
p.(None): assure the widespread dissemination of such information'' and
p.(None): inserting ``disseminate mental health information, including
p.(None): evidence-based practices,'';
p.(None): (9) in paragraph (15), as so redesignated, by striking
p.(None): ``and'' at the end;
p.(None): (10) in paragraph (16), as so redesignated, by striking the
p.(None): period and inserting ``; and''; and
p.(None): (11) by adding at the end the following:
p.(None): ``(17) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded.''.
p.(None):
p.(None): (b) Director of the Center for Substance Abuse Prevention.--Section
p.(None): 515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
p.(None): (1) in the section heading, by striking ``office'' and
p.(None): inserting ``center'';
p.(None):
p.(None): [[Page 130 STAT. 1213]]
p.(None):
p.(None): (2) in subsection (a)--
p.(None): (A) by striking ``an Office'' and inserting ``a
p.(None): Center''; and
p.(None): (B) by striking ``The Office'' and inserting ``The
p.(None): Prevention Center''; and
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by inserting ``through the
p.(None): reduction of risk and the promotion of resiliency''
p.(None): before the semicolon;
p.(None): (B) by redesignating paragraphs (3) through (11) as
p.(None): paragraphs (4) through (12), respectively;
p.(None): (C) by inserting after paragraph (2) the following:
p.(None): ``(3) collaborate with the Director of the National
p.(None): Institute on Drug Abuse, the Director of the National Institute
p.(None): on Alcohol Abuse and Alcoholism, and States to promote the study
p.(None): of substance abuse prevention and the dissemination and
p.(None): implementation of research findings that will improve the
p.(None): delivery and effectiveness of substance abuse prevention
p.(None): activities;'';
p.(None): (D) in paragraph (4), as so redesignated, by
p.(None): striking ``literature on the adverse effects of cocaine
p.(None): free base (known as crack)'' and inserting ``educational
p.(None): information on the effects of drugs abused by
p.(None): individuals, including drugs that are emerging as abused
p.(None): drugs'';
p.(None): (E) in paragraph (6), as so redesignated--
p.(None): (i) by striking ``substance abuse counselors''
p.(None): and inserting ``health professionals who provide
p.(None): substance use and misuse prevention and treatment
p.(None): services''; and
p.(None): (ii) by striking ``drug abuse education,
p.(None): prevention,'' and inserting ``illicit drug use
p.(None): education and prevention'';
p.(None): (F) by amending paragraph (7), as so redesignated,
p.(None): to read as follows:
p.(None): ``(7) in cooperation with the Director of the Centers for
p.(None): Disease Control and Prevention, develop and disseminate
p.(None): educational materials to increase awareness for individuals at
p.(None): greatest risk for substance use disorders to prevent the
p.(None): transmission of communicable diseases, such as HIV, hepatitis,
p.(None): tuberculosis, and other communicable diseases;'';
p.(None): (G) in paragraph (9), as so redesignated--
p.(None): (i) by striking ``to discourage'' and
p.(None): inserting ``that reduce the risk of''; and
p.(None): (ii) by inserting before the semicolon ``and
p.(None): promote resiliency'';
p.(None): (H) in paragraph (11), as so redesignated, by
p.(None): striking ``and'' after the semicolon;
p.(None): (I) in paragraph (12), as so redesignated, by
p.(None): striking the period and inserting a semicolon; and
p.(None): (J) by adding at the end the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) assist and support States in preventing illicit drug
p.(None): use, including emerging illicit drug use issues.''.
p.(None):
p.(None): [[Page 130 STAT. 1214]]
p.(None):
p.(None): (c) Director of the Center for Substance Abuse Treatment.--Section
p.(None): 507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``treatment of substance abuse'' and
p.(None): inserting ``treatment of substance use disorders''; and
p.(None): (B) by striking ``abuse treatment systems'' and
p.(None): inserting ``use disorder treatment systems''; and
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (B) in paragraph (3), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (C) in paragraph (4), by striking ``individuals who
p.(None): abuse drugs'' and inserting ``individuals who illicitly
p.(None): use drugs'';
p.(None): (D) in paragraph (9), by striking ``carried out by
p.(None): the Director'';
p.(None): (E) by striking paragraph (10);
p.(None): (F) by redesignating paragraphs (11) through (14) as
p.(None): paragraphs (10) through (13), respectively;
p.(None): (G) in paragraph (12), as so redesignated, by
p.(None): striking ``; and'' and inserting a semicolon; and
p.(None): (H) by striking paragraph (13), as so redesignated,
p.(None): and inserting the following:
p.(None): ``(13) ensure the consistent documentation of the
p.(None): application of criteria when awarding grants and the ongoing
p.(None): oversight of grantees after such grants are awarded; and
p.(None): ``(14) work with States, providers, and individuals in
p.(None): recovery, and their families, to promote the expansion of
p.(None): recovery support services and systems of care oriented toward
p.(None): recovery.''.
