[114th Congress Public Law 255]
[From the U.S. Government Publishing Office]
[[Page 130 STAT. 1033]]
Public Law 114-255
114th Congress
An Act
To accelerate the discovery, development, and delivery of 21st century
cures, and for other purposes. <<NOTE: Dec. 13, 2016 - [H.R. 34]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: 21st Century
Cures Act. 42 USC 201 note.>>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st Century Cures
Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
DIVISION A--21ST CENTURY CURES
Sec. 1000. Short title.
TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.
TITLE II--DISCOVERY
Subtitle A--National Institutes of Health Reauthorization
Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.
Subtitle B--Advancing Precision Medicine
Sec. 2011. Precision Medicine Initiative.
Sec. 2012. Privacy protection for human research subjects.
Sec. 2013. Protection of identifiable and sensitive information.
Sec. 2014. Data sharing.
Subtitle C--Supporting Young Emerging Scientists
Sec. 2021. Investing in the next generation of researchers.
Sec. 2022. Improvement of loan repayment program.
Subtitle D--National Institutes of Health Planning and Administration
Sec. 2031. National Institutes of Health strategic plan.
Sec. 2032. Triennial reports.
Sec. 2033. Increasing accountability at the National Institutes of
Health.
Sec. 2034. Reducing administrative burden for researchers.
Sec. 2035. Exemption for the National Institutes of Health from the
Paperwork Reduction Act requirements.
Sec. 2036. High-risk, high-reward research.
Sec. 2037. National Center for Advancing Translational Sciences.
Sec. 2038. Collaboration and coordination to enhance research.
Sec. 2039. Enhancing the rigor and reproducibility of scientific
research.
Sec. 2040. Improving medical rehabilitation research at the National
Institutes of Health.
[[Page 130 STAT. 1034]]
Sec. 2041. Task force on research specific to pregnant women and
lactating women.
Sec. 2042. Streamlining National Institutes of Health reporting
requirements.
Sec. 2043. Reimbursement for research substances and living organisms.
Sec. 2044. Sense of Congress on increased inclusion of underrepresented
populations in clinical trials.
Subtitle E--Advancement of the National Institutes of Health Research
and Data Access
Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.
Subtitle F--Facilitating Collaborative Research
Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research
purposes.
Subtitle G--Promoting Pediatric Research
Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
Sec. 3001. Patient experience data.
Sec. 3002. Patient-focused drug development guidance.
Sec. 3003. Streamlining patient input.
Sec. 3004. Report on patient experience drug development.
Subtitle B--Advancing New Drug Therapies
Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare
pediatric diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.
Subtitle C--Modern Trial Design and Evidence Development
Sec. 3021. Novel clinical trial designs.
Sec. 3022. Real world evidence.
Sec. 3023. Protection of human research subjects.
Sec. 3024. Informed consent waiver or alteration for clinical
investigations.
Subtitle D--Patient Access to Therapies and Information
Sec. 3031. Summary level review.
Sec. 3032. Expanded access policy.
Sec. 3033. Accelerated approval for regenerative advanced therapies.
Sec. 3034. Guidance regarding devices used in the recovery, isolation,
or delivery of regenerative advanced therapies.
Sec. 3035. Report on regenerative advanced therapies.
Sec. 3036. Standards for regenerative medicine and regenerative advanced
therapies.
Sec. 3037. Health care economic information.
Sec. 3038. Combination product innovation.
Subtitle E--Antimicrobial Innovation and Stewardship
Sec. 3041. Antimicrobial resistance monitoring.
Sec. 3042. Limited population pathway.
Sec. 3043. Prescribing authority.
Sec. 3044. Susceptibility test interpretive criteria for microorganisms;
antimicrobial susceptibility testing devices.
Subtitle F--Medical Device Innovations
Sec. 3051. Breakthrough devices.
Sec. 3052. Humanitarian device exemption.
Sec. 3053. Recognition of standards.
Sec. 3054. Certain class I and class II devices.
[[Page 130 STAT. 1035]]
Sec. 3055. Classification panels.
Sec. 3056. Institutional review board flexibility.
Sec. 3057. CLIA waiver improvements.
Sec. 3058. Least burdensome device review.
Sec. 3059. Cleaning instructions and validation data requirement.
Sec. 3060. Clarifying medical software regulation.
Subtitle G--Improving Scientific Expertise and Outreach at FDA
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical
Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional
personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter
Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
Subtitle H--Medical Countermeasures Innovation
Sec. 3081. Medical countermeasure guidelines.
Sec. 3082. Clarifying BARDA contracting authority.
Sec. 3083. Countermeasure budget plan.
Sec. 3084. Medical countermeasures innovation.
Sec. 3085. Streamlining Project BioShield procurement.
Sec. 3086. Encouraging treatments for agents that present a national
security threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health
emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use
authorization.
Subtitle I--Vaccine Access, Certainty, and Innovation
Sec. 3091. Predictable review timelines of vaccines by the Advisory
Committee on Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on
Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.
Subtitle J--Technical Corrections
Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.
TITLE IV--DELIVERY
Sec. 4001. Assisting doctors and hospitals in improving quality of care
for patients.
Sec. 4002. Transparent reporting on usability, security, and
functionality.
Sec. 4003. Interoperability.
Sec. 4004. Information blocking.
Sec. 4005. Leveraging electronic health records to improve patient care.
Sec. 4006. Empowering patients and improving patient access to their
electronic health information.
Sec. 4007. GAO study on patient matching.
Sec. 4008. GAO study on patient access to health information.
Sec. 4009. Improving Medicare local coverage determinations.
Sec. 4010. Medicare pharmaceutical and technology ombudsman.
Sec. 4011. Medicare site-of-service price transparency.
Sec. 4012. Telehealth services in Medicare.
TITLE V--SAVINGS
Sec. 5001. Savings in the Medicare Improvement Fund.
Sec. 5002. Medicaid reimbursement to States for durable medical
equipment.
Sec. 5003. Penalties for violations of grants, contracts, and other
agreements.
Sec. 5004. Reducing overpayments of infusion drugs.
Sec. 5005. Increasing oversight of termination of Medicaid providers.
Sec. 5006. Requiring publication of fee-for-service provider directory.
Sec. 5007. Fairness in Medicaid supplemental needs trusts.
Sec. 5008. Eliminating Federal financial participation with respect to
expenditures under Medicaid for agents used for cosmetic
purposes or hair growth.
Sec. 5009. Amendment to the Prevention and Public Health Fund.
Sec. 5010. Strategic Petroleum Reserve drawdown.
Sec. 5011. Rescission of portion of ACA territory funding.
Sec. 5012. Medicare coverage of home infusion therapy.
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
Sec. 6000. Short title.
[[Page 130 STAT. 1036]]
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A--Leadership
Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and
Mental Health Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance
abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.
Subtitle B--Oversight and Accountability
Sec. 6021. Improving oversight of mental and substance use disorders
programs through the Assistant Secretary for Planning and
Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
Committee.
TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs
and practices.
Sec. 7003. Priority mental health needs of regional and national
significance.
Sec. 7004. Priority substance use disorder treatment needs of regional
and national significance.
Sec. 7005. Priority substance use disorder prevention needs of regional
and national significance.
TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse
prevention and treatment block grant and the community mental
health services block grant.
TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
CARE
Subtitle A--Helping Individuals and Families
Sec. 9001. Grants for treatment and recovery for homeless individuals.
Sec. 9002. Grants for jail diversion programs.
Sec. 9003. Promoting integration of primary and behavioral health care.
Sec. 9004. Projects for assistance in transition from homelessness.
Sec. 9005. National Suicide Prevention Lifeline Program.
Sec. 9006. Connecting individuals and families with care.
Sec. 9007. Strengthening community crisis response systems.
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
Sec. 9009. Adult suicide prevention.
Sec. 9010. Mental health awareness training grants.
Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska
Native youth within suicide prevention programs.
Sec. 9012. Evidence-based practices for older adults.
Sec. 9013. National violent death reporting system.
Sec. 9014. Assisted outpatient treatment.
Sec. 9015. Assertive community treatment grant program.
Sec. 9016. Sober truth on preventing underage drinking reauthorization.
Sec. 9017. Center and program repeals.
Subtitle B--Strengthening the Health Care Workforce
Sec. 9021. Mental and behavioral health education and training grants.
[[Page 130 STAT. 1037]]
Sec. 9022. Strengthening the mental and substance use disorders
workforce.
Sec. 9023. Clarification on current eligibility for loan repayment
programs.
Sec. 9024. Minority fellowship program.
Sec. 9025. Liability protections for health professional volunteers at
community health centers.
Sec. 9026. Reports.
Subtitle C--Mental Health on Campus Improvement
Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.
TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
CHILDREN AND ADOLESCENTS
Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention
services for children and adolescents.
Sec. 10004. Children's recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion,
intervention, and treatment.
TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of protected
health information.
Sec. 11004. Development and dissemination of model training programs.
TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
Sec. 12001. Rule of construction related to Medicaid coverage of mental
health services and primary care services furnished on the
same day.
Sec. 12002. Study and report related to Medicaid managed care
regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric
demonstration project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal
care services and home health care services under Medicaid.
TITLE XIII--MENTAL HEALTH PARITY
Sec. 13001. Enhanced compliance with mental health and substance use
disorder coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and
substance use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health
and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use
disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.
TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A--Mental Health and Safe Communities
Sec. 14001. Law enforcement grants for crisis intervention teams, mental
health purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges in
drug courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
[[Page 130 STAT. 1038]]
Sec. 14012. Co-occurring substance abuse and mental health challenges in
residential substance abuse treatment programs.
Sec. 14013. Mental health and drug treatment alternatives to
incarceration programs.
Sec. 14014. National criminal justice and mental health training and
technical assistance.
Sec. 14015. Improving Department of Justice data collection on mental
illness involved in crime.
Sec. 14016. Reports on the number of mentally ill offenders in prison.
Sec. 14017. Codification of due process for determinations by secretary
of veterans affairs of mental capacity of beneficiaries.
Sec. 14018. Reauthorization of appropriations.
Subtitle B--Comprehensive Justice and Mental Health
Sec. 14021. Sequential intercept model.
Sec. 14022. Prison and jails.
Sec. 14023. Allowable uses.
Sec. 14024. Law enforcement training.
Sec. 14025. Federal law enforcement training.
Sec. 14026. GAO report.
Sec. 14027. Evidence based practices.
Sec. 14028. Transparency, program accountability, and enhancement of
local authority.
Sec. 14029. Grant accountability.
DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
AMERICANS
Sec. 15000. Short title.
TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
similar hospital services.
Sec. 15002. Establishing beneficiary equity in the Medicare hospital
readmission program.
Sec. 15003. Five-year extension of the rural community hospital
demonstration program.
Sec. 15004. Regulatory relief for LTCHs.
Sec. 15005. Savings from IPPS MACRA pay-for through not applying
documentation and coding adjustments.
Sec. 15006. Extension of certain LTCH Medicare payment rules.
Sec. 15007. Application of rules on the calculation of hospital length
of stay to all LTCHs.
Sec. 15008. Change in Medicare classification for certain hospitals.
Sec. 15009. Temporary exception to the application of the Medicare LTCH
site neutral provisions for certain spinal cord specialty
hospitals.
Sec. 15010. Temporary extension to the application of the Medicare LTCH
site neutral provisions for certain discharges with severe
wounds.
TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
Sec. 16001. Continuing Medicare payment under HOPD prospective payment
system for services furnished by mid-build off-campus
outpatient departments of providers.
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient
department of a provider policy.
Sec. 16003. Treatment of eligible professionals in ambulatory surgical
centers for meaningful use and MIPS.
Sec. 16004. Continuing Access to Hospitals Act of 2016.
Sec. 16005. Delay of implementation of Medicare fee schedule adjustments
for wheelchair accessories and seating systems when used in
conjunction with complex rehabilitation technology (CRT)
wheelchairs.
Sec. 16006. Allowing physical therapists to utilize locum tenens
arrangements under Medicare.
Sec. 16007. Extension of the transition to new payment rates for durable
medical equipment under the Medicare program.
Sec. 16008. Requirements in determining adjustments using information
from competitive bidding programs.
TITLE XVII--OTHER MEDICARE PROVISIONS
Sec. 17001. Delay in authority to terminate contracts for Medicare
Advantage plans failing to achieve minimum quality ratings.
[[Page 130 STAT. 1039]]
Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly
enrolled providers or suppliers within a temporary moratorium
area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare
Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a
Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the
Medicare Shared Savings Program.
TITLE XVIII--OTHER PROVISIONS
Sec. 18001. Exception from group health plan requirements for qualified
small employer health reimbursement arrangements.
DIVISION <<NOTE: 21st Century Cures Act.>> A--21ST CENTURY CURES
SEC. 1000. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This Division may be cited as the ``21st Century Cures Act''.
TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION PROJECTS.
(a) In General.--The Director of the National Institutes of Health
(referred to in this section as the ``Director of NIH'') shall use any
funds appropriated pursuant to the authorization of appropriations in
subsection (b)(3) to carry out the National Institutes of Health
innovation projects described in subsection (b)(4) (referred to in this
section as the ``NIH Innovation Projects'').
(b) National Institutes of Health Innovation Account.--
(1) Establishment of nih innovation account.--There is
established in the Treasury an account, to be known as the ``NIH
Innovation Account'' (referred to in this subsection as the
``Account''), for purposes of carrying out the NIH Innovation
Projects described in paragraph (4).
(2) Transfer of direct spending savings.--
(A) In general.--The following amounts shall be
transferred to the Account from the general fund of the
Treasury:
(i) For fiscal year 2017, $352,000,000.
(ii) For fiscal year 2018, $496,000,000.
(iii) For fiscal year 2019, $711,000,000.
(iv) For fiscal year 2020, $492,000,000.
(v) For fiscal year 2021, $404,000,000.
(vi) For fiscal year 2022, $496,000,000.
(vii) For fiscal year 2023, $1,085,000,000.
(viii) For fiscal year 2024, $407,000,000.
(ix) For fiscal year 2025, $127,000,000.
(x) For fiscal year 2026, $226,000,000.
(B) Amounts deposited.--Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant to
paragraph (3).
(3) Appropriations.--
(A) Authorization of appropriations.--For each of
the fiscal years 2017 through 2026, there is authorized
[[Page 130 STAT. 1040]]
to be appropriated from the Account to the Director of
NIH, for the purpose of carrying out the NIH Innovation
Projects, an amount not to exceed the total amount
transferred to the Account under paragraph (2)(A), to
remain available until expended.
(B) Offsetting future appropriations.--For any of
fiscal years 2017 through 2026, for any discretionary
appropriation under the heading ``NIH Innovation
Account'' provided to the Director of NIH pursuant to
the authorization of appropriations under subparagraph
(A) for the purpose of carrying out the NIH Innovation
Projects, the total amount of such appropriations for
the applicable fiscal year (not to exceed the total
amount remaining in the Account) shall be subtracted
from the estimate of discretionary budget authority and
the resulting outlays for any estimate under the
Congressional Budget and Impoundment Control Act of 1974
or the Balanced Budget and Emergency Deficit Control Act
of 1985, and the amount transferred to the Account shall
be reduced by the same amount.
