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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsfelony1
PoliticalIllegal Activitycrime26
PoliticalIndigenousnative5
Politicalcriminalcriminal45
Politicalpolitical affiliationparty11
Politicalpolitical affiliationpolitical8
Politicalstateless personsnation2
Politicalvulnerablevulnerable7
HealthCognitive Impairmentcognitive2
HealthCognitive Impairmentimpairment4
HealthDrug Dependencedependence1
HealthDrug Dependencedependency2
HealthDrug Usagedrug429
HealthDrug Usageinfluence2
HealthDrug Usagesubstance135
HealthDrug Usageusage1
HealthHIV/AIDSHIV4
HealthHealthy Peoplevolunteers4
HealthMentally Disabledmentally6
HealthMentally Disableddisability2
HealthMotherhood/Familyfamily33
HealthPhysically Disabledillness142
HealthPregnantpregnant28
Healthalcoholismalcoholism5
Healthillill6
Healthinjuredinjured2
Healthpatients in emergency situationsemergencies2
Healthstem cellsstem cells2
Healthsubstance usesubstance use229
SocialAccess to Social Goodsaccess130
SocialAccess to informationaccess to information5
SocialAgeage40
SocialChildchild31
SocialChildchildren70
SocialEthnicityethnic4
SocialEthnicityethnicity3
SocialHomeless Personshomeless5
SocialIncarceratedincarcerated3
SocialIncarceratedjail6
SocialIncarceratedprison6
SocialInfantinfant9
SocialLinguistic Proficiencylanguage1
SocialLinguistic Proficiencylinguistic1
SocialLiteracyliteracy1
SocialMarital Statussingle28
SocialMothersmothers1
SocialOccupationjob5
SocialPolice Officerofficer23
SocialPolice Officerpolice1
SocialProperty Ownershiphome67
SocialProperty Ownershipproperty15
SocialRacial Minorityminority24
SocialRacial Minorityrace3
SocialRacial Minorityracial4
SocialReligionfaith2
SocialReligionconviction1
SocialSoldierarmedXforces1
SocialStudentstudent1
SocialThreat of Stigmastigma6
SocialThreat of Stigmathreat19
SocialThreat of Violenceviolence10
SocialTrade Union Membershipunion2
SocialUnemploymentunemployment1
SocialVictim of Abusetrauma13
SocialVictim of Abuseabuse168
SocialWomenwomen62
SocialYouth/Minorsminor2
SocialYouth/Minorsyouth9
Socialeducationeducation144
Socialeducationeducational11
Socialemployeesemployees17
Socialgendergender5
Socialorphanorphan3
Socialparentsparent4
Socialparentsparents1
Socialphilosophical differences/differences of opinionopinion1
Economicinvestors/intellectual rightsinvestors2
General/OtherDependentdependent3
General/OtherDeveloping Countryunderdeveloped1
General/OtherIncapacitatedincapacitated1
General/OtherIncapacitatedincapacity1
General/OtherPublic Emergencyemergency53
General/OtherRelationship to Authorityauthority71
General/Othercultural differenceculturally10
General/Otherpeople living in remote/rural arearural area2

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:

(return to top)
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:

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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

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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:

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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
...

Political / stateless persons

Searching for indicator nation:

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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,
...

Searching for indicator impairment:

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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
...

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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 Demo