p.(None): SEC. 6008. ADVISORY COUNCILS.
p.(None):
p.(None): Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 1(b)) is amended--
p.(None): (1) in paragraph (2)--
p.(None): (A) in subparagraph (E), by striking ``and'' after
p.(None): the semicolon;
p.(None): (B) by redesignating subparagraph (F) as
p.(None): subparagraph (J); and
p.(None): (C) by inserting after subparagraph (E), the
p.(None): following:
p.(None): ``(F) the Chief Medical Officer, appointed under
p.(None): section 501(g);
p.(None): ``(G) the Director of the National Institute of
p.(None): Mental Health for the advisory councils appointed under
p.(None): subsections (a)(1)(A) and (a)(1)(D);
p.(None): ``(H) the Director of the National Institute on Drug
p.(None): Abuse for the advisory councils appointed under
p.(None): subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.(None): ``(I) the Director of the National Institute on
p.(None): Alcohol Abuse and Alcoholism for the advisory councils
p.(None): appointed under subsections (a)(1)(A), (a)(1)(B), and
p.(None): (a)(1)(C); and''; and
p.(None): (2) in paragraph (3), by adding at the end the following:
p.(None): ``(C) Not less than half of the members of the
p.(None): advisory council appointed under subsection (a)(1)(D)--
p.(None): ``(i) shall--
p.(None):
p.(None): [[Page 130 STAT. 1215]]
p.(None):
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree in
p.(None): psychology; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall specialize in the mental health
p.(None): field.
p.(None): ``(D) Not less than half of the members of the
p.(None): advisory councils appointed under subsections (a)(1)(B)
p.(None): and (a)(1)(C)--
p.(None): ``(i) shall--
p.(None): ``(I) have a medical degree;
p.(None): ``(II) have a doctoral degree; or
p.(None): ``(III) have an advanced degree in
p.(None): nursing, public health, behavioral or
p.(None): social sciences, or social work from an
p.(None): accredited graduate school or be a
p.(None): certified physician assistant; and
p.(None): ``(ii) shall have experience in the provision
p.(None): of substance use disorder services or the
p.(None): development and implementation of programs to
p.(None): prevent substance misuse.''.
p.(None): SEC. 6009. PEER REVIEW.
p.(None):
p.(None): Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
p.(None): 3(b)) is amended by adding at the end the following: ``In the case of
p.(None): any such peer review group that is reviewing a grant, cooperative
...
p.(None):
p.(None): [[Page 130 STAT. 1216]]
p.(None):
p.(None): (1) include a plan for evaluating programs related to mental
p.(None): and substance use disorders, including co-occurring disorders,
p.(None): across agencies, as appropriate, including programs related to--
p.(None): (A) prevention, intervention, treatment, and
p.(None): recovery support services, including such services for
p.(None): adults with a serious mental illness or children with a
p.(None): serious emotional disturbance;
p.(None): (B) the reduction of homelessness and incarceration
p.(None): among individuals with a mental or substance use
p.(None): disorder; and
p.(None): (C) public health and health services; and
p.(None): (2) include a plan for assessing the use of performance
p.(None): metrics to evaluate activities carried out by entities receiving
p.(None): grants, contracts, or cooperative agreements related to mental
p.(None): and substance use disorders prevention and treatment services
p.(None): under title V or title XIX of the Public Health Service Act (42
p.(None): U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
p.(None):
p.(None): (c) Consultation.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall consult, as appropriate,
p.(None): with the Assistant Secretary for Mental Health and Substance Use, the
p.(None): Chief Medical Officer of the Substance Abuse and Mental Health Services
p.(None): Administration appointed under section 501(g) of the Public Health
p.(None): Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
p.(None): Behavioral Health Coordinating Council of the Department of Health and
p.(None): Human Services, other agencies within the Department of Health and Human
p.(None): Services, and other relevant Federal departments and agencies.
p.(None): (d) Recommendations.--In carrying out this section, the Assistant
p.(None): Secretary for Planning and Evaluation shall provide recommendations to
p.(None): the Secretary of Health and Human Services, the Assistant Secretary for
p.(None): Mental Health and Substance Use, and the Congress on improving the
p.(None): quality of prevention and treatment programs and activities related to
p.(None): mental and substance use disorders, including recommendations for the
p.(None): use of performance metrics. The Assistant Secretary for Mental Health
p.(None): and Substance Use shall include such recommendations in the biennial
p.(None): report required by subsection 501(m) of the Public Health Service Act,
p.(None): as redesignated by section 6003 of this Act.
p.(None): SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
p.(None):
p.(None): (a) Public Availability of Reports.--Section 105(a)(7) of the
p.(None): Protection and Advocacy for Individuals with Mental Illness Act (42
p.(None): U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and
p.(None): inserting ``is located, and make publicly available, a report''.