(4) NIH innovation projects.--NIH Innovation Projects
authorized to be funded under this section shall consist of the
following and, of the total amounts authorized to be
appropriated under paragraph (3), there are authorized to be
appropriated to each such project a total amount not to exceed
the following, over the period of fiscal years 2017 through
2026:
(A) For the Precision Medicine Initiative, including
for the advancement of a cohort of individuals to
support the goals of the Precision Medicine Initiative,
not to exceed a total of $1,455,000,000, as follows:
(i) For fiscal year 2017, $40,000,000.
(ii) For fiscal year 2018, $100,000,000.
(iii) For fiscal year 2019, $186,000,000.
(iv) For fiscal year 2020, $149,000,000.
(v) For fiscal year 2021, $109,000,000.
(vi) For fiscal year 2022, $150,000,000.
(vii) For fiscal year 2023, $419,000,000.
(viii) For fiscal year 2024, $235,000,000.
(ix) For fiscal year 2025, $36,000,000.
(x) For fiscal year 2026, $31,000,000.
(B) For the Brain Research through Advancing
Innovative Neurotechnologies Initiative (known as the
``BRAIN Initiative''), not to exceed a total of
$1,511,000,000, as follows:
(i) For fiscal year 2017, $10,000,000.
(ii) For fiscal year 2018, $86,000,000.
(iii) For fiscal year 2019, $115,000,000.
(iv) For fiscal year 2020, $140,000,000.
(v) For fiscal year 2021, $100,000,000.
(vi) For fiscal year 2022, $152,000,000.
(vii) For fiscal year 2023, $450,000,000.
(viii) For fiscal year 2024, $172,000,000.
(ix) For fiscal year 2025, $91,000,000.
(x) For fiscal year 2026, $195,000,000.
(C) To support cancer research, such as the
development of cancer vaccines, the development of more
sensitive
[[Page 130 STAT. 1041]]
diagnostic tests for cancer, immunotherapy and the
development of combination therapies, and research that
has the potential to transform the scientific field,
that has inherently higher risk, and that seeks to
address major challenges related to cancer, not to
exceed a total of $1,800,000,000, as follows:
(i) For fiscal year 2017, $300,000,000.
(ii) For fiscal year 2018, $300,000,000.
(iii) For fiscal year 2019, $400,000,000.
(iv) For fiscal year 2020, $195,000,000.
(v) For fiscal year 2021, $195,000,000.
(vi) For fiscal year 2022, $194,000,000.
(vii) For fiscal year 2023, $216,000,000.
(D) For the National Institutes of Health, in
coordination with the Food and Drug Administration, to
award grants and contracts for clinical research to
further the field of regenerative medicine using adult
stem cells, including autologous stem cells, for which
grants and contracts shall be contingent upon the
recipient making available non-Federal contributions
toward the costs of such research in an amount not less
than $1 for each $1 of Federal funds provided in the
award, not to exceed a total of $30,000,000, as follows:
(i) For fiscal year 2017, $2,000,000.
(ii) For each of fiscal years 2018 and 2019,
$10,000,000.
(iii) For fiscal year 2020, $8,000,000.
(iv) For each of fiscal years 2021 through
2026, $0.
(c) Accountability and Oversight.--
(1) Work plan.--
(A) In general.--Not later than 180 days after the
date of enactment of this Act, the Director of NIH shall
submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of
Representatives, a work plan including the proposed
allocation of funds authorized to be appropriated
pursuant to subsection (b)(3) for each of fiscal years
2017 through 2026 for the NIH Innovation Projects and
the contents described in subparagraph (B).
(B) Contents.--The work plan submitted under
subparagraph (A) shall include--
(i) recommendations from the Advisory
Committee described in subparagraph (C);
(ii) the amount of money to be obligated or
expended in each fiscal year for each NIH
Innovation Project;
(iii) a description and justification of each
such project; and
(iv) a description of how each such project
supports the strategic research priorities
identified in the NIH Strategic Plan under
subsection (m) of section 402 of the Public Health
Service Act (42 U.S.C. 282), as added by section
2031.
[[Page 130 STAT. 1042]]
(C) Recommendations.--Prior to submitting the work
plan under this paragraph, the Director of NIH shall
seek recommendations from the Advisory Committee to the
Director of NIH appointed under section 222 of the
Public Health Service Act (42 U.S.C. 217a) on--
(i) the allocations of funds appropriated
pursuant to the authorization of appropriations
under subsection (b)(3) for each of fiscal years
2017 through 2026; and
(ii) on the contents of the proposed work
plan.
(2) Reports.--
(A) Annual reports.--Not later than October 1 of
each of fiscal years 2018 through 2027, the Director of
NIH shall submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate and the Committee on Energy and Commerce
and the Committee on Appropriations of the House of
Representatives, a report including--
(i) the amount of money obligated or expended
in the prior fiscal year for each NIH Innovation
Project;
(ii) a description of any such project using
funds provided pursuant to the authorization of
appropriations under subsection (b)(3); and
(iii) whether such projects are advancing the
strategic research priorities identified in the
NIH Strategic Plan under subsection (m) of section
402 of the Public Health Service Act (42 U.S.C.
282), as added by section 2031.
(B) Additional reports.--At the request of the
Committee on Health, Education, Labor, and Pensions or
the Committee on Appropriations of the Senate, or the
Committee on Energy and Commerce or the Committee on
Appropriations of the House of Representatives, the
Director of NIH shall provide an update in the form of
testimony and any additional reports to the respective
congressional committee regarding the allocation of
funding under this section or the description of the NIH
Innovation Projects.
(d) Limitations.--Notwithstanding any transfer authority authorized
by this Act or any appropriations Act, any funds made available pursuant
to the authorization of appropriations under subsection (b)(3) may not
be used for any purpose other than a NIH Innovation Project.
(e) Sunset.--This section shall expire on September 30, 2026.
SEC. 1002. FDA INNOVATION PROJECTS.
(a) In General.--The Commissioner of Food and Drugs (referred to in
this section as the ``Commissioner'') shall use any funds appropriated
pursuant to the authorization of appropriations under subsection (b)(3)
to carry out the activities described in subsection (b)(4).
(b) FDA Innovation Account.--
(1) Establishment of fda innovation account.--There is
established in the Treasury an account, to be known as the ``FDA
Innovation Account'' (referred to in this subsection as the
``Account''), for purposes of carrying out the activities
described in paragraph (4).
(2) Transfer of direct spending savings.--
[[Page 130 STAT. 1043]]
(A) In general.--For each of fiscal years 2017
through 2025, the following amounts shall be transferred
to the Account from the general fund of the Treasury:
(i) For fiscal year 2017, $20,000,000.
(ii) For fiscal year 2018, $60,000,000.
(iii) For fiscal year 2019, $70,000,000.
(iv) For fiscal year 2020, $75,000,000.
(v) For fiscal year 2021, $70,000,000.
(vi) For fiscal year 2022, $50,000,000.
(vii) For fiscal year 2023, $50,000,000.
(viii) For fiscal year 2024, $50,000,000.
(ix) For fiscal year 2025, $55,000,000.
(B) Amounts deposited.--Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant to
paragraph (3).
(3) Appropriations.--
(A) Authorization of appropriations.--For each of
the fiscal years 2017 through 2025, there is authorized
to be appropriated from the Account to the Commissioner,
for the purpose of carrying out the activities described
in paragraph (5), an amount not to exceed the total
amount transferred to the Account under paragraph
(2)(A), to remain available until expended.
(B) Offsetting future appropriations.--For any of
fiscal years 2017 through 2025, for any discretionary
appropriation under the heading ``FDA Innovation
Account'' provided to the Commissioner pursuant to the
authorization of appropriations under subparagraph (A)
for the purpose of carrying out the projects activities
described in paragraph (4), the total amount of such
appropriations in the applicable fiscal year (not to
exceed the total amount remaining in the Account) shall
be subtracted from the estimate of discretionary budget
authority and the resulting outlays for any estimate
under the Congressional Budget and Impoundment Control
Act of 1974 or the Balanced Budget and Emergency Deficit
Control Act of 1985, and the amount transferred to the
Account shall be reduced by the same amount.
(4) FDA activities.--The activities authorized to be funded
under this section are the activities under subtitles A through
F (including the amendments made by such subtitles) of title III
of this Act and section 1014 of the Federal Food, Drug, and
Cosmetic Act, as added by section 3073 of this Act.
(c) Accountability and Oversight.--
(1) Work plan.--
(A) In general.--Not later than 180 days after the
date of enactment of this Act, the Commissioner shall
submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of
Representatives, a work plan including the proposed
allocation of funds appropriated pursuant to the
authorization of appropriations under subsection (b)(3)
for each of fiscal years 2017 through 2025 and the
contents described in subparagraph (B).
[[Page 130 STAT. 1044]]
(B) Contents.--The work plan submitted under
subparagraph (A) shall include--
(i) recommendations from the Advisory
Committee described in subparagraph (C);
(ii) the amount of money to be obligated or
expended in each fiscal year for each activity
described in subsection (b)(4); and
(iii) a description and justification of each
such project activity.
(C) Recommendations.--Prior to submitting the work
plan under this paragraph, the Commissioner shall seek
recommendations from the Science Board to the Food and
Drug Administration, on the proposed allocation of funds
appropriated pursuant to the authorization of
appropriations under subsection (b)(3) for each of
fiscal years 2017 through 2025 and on the contents of
the proposed work plan.
(2) Reports.--
(A) Annual reports.--Not later than October 1 of
each of fiscal years 2018 through 2026, the Commissioner
shall submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate and the Committee on Energy and Commerce
and the Committee on Appropriations of the House of
Representatives, a report including--
(i) the amount of money obligated or expended
in the prior fiscal year for each activity
described in subsection (b)(4);
(ii) a description of all such activities
using funds provided pursuant to the authorization
of appropriations under subsection (b)(3); and
(iii) how the activities are advancing public
health.
(B) Additional reports.--At the request of the
Committee on Health, Education, Labor, and Pensions or
the Committee on Appropriations of the Senate, or the
Committee on Energy and Commerce or the Committee on
Appropriations of the House of Representatives, the
Commissioner shall provide an update in the form of
testimony and any additional reports to the respective
congressional committee regarding the allocation of
funding under this section or the description of the
activities undertaken with such funding.
(d) Limitations.--Notwithstanding any transfer authority authorized
by this Act or any appropriations Act, any funds made available pursuant
to the authorization of appropriations in subsection (b)(3) shall not be
used for any purpose other than an activity described in subsection
(b)(4).
(e) Sunset.--This section shall expire on September 30, 2025.
SEC. 1003. <<NOTE: 42 USC 290ee-3 note.>> ACCOUNT FOR THE STATE
RESPONSE TO THE OPIOID ABUSE CRISIS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall use any funds
appropriated pursuant to the authorization of appropriations under
subsection (b) to carry out the grant program described in subsection
(c) for purposes of addressing the opioid abuse crisis within the
States.
[[Page 130 STAT. 1045]]
(b) Account for the State Response to the Opioid Abuse Crisis.--
(1) Establishment.--There is established in the Treasury an
account, to be known as the ``Account For the State Response to
the Opioid Abuse Crisis'' (referred to in this subsection as the
``Account''), to carry out the opioid grant program described in
subsection (c).
(2) Transfer of direct spending savings.--
(A) In general.--The following amounts shall be
transferred to the Account from the general fund of the
Treasury:
(i) For fiscal year 2017, $500,000,000.
(ii) For fiscal year 2018, $500,000,000.
(B) Amounts deposited.--Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant to
paragraph (3).
(3) Appropriations.--
(A) Authorization of appropriations.--In each of the
fiscal years 2017 and 2018, there is authorized to be
appropriated from the Account to the Secretary, for the
grant program described in subsection (c), an amount not
to exceed the total amount transferred to the Account
under paragraph (2)(A), to remain available until
expended.
(B) Offsetting future appropriations.--In each of
fiscal years 2017 and 2018, for any discretionary
appropriation under the heading ``Account For the State
Response to the Opioid Abuse Crisis'' for the grant
program described in subsection (c), the total amount of
such appropriations in the applicable fiscal year (not
to exceed the total amount remaining in the Account)
shall be subtracted from the estimate of discretionary
budget authority and the resulting outlays for any
estimate under the Congressional Budget and Impoundment
Control Act of 1974 or the Balanced Budget and Emergency
Deficit Control Act of 1985, and the amount transferred
to the Account shall be reduced by the same amount.
(c) Opioid Grant Program.--
(1) State response to the opioid abuse crisis.--Subject to
the availability of appropriations, the Secretary shall award
grants to States for the purpose of addressing the opioid abuse
crisis within such States, in accordance with subparagraph (B).
In awarding such grants, the Secretary shall give preference to
States with an incidence or prevalence of opioid use disorders
that is substantially higher relative to other States.
(2) Opioid grants.--Grants awarded to a State under this
subsection shall be used for carrying out activities that
supplement activities pertaining to opioids undertaken by the
State agency responsible for administering the substance abuse
prevention and treatment block grant under subpart II of part B
of title XIX of the Public Health Service Act (42 U.S.C. 300x-21
et seq.), which may include public health-related activities
such as the following:
(A) Improving State prescription drug monitoring
programs.
[[Page 130 STAT. 1046]]
(B) Implementing prevention activities, and
evaluating such activities to identify effective
strategies to prevent opioid abuse.
(C) Training for health care practitioners, such as
best practices for prescribing opioids, pain management,
recognizing potential cases of substance abuse, referral
of patients to treatment programs, and overdose
prevention.
(D) Supporting access to health care services,
including those services provided by Federally certified
opioid treatment programs or other appropriate health
care providers to treat substance use disorders.
(E) Other public health-related activities, as the
State determines appropriate, related to addressing the
opioid abuse crisis within the State.
(d) Accountability and Oversight.--A State receiving a grant under
subsection (c) shall include in a report related to substance abuse
submitted to the Secretary pursuant to section 1942 of the Public Health
Service Act (42 U.S.C. 300x-52), a description of--
(1) the purposes for which the grant funds received by the
State under such subsection for the preceding fiscal year were
expended and a description of the activities of the State under
the program; and
(2) the ultimate recipients of amounts provided to the State
in the grant.
(e) Limitations.--Any funds made available pursuant to the
authorization of appropriations under subsection (b)--
(1) notwithstanding any transfer authority in any
appropriations Act, shall not be used for any purpose other than
the grant program in subsection (c); and
(2) shall be subject to the same requirements as substance
abuse prevention and treatment programs under titles V and XIX
of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w
et seq.).
(f) Sunset.--This section shall expire on September 30, 2026.
SEC. 1004. BUDGETARY TREATMENT.
(a) Statutory Paygo Scorecards.--The budgetary effects of division A
of this Act shall not be entered on either PAYGO scorecard maintained
pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
(b) Senate Paygo Scorecards.--The budgetary effects of division A of
this Act shall not be entered on any PAYGO scorecard maintained for
purposes of section 201 of S. Con. Res. 21 (110th Congress).