...
p.(None): (b) Contents.--The report and evaluation required under subsection
p.(None): (a) shall include--
p.(None): (1) a review of the programs described in such subsection
p.(None): that are carried out by State agencies and such programs that
p.(None): are carried out by private, nonprofit organizations; and
p.(None): (2) a review of the compliance of the programs described in
p.(None): subsection (a) with statutory and regulatory responsibilities,
p.(None): such as--
p.(None): (A) responsibilities relating to family engagement;
p.(None): (B) responsibilities relating to the grievance
p.(None): procedure for clients or prospective clients of the
p.(None): system to assure that individuals with mental illness
p.(None): have full access to the services of the system, for
p.(None): individuals who have received or are receiving mental
p.(None): health services, and for family members of such
p.(None): individuals with mental illness, or representatives of
p.(None): such individuals or family members, to assure that the
p.(None): eligible system is operating in compliance with the
p.(None): provisions of the Protection and Advocacy for
p.(None): Individuals with Mental Illness Act, as required to be
p.(None): established by section 105(a)(9) of such Act (42 U.S.C.
p.(None): 10805(a)(9));
p.(None): (C) investigation of alleged abuse and neglect of
p.(None): persons with mental illness;
p.(None): (D) availability of adequate medical and behavioral
p.(None): health treatment;
p.(None): (E) denial of rights for persons with mental
p.(None): illness; and
p.(None): (F) compliance with the Federal prohibition on
p.(None): lobbying.
p.(None):
p.(None): Subtitle C--Interdepartmental Serious Mental Illness Coordinating
p.(None): Committee
p.(None):
p.(None): SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
p.(None): COMMITTEE.
p.(None):
p.(None): (a) Establishment.--
p.(None): (1) In general.--Not later than 3 months after the date of
p.(None): enactment of this Act, the Secretary of Health and Human
p.(None): Services, or the designee of the Secretary, shall establish a
p.(None): committee to be known as the Interdepartmental Serious Mental
p.(None): Illness Coordinating Committee (in this section referred to as
p.(None): the ``Committee'').
p.(None):
p.(None): [[Page 130 STAT. 1218]]
p.(None):
p.(None): (2) Federal advisory committee act.--Except as provided in
p.(None): this section, the provisions of the Federal Advisory Committee
p.(None): Act (5 U.S.C. App.) shall apply to the Committee.
p.(None):
p.(None): (b) Meetings.--The Committee shall meet not fewer than 2 times each
p.(None): year.
p.(None): (c) Responsibilities.--Not later than 1 year after the date of
p.(None): enactment of this Act, and 5 years after such date of enactment, the
p.(None): Committee shall submit to Congress and any other relevant Federal
p.(None): department or agency a report including--
...
p.(None):
p.(None): under subparagraph (A) or (B) and merging such programs
p.(None): or activities into other successful programs or
p.(None): activities; and
p.(None): ``(6) carry out other activities as deemed necessary to
p.(None): continue to encourage innovation and disseminate evidence-based
p.(None): programs and practices.
p.(None):
p.(None): ``(c) Evidence-Based Practices and Service Delivery Models.--
p.(None): ``(1) In general.--In carrying out subsection (b)(3), the
p.(None): Laboratory--
p.(None): ``(A) may give preference to models that improve--
p.(None): ``(i) the coordination between mental health
p.(None): and physical health providers;
p.(None): ``(ii) the coordination among such providers
p.(None): and the justice and corrections system; and
p.(None): ``(iii) the cost effectiveness, quality,
p.(None): effectiveness, and efficiency of health care
p.(None): services furnished to adults with a serious mental
p.(None): illness, children with a serious emotional
p.(None): disturbance, or individuals in a mental health
p.(None): crisis; and
p.(None): ``(B) may include clinical protocols and practices
p.(None): that address the needs of individuals with early serious
p.(None): mental illness.
p.(None): ``(2) Consultation.--In carrying out this section, the
p.(None): Laboratory shall consult with--
p.(None): ``(A) the Chief Medical Officer appointed under
p.(None): section 501(g);
p.(None): ``(B) representatives of the National Institute of
p.(None): Mental Health, the National Institute on Drug Abuse, and
p.(None): the National Institute on Alcohol Abuse and Alcoholism,
p.(None): on an ongoing basis;
p.(None): ``(C) other appropriate Federal agencies;
p.(None): ``(D) clinical and analytical experts with expertise
p.(None): in psychiatric medical care and clinical psychological
p.(None): care, health care management, education, corrections
p.(None): health care, and mental health court systems, as
p.(None): appropriate; and
p.(None): ``(E) other individuals and agencies as determined
p.(None): appropriate by the Assistant Secretary.
p.(None):
p.(None): ``(d) Deadline for Beginning Implementation.--The Laboratory shall
p.(None): begin implementation of this section not later than January 1, 2018.
p.(None): ``(e) Promoting Innovation.--
p.(None): ``(1) In general.--The Assistant Secretary, in coordination
p.(None): with the Laboratory, may award grants to States, local
p.(None): governments, Indian tribes or tribal organizations (as such
p.(None): terms are defined in section 4 of the Indian Self-Determination
p.(None): and Education Assistance Act), educational institutions, and
p.(None): nonprofit organizations to develop evidence-based interventions,
p.(None): including culturally and linguistically appropriate services, as
p.(None): appropriate, for--
p.(None): ``(A) evaluating a model that has been
p.(None): scientifically demonstrated to show promise, but would
p.(None): benefit from further applied development, for--
p.(None):
p.(None): [[Page 130 STAT. 1222]]
p.(None):
p.(None): ``(i) enhancing the prevention, diagnosis,
p.(None): intervention, and treatment of, and recovery from,
p.(None): mental illness, serious emotional disturbances,
p.(None): substance use disorders, and co-occurring illness
p.(None): or disorders; or
p.(None): ``(ii) integrating or coordinating physical
p.(None): health services and mental and substance use
p.(None): disorders services; and
p.(None): ``(B) expanding, replicating, or scaling evidence-
p.(None): based programs across a wider area to enhance effective
p.(None): screening, early diagnosis, intervention, and treatment
p.(None): with respect to mental illness, serious mental illness,
p.(None): serious emotional disturbances, and substance use
p.(None): disorders, primarily by--
p.(None): ``(i) applying such evidence-based programs to
p.(None): the delivery of care, including by training staff
p.(None): in effective evidence-based treatments; or
p.(None): ``(ii) integrating such evidence-based
p.(None): programs into models of care across specialties
p.(None): and jurisdictions.
p.(None): ``(2) Consultation.--In awarding grants under this
p.(None): subsection, the Assistant Secretary shall, as appropriate,
p.(None): consult with the Chief Medical Officer, appointed under section
p.(None): 501(g), the advisory councils described in section 502, the
p.(None): National Institute of Mental Health, the National Institute on
p.(None): Drug Abuse, and the National Institute on Alcohol Abuse and
p.(None): Alcoholism, as appropriate.
p.(None): ``(3) Authorization of appropriations.--There are authorized
p.(None): to be appropriated--
p.(None): ``(A) to carry out paragraph (1)(A), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020; and
p.(None): ``(B) to carry out paragraph (1)(B), $7,000,000 for
p.(None): the period of fiscal years 2018 through 2020.''.
p.(None): SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
p.(None): PROGRAMS AND PRACTICES.
p.(None):
p.(None): Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
p.(None): et seq.) is amended by inserting after section 543 of such Act (42
p.(None): U.S.C. 290dd-2) the following:
p.(None): ``SEC. 543A. <> PROMOTING ACCESS TO
p.(None): INFORMATION ON EVIDENCE-BASED PROGRAMS
p.(None): AND PRACTICES.
p.(None):
p.(None): ``(a) In General.--The Assistant Secretary shall, as appropriate,
p.(None): improve access to reliable and valid information on evidence-based
p.(None): programs and practices, including information on the strength of
p.(None): evidence associated with such programs and practices, related to mental
p.(None): and substance use disorders for States, local communities, nonprofit
p.(None): entities, and other stakeholders, by posting on the Internet website of
p.(None): the Administration information on evidence-based programs and practices
p.(None): that have been reviewed by the Assistant Secretary in accordance with
p.(None): the requirements of this section.
p.(None): ``(b) Applications.--
p.(None): ``(1) Application period.--In carrying out subsection (a),
...
p.(None): applications, publicly available.''.
p.(None): SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
p.(None): SIGNIFICANCE.
p.(None):
p.(None): Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32)
p.(None): is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in paragraph (4), by inserting before the period
p.(None): ``, which may include technical assistance centers'';
p.(None): and
p.(None): (B) in the flush sentence following paragraph (4)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or''; and
p.(None): (2) by amending subsection (f) to read as follows:
p.(None):
p.(None): ``(f) Authorization of Appropriations.--There are authorized to be
p.(None): appropriated to carry out this section $394,550,000 for each of fiscal
p.(None): years 2018 through 2022.''.