(c) Reservation of Savings.--None of the funds in the NIH Innovation
Account, the FDA Innovation Account, or the Account For the State
Response to the Opioid Abuse Crisis established by this title shall be
made available except to the extent provided in advance in
appropriations Acts, and legislation or an Act that rescinds or reduces
amounts in such accounts shall not be estimated as a reduction in direct
spending under the Congressional Budget and Impoundment Control Act of
1974 or the Balanced Budget and Emergency Deficit Control Act of 1985.
[[Page 130 STAT. 1047]]
TITLE II--DISCOVERY
Subtitle A--National Institutes of Health Reauthorization
SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
Section 402A(a)(1) of the Public Health Service Act (42 U.S.C.
282a(a)(1)) is amended--
(1) in subparagraph (B), by striking ``and'' at the end;
(2) in subparagraph (C), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
``(D) $34,851,000,000 for fiscal year 2018;
``(E) $35,585,871,000 for fiscal year 2019; and
``(F) $36,472,442,775 for fiscal year 2020.''.
SEC. 2002. <<NOTE: 42 USC 283q.>> EUREKA PRIZE COMPETITIONS.
(a) In General.--Pursuant to the authorities and processes
established under section 24 of the Stevenson-Wydler Technology
Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National
Institutes of Health shall support prize competitions for one or both of
the following goals:
(1) Identifying and funding areas of biomedical science that
could realize significant advancements through a prize
competition.
(2) Improving health outcomes, particularly with respect to
human diseases and conditions--
(A) for which public and private investment in
research is disproportionately small relative to Federal
Government expenditures on prevention and treatment
activities with respect to such diseases and conditions,
such that Federal expenditures on health programs would
be reduced;
(B) that are serious and represent a significant
disease burden in the United States; or
(C) for which there is potential for significant
return on investment to the United States.
(b) Tracking; Reporting.--The Director of the National Institutes of
Health shall--
(1) collect information on--
(A) the effect of innovations funded through the
prize competitions under this section in advancing
biomedical science or improving health outcomes pursuant
to subsection (a); and
(B) the effect of the innovations on Federal
expenditures; and
(2) include the information collected under paragraph (1) in
the triennial report under section 403 of the Public Health
Service Act (42 U.S.C. 283) (as amended by section 2032).
Subtitle B--Advancing Precision Medicine
SEC. 2011. <<NOTE: 42 USC 289g-5.>> PRECISION MEDICINE
INITIATIVE.
Part H of title IV of the Public Health Service Act (42 U.S.C. 289
et seq.) is amended by adding at the end the following:
[[Page 130 STAT. 1048]]
``SEC. 498E. PRECISION MEDICINE INITIATIVE.
``(a) In General.--The Secretary is encouraged to establish and
carry out an initiative, to be known as the `Precision Medicine
Initiative' (in this section referred to as the `Initiative'), to
augment efforts to address disease prevention, diagnosis, and treatment.
``(b) Components.--The Initiative described under subsection (a) may
include--
``(1) developing a network of scientists to assist in
carrying out the purposes of the Initiative;
``(2) developing new approaches for addressing scientific,
medical, public health, and regulatory science issues;
``(3) applying genomic technologies, such as whole genomic
sequencing, to provide data on the molecular basis of disease;
``(4) collecting information voluntarily provided by a
diverse cohort of individuals that can be used to better
understand health and disease; and
``(5) other activities to advance the goals of the
Initiative, as the Secretary determines appropriate.
``(c) Authority of the Secretary.--In carrying out this section, the
Secretary may--
``(1) coordinate with the Secretary of Energy, private
industry, and others, as the Secretary determines appropriate,
to identify and address the advanced supercomputing and other
advanced technology needs for the Initiative;
``(2) develop and utilize public-private partnerships; and
``(3) leverage existing data sources.
``(d) Requirements.--In the implementation of the Initiative under
subsection (a), the Secretary shall--
``(1) ensure the collaboration of the National Institutes of
Health, the Food and Drug Administration, the Office of the
National Coordinator for Health Information Technology, and the
Office for Civil Rights of the Department of Health and Human
Services;
``(2) comply with existing laws and regulations for the
protection of human subjects involved in research, including the
protection of participant privacy;
``(3) implement policies and mechanisms for appropriate
secure data sharing across systems that include protections for
privacy and security of data;
``(4) consider the diversity of the cohort to ensure
inclusion of a broad range of participants, including
consideration of biological, social, and other determinants of
health that contribute to health disparities;
``(5) ensure that only authorized individuals may access
controlled or sensitive, identifiable biological material and
associated information collected or stored in connection with
the Initiative; and
``(6) on the appropriate Internet website of the Department
of Health and Human Services, identify any entities with access
to such information and provide information with respect to the
purpose of such access, a summary of the research project for
which such access is granted, as applicable, and a description
of the biological material and associated information to which
the entity has access.
``(e) Report.--Not later than 1 year after the date of enactment of
the 21st Century Cures Act, the Secretary shall submit a report
[[Page 130 STAT. 1049]]
on the relevant data access policies and procedures to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives. Such report
shall include steps the Secretary has taken to consult with experts or
other heads of departments or agencies of the Federal Government in the
development of such policies.''.
SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.
(a) In General.--Subsection (d) of section 301 of the Public Health
Service Act (42 U.S.C. 241) is amended to read as follows:
``(d)(1)(A) If a person is engaged in biomedical, behavioral,
clinical, or other research, in which identifiable, sensitive
information is collected (including research on mental health and
research on the use and effect of alcohol and other psychoactive drugs),
the Secretary, in coordination with other agencies, as applicable--
``(i) shall issue to such person a certificate of
confidentiality to protect the privacy of individuals who are
the subjects of such research if the research is funded wholly
or in part by the Federal Government; and
``(ii) may, upon application by a person engaged in
research, issue to such person a certificate of confidentiality
to protect the privacy of such individuals if the research is
not so funded.
``(B) Except as provided in subparagraph (C), any person to whom a
certificate is issued under subparagraph (A) to protect the privacy of
individuals described in such subparagraph shall not disclose or provide
to any other person not connected with the research the name of such an
individual or any information, document, or biospecimen that contains
identifiable, sensitive information about such an individual and that
was created or compiled for purposes of the research.
``(C) The disclosure prohibition in subparagraph (B) shall not apply
to disclosure or use that is--
``(i) required by Federal, State, or local laws, excluding
instances described in subparagraph (D);
``(ii) necessary for the medical treatment of the individual
to whom the information, document, or biospecimen pertains and
made with the consent of such individual;
``(iii) made with the consent of the individual to whom the
information, document, or biospecimen pertains; or
``(iv) made for the purposes of other scientific research
that is in compliance with applicable Federal regulations
governing the protection of human subjects in research.
``(D) Any person to whom a certificate is issued under subparagraph
(A) to protect the privacy of an individual described in such
subparagraph shall not, in any Federal, State, or local civil, criminal,
administrative, legislative, or other proceeding, disclose or provide
the name of such individual or any such information, document, or
biospecimen that contains identifiable, sensitive information about the
individual and that was created or compiled for purposes of the
research, except in the circumstance described in subparagraph (C)(iii).
``(E) Identifiable, sensitive information protected under
subparagraph (A), and all copies thereof, shall be immune from the legal
process, and shall not, without the consent of the individual to whom
the information pertains, be admissible as evidence or used
[[Page 130 STAT. 1050]]
for any purpose in any action, suit, or other judicial, legislative, or
administrative proceeding.
``(F) Identifiable, sensitive information collected by a person to
whom a certificate has been issued under subparagraph (A), and all
copies thereof, shall be subject to the protections afforded by this
section for perpetuity.
``(G) The Secretary shall take steps to minimize the burden to
researchers, streamline the process, and reduce the time it takes to
comply with the requirements of this subsection.
``(2) The Secretary shall coordinate with the heads of other
applicable Federal agencies to ensure that such departments have
policies in place with respect to the issuance of a certificate of
confidentiality pursuant to paragraph (1) and other requirements of this
subsection.
``(3) Nothing in this subsection shall be construed to limit the
access of an individual who is a subject of research to information
about himself or herself collected during such individual's
participation in the research.
``(4) For purposes of this subsection, the term `identifiable,
sensitive information' means information that is about an individual and
that is gathered or used during the course of research described in
paragraph (1)(A) and--
``(A) through which an individual is identified; or
``(B) for which there is at least a very small risk, as
determined by current scientific practices or statistical
methods, that some combination of the information, a request for
the information, and other available data sources could be used
to deduce the identity of an individual.''.
(b) <<NOTE: 42 USC 241 note.>> Applicability.--Beginning 180 days
after the date of enactment of this Act, all persons engaged in research
and authorized by the Secretary of Health and Human Services to protect
information under section 301(d) of the Public Health Service Act (42
U.S.C. 241(d)) prior to the date of enactment of this Act shall be
subject to the requirements of such section (as amended by this Act).
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
Section 301 of the Public Health Service Act (42 U.S.C. 241) is
amended by adding at the end the following:
``(f)(1) The Secretary may exempt from disclosure under section
552(b)(3) of title 5, United States Code, biomedical information that is
about an individual and that is gathered or used during the course of
biomedical research if--
``(A) an individual is identified; or
``(B) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that some
combination of the information, the request, and other available
data sources could be used to deduce the identity of an
individual.
``(2)(A) Each determination of the Secretary under paragraph (1) to
exempt information from disclosure shall be made in writing and
accompanied by a statement of the basis for the determination.
``(B) Each such determination and statement of basis shall be
available to the public, upon request, through the Office of the Chief
FOIA Officer of the Department of Health and Human Services.
[[Page 130 STAT. 1051]]
``(3) Nothing in this subsection shall be construed to limit a
research participant's access to information about such participant
collected during the participant's participation in the research.''.
SEC. 2014. DATA SHARING.
(a) In General.--Section 402(b) of the Public Health Service Act (42
U.S.C. 282(b)) is amended--
(1) in paragraph (23), by striking ``and'' at the end;
(2) in paragraph (24), by striking the period and inserting
``; and''; and
(3) by inserting after paragraph (24) the following:
``(25) may require recipients of National Institutes of
Health awards to share scientific data, to the extent feasible,
generated from such National Institutes of Health awards in a
manner that is consistent with all applicable Federal laws and
regulations, including such laws and regulations for the
protection of--
``(A) human research participants, including with
respect to privacy, security, informed consent, and
protected health information; and
``(B) proprietary interests, confidential commercial
information, and the intellectual property rights of the
funding recipient.''.
(b) <<NOTE: 42 USC 282 note.>> Confidentiality.--Nothing in the
amendments made by subsection (a) authorizes the Secretary of Health and
Human Services to disclose any information that is a trade secret, or
other privileged or confidential information, described in section
552(b)(4) of title 5, United States Code, or section 1905 of title 18,
United States Code, or be construed to require recipients of grants or
cooperative agreements through the National Institutes of Health to
share such information.
Subtitle C--Supporting Young Emerging Scientists
SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.
(a) In General.--Part A of title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended by adding at the end the following:
``SEC. 404M. <<NOTE: 42 USC 283o.>> NEXT GENERATION OF
RESEARCHERS.
``(a) Next Generation of Researchers Initiative.--There shall be
established within the Office of the Director of the National Institutes
of Health, the Next Generation of Researchers Initiative (referred to in
this section as the `Initiative'), through which the Director shall
coordinate all policies and programs within the National Institutes of
Health that are focused on promoting and providing opportunities for new
researchers and earlier research independence.
``(b) Activities.--The Director of the National Institutes of
Health, through the Initiative shall--
``(1) promote policies and programs within the National
Institutes of Health that are focused on improving opportunities
for new researchers and promoting earlier research independence,
including existing policies and programs, as appropriate;
[[Page 130 STAT. 1052]]
``(2) develop, modify, or prioritize policies, as needed,
within the National Institutes of Health to promote
opportunities for new researchers and earlier research
independence, such as policies to increase opportunities for new
researchers to receive funding, enhance training and mentorship
programs for researchers, and enhance workforce diversity;
``(3) coordinate, as appropriate, with relevant agencies,
professional and academic associations, academic institutions,
and others, to improve and update existing information on the
biomedical research workforce in order to inform programs
related to the training, recruitment, and retention of
biomedical researchers; and
``(4) carry out other activities, including evaluation and
oversight of existing programs, as appropriate, to promote the
development of the next generation of researchers and earlier
research independence.''.
(b) Consideration of Recommendations.--In carrying out activities
under section 404M(b) of the Public Health Service Act, the Director of
the National Institutes of Health shall take into consideration the
recommendations made by the National Academies of Sciences, Engineering,
and Medicine as part of the comprehensive study on policies affecting
the next generation of researchers under the Department of Health and
Human Services Appropriations Act, 2016 (Public Law 114-113), and submit
a report to the Committee on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate, and the Committee on
Energy and Commerce and the Committee on Appropriations of the House of
Representatives, with respect to any actions taken by the National
Institutes of Health based on the recommendations not later than 2 years
after the completion of the study required pursuant to the Department of
Health and Human Services Appropriations Act, 2016.
SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.
(a) Intramural Loan Repayment Program.--Section 487A of the Public
Health Service Act (42 U.S.C. 288-1) is amended--
(1) by amending the section heading to read as follows:
``intramural loan repayment program'';
(2) in subsection (a)--
(A) by striking ``The Secretary shall carry out a
program'' and inserting ``The Director of the National
Institutes of Health shall, as appropriate and based on
workforce and scientific priorities, carry out a program
through the subcategories listed in subsection (b)(1)
(or modified subcategories as provided for in subsection
(b)(2))'';
(B) by striking ``conduct'' and inserting ``conduct
research'';
(C) by striking ``research with respect to acquired
immune deficiency syndrome''; and
(D) by striking ``$35,000'' and inserting
``$50,000'';
(3) by redesignating subsection (b) as subsection (d);
(4) by inserting after subsection (a), the following:
``(b) Subcategories of Research.--
``(1) In general.--In carrying out the program under
subsection (a), the Director of the National Institutes of
Health--
``(A) shall continue to focus on--
``(i) general research;
[[Page 130 STAT. 1053]]
``(ii) research on acquired immune deficiency
syndrome; and
``(iii) clinical research conducted by
appropriately qualified health professional who
are from disadvantaged backgrounds; and
``(B) may focus on an area of emerging scientific or
workforce need.
``(2) Elimination or establishment of subcategories.--The
Director of the National Institutes of Health may eliminate one
or more subcategories provided for in paragraph (1) due to
changes in workforce or scientific needs related to biomedical
research. The Director may establish other subcategory areas
based on workforce and scientific priorities if the total number
of subcategories does not exceed the number of subcategories
listed in paragraph (1).
``(c) Limitation.--The Director of the National Institutes of Health
may not enter into a contract with a health professional pursuant to
subsection (a) unless such professional has a substantial amount of
education loans relative to income (as determined pursuant to guidelines
issued by the Director).''; and
(5) by adding at the end the following:
``(e) Availability of Appropriations.--Amounts available for
carrying out this section shall remain available until the expiration of
the second fiscal year beginning after the fiscal year for which such
amounts are made available.''.