p.(None): SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
p.(None): amended--
p.(None): (1) in subsection (a)--
p.(None):
p.(None): [[Page 130 STAT. 1224]]
p.(None):
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``that permit States, local governments, communities,
p.(None): and Indian tribes and tribal organizations (as the terms
p.(None): `Indian tribes' and `tribal organizations' are defined
p.(None): in section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act) to focus on emerging trends in
p.(None): substance abuse and co-occurrence of substance use
p.(None): disorders with mental illness or other conditions''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health Service,
p.(None): or'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2), by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (3) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (4) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$333,806,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None): SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
p.(None): REGIONAL AND NATIONAL SIGNIFICANCE.
p.(None):
p.(None): Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
p.(None): amended--
p.(None): (1) in the section heading, by striking ``abuse'' and
p.(None): inserting ``use disorder'';
p.(None): (2) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``abuse'' and inserting ``use disorder'';
p.(None): (B) in paragraph (3), by inserting before the period
p.(None): ``, including such programs that focus on emerging drug
p.(None): abuse issues''; and
p.(None): (C) in the flush sentence following paragraph (3)--
p.(None): (i) by inserting ``, contracts,'' before ``or
p.(None): cooperative agreements''; and
p.(None): (ii) by striking ``Indian tribes and tribal
p.(None): organizations,'' and inserting ``Indian tribes or
p.(None): tribal organizations (as such terms are defined in
p.(None): section 4 of the Indian Self-Determination and
p.(None): Education Assistance Act), health facilities, or
p.(None): programs operated by or in accordance with a
p.(None): contract or grant with the Indian Health
p.(None): Service,'';
p.(None): (3) in subsection (b)--
p.(None): (A) in paragraph (1), by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (B) in paragraph (2)--
p.(None):
p.(None): [[Page 130 STAT. 1225]]
p.(None):
p.(None): (i) in subparagraph (A), by striking ``; and''
p.(None): at the end and inserting ``;'';
p.(None): (ii) in subparagraph (B)--
p.(None): (I) by striking ``abuse'' and
p.(None): inserting ``use disorder''; and
p.(None): (II) by striking the period and
p.(None): inserting ``; and''; and
p.(None): (iii) by adding at the end the following:
p.(None): ``(C) substance use disorder prevention among high-
p.(None): risk groups.'';
p.(None): (4) in subsection (e), by striking ``abuse'' and inserting
p.(None): ``use disorder''; and
p.(None): (5) in subsection (f), by striking ``$300,000,000'' and all
p.(None): that follows through the period and inserting ``$211,148,000 for
p.(None): each of fiscal years 2018 through 2022.''.
p.(None):
p.(None): TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
p.(None): MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
p.(None):
p.(None): SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1911(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x(b)) is amended--
p.(None): (1) by redesignating paragraphs (1) through (3) as
p.(None): paragraphs (2) through (4), respectively; and
p.(None): (2) by inserting before paragraph (2) (as so redesignated)
p.(None): the following:
p.(None): ``(1) providing community mental health services for adults
p.(None): with a serious mental illness and children with a serious
p.(None): emotional disturbance as defined in accordance with section
p.(None): 1912(c);''.
p.(None):
p.(None): (b) State Plan.--Section 1912(b) of the Public Health Service Act
p.(None): (42 U.S.C. 300x-1(b)) is amended--
p.(None): (1) in paragraph (3), by redesignating subparagraphs (A)
p.(None): through (C) as clauses (i) through (iii), respectively, and
p.(None): realigning the margins accordingly;
p.(None): (2) by redesignating paragraphs (1) through (5) as
p.(None): subparagraphs (A) through (E), respectively, and realigning the
p.(None): margins accordingly;
p.(None): (3) in the matter preceding subparagraph (A) (as so
p.(None): redesignated), by striking ``With respect to'' and all that
p.(None): follows through ``are as follows:'' and inserting ``In
...