(b) Extramural Loan Repayment Program.--Section 487B of the Public
Health Service Act (42 U.S.C. 288-2) is amended--
(1) by amending the section heading to read as follows:
``extramural loan repayment program'';
(2) in subsection (a)--
(A) by striking ``The Secretary, in consultation
with the Director of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, shall
establish a program'' and inserting ``In General.--The
Director of the National Institutes of Health shall, as
appropriate and based on workforce and scientific
priorities, carry out a program through the
subcategories listed in subsection (b)(1) (or modified
subcategories as provided for in subsection (b)(2)),'';
(B) by striking ``(including graduate students)'';
(C) by striking ``with respect to contraception, or
with respect to infertility,''; and
(D) by striking ``service, not more than $35,000''
and inserting ``research, not more than $50,000'';
(3) by redesignating subsections (b) and (c) as subsections
(d) and (e), respectively;
(4) by inserting after subsection (a), the following:
``(b) Subcategories of Research.--
``(1) In general.--In carrying out the program under
subsection (a), the Director of the National Institutes of
Health--
``(A) shall continue to focus on--
``(i) contraception or infertility research;
``(ii) pediatric research, including pediatric
pharmacological research;
``(iii) minority health disparities research;
``(iv) clinical research; and
[[Page 130 STAT. 1054]]
``(v) clinical research conducted by
appropriately qualified health professional who
are from disadvantaged backgrounds; and
``(B) may focus on an area of emerging scientific or
workforce need.
``(2) Elimination or establishment of subcategories.--The
Director of the National Institutes of Health may eliminate one
or more subcategories provided for in paragraph (1) due to
changes in workforce or scientific needs related to biomedical
research. The Director may establish other subcategory areas
based on workforce and scientific priorities if the total number
of subcategories does not exceed the number of subcategories
listed in paragraph (1).
``(c) Limitation.--The Director of the National Institutes of Health
may not enter into a contract with a health professional pursuant to
subsection (a) unless such professional has a substantial amount of
education loans relative to income (as determined pursuant to guidelines
issued by the Director).'';
(5) in subsection (d) (as so redesignated), by striking
``The provisions'' and inserting ``Applicability of Certain
Provisions Regarding Obligated Service.--The provisions''; and
(6) in subsection (e) (as so redesignated), by striking
``Amounts'' and inserting ``Availability of Appropriations.--
Amounts''.
(c) Technical and Conforming Amendments.--Title IV of the Public
Health Service Act is amended--
(1) by striking section 464z-5 (42 U.S.C. 285t-2);
(2) by striking section 487C (42 U.S.C. 288-3);
(3) by striking section 487E (42 U.S.C. 288-5);
(4) by striking section 487F (42 U.S.C. 288-5a), as added by
section 205 of Public Law 106-505, relating to loan repayment
for clinical researchers; and
(5) by striking section 487F (42 U.S.C. 288-6), as added by
section 1002(b) of Public Law 106-310 relating to pediatric
research loan repayment.
(d) GAO Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to Congress a report on the efforts of the National
Institutes of Health to attract, retain, and develop emerging
scientists, including underrepresented individuals in the sciences, such
as women, racial and ethnic minorities, and other groups. Such report
shall include an analysis of the impact of the additional authority
provided to the Secretary of Health and Human Services under this Act to
address workforce shortages and gaps in priority research areas,
including which centers and research areas offered loan repayment
program participants the increased award amount.
Subtitle D--National Institutes of Health Planning and Administration
SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
(a) Strategic Plan.--Section 402 of the Public Health Service Act
(42 U.S.C. 282) is amended--
(1) in subsection (b)(5), by inserting before the semicolon
the following: ``, and through the development, implementation,
[[Page 130 STAT. 1055]]
and updating of the strategic plan developed under subsection
(m)''; and
(2) by adding at the end the following:
``(m) National Institutes of Health Strategic Plan.--
``(1) In general.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, and at least every 6
years thereafter, the Director of the National Institutes of
Health shall develop and submit to the appropriate committees of
Congress and post on the Internet website of the National
Institutes of Health, a coordinated strategy (to be known as the
`National Institutes of Health Strategic Plan') to provide
direction to the biomedical research investments made by the
National Institutes of Health, to facilitate collaboration
across the institutes and centers, to leverage scientific
opportunity, and to advance biomedicine.
``(2) Requirements.--The strategy under paragraph (1)
shall--
``(A) identify strategic research priorities and
objectives across biomedical research, including--
``(i) an assessment of the state of biomedical
and behavioral research, including areas of
opportunity with respect to basic, clinical, and
translational research;
``(ii) priorities and objectives to advance
the treatment, cure, and prevention of health
conditions;
``(iii) emerging scientific opportunities,
rising public health challenges, and scientific
knowledge gaps; and
``(iv) the identification of near-, mid-, and
long-term scientific needs;
``(B) consider, in carrying out subparagraph (A)--
``(i) disease burden in the United States and
the potential for return on investment to the
United States;
``(ii) rare diseases and conditions;
``(iii) biological, social, and other
determinants of health that contribute to health
disparities; and
``(iv) other factors the Director of National
Institutes of Health determines appropriate;
``(C) include multi-institute priorities, including
coordination of research among institutes and centers;
``(D) include strategic priorities for funding
research through the Common Fund, in accordance with
section 402A(c)(1)(C);
``(E) address the National Institutes of Health's
proposed and ongoing activities related to training and
the biomedical workforce; and
``(F) describe opportunities for collaboration with
other agencies and departments, as appropriate.
``(3) Use of plans.--Strategic plans developed and updated
by the national research institutes and national centers of the
National Institutes of Health shall be prepared regularly and in
such a manner that such plans will be informed by the strategic
plans developed and updated under this subsection. Such plans
developed by and updated by the national research institutes and
national centers shall have a common template.
[[Page 130 STAT. 1056]]
``(4) Consultation.--The Director of National Institutes of
Health shall develop the strategic plan under paragraph (1) in
consultation with the directors of the national research
institutes and national centers, researchers, patient advocacy
groups, and industry leaders.''.
(b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public
Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking
``Not later than June 1, 2007, and every 2 years thereafter,'' and
inserting ``As part of the National Institutes of Health Strategic Plan
required under section 402(m),''.
(c) Strategic Plan.--Section 492B(a) of the Public Health Service
Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the following:
``(3) Strategic planning.--
``(A) In general.--The directors of the national
institutes and national centers shall consult at least
once annually with the Director of the National
Institute on Minority Health and Health Disparities and
the Director of the Office of Research on Women's Health
regarding objectives of the national institutes and
national centers to ensure that future activities by
such institutes and centers take into account women and
minorities and are focused on reducing health
disparities.
``(B) Strategic plans.--Any strategic plan issued by
a national institute or national center shall include
details on the objectives described in subparagraph
(A).''.
SEC. 2032. TRIENNIAL REPORTS.
Section 403 of the Public Health Service Act (42 U.S.C. 283) is
amended--
(1) in the section heading, by striking ``biennial'' and
inserting ``triennial'' ; and
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``biennial'' and inserting ``triennial'';
(B) by amending paragraph (3) to read as follows:
``(3) A description of intra-National Institutes of Health
activities, including--
``(A) identification of the percentage of funds made
available by each national research institute and
national center with respect to each applicable fiscal
year for conducting or supporting research that involves
collaboration between the institute or center and 1 or
more other national research institutes or national
centers; and
``(B) recommendations for promoting coordination of
information among the centers of excellence.'';
(C) in paragraph (4)--
(i) in subparagraph (B), by striking
``demographic variables and other variables'' and
inserting ``demographic variables, including
biological and social variables and relevant age
categories (such as pediatric subgroups), and
determinants of health,''; and
(ii) in subparagraph (C)(v)--
(I) by striking ``demographic
variables and such'' and inserting
``demographic variables, including
relevant age categories (such as
pediatric subgroups), information
submitted by each
[[Page 130 STAT. 1057]]
national research institute and national
center to the Director of National
Institutes of Health under section
492B(f), and such''; and
(II) by striking ``(regarding
inclusion of women and minorities in
clinical research)'' and inserting ``and
other applicable requirements regarding
inclusion of demographic groups''; and
(D) in paragraph (6)--
(i) in the matter preceding subparagraph (A),
by striking ``the following:'' and inserting ``the
following--'';
(ii) in subparagraph (A)--
(I) by striking ``An evaluation''
and inserting ``an evaluation''; and
(II) by striking the period and
inserting ``; and'';
(iii) by striking subparagraphs (B) and (D);
(iv) by redesignating subparagraph (C) as
subparagraph (B); and
(v) in subparagraph (B), as redesignated by
clause (iv), by striking ``Recommendations'' and
inserting ``recommendations''.
SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL INSTITUTES OF
HEALTH.
(a) Appointment and Terms of Directors of National Research
Institutes and National Centers.--Subsection (a) of section 405 of the
Public Health Service Act (42 U.S.C. 284) is amended to read as follows:
``(a) Appointment.--
``(1) In general.--The Director of the National Cancer
Institute shall be appointed by the President, and the Directors
of the other national research institutes and national centers
shall be appointed by the Secretary, acting through the Director
of National Institutes of Health. Each Director of a national
research institute or national center shall report directly to
the Director of National Institutes of Health.
``(2) Appointment.--
``(A) Term.--A Director of a national research
institute or national center who is appointed by the
Secretary, acting through the Director of National
Institutes of Health, shall be appointed for 5 years.
``(B) Reappointment.--At the end of the term of a
Director of a national research institute or national
center, the Director may be reappointed in accordance
with standards applicable to the relevant appointment
mechanism. There shall be no limit on the number of
terms that a Director may serve.
``(C) Vacancies.--If the office of a Director of a
national research institute or national center becomes
vacant before the end of such Director's term, the
Director appointed to fill the vacancy shall be
appointed for a 5-year term starting on the date of such
appointment.
``(D) Current directors.--Each Director of a
national research institute or national center who is
serving on the date of enactment of the 21st Century
Cures Act shall
[[Page 130 STAT. 1058]]
be deemed to be appointed for a 5-year term under this
subsection beginning on such date of enactment.
``(E) Rule of construction.--Nothing in this
subsection shall be construed to limit the authority of
the Secretary or the Director of National Institutes of
Health to terminate the appointment of a director
referred to in subparagraph (A) before the expiration of
such director's 5-year term.
``(F) Nature of appointment.--Appointments and
reappointments under this subsection shall be made on
the basis of ability and experience as it relates to the
mission of the National Institutes of Health and its
components, including compliance with any legal
requirement that the Secretary or Director of National
Institutes of Health determines relevant.
``(3) Nonapplication of certain provision.--The restrictions
contained in section 202 of the Departments of Labor, Health and
Human Services, and Education, and Related Agencies
Appropriations Act, 1993 (Public Law 102-394; 42 U.S.C. 238f
note) related to consultants and individual scientists appointed
for limited periods of time shall not apply to Directors
appointed under this subsection.''.
(b) Review of Certain Awards by Directors.--Section 405(b) of the
Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at the
end the following:
``(3) Before an award is made by a national research institute or by
a national center for a grant for a research program or project
(commonly referred to as an `R-series grant'), other than an award
constituting a noncompetitive renewal of such a grant, or a
noncompetitive administrative supplement to such a grant, the Director
of such national research institute or national center shall, consistent
with the peer review process--
``(A) review and make the final decision with respect to
making the award; and
``(B) take into consideration, as appropriate--
``(i) the mission of the national research institute
or national center and the scientific priorities
identified in the strategic plan under section 402(m);
``(ii) programs or projects funded by other agencies
on similar research topics; and
``(iii) advice by staff and the advisory council or
board of such national research institute or national
center.''.
(c) Report on Duplication in Federal Biomedical Research.--The
Secretary of Health and Human Services (referred to in this subsection
as the ``Secretary''), shall, not later than 2 years after the date of
enactment of this Act, submit a report to Congress on efforts to prevent
and eliminate duplicative biomedical research that is not necessary for
scientific purposes. Such report shall--
(1) describe the procedures in place to identify such
duplicative research, including procedures for monitoring
research applications and funded research awards to prevent
unnecessary duplication;
(2) describe the steps taken to improve the procedures
described in paragraph (1), in response to relevant
recommendations made by the Comptroller General of the United
States;
[[Page 130 STAT. 1059]]
(3) describe how the Secretary operationally distinguishes
necessary and appropriate scientific replication from
unnecessary duplication; and
(4) provide examples of instances where the Secretary has
identified unnecessarily duplicative research and the steps
taken to eliminate the unnecessary duplication.
SEC. 2034. <<NOTE: 42 USC 3501 note.>> REDUCING ADMINISTRATIVE
BURDEN FOR RESEARCHERS.
(a) Plan Preparation and Implementation of Measures To Reduce
Administrative Burdens.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall--
(A) lead a review by research funding agencies of
all regulations and policies related to the disclosure
of financial conflicts of interest, including the
minimum threshold for reporting financial conflicts of
interest;
(B) make revisions, as appropriate, to harmonize
existing policies and reduce administrative burden on
researchers while maintaining the integrity and
credibility of research findings and protections of
human participants; and
(C) confer with the Office of the Inspector General
about the activities of such office related to financial
conflicts of interest involving research funding
agencies.
(2) Considerations.--In updating policies under paragraph
(1)(B), the Secretary shall consider--
(A) modifying the timelines for the reporting of
financial conflicts of interest to just-in-time
information by institutions receiving grant or
cooperative agreement funding from the National
Institutes of Health;
(B) ensuring that financial interest disclosure
reporting requirements are appropriate for, and relevant
to, awards that will directly fund research, which may
include modification of the definition of the term
``investigator'' for purposes of the regulations and
policies described in subparagraphs (A) and (B) of
paragraph (1); and
(C) updating any applicable training modules of the
National Institutes of Health related to Federal
financial interest disclosure.
(b) Monitoring of Subrecipients of Funding From the National
Institutes of Health.--The Director of the National Institutes of Health
(referred to in this section as the ``Director of National Institutes of
Health'') shall implement measures to reduce the administrative burdens
related to monitoring of subrecipients of grants by primary awardees of
funding from the National Institutes of Health, which may incorporate
findings and recommendations from existing and ongoing activities. Such
measures may include, as appropriate--
(1) an exemption from subrecipient monitoring requirements,
upon request from the primary awardees, provided that--
(A) the subrecipient is subject to Federal audit
requirements pursuant to the Uniform Guidance of the
Office of Management and Budget;
(B) the primary awardee conducts, pursuant to
guidance of the National Institutes of Health, a pre-
award
[[Page 130 STAT. 1060]]
evaluation of each subrecipient's risk of noncompliance
with Federal statutes and regulations, the conditions of
the subaward, and any recurring audit findings; and
(C) such exemption does not absolve the primary
awardee of liability for misconduct by subrecipients;
and
(2) the implementation of alternative grant structures that
obviate the need for subrecipient monitoring, which may include
collaborative grant models allowing for multiple primary
awardees.
(c) Reporting of Financial Expenditures.--The Secretary, in
consultation with the Director of National Institutes of Health, shall
evaluate financial expenditure reporting procedures and requirements for
recipients of funding from the National Institutes of Health and take
action, as appropriate, to avoid duplication between department and
agency procedures and requirements and minimize burden to funding
recipients.