p.(None): ``(III) a description of how the
p.(None): State integrates mental health and
p.(None): primary care using the block grant
p.(None): funds, which may include providing, in
p.(None): the case of individuals with co-
p.(None): occurring mental and
p.(None):
p.(None): [[Page 130 STAT. 1227]]
p.(None):
p.(None): substance use disorders, both mental and
p.(None): substance use disorders services in
p.(None): primary care settings or arrangements to
p.(None): provide primary and specialty care
p.(None): services in community-based mental and
p.(None): substance use disorders settings; and
p.(None): ``(IV) a description of recovery and
p.(None): recovery support services for adults
p.(None): with a serious mental illness and
p.(None): children with a serious emotional
p.(None): disturbance.'';
p.(None): (6) in subparagraph (B) (as so redesignated)--
p.(None): (A) by striking ``The plan contains'' and inserting
p.(None): ``The plan shall contain''; and
p.(None): (B) by striking ``presents quantitative targets to
p.(None): be achieved in the implementation of the system
p.(None): described in paragraph (1)'' and inserting ``present
p.(None): quantitative targets and outcome measures for programs
p.(None): and services provided under this subpart'';
p.(None): (7) in subparagraph (C) (as so redesignated)--
p.(None): (A) by striking ``serious emotional disturbance'' in
p.(None): the matter preceding clause (i) (as so redesignated) and
p.(None): all that follows through ``substance abuse services'' in
p.(None): clause (i) (as so redesignated) and inserting the
p.(None): following: ``a serious emotional disturbance (as defined
p.(None): pursuant to subsection (c)), the plan shall provide for
p.(None): a system of integrated social services, educational
p.(None): services, child welfare services, juvenile justice
p.(None): services, law enforcement services, and substance use
p.(None): disorder services'';
p.(None): (B) by striking ``Education Act);'' and inserting
p.(None): ``Education Act).''; and
p.(None): (C) by striking clauses (ii) and (iii) (as so
p.(None): redesignated);
p.(None): (8) in subparagraph (D) (as so redesignated), by striking
p.(None): ``plan describes'' and inserting ``plan shall describe'';
p.(None): (9) in subparagraph (E) (as so redesignated)--
p.(None): (A) in the subparagraph heading by striking
p.(None): ``systems'' and inserting ``services'';
p.(None): (B) in the first sentence, by striking ``plan
p.(None): describes'' and all that follows through ``and provides
p.(None): for'' and inserting ``plan shall describe the financial
p.(None): resources available, the existing mental health
p.(None): workforce, and the workforce trained in treating
p.(None): individuals with co-occurring mental and substance use
p.(None): disorders, and shall provide for''; and
p.(None): (C) in the second sentence--
p.(None): (i) by striking ``further describes'' and
p.(None): inserting ``shall further describe''; and
...
p.(None): in lieu of having the amount of the allotment
p.(None): under section 1911 for the State reduced for the
p.(None): fiscal year of the grant, agree to comply with a
p.(None): negotiated agreement that is approved by the
p.(None): Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State
p.(None): fails to enter into or comply with a negotiated
p.(None): agreement, the Secretary may take action under
p.(None): this paragraph or the terms of the negotiated
p.(None): agreement.''; and
p.(None): (B) in subparagraph (B)--
p.(None):
p.(None): [[Page 130 STAT. 1229]]
p.(None):
p.(None): (i) by inserting after the subparagraph
p.(None): designation the following: ``Submission of
p.(None): information to the secretary.--''; and
p.(None): (ii) by striking ``subparagraph (A)'' and
p.(None): inserting ``subparagraph (A)(i)''.
p.(None):
p.(None): (e) Application for Grant.--Section 1917(a) of the Public Health
p.(None): Service Act (42 U.S.C. 300x-6(a)) is amended--
p.(None): (1) in paragraph (1), by striking ``1941'' and inserting
p.(None): ``1942(a)''; and
p.(None): (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and
p.(None): inserting ``1915(b)''.
p.(None):
p.(None): (f) Funding.--Section 1920 of the Public Health Service Act (42
p.(None): U.S.C. 300x-9) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(c)''; and
p.(None): (B) by striking ``$450,000,000'' and all that
p.(None): follows through the period and inserting ``$532,571,000
p.(None): for each of fiscal years 2018 through 2022.''; and
p.(None): (2) in subsection (b)(2) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(c) and''.
p.(None): SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.
p.(None):
p.(None): (a) Formula Grants.--Section 1921(b) of the Public Health Service
p.(None): Act (42 U.S.C. 300x-21(b)) is amended--
p.(None): (1) by inserting ``carrying out the plan developed in
p.(None): accordance with section 1932(b) and for'' after ``for the
p.(None): purpose of''; and
p.(None): (2) by striking ``abuse'' and inserting ``use disorders''.
p.(None):
p.(None): (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the
p.(None): Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
p.(None): (1) in the subsection heading, by striking ``Regarding
p.(None): Intravenous Substance Abuse'' and inserting ``to Persons Who
p.(None): Inject Drugs''; and
p.(None): (2) by striking ``for intravenous drug abuse'' and inserting
p.(None): ``for persons who inject drugs''.