(d) Animal Care and Use in Research.--Not later than 2 years after
the date of enactment of this Act, the Director of National Institutes
of Health, in collaboration with the Secretary of Agriculture and the
Commissioner of Food and Drugs, shall complete a review of applicable
regulations and policies for the care and use of laboratory animals and
make revisions, as appropriate, to reduce administrative burden on
investigators while maintaining the integrity and credibility of
research findings and protection of research animals. In carrying out
this effort, the Director of the National Institutes of Health shall
seek the input of experts, as appropriate. The Director of the National
Institutes of Health shall--
(1) identify ways to ensure such regulations and policies
are not inconsistent, overlapping, or unnecessarily duplicative,
including with respect to inspection and review requirements by
Federal agencies and accrediting associations;
(2) take steps to eliminate or reduce identified
inconsistencies, overlap, or duplication among such regulations
and policies; and
(3) take other actions, as appropriate, to improve the
coordination of regulations and policies with respect to
research with laboratory animals.
(e) Documentation of Personnel Expenses.--The Secretary shall
clarify the applicability of the requirements under the Office of
Management and Budget Uniform Guidance for management and certification
systems adopted by entities receiving Federal research grants through
the Department of Health and Human Services regarding documentation of
personnel expenses, including clarification of the extent to which any
flexibility to such requirements specified in such Uniform Guidance
applies to entities receiving grants through the Department of Health
and Human Services.
(f) Research Policy Board.--
(1) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Director of the Office of Management
and Budget shall establish an advisory committee, to be known as
the ``Research Policy Board'' (referred to in this subsection as
the ``Board''), to provide Federal Government officials with
information on the effects of regulations related to Federal
research requirements.
(2) Membership.--
[[Page 130 STAT. 1061]]
(A) In general.--The Board shall include not more
than 10 Federal members, including each of the following
Federal members or their designees:
(i) The Administrator of the Office of
Information and Regulatory Affairs of the Office
of Management and Budget.
(ii) The Director of the Office of Science and
Technology Policy.
(iii) The Secretary of Health and Human
Services.
(iv) The Director of the National Science
Foundation.
(v) The secretaries and directors of other
departments and agencies that support or regulate
scientific research, as determined by the Director
of the Office of Management and Budget.
(B) Non-federal members.--The Board shall be
comprised of not less than 9 and not more than 12
representatives of academic research institutions, other
private, nonprofit research institutions, or other
nonprofit organizations with relevant expertise. Such
members shall be appointed by a formal process, to be
established by the Director of the Office of Management
and Budget, in consultation with the Federal membership,
and that incorporates--
(i) nomination by members of the nonprofit
scientific research community, including academic
research institutions; and
(ii) procedures to fill membership positions
vacated before the end of a member's term.
(3) Purpose and responsibilities.--The Board shall make
recommendations regarding the modification and harmonization of
regulations and policies having similar purposes across research
funding agencies to ensure that the administrative burden of
such research policy and regulation is minimized to the greatest
extent possible and consistent with maintaining responsible
oversight of federally funded research. Activities of the Board
may include--
(A) providing thorough and informed analysis of
regulations and policies;
(B) identifying negative or adverse consequences of
existing policies and making actionable recommendations
regarding possible improvement of such policies;
(C) making recommendations with respect to efforts
within the Federal Government to improve coordination of
regulation and policy related to research;
(D) creating a forum for the discussion of research
policy or regulatory gaps, challenges, clarification, or
harmonization of such policies or regulation, and best
practices; and
(E) conducting ongoing assessment and evaluation of
regulatory burden, including development of metrics,
periodic measurement, and identification of process
improvements and policy changes.
(4) Expert subcommittees.--The Board may form temporary
expert subcommittees, as appropriate, to develop timely analysis
on pressing issues and assist the Board in anticipating future
regulatory challenges, including challenges emerging from new
scientific advances.
[[Page 130 STAT. 1062]]
(5) Reporting requirements.--Not later than 2 years after
the date of enactment of this Act, and once thereafter, the
Board shall submit a report to the Director of the Office of
Management and Budget, the Administrator of the Office of
Information and Regulatory Affairs of the Office of Management
and Budget, the Director of the Office of Science and Technology
Policy, the heads of relevant Federal departments and agencies,
the Committee on Health, Education, Labor, and Pensions of the
Senate, and the Committee on Energy and Commerce of the House of
Representatives containing formal recommendations on the
conceptualization, development, harmonization, and
reconsideration of scientific research policy, including the
regulatory benefits and burdens.
(6) Sunset.--The Board shall terminate on September 30,
2021.
(7) GAO report.--Not later than 4 years after the date of
enactment of this Act, the Comptroller General of the United
States shall conduct an independent evaluation of the activities
carried out by the Board pursuant to this subsection and submit
to the appropriate committees of Congress a report regarding the
results of the independent evaluation. Such report shall review
and assess the Board's activities with respect to the
responsibilities described in paragraph (3).
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM
THE PAPERWORK REDUCTION ACT
REQUIREMENTS.
Section 301 of the Public Health Service Act (42 U.S.C. 241), as
amended by section 2013, is further amended by adding at the end the
following:
``(g) Subchapter I of chapter 35 of title 44, United States Code,
shall not apply to the voluntary collection of information during the
conduct of research by the National Institutes of Health.''.
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.
(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282), as amended by section 2031, is further amended by adding at
the end the following:
``(n) Unique Research Initiatives.--
``(1) In general.--The Director of NIH may approve, after
consideration of a proposal under paragraph (2)(A), requests by
the national research institutes and centers, or program
officers within the Office of the Director to engage in
transactions other than a contract, grant, or cooperative
agreement with respect to projects that carry out--
``(A) the Precision Medicine Initiative under
section 498E; or
``(B) section 402(b)(7), except that not more than
50 percent of the funds available for a fiscal year
through the Common Fund under section 402A(c)(1) for
purposes of carrying out such section 402(b)(7) may be
used to engage in such other transactions.
``(2) Requirements.--The authority provided under this
subsection may be used to conduct or support high impact
cutting-edge research described in paragraph (1) using the other
transactions authority described in such paragraph if the
institute, center, or office--
[[Page 130 STAT. 1063]]
``(A) submits a proposal to the Director of NIH for
the use of such authority before conducting or
supporting the research, including why the use of such
authority is essential to promoting the success of the
project;
``(B) receives approval for the use of such
authority from the Director of NIH; and
``(C) for each year in which the institute, center,
or office has used such authority in accordance with
this subsection, submits a report to the Director of NIH
on the activities of the institute, center, or office
relating to such research.''.
(b) Report to Congress.--Not later than September 30, 2020, the
Secretary of Health and Human Services, acting through the Director of
the National Institutes of Health, shall conduct an evaluation of the
activities under subsection (n) of section 402 of the Public Health
Service Act (42 U.S.C. 282), as added by subsection (a), and submit a
report to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives on the results of such evaluation.
(c) Duties of Directors of Institutes.--Section 405(b)(1) of the
Public Health Service Act (42 U.S.C. 284(b)(1)) is amended--
(1) by redesignating subparagraphs (C) through (L) as
subparagraphs (D) through (M), respectively; and
(2) by inserting after subparagraph (B), the following:
``(C) shall, as appropriate, conduct and support research
that has the potential to transform the scientific field, has
inherently higher risk, and that seeks to address major current
challenges;''.
SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.
(a) In General.--Section 479(b) of the Public Health Service Act (42
U.S.C. 287(b)) is amended--
(1) in paragraph (1), by striking ``phase IIA'' and
inserting ``phase IIB''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A), by
striking ``phase IIB'' and inserting ``phase III'';
(B) in subparagraph (A), by striking ``phase IIB''
and inserting ``phase III'';
(C) in subparagraph (B), by striking ``phase IIA''
and inserting ``phase IIB''; and
(D) in subparagraph (C), by striking ``phase IIB''
and inserting ``phase III''.
(b) Increased Transparency.--Section 479 of the Public Health
Service Act (42 U.S.C. 287) is amended--
(1) in subsection (c)--
(A) in paragraph (4)(D), by striking ``and'' at the
end;
(B) in paragraph (5), by striking the period and
inserting a semicolon; and
(C) by adding at the end the following:
``(6) the methods and tools, if any, that have been
developed since the last biennial report was prepared; and
``(7) the methods and tools, if any, that have been
developed and are being utilized by the Food and Drug
Administration to support medical product reviews.''; and
[[Page 130 STAT. 1064]]
(2) by adding at the end the following:
``(d) Inclusion of List.--The first biennial report submitted under
this section after the date of enactment of the 21st Century Cures Act
shall include a complete list of all of the methods and tools, if any,
which have been developed by research supported by the Center.
``(e) Rule of Construction.--Nothing in this section shall be
construed as authorizing the Secretary to disclose any information that
is a trade secret, or other privileged or confidential information
subject to section 552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code.''.
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.
(a) Research Priorities; Collaborative Research Projects.--Section
402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
(1) by amending paragraph (4) to read as follows:
``(4) shall assemble accurate data to be used to assess
research priorities, including--
``(A) information to better evaluate scientific
opportunity, public health burdens, and progress in
reducing health disparities; and
``(B) data on study populations of clinical
research, funded by or conducted at each national
research institute and national center, which--
``(i) specifies the inclusion of--
``(I) women;
``(II) members of minority groups;
``(III) relevant age categories,
including pediatric subgroups; and
``(IV) other demographic variables
as the Director of the National
Institutes of Health determines
appropriate;
``(ii) is disaggregated by research area,
condition, and disease categories; and
``(iii) is to be made publicly available on
the Internet website of the National Institutes of
Health;''; and
(2) in paragraph (8)--
(A) in subparagraph (A), by striking ``and'' at the
end; and
(B) by adding at the end the following:
``(C) foster collaboration between clinical research
projects funded by the respective national research
institutes and national centers that--
``(i) conduct research involving human
subjects; and
``(ii) collect similar data; and
``(D) encourage the collaboration described in
subparagraph (C) to--
``(i) allow for an increase in the number of
subjects studied; and
``(ii) utilize diverse study populations, with
special consideration to biological, social, and
other determinants of health that contribute to
health disparities;''.
[[Page 130 STAT. 1065]]
(b) Reporting.--Section 492B(f) of the Public Health Service Act (42
U.S.C. 289a-2(f)) is amended--
(1) by striking ``biennial'' each place such term appears
and inserting ``triennial'';
(2) by striking ``The advisory council'' and inserting the
following:
``(1) In general.--The advisory council''; and
(3) by adding at the end the following:
``(2) Contents.--Each triennial report prepared by an
advisory council of each national research institute as
described in paragraph (1) shall include each of the following:
``(A) The number of women included as subjects, and
the proportion of subjects that are women, in any
project of clinical research conducted during the
applicable reporting period, disaggregated by categories
of research area, condition, or disease, and accounting
for single-sex studies.
``(B) The number of members of minority groups
included as subjects, and the proportion of subjects
that are members of minority groups, in any project of
clinical research conducted during the applicable
reporting period, disaggregated by categories of
research area, condition, or disease and accounting for
single-race and single-ethnicity studies.
``(C) For the applicable reporting period, the
number of projects of clinical research that include
women and members of minority groups and that--
``(i) have been completed during such
reporting period; and
``(ii) are being carried out during such
reporting period and have not been completed.
``(D) The number of studies completed during the
applicable reporting period for which reporting has been
submitted in accordance with subsection (c)(2)(A).''.
(c) Coordination.--Section 486(c)(2) of the Public Health Service
Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
inserting ``senior-level staff designees''.
(d) In General.--Part A of title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.), as amended by section 2021, is further amended
by adding at the end the following:
``SEC. 404N. <<NOTE: 42 USC 283p.>> POPULATION FOCUSED RESEARCH.
``The Director of the National Institutes of Health shall, as
appropriate, encourage efforts to improve research related to the health
of sexual and gender minority populations, including by--
``(1) facilitating increased participation of sexual and
gender minority populations in clinical research supported by
the National Institutes of Health, and reporting on such
participation, as applicable;
``(2) facilitating the development of valid and reliable
methods for research relevant to sexual and gender minority
populations; and
``(3) addressing methodological challenges.''.
(e) <<NOTE: 42 USC 283p note.>> Reporting.--
(1) In general.--The Secretary, in collaboration with the
Director of the National Institutes of Health, shall as
appropriate--
[[Page 130 STAT. 1066]]
(A) continue to support research for the development
of appropriate measures related to reporting health
information about sexual and gender minority
populations; and
(B) not later than 2 years after the date of
enactment of this Act, disseminate and make public such
measures.
(2) National academy of medicine recommendations.--In
developing the measures described in paragraph (1)(A), the
Secretary shall take into account recommendations made by the
National Academy of Medicine.
(f) Improving Coordination Related to Minority Health and Health
Disparities.--Section 464z-3 of the Public Health Service Act (42 U.S.C.
285t) is amended--
(1) by redesignating subsection (h), relating to interagency
coordination, that follows subsection (j) as subsection (k); and
(2) in subsection (k) (as so redesignated)--
(A) in the subsection heading, by striking
``Interagency'' and inserting ``Intra-National
Institutes of Health'';
(B) by striking ``as the primary Federal officials''
and inserting ``as the primary Federal official'';
(C) by inserting a comma after ``review'';
(D) by striking ``Institutes and Centers of the
National Institutes of Health'' and inserting ``national
research institutes and national centers''; and
(E) by adding at the end the following: ``The
Director of the Institute may foster partnerships
between the national research institutes and national
centers and may encourage the funding of collaborative
research projects to achieve the goals of the National
Institutes of Health that are related to minority health
and health disparities.''.
(g) <<NOTE: 42 USC 284r.>> Basic Research.--
(1) Developing policies.--Not later than 2 years after the
date of enactment of this Act, the Director of the National
Institutes of Health (referred to in this section as the
``Director of the National Institutes of Health''), taking into
consideration the recommendations developed under section 2039,
shall develop policies for projects of basic research funded by
National Institutes of Health to assess--
(A) relevant biological variables including sex, as
appropriate; and
(B) how differences between male and female cells,
tissues, or animals may be examined and analyzed.
(2) Revising policies.--The Director of the National
Institutes of Health may update or revise the policies developed
under paragraph (1) as appropriate.
(3) Consultation and outreach.--In developing, updating, or
revising the policies under this section, the Director of the
National Institutes of Health shall--
(A) consult with--
(i) the Office of Research on Women's Health;
(ii) the Office of Laboratory Animal Welfare;
and
(iii) appropriate members of the scientific
and academic communities; and
(B) conduct outreach to solicit feedback from
members of the scientific and academic communities on
the influence of sex as a variable in basic research,
including feedback
[[Page 130 STAT. 1067]]
on when it is appropriate for projects of basic research
involving cells, tissues, or animals to include both
male and female cells, tissues, or animals.
(4) Additional requirements.--The Director of the National
Institutes of Health shall--
(A) ensure that projects of basic research funded by
the National Institutes of Health are conducted in
accordance with the policies developed, updated, or
revised under this section, as applicable; and
(B) encourage that the results of such research,
when published or reported, be disaggregated as
appropriate with respect to the analysis of any sex
differences.
(h) <<NOTE: 42 USC 289a-2 note.>> Clinical Research.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Director of the National Institutes
of Health, in consultation with the Director of the Office of
Research on Women's Health and the Director of the National
Institute on Minority Health and Health Disparities, shall
update the guidelines established under section 492B(d) of
Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance
with paragraph (2).
(2) Requirements.--The updated guidelines described in
paragraph (1) shall--
(A) reflect the science regarding sex differences;
(B) improve adherence to the requirements under
section 492B of the Public Health Service Act (42 U.S.C.
289a-2), including the reporting requirements under
subsection (f) of such section; and
(C) clarify the circumstances under which studies
should be designed to support the conduct of analyses to
detect significant differences in the intervention
effect due to demographic factors related to section
492B of the Public Health Service Act, including in the
absence of prior studies that demonstrate a difference
in study outcomes on the basis of such factors and
considering the effects of the absence of such analyses
on the availability of data related to demographic
differences.
(i) <<NOTE: 42 USC 282 note.>> Appropriate Age Groupings in
Clinical Research.--
(1) Input from experts.--Not later than 180 days after the
date of enactment of this Act, the Director of the National
Institutes of Health shall convene a workshop of experts on
pediatric and older populations to provide input on--
(A) appropriate age groups to be included in
research studies involving human subjects; and
(B) acceptable justifications for excluding
participants from a range of age groups from human
subjects research studies.
(2) Policy updates.--Not later than 180 days after the
conclusion of the workshop under paragraph (1), the Director of
the National Institutes of Health shall make a determination
with respect to whether the policies of the National Institutes
of Health on the inclusion of relevant age groups in clinical
studies need to be updated, and shall update such policies as
appropriate. In making the determination, the Director of the
National Institutes of Health shall take into consideration
whether such policies--
[[Page 130 STAT. 1068]]
(A) address the consideration of age as an inclusion
variable in research involving human subjects; and
(B) identify the criteria for justification for any
age-related exclusions in such research.
(3) Public availability of findings and conclusions.--The
Director of the National Institutes of Health shall--
(A) make the findings and conclusions resulting from
the workshop under paragraph (1) and updates to policies
in accordance with paragraph (2), as applicable,
available to the public on the Internet website of the
National Institutes of Health; and
(B) ensure that age-related data reported in the
triennial report under section 403 of the Public Health
Service Act (42 U.S.C. 283) (as amended by section 2032)
are made available to the public on the Internet website
of the National Institutes of Health.
SEC. 2039. <<NOTE: 42 USC 282 note.>> ENHANCING THE RIGOR AND
REPRODUCIBILITY OF SCIENTIFIC RESEARCH.
(a) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Director of the National Institutes of Health, shall
convene a working group under the Advisory Committee to the Director of
the National Institutes of Health (referred to in this section as the
``Advisory Committee''), appointed under section 222 of the Public
Health Service Act (42 U.S.C. 217a), to develop and issue
recommendations through the Advisory Committee for a formal policy,
which may incorporate or be informed by relevant existing and ongoing
activities, to enhance rigor and reproducibility of scientific research
funded by the National Institutes of Health.
(b) Considerations.--In developing and issuing recommendations
through the Advisory Committee under subsection (a), the working group
established under such subsection shall consider, as appropriate--
(1) preclinical experiment design, including analysis of sex
as a biological variable;
(2) clinical experiment design, including--
(A) the diversity of populations studied for
clinical research, with respect to biological, social,
and other determinants of health that contribute to
health disparities;
(B) the circumstances under which summary
information regarding biological, social, and other
factors that contribute to health disparities should be
reported; and
(C) the circumstances under which clinical studies,
including clinical trials, should conduct an analysis of
the data collected during the study on the basis of
biological, social, and other factors that contribute to
health disparities;
(3) applicable levels of rigor in statistical methods,
methodology, and analysis;
(4) data and information sharing in accordance with
applicable privacy laws and regulations; and
(5) any other matter the working group determines relevant.
(c) Policies.--Not later than 18 months after the date of enactment
of this Act, the Director of the National Institutes of Health shall
consider the recommendations developed by the working group
[[Page 130 STAT. 1069]]
and issued by the Advisory Committee under subsection (a) and develop or
update policies as appropriate.
(d) Report.--Not later than 2 years after the date of enactment of
this Act, the Director of the National Institutes of Health shall issue
a report to the Secretary of Health and Human Services, the Committee on
Health, Education, Labor, and Pensions of the Senate, and the Committee
on Energy and Commerce of the House of Representatives regarding
recommendations developed under subsection (a) and any subsequent policy
changes implemented, to enhance rigor and reproducibility in scientific
research funded by the National Institutes of Health.
(e) Confidentiality.--Nothing in this section authorizes the
Secretary of Health and Human Services to disclose any information that
is a trade secret, or other privileged or confidential information,
described in section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE
NATIONAL INSTITUTES OF HEALTH.
(a) In General.--Section 452 of the Public Health Service Act (42
U.S.C. 285g-4) is amended--
(1) in subsection (b), by striking ``conduct and support''
and inserting ``conduct, support, and coordination'';
(2) in subsection (c)(1)(C), by striking ``of the Center''
and inserting ``within the Center'';
(3) in subsection (d)--
(A) by striking ``(d)(1) In consultation'' and all
that follows through the end of paragraph (1) and
inserting the following:
``(d)(1) The Director of the Center, in consultation with the
Director of the Institute, the coordinating committee established under
subsection (e), and the advisory board established under subsection (f),
shall develop a comprehensive plan (referred to in this section as the
`Research Plan') for the conduct, support, and coordination of medical
rehabilitation research.'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``; and''
and inserting a semicolon;
(ii) in subparagraph (B), by striking the
period and inserting ``; and''; and
(iii) by adding at the end the following:
``(C) include goals and objectives for conducting,
supporting, and coordinating medical rehabilitation research,
consistent with the purpose described in subsection (b).'';
(C) by striking paragraph (4) and inserting the
following:
``(4) The Director of the Center, in consultation with the Director
of the Institute, the coordinating committee established under
subsection (e), and the advisory board established under subsection (f),
shall revise and update the Research Plan periodically, as appropriate,
or not less than every 5 years. Not later than 30 days after the
Research Plan is so revised and updated, the Director of the Center
shall transmit the revised and updated Research Plan to the President,
the Committee on Health, Education, Labor, and Pensions of the Senate,
and the Committee on Energy and Commerce of the House of
Representatives.''; and
(D) by adding at the end the following:
[[Page 130 STAT. 1070]]
``(5) The Director of the Center, in consultation with the Director
of the Institute, shall, prior to revising and updating the Research
Plan, prepare a report for the coordinating committee established under
subsection (e) and the advisory board established under subsection (f)
that describes and analyzes the progress during the preceding fiscal
year in achieving the goals and objectives described in paragraph (2)(C)
and includes expenditures for rehabilitation research at the National
Institutes of Health. The report shall include recommendations for
revising and updating the Research Plan, and such initiatives as the
Director of the Center and the Director of the Institute determine
appropriate. In preparing the report, the Director of the Center and the
Director of the Institute shall consult with the Director of the
National Institutes of Health.'';
(4) in subsection (e)--
(A) in paragraph (2), by inserting ``periodically
host a scientific conference or workshop on medical
rehabilitation research and'' after ``The Coordinating
Committee shall''; and
(B) in paragraph (3), by inserting ``the Director of
the Division of Program Coordination, Planning, and
Strategic Initiatives within the Office of the Director
of the National Institutes of Health,'' after ``shall be
composed of'';
(5) in subsection (f)(3)(B)--
(A) by redesignating clauses (ix) through (xi) as
clauses (x) through (xii), respectively; and
(B) by inserting after clause (viii) the following:
``(ix) The Director of the Division of Program Coordination,
Planning, and Strategic Initiatives.''; and
(6) by adding at the end the following:
``(g)(1) The Secretary and the heads of other Federal agencies shall
jointly review the programs carried out (or proposed to be carried out)
by each such official with respect to medical rehabilitation research
and, as appropriate, enter into agreements preventing duplication among
such programs.
``(2) The Secretary shall, as appropriate, enter into interagency
agreements relating to the coordination of medical rehabilitation
research conducted by agencies of the National Institutes of Health and
other agencies of the Federal Government.
``(h) For purposes of this section, the term `medical rehabilitation
research' means the science of mechanisms and interventions that
prevent, improve, restore, or replace lost, underdeveloped, or
deteriorating function.''.
(b) Conforming Amendment.--Section 3 of the National Institutes of
Health Amendments of 1990 (42 U.S.C. 285g-4 note) is amended--
(1) in subsection (a), by striking ``In General.--''; and
(2) by striking subsection (b).
SEC. 2041. <<NOTE: 42 USC 289a-2 note.>> TASK FORCE ON RESEARCH
SPECIFIC TO PREGNANT WOMEN AND LACTATING
WOMEN.
(a) Task Force on Research Specific to Pregnant Women and Lactating
Women.--
(1) Establishment.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall establish a task force, in accordance with the Federal
Advisory Committee Act (5 U.S.C. App.), to be known as the
``Task
[[Page 130 STAT. 1071]]
Force on Research Specific to Pregnant Women and Lactating
Women'' (in this section referred to as the ``Task Force'').
(2) Duties.--The Task Force shall provide advice and
guidance to the Secretary regarding Federal activities related
to identifying and addressing gaps in knowledge and research
regarding safe and effective therapies for pregnant women and
lactating women, including the development of such therapies and
the collaboration on and coordination of such activities.
(3) Membership.--
(A) Federal members.--The Task Force shall be
composed of each of the following Federal members, or
the designees of such members:
(i) The Director of the Centers for Disease
Control and Prevention.
(ii) The Director of the National Institutes
of Health, the Director of the Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, and the directors of such other
appropriate national research institutes.
(iii) The Commissioner of Food and Drugs.
(iv) The Director of the Office on Women's
Health.
(v) The Director of the National Vaccine
Program Office.
(vi) The head of any other research-related
agency or department not described in clauses (i)
through (v) that the Secretary determines
appropriate, which may include the Department of
Veterans Affairs and the Department of Defense.
(B) Non-federal members.--The Task Force shall be
composed of each of the following non-Federal members,
including--
(i) representatives from relevant medical
societies with subject matter expertise on
pregnant women, lactating women, or children;
(ii) nonprofit organizations with expertise
related to the health of women and children;
(iii) relevant industry representatives; and
(iv) other representatives, as appropriate.
(C) Limitations.--The non-Federal members described
in subparagraph (B) shall--
(i) compose not more than one-half, and not
less than one-third, of the total membership of
the Task Force; and
(ii) be appointed by the Secretary.
(4) Termination.--
(A) In general.--Subject to subparagraph (B), the
Task Force shall terminate on the date that is 2 years
after the date on which the Task Force is established
under paragraph (1).
(B) Extension.--The Secretary may extend the
operation of the Task Force for one additional 2-year
period following the 2-year period described in
subparagraph (A), if the Secretary determines that the
extension is appropriate for carrying out the purpose of
this section.
(5) Meetings.--The Task Force shall meet not less than 2
times each year and shall convene public meetings, as
appropriate, to fulfill its duties under paragraph (2).
[[Page 130 STAT. 1072]]
(6) Task force report to congress.--Not later than 18 months
after the date on which the Task Force is established under
paragraph (1), the Task Force shall prepare and submit to the
Secretary, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and Commerce
of the House of Representatives a report that includes each of
the following:
(A) A plan to identify and address gaps in knowledge
and research regarding safe and effective therapies for
pregnant women and lactating women, including the
development of such therapies.
(B) Ethical issues surrounding the inclusion of
pregnant women and lactating women in clinical research.
(C) Effective communication strategies with health
care providers and the public on information relevant to
pregnant women and lactating women.
(D) Identification of Federal activities,
including--
(i) the state of research on pregnancy and
lactation;
(ii) recommendations for the coordination of,
and collaboration on research related to pregnant
women and lactating women;
(iii) dissemination of research findings and
information relevant to pregnant women and
lactating women to providers and the public; and
(iv) existing Federal efforts and programs to
improve the scientific understanding of the health
impacts on pregnant women, lactating women, and
related birth and pediatric outcomes, including
with respect to pharmacokinetics,
pharmacodynamics, and toxicities.
(E) Recommendations to improve the development of
safe and effective therapies for pregnant women and
lactating women.
(b) Confidentiality.--Nothing in this section shall authorize the
Secretary of Health and Human Services to disclose any information that
is a trade secret, or other privileged or confidential information,
described in section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
(c) Updating Protections for Pregnant Women and Lactating Women in
Research.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary, considering any
recommendations of the Task Force available at such time and in
consultation with the heads of relevant agencies of the
Department of Health and Human Services, shall, as appropriate,
update regulations and guidance, as applicable, regarding the
inclusion of pregnant women and lactating women in clinical
research.
(2) Criteria for excluding pregnant or lactating women.--In
updating any regulations or guidance described in paragraph (1),
the Secretary shall consider any appropriate criteria to be used
by institutional review boards and individuals reviewing grant
proposals for excluding pregnant women or lactating women as a
study population requiring additional protections from
participating in human subject research.
[[Page 130 STAT. 1073]]
SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH REPORTING
REQUIREMENTS.
(a) Trans-National Institutes of Health Research Reporting.--Section
402A(c)(2) of the Public Health Service Act (42 U.S.C. 282a(c)(2)) is
amended--
(1) by amending subparagraph (B) to read as follows:
``(B) Reporting.--Not later than 2 years after the
date of enactment of 21st Century Cures Act, the head of
each national research institute or national center
shall submit to the Director of the National Institutes
of Health a report, to be included in the triennial
report under section 403, on the amount made available
by the institute or center for conducting or supporting
research that involves collaboration between the
institute or center and 1 or more other national
research institutes or national centers.''; and
(2) in subparagraphs (D) and (E) by striking ``(B)(i)'' each
place it appears and inserting ``(B)''.
(b) Fraud and Abuse Reporting.--Section 403B of the Public Health
Service Act (42 U.S.C. 283a-1) is amended--
(1) by striking subsection (b);
(2) by redesignating subsection (c) as subsection (b); and
(3) in subsection (b) (as so redesignated), by striking
``subsections (a) and (b)'' and inserting ``subsection (a)''.
(c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public
Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking
``(not including any leaves of absence)''.
(d) Vaccine Reporting.--Section 404B of the Public Health Service
Act (42 U.S.C. 283d) is amended--
(1) by striking subsection (b); and
(2) by striking ``(a) Development of New Vaccines.--The
Secretary'' and inserting ``The Secretary''.
(e) National Center for Advancing Translational Sciences.--Section
479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
(1) in the subsection heading, by striking ``Annual'' and
inserting ``Biennial''; and
(2) in the matter preceding paragraph (1), by striking ``an
annual report'' and inserting ``a report on a biennial basis''.
(f) Review of Centers of Excellence.--
(1) Repeal.--Section 404H of the Public Health Service Act
(42 U.S.C. 283j) is repealed.
(2) Conforming amendment.--Section 399EE(c) of the Public
Health Service Act (42 U.S.C. 280-4(c)) is amended by striking
``399CC, 404H,'' and inserting ``399CC''.
(g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE
Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
(1) by striking paragraph (2); and
(2) by redesignating paragraph (3) as paragraph (2).
(h) National Institute of Nursing Research.--
(1) Repeal.--Section 464Y of the Public Health Service Act
(42 U.S.C. 285q-3) is repealed.
(2) Conforming amendment.--Section 464X(g) of the Public
Health Service Act (42 U.S.C. 285q-2(g)) is amended by striking
``biennial report made under section 464Y,'' and inserting
``triennial report made under section 403''.
[[Page 130 STAT. 1074]]
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING
ORGANISMS.
Section 301 of the Public Health Service Act (42 U.S.C. 241), as
amended by section 2035, is further amended--
(1) in the flush matter at the end of subsection (a)--
(A) by redesignating such matter as subsection
(h)(1); and
(B) by moving such matter so as to appear at the end
of such section; and
(2) in subsection (h) (as so redesignated), by adding at the
end the following:
``(2) Where research substances and living organisms are made
available under paragraph (1) through contractors, the Secretary may
direct such contractors to collect payments on behalf of the Secretary
for the costs incurred to make available such substances and organisms
and to forward amounts so collected to the Secretary, in the time and
manner specified by the Secretary.
``(3) Amounts collected under paragraph (2) shall be credited to the
appropriations accounts that incurred the costs to make available the
research substances and living organisms involved, and shall remain
available until expended for carrying out activities under such
accounts.''.
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF
UNDERREPRESENTED POPULATIONS IN CLINICAL
TRIALS.
It is the sense of Congress that the National Institute on Minority
Health and Health Disparities should include within its strategic plan
under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m))
ways to increase representation of underrepresented populations in
clinical trials.
Subtitle E--Advancement of the National Institutes of Health Research
and Data Access
SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
282(j)(2)(D)) is amended--
(1) in clause (ii)(I), by inserting before the semicolon ``,
unless the responsible party affirmatively requests that the
Director of the National Institutes of Health publicly post such
clinical trial information for an applicable device clinical
trial prior to such date of clearance or approval''; and
(2) by adding at the end the following:
``(iii) Option to make certain clinical trial
information available earlier.--The Director of
the National Institutes of Health shall inform
responsible parties of the option to request that
clinical trial information for an applicable
device clinical trial be publicly posted prior to
the date of clearance or approval, in accordance
with clause (ii)(I).
``(iv) Combination products.--An applicable
clinical trial for a product that is a combination
of drug, device, or biological product shall be
considered--
[[Page 130 STAT. 1075]]
``(I) an applicable drug clinical
trial, if the Secretary determines under
section 503(g) of the Federal Food,
Drug, and Cosmetic Act that the primary
mode of action of such product is that
of a drug or biological product; or
``(II) an applicable device clinical
trial, if the Secretary determines under
such section that the primary mode of
action of such product is that of a
device.''.
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
(a) Definitions.--In this section:
(1) Applicable clinical trial.--The term ``applicable
clinical trial'' has the meaning given the term in section
402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Report on Activities To Encourage Compliance.--Not later than 2
years after the date of enactment of this Act, the Secretary, acting
through the Director of the National Institutes of Health and in
collaboration with the Commissioner of Food and Drugs, shall submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives, a report that describes education and outreach,
guidance, enforcement, and other activities undertaken to encourage
compliance with section 402(j) of the Public Health Service Act (42
U.S.C. 282(j)).
(c) Reports on Clinical Trials.--
(1) In general.--Not later than 2 years after the final
compliance date under the final rule implementing section 402(j)
of the Public Health Service Act, and every 2 years thereafter
for the next 4 years, the Secretary, acting through the Director
of the National Institutes of Health and in collaboration with
the Commissioner of Food and Drugs, shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives, a report describing--
(A) the total number of applicable clinical trials
with complete data bank registration information
registered during the period for which the report is
being prepared (broken down by each year of such
reporting period);
(B) the total number of applicable clinical trials
registered during the period for which the report is
being prepared for which results have been submitted to
the data bank (broken down by each year of such
reporting period);
(C) the activities undertaken by the Secretary to
educate responsible persons about data bank registration
and results submission requirements, including through
issuance of guidance documents, informational meetings,
and training sessions; and
(D) the activities described in the report submitted
under subsection (b).
(2) Actions to enforce compliance.--After the Secretary has
undertaken the educational activities described in paragraph
(1)(C), the Secretary shall include in subsequent reports
[[Page 130 STAT. 1076]]
submitted under paragraph (1) the number of actions taken by the
Secretary during the period for which the report is being
prepared to enforce compliance with data bank registration and
results submission requirements.
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.
Section 492B(c) of the Public Health Service Act (42 U.S.C. 289a-
2(c)) is amended--
(1) by striking ``In the case'' and inserting the following:
``(1) In general.--In the case''; and
(2) by adding at the end the following:
``(2) Reporting requirements.--For any new and competing
project of clinical research subject to the requirements under
this section that receives a grant award 1 year after the date
of enactment of the 21st Century Cures Act, or any date
thereafter, for which a valid analysis is provided under
paragraph (1)--
``(A) and which is an applicable clinical trial as
defined in section 402(j), the entity conducting such
clinical research shall submit the results of such valid
analysis to the clinical trial registry data bank
expanded under section 402(j)(3), and the Director of
the National Institutes of Health shall, as appropriate,
consider whether such entity has complied with the
reporting requirement described in this subparagraph in
awarding any future grant to such entity, including
pursuant to section 402(j)(5)(A)(ii) when applicable;
and
``(B) the Director of the National Institutes of
Health shall encourage the reporting of the results of
such valid analysis described in paragraph (1) through
any additional means determined appropriate by the
Director.''.
SEC. 2054. CONSULTATION.
Not later than 90 days after the date of enactment of this Act, the
Secretary of Health and Human Services shall consult with relevant
Federal agencies, including the Food and Drug Administration, the Office
of the National Coordinator for Health Information Technology, and the
National Institutes of Health, as well as other stakeholders (including
patients, researchers, physicians, industry representatives, and
developers of health information technology) to receive recommendations
with respect to enhancements to the clinical trial registry data bank
under section 402(j) of the Public Health Service Act (42 U.S.C.
282(j)), including with respect to usability, functionality, and search
capability.
Subtitle F--Facilitating Collaborative Research
SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE SYSTEM.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g
et seq.) is amended by inserting after section 399S the following:
[[Page 130 STAT. 1077]]
``SEC. 399S-1. <<NOTE: 42 USC 280g-7a.>> SURVEILLANCE OF
NEUROLOGICAL DISEASES.
``(a) In General.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention and in coordination with
other agencies as the Secretary determines, shall, as appropriate--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases; and
``(2) incorporate information obtained through such
activities into an integrated surveillance system, which may
consist of or include a registry, to be known as the National
Neurological Conditions Surveillance System.
``(b) Research.--The Secretary shall ensure that the National
Neurological Conditions Surveillance System is designed in a manner that
facilitates further research on neurological diseases.
``(c) Content.--In carrying out subsection (a), the Secretary--
``(1) shall provide for the collection and storage of
information on the incidence and prevalence of neurological
diseases in the United States;
``(2) to the extent practicable, shall provide for the
collection and storage of other available information on
neurological diseases, including information related to persons
living with neurological diseases who choose to participate,
such as--
``(A) demographics, such as age, race, ethnicity,
sex, geographic location, family history, and other
information, as appropriate;
``(B) risk factors that may be associated with
neurological diseases, such as genetic and environmental
risk factors and other information, as appropriate; and
``(C) diagnosis and progression markers;
``(3) may provide for the collection and storage of
information relevant to analysis on neurological diseases, such
as information concerning--
``(A) the natural history of the diseases;
``(B) the prevention of the diseases;
``(C) the detection, management, and treatment
approaches for the diseases; and
``(D) the development of outcomes measures;
``(4) may address issues identified during the consultation
process under subsection (d); and
``(5) initially may address a limited number of neurological
diseases.
``(d) Consultation.--In carrying out this section, the Secretary
shall consult with individuals with appropriate expertise, which may
include--
``(1) epidemiologists with experience in disease
surveillance or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on neurological diseases; and
``(B) have demonstrated experience in research,
care, or patient services;
``(3) health information technology experts or other
information management specialists;
``(4) clinicians with expertise in neurological diseases;
and
``(5) research scientists with experience conducting
translational research or utilizing surveillance systems for
scientific research purposes.
[[Page 130 STAT. 1078]]
``(e) Grants.--The Secretary may award grants to, or enter into
contracts or cooperative agreements with, public or private nonprofit
entities to carry out activities under this section.
``(f) Coordination With Other Federal, State, and Local Agencies.--
Subject to subsection (h), the Secretary shall--
``(1) make information and analysis in the National
Neurological Conditions Surveillance System available, as
appropriate--
``(A) to Federal departments and agencies, such as
the National Institutes of Health and the Department of
Veterans Affairs; and
``(B) to State and local agencies; and
``(2) identify, build upon, leverage, and coordinate among
existing data and surveillance systems, surveys, registries, and
other Federal public health infrastructure, wherever
practicable.
``(g) Public Access.--Subject to subsection (h), the Secretary shall
ensure that information and analysis in the National Neurological
Conditions Surveillance System are available, as appropriate, to the
public, including researchers.
``(h) Privacy.--The Secretary shall ensure that information and
analysis in the National Neurological Conditions Surveillance System are
made available only to the extent permitted by applicable Federal and
State law, and in a manner that protects personal privacy, to the extent
required by applicable Federal and State privacy law, at a minimum.
``(i) Reports.--
``(1) Report on information and analyses.--Not later than 1
year after the date on which any system is established under
this section, the Secretary shall submit an interim report to
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives regarding aggregate information collected
pursuant to this section and epidemiological analyses, as
appropriate. Such report shall be posted on the Internet website
of the Department of Health and Human Services and shall be
updated biennially.
``(2) Implementation report.--Not later than 4 years after
the date of the enactment of this section, the Secretary shall
submit a report to the Congress concerning the implementation of
this section. Such report shall include information on--
``(A) the development and maintenance of the
National Neurological Conditions Surveillance System;
``(B) the type of information collected and stored
in the surveillance system;
``(C) the use and availability of such information,
including guidelines for such use; and
``(D) the use and coordination of databases that
collect or maintain information on neurological
diseases.
``(j) Definition.--In this section, the term `national voluntary
health association' means a national nonprofit organization with
chapters, other affiliated organizations, or networks in States
throughout the United States with experience serving the population of
individuals with neurological disease and have demonstrated experience
in neurological disease research, care, and patient services.
[[Page 130 STAT. 1079]]
``(k) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2018 through 2022.''.
SEC. 2062. <<NOTE: 42 USC 284s.>> TICK-BORNE DISEASES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as ``the Secretary'') shall continue to
conduct or support epidemiological, basic, translational, and clinical
research related to vector-borne diseases, including tick-borne
diseases.
(b) Reports.--The Secretary shall ensure that each triennial report
under section 403 of the Public Health Service Act (42 U.S.C. 283) (as
amended by section 2032) includes information on actions undertaken by
the National Institutes of Health to carry out subsection (a) with
respect to tick-borne diseases.
(c) Tick-borne Diseases Working Group.--
(1) Establishment.--The Secretary shall establish a working
group, to be known as the Tick-Borne Disease Working Group
(referred to in this section as the ``Working Group''),
comprised of representatives of appropriate Federal agencies and
other non-Federal entities, to provide expertise and to review
all efforts within the Department of Health and Human Services
related to all tick-borne diseases, to help ensure interagency
coordination and minimize overlap, and to examine research
priorities.
(2) Responsibilities.--The working group shall--
(A) not later than 2 years after the date of
enactment of this Act, develop or update a summary of--
(i) ongoing tick-borne disease research,
including research related to causes, prevention,
treatment, surveillance, diagnosis, diagnostics,
duration of illness, and intervention for
individuals with tick-borne diseases;
(ii) advances made pursuant to such research;
(iii) Federal activities related to tick-borne
diseases, including--
(I) epidemiological activities
related to tick-borne diseases; and
(II) basic, clinical, and
translational tick-borne disease
research related to the pathogenesis,
prevention, diagnosis, and treatment of
tick-borne diseases;
(iv) gaps in tick-borne disease research
described in clause (iii)(II);
(v) the Working Group's meetings required
under paragraph (4); and
(vi) the comments received by the Working
Group;
(B) make recommendations to the Secretary regarding
any appropriate changes or improvements to such
activities and research; and
(C) solicit input from States, localities, and
nongovernmental entities, including organizations
representing patients, health care providers,
researchers, and industry regarding scientific advances,
research questions, surveillance activities, and
emerging strains in species of pathogenic organisms.
[[Page 130 STAT. 1080]]
(3) Membership.--The members of the working group shall
represent a diversity of scientific disciplines and views and
shall be composed of the following members:
(A) Federal members.--Seven Federal members,
consisting of one or more representatives of each of the
following:
(i) The Office of the Assistant Secretary for
Health.
(ii) The Food and Drug Administration.
(iii) The Centers for Disease Control and
Prevention.
(iv) The National Institutes of Health.
(v) Such other agencies and offices of the
Department of Health and Human Services as the
Secretary determines appropriate.
(B) Non-Federal public members.--Seven non-Federal
public members, consisting of representatives of the
following categories:
(i) Physicians and other medical providers
with experience in diagnosing and treating tick-
borne diseases.
(ii) Scientists or researchers with expertise.
(iii) Patients and their family members.
(iv) Nonprofit organizations that advocate for
patients with respect to tick-borne diseases.
(v) Other individuals whose expertise is
determined by the Secretary to be beneficial to
the functioning of the Working Group.
(4) Meetings.--The Working Group shall meet not less than
twice each year.
(5) Reporting.--Not later than 2 years after the date of
enactment of this Act, and every 2 years thereafter until
termination of the Working Group pursuant to paragraph (7), the
Working Group shall--
(A) submit a report on its activities under
paragraph (2)(A) and any recommendations under paragraph
(2)(B) to the Secretary, the Committee on Energy and
Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of
the Senate; and
(B) make such report publicly available on the
Internet website of the Department of Health and Human
Services.
(6) Applicability of faca.--The Working Group shall be
treated as an advisory committee subject to the Federal Advisory
Committee Act (5 U.S.C. App.).
(7) Sunset.--The Working Group under this section shall
terminate 6 years after the date of enactment of this Act.
SEC. 2063. <<NOTE: 42 USC 1320d-2 note.>> ACCESSING, SHARING, AND
USING HEALTH DATA FOR RESEARCH PURPOSES.
(a) Guidance Related to Remote Access.--Not later than 1 year after
the date of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') shall issue
guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii)
of part 164 of the Rule (prohibiting the removal of protected health
information by a researcher) does not prohibit remote access to health
information by a researcher for such purposes as described in section
164.512(i)(1)(ii) of part 164 of the Rule so long as--
[[Page 130 STAT. 1081]]
(1) at a minimum, security and privacy safeguards,
consistent with the requirements of the Rule, are maintained by
the covered entity and the researcher; and
(2) the protected health information is not copied or
otherwise retained by the researcher.
(b) Guidance Related to Streamlining Authorization.--Not later than
1 year after the date of enactment of this Act, the Secretary shall
issue guidance on the following:
(1) Authorization for use and disclosure of health
information.--Clarification of the circumstances under which the
authorization for the use or disclosure of protected health
information, with respect to an individual, for future research
purposes contains a sufficient description of the purpose of the
use or disclosure, such as if the authorization--
(A) sufficiently describes the purposes such that it
would be reasonable for the individual to expect that
the protected health information could be used or
disclosed for such future research;
(B) either--
(i) states that the authorization will expire
on a particular date or on the occurrence of a
particular event; or
(ii) states that the authorization will remain
valid unless and until it is revoked by the
individual; and
(C) provides instruction to the individual on how to
revoke such authorization at any time.
(2) Reminder of the right to revoke.--Clarification of the
circumstances under which it is appropriate to provide an
individual with an annual notice or reminder that the individual
has the right to revoke such authorization.
(3) Revocation of authorization.--Clarification of
appropriate mechanisms by which an individual may revoke an
authorization for future research purposes, such as described in
paragraph (1)(C).
(c) Working Group on Protected Health Information for Research.--
(1) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall convene a working
group to study and report on the uses and disclosures of
protected health information for research purposes, under the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191).
(2) Members.--The working group shall include
representatives of--
(A) relevant Federal agencies, including the
National Institutes of Health, the Centers for Disease
Control and Prevention, the Food and Drug
Administration, and the Office for Civil Rights;
(B) the research community;
(C) patients;
(D) experts in civil rights, such as privacy rights;
(E) developers of health information technology;
(F) experts in data privacy and security;
(G) health care providers;
(H) bioethicists; and
(I) other experts and entities, as the Secretary
determines appropriate.
[[Page 130 STAT. 1082]]
(3) Report.--Not later than 1 year after the date on which
the working group is convened under paragraph (1), the working
group shall conduct a review and submit a report to the
Secretary containing recommendations on whether the uses and
disclosures of protected health information for research
purposes should be modified to allow protected health
information to be available, as appropriate, for research
purposes, including studies to obtain generalizable knowledge,
while protecting individuals' privacy rights. In conducting the
review and making recommendations, the working group shall--
(A) address, at a minimum--
(i) the appropriate manner and timing of
authorization, including whether additional
notification to the individual should be required
when the individual's protected health information
will be used or disclosed for such research;
(ii) opportunities for individuals to set
preferences on the manner in which their protected
health information is used in research;
(iii) opportunities for patients to revoke
authorization;
(iv) notification to individuals of a breach
in privacy;
(v) existing gaps in statute, regulation, or
policy related to protecting the privacy of
individuals, and
(vi) existing barriers to research related to
the current restrictions on the uses and
disclosures of protected health information; and
(B) consider, at a minimum--
(i) expectations and preferences on how an
individual's protected health information is
shared and used;
(ii) issues related to specific subgroups of
people, such as children, incarcerated
individuals, and individuals with a cognitive or
intellectual disability impacting capacity to
consent;
(iii) relevant Federal and State laws;
(iv) models of facilitating data access and
levels of data access, including data
segmentation, where applicable;
(v) potential impacts of disclosure and non-
disclosure of protected health information on
access to health care services; and
(vi) the potential uses of such data.
(4) Report submission.--The Secretary shall submit the
report under paragraph (3) to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, and
shall post such report on the appropriate Internet website of
the Department of Health and Human Services.
(5) Termination.--The working group convened under paragraph
(1) shall terminate the day after the report under paragraph (3)
is submitted to Congress and made public in accordance with
paragraph (4).
(d) Definitions.--In this section:
[[Page 130 STAT. 1083]]
(1) The rule.--References to ``the Rule'' refer to part 160
or part 164, as appropriate, of title 45, Code of Federal
Regulations (or any successor regulation).
(2) Part 164.--References to a specified section of ``part
164'', refer to such specified section of part 164 of title 45,
Code of Federal Regulations (or any successor section).
Subtitle G--Promoting Pediatric Research
SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d))
is amended--
(1) in paragraph (1), by striking ``in consultation with the
Director of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development and in collaboration with
other appropriate national research institutes and national
centers that carry out activities involving pediatric research,
may provide for the establishment of'' and inserting ``in
collaboration with the national research institutes and national
centers that carry out activities involving pediatric research,
shall support''; and
(2) in paragraph (2)(A) and the first sentence of paragraph
(2)(E), by striking ``may'' each place such term appears and
inserting ``shall''.
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
It is the sense of Congress that--
(1) the National Institutes of Health should encourage a
global pediatric clinical study network by providing grants,
contracts, or cooperative agreements to support new and early
stage investigators who participate in the global pediatric
clinical study network;
(2) the Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') should engage with
clinical investigators and appropriate authorities outside of
the United States, including authorities in the European Union,
during the formation of the global pediatric clinical study
network to encourage the participation of such investigator and
authorities; and
(3) once a global pediatric clinical study network is
established and becomes operational, the Secretary should
continue to encourage and facilitate the participation of
clinical investigators and appropriate authorities outside of
the United States, including in the European Union, to
participate in the network with the goal of enhancing the global
reach of the network.
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
SEC. 3001. PATIENT EXPERIENCE DATA.
Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) is amended--
[[Page 130 STAT. 1084]]
(1) in subsection (a)--
(A) in the subsection heading, by striking ``In
General'' and inserting ``Patient Engagement in Drugs
and Devices'';
(B) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving such
subparagraphs 2 ems to the right; and
(C) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary'';
(2) by redesignating subsections (b) through (e) as
paragraphs (2) through (5), respectively, and moving such
paragraphs 2 ems to the right; and
(3) by adding at the end the following:
``(b) Statement of Patient Experience.--
``(1) In general.--Following the approval of an application
that was submitted under section 505(b) of this Act or section
351(a) of the Public Health Service Act at least 180 days after
the date of enactment of the 21st Century Cures Act, the
Secretary shall make public a brief statement regarding the
patient experience data and related information, if any,
submitted and reviewed as part of such application.
``(2) Data and information.--The data and information
referred to in paragraph (1) are--
``(A) patient experience data;
``(B) information on patient-focused drug
development tools; and
``(C) other relevant information, as determined by
the Secretary.
``(c) Patient Experience Data.--For purposes of this section, the
term `patient experience data' includes data that--
``(1) are collected by any persons (including patients,
family members and caregivers of patients, patient advocacy
organizations, disease research foundations, researchers, and
drug manufacturers); and
``(2) are intended to provide information about patients'
experiences with a disease or condition, including--
``(A) the impact of such disease or condition, or a
related therapy, on patients' lives; and
``(B) patient preferences with respect to treatment
of such disease or condition.''.
SEC. 3002. <<NOTE: 21 USC 360bbb-8c note.>> PATIENT-FOCUSED DRUG
DEVELOPMENT GUIDANCE.
(a) Publication of Guidance Documents.--Not later than 180 days
after the date of enactment of this Act, the Secretary of Health and
Human Services (referred to in this section as the ``Secretary''),
acting through the Commissioner of Food and Drugs, shall develop a plan
to issue draft and final versions of one or more guidance documents,
over a period of 5 years, regarding the collection of patient experience
data, and the use of such data and related information in drug
development. Not later than 18 months after the date of enactment of
this Act, the Secretary shall issue a draft version of at least one such
guidance document. Not later than 18 months after the public comment
period on the draft guidance ends, the Secretary shall issue a revised
draft guidance or final guidance.
[[Page 130 STAT. 1085]]
(b) Patient Experience Data.--For purposes of this section, the term
``patient experience data'' has the meaning given such term in section
569C of the Federal Food, Drug, and Cosmetic Act (as added by section
3001).
(c) Contents.--The guidance documents described in subsection (a)
shall address--
(1) methodological approaches that a person seeking to
collect patient experience data for submission to, and proposed
use by, the Secretary in regulatory decisionmaking may use, that
are relevant and objective and ensure that such data are
accurate and representative of the intended population,
including methods to collect meaningful patient input throughout
the drug development process and methodological considerations
for data collection, reporting, management, and analysis;
(2) methodological approaches that may be used to develop
and identify what is most important to patients with respect to
burden of disease, burden of treatment, and the benefits and
risks in the management of the patient's disease;
(3) approaches to identifying and developing methods to
measure impacts to patients that will help facilitate collection
of patient experience data in clinical trials;
(4) methodologies, standards, and technologies to collect
and analyze clinical outcome assessments for purposes of
regulatory decisionmaking;
(5) how a person seeking to develop and submit proposed
draft guidance relating to patient experience data for
consideration by the Secretary may submit such proposed draft
guidance to the Secretary;
(6) the format and content required for submissions under
this section to the Secretary, including with respect to the
information described in paragraph (1);
(7) how the Secretary intends to respond to submissions of
information described in paragraph (1), if applicable, including
any timeframe for response when such submission is not part of a
regulatory application or other submission that has an
associated timeframe for response; and
(8) how the Secretary, if appropriate, anticipates using
relevant patient experience data and related information,
including with respect to the structured risk-benefit assessment
framework described in section 505(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory
decisionmaking.
SEC. 3003. <<NOTE: 21 USC 360bbb-8c note.>> STREAMLINING PATIENT
INPUT.
Chapter 35 of title 44, United States Code, shall not apply to the
collection of information to which a response is voluntary, that is
initiated by the Secretary under section 569C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c) (as amended by section 3001) or
section 3002.
SEC. 3004. <<NOTE: 21 USC 355 note.>> REPORT ON PATIENT
EXPERIENCE DRUG DEVELOPMENT.
Not later than June 1 of 2021, 2026, and 2031, the Secretary of
Health and Human Services, acting through the Commissioner of Food and
Drugs, shall prepare and publish on the Internet website of the Food and
Drug Administration a report assessing the use of patient experience
data in regulatory decisionmaking, in particular with respect to the
review of patient experience data and information on patient-focused
drug development tools as part
[[Page 130 STAT. 1086]]
of applications approved under section 505(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)).
Subtitle B--Advancing New Drug Therapies
SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F
the following new section:
``SEC. 507. <<NOTE: 21 USC 357.>> QUALIFICATION OF DRUG
DEVELOPMENT TOOLS.
``(a) Process for Qualification.--
``(1) In general.--The Secretary shall establish a process
for the qualification of drug development tools for a proposed
context of use under which--
``(A)(i) a requestor initiates such process by
submitting a letter of intent to the Secretary; and
``(ii) the Secretary accepts or declines to accept
such letter of intent;
``(B)(i) if the Secretary accepts the letter of
intent, a requestor submits a qualification plan to the
Secretary; and
``(ii) the Secretary accepts or declines to accept
the qualification plan; and
``(C)(i) if the Secretary accepts the qualification
plan, the requestor submits to the Secretary a full
qualification package;
``(ii) the Secretary determines whether to accept
such qualification package for review; and
``(iii) if the Secretary accepts such qualification
package for review, the Secretary conducts such review
in accordance with this section.
``(2) Acceptance and review of submissions.--
``(A) In general.--Subparagraphs (B), (C), and (D)
shall apply with respect to the treatment of a letter of
intent, a qualification plan, or a full qualification
package submitted under paragraph (1) (referred to in
this paragraph as `qualification submissions').
``(B) Acceptance factors; nonacceptance.--The
Secretary shall determine whether to accept a
qualification submission based on factors which may
include the scientific merit of the qualification
submission. A determination not to accept a submission
under paragraph (1) shall not be construed as a final
determination by the Secretary under this section
regarding the qualification of a drug development tool
for its proposed context of use.
``(C) Prioritization of qualification review.--The
Secretary may prioritize the review of a full
qualification package submitted under paragraph (1) with
respect to a drug development tool, based on factors
determined appropriate by the Secretary, including--
``(i) as applicable, the severity, rarity, or
prevalence of the disease or condition targeted by
the drug
[[Page 130 STAT. 1087]]
development tool and the availability or lack of
alternative treatments for such disease or
condition; and
``(ii) the identification, by the Secretary or
by biomedical research consortia and other expert
stakeholders, of such a drug development tool and
its proposed context of use as a public health
priority.
``(D) Engagement of external experts.--The Secretary
may, for purposes of the review of qualification
submissions, through the use of cooperative agreements,
grants, or other appropriate mechanisms, consult with
biomedical research consortia and may consider the
recommendations of such consortia with respect to the
review of any qualification plan submitted under
paragraph (1) or the review of any full qualification
package under paragraph (3).
``(3) Review of full qualification package.--The Secretary
shall--
``(A) conduct a comprehensive review of a full
qualification package accepted under paragraph (1)(C);
and
``(B) determine whether the drug development tool at
issue is qualified for its proposed context of use.
``(4) Qualification.--The Secretary shall determine whether
a drug development tool is qualified for a proposed context of
use based on the scientific merit of a full qualification
package reviewed under paragraph (3).
``(b) Effect of Qualification.--
``(1) In general.--A drug development tool determined to be
qualified under subsection (a)(4) for a proposed context of use
specified by the requestor may be used by any person in such
context of use for the purposes described in paragraph (2).
``(2) Use of a drug development tool.--Subject to paragraph
(3), a drug development tool qualified under this section may be
used for--
``(A) supporting or obtaining approval or licensure
(as applicable) of a drug or biological product
(including in accordance with section 506(c)) under
section 505 of this Act or section 351 of the Public
Health Service Act; or
``(B) supporting the investigational use of a drug
or biological product under section 505(i) of this Act
or section 351(a)(3) of the Public Health Service Act.
``(3) Rescission or modification.--
``(A) In general.--The Secretary may rescind or
modify a determination under this section to qualify a
drug development tool if the Secretary determines that
the drug development tool is not appropriate for the
proposed context of use specified by the requestor. Such
a determination may be based on new information that
calls into question the basis for such qualification.
``(B) Meeting for review.--If the Secretary rescinds
or modifies under subparagraph (A) a determination to
qualify a drug development tool, the requestor involved
shall, on request, be granted a meeting with the
Secretary to discuss the basis of the Secretary's
decision to rescind or modify the determination before
the effective date of the rescission or modification.
``(c) Transparency.--
[[Page 130 STAT. 1088]]
``(1) In general.--Subject to paragraph (3), the Secretary
shall make publicly available, and update on at least a biannual
basis, on the Internet website of the Food and Drug
Administration the following:
``(A) Information with respect to each qualification
submission under the qualification process under
subsection (a), including--
``(i) the stage of the review process
applicable to the submission;
``(ii) the date of the most recent change in
stage status;
``(iii) whether external scientific experts
were utilized in the development of a
qualification plan or the review of a full
qualification package; and
``(iv) submissions from requestors under the
qualification process under subsection (a),
including any data and evidence contained in such
submissions, and any updates to such submissions.
``(B) The Secretary's formal written determinations
in response to such qualification submissions.
``(C) Any rescissions or modifications under
subsection (b)(3) of a determination to qualify a drug
development tool.
``(D) Summary reviews that document conclusions and
recommendations for determinations to qualify drug
development tools under subsection (a).
``(E) A comprehensive list of--
``(i) all drug development tools qualified
under subsection (a); and
``(ii) all surrogate endpoints which were the
basis of approval or