p.(None):
p.(None): (c) Requirements Regarding Tuberculosis and Human Immunodeficiency
p.(None): Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
p.(None): 24) is amended--
p.(None): (1) in subsection (a)(1)--
p.(None): (A) in the matter preceding subparagraph (A), by
p.(None): striking ``substance abuse'' and inserting ``substance
p.(None): use disorders''; and
p.(None): (B) in subparagraph (A), by striking ``such abuse''
p.(None): and inserting ``such disorders'';
p.(None): (2) in subsection (b)--
p.(None): (A) in paragraph (1)(A), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (B) in paragraph (2), by inserting ``and
p.(None): Prevention'' after ``Disease Control'';
p.(None): (C) in paragraph (3)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``abuse'' and inserting ``use disorders''; and
p.(None): (ii) by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None):
p.(None): [[Page 130 STAT. 1230]]
p.(None):
p.(None): (D) in paragraph (6)(B), by striking ``substance
p.(None): abuse'' and inserting ``substance use disorders'';
p.(None): (3) by striking subsection (d); and
p.(None): (4) by redesignating subsection (e) as subsection (d).
p.(None):
p.(None): (d) Group Homes.--Section 1925 of the Public Health Service Act (42
p.(None): U.S.C. 300x-25) is amended--
p.(None): (1) in the section heading, by striking ``recovering
p.(None): substance abusers'' and inserting ``persons in recovery from
p.(None): substance use disorders''; and
p.(None): (2) in subsection (a), in the matter preceding paragraph
p.(None): (1), by striking ``recovering substance abusers'' and inserting
p.(None): ``persons in recovery from substance use disorders''.
p.(None):
p.(None): (e) Additional Agreements.--Section 1928 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-28) is amended--
p.(None): (1) in subsection (a), by striking ``(relative to fiscal
p.(None): year 1992)'';
p.(None): (2) by striking subsection (b) and inserting the following:
p.(None):
p.(None): ``(b) Professional Development.--A funding agreement for a grant
p.(None): under section 1921 is that the State involved will ensure that
p.(None): prevention, treatment, and recovery personnel operating in the State's
p.(None): substance use disorder prevention, treatment, and recovery systems have
p.(None): an opportunity to receive training, on an ongoing basis, concerning--
p.(None): ``(1) recent trends in substance use disorders in the State;
p.(None): ``(2) improved methods and evidence-based practices for
p.(None): providing substance use disorder prevention and treatment
p.(None): services;
p.(None): ``(3) performance-based accountability;
p.(None): ``(4) data collection and reporting requirements; and
p.(None): ``(5) any other matters that would serve to further improve
p.(None): the delivery of substance use disorder prevention and treatment
p.(None): services within the State.''; and
p.(None): (3) in subsection (d)(1), by striking ``substance abuse''
p.(None): and inserting ``substance use disorders''.
p.(None):
p.(None): (f) Repeal.--Section 1929 of the Public Health Service Act (42
p.(None): U.S.C. 300x-29) is repealed.
p.(None): (g) Maintenance of Effort.--Section 1930 of the Public Health
p.(None): Service Act (42 U.S.C. 300x-30) is amended--
p.(None): (1) in subsection (c)(1), by striking ``in the State justify
p.(None): the waiver'' and inserting ``exist in the State, or any part of
p.(None): the State, to justify the waiver''; and
p.(None): (2) in subsection (d), by inserting at the end the
p.(None): following:
p.(None): ``(3) Alternative.--A State that has failed to comply with
p.(None): this section and would otherwise be subject to a reduction in
p.(None): the State's allotment under section 1921, may, upon request by
p.(None): the State, in lieu of having the State's allotment under section
p.(None): 1921 reduced, agree to comply with a negotiated agreement that
p.(None): is approved by the Secretary and carried out in accordance with
p.(None): guidelines issued by the Secretary. If a State fails to enter
p.(None): into or comply with a negotiated agreement, the Secretary may
p.(None): take action under this paragraph or the terms of the negotiated
p.(None): agreement.''.
p.(None):
p.(None): (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
p.(None): Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
p.(None): ``substance abuse'' and inserting ``substance use disorders''.
p.(None):
p.(None): [[Page 130 STAT. 1231]]
p.(None):
p.(None): (i) Application.--Section 1932 of the Public Health Service Act (42
p.(None): U.S.C. 300x-32) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) in the matter preceding paragraph (1), by
p.(None): striking ``subsections (c) and (d)(2)'' and inserting
p.(None): ``subsection (c)''; and
p.(None): (B) in paragraph (5), by striking ``the information
p.(None): required in section 1929, the information required in
p.(None): section 1930(c)(2), and'';
p.(None): (2) in subsection (b)--
p.(None): (A) by striking paragraph (1) and inserting the
p.(None): following:
p.(None): ``(1) In general.--In order for a State to be in compliance
p.(None): with subsection (a)(6), the State shall submit to the Secretary
p.(None): a plan that, at a minimum, includes the following:
p.(None): ``(A) A description of the State's system of care
p.(None): that--
p.(None): ``(i) identifies the single State agency
p.(None): responsible for the administration of the program,
p.(None): including any third party who administers
p.(None): substance use disorder services and is responsible
p.(None): for complying with the requirements of the grant;
p.(None): ``(ii) provides information on the need for
p.(None): substance use disorder prevention and treatment
p.(None): services in the State, including estimates on the
p.(None): number of individuals who need treatment, who are
...
p.(None): ``(B) The establishment of goals and objectives for
p.(None): the period of the plan, including targets and milestones
p.(None): that are intended to be met, and the activities that
p.(None): will be undertaken to achieve those targets.
p.(None): ``(C) A description of how the State will comply
p.(None): with each funding agreement for a grant under section
p.(None): 1921 that is applicable to the State, including a
p.(None): description of the manner in which the State intends to
p.(None): expend grant funds.''; and
p.(None): (B) in paragraph (2)--
p.(None): (i) in the paragraph heading, by striking
p.(None): ``authority of secretary regarding modifications''
p.(None): and inserting ``modifications'';
p.(None): (ii) by striking ``As a condition'' and
p.(None): inserting the following:
p.(None): ``(A) Authority of secretary.--As a condition;'';
p.(None): and
p.(None): (iii) by adding at the end the following:
p.(None): ``(B) State request for modification.--If the State
p.(None): determines that a modification to such plan is
p.(None): necessary, the State may request the Secretary to
p.(None): approve the modification. Any such modification shall be
p.(None): in accordance with paragraph (1) and section 1941.'';
p.(None): and
p.(None): (C) in paragraph (3), by inserting, ``, including
p.(None): any modification under paragraph (2)'' after
p.(None): ``subsection (a)(6)''; and
p.(None): (3) in subsection (e)(2), by striking ``section 1922(c)''
p.(None): and inserting ``section 1922(b)''.
p.(None):
p.(None): (j) Definitions.--Section 1934 of the Public Health Service Act (42
p.(None): U.S.C. 300x-34) is amended--
p.(None): (1) in paragraph (3), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''; and
p.(None): (2) in paragraph (7), by striking ``substance abuse'' and
p.(None): inserting ``substance use disorders''.
p.(None): (k) Funding.--Section 1935 of the Public Health Service Act (42
p.(None): U.S.C. 300x-35) is amended--
p.(None): (1) in subsection (a)--
p.(None): (A) by striking ``section 505'' and inserting
p.(None): ``section 505(d)''; and
p.(None): (B) by striking ``$2,000,000,000 for fiscal year
p.(None): 2001, and such sums as may be necessary for each of the
p.(None): fiscal years 2002 and 2003'' and inserting
p.(None): ``$1,858,079,000 for each of fiscal years 2018 through
p.(None): 2022.''; and
p.(None): (2) in subsection (b)(1)(B) by striking ``sections 505 and''
p.(None): and inserting ``sections 505(d) and''.
p.(None): SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
p.(None):
p.(None): Subpart III of part B of title XIX of the Public Health Service Act
p.(None): (42 U.S.C. 300x-51 et seq.) is amended--
p.(None): (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
p.(None): striking ``section 505'' and inserting ``subsections (c) and (d)
p.(None): of section 505'';
p.(None):
p.(None): [[Page 130 STAT. 1233]]
p.(None):
p.(None): (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
p.(None): ``substance abuse'' and inserting ``substance use disorder'';
p.(None): and
p.(None): (3) by adding at the end the following:
p.(None): ``SEC. 1957. <> PUBLIC HEALTH EMERGENCIES.
p.(None):
p.(None): ``In the case of a public health emergency (as determined under
p.(None): section 319), the Secretary, on a State by State basis, may, as the
p.(None): circumstances of the emergency reasonably require and for the period of
p.(None): the emergency, grant an extension, or waive application deadlines or
p.(None): compliance with any other requirement, of a grant authorized under
p.(None): section 521, 1911, or 1921 or an allotment authorized under Public Law
p.(None): 99-319 (42 U.S.C. 10801 et seq.).
p.(None): ``SEC. 1958. <> JOINT APPLICATIONS.
p.(None):
p.(None): ``The Secretary, acting through the Assistant Secretary for Mental
p.(None): Health and Substance Use, shall permit a joint application to be
p.(None): submitted for grants under subpart I and subpart II upon the request of
p.(None): a State. Such application may be jointly reviewed and approved by the
p.(None): Secretary with respect to such subparts, consistent with the purposes
p.(None): and authorized activities of each such grant program. A State submitting
p.(None): such a joint application shall otherwise meet the requirements with
p.(None): respect to each such subpart.''.
p.(None): SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
p.(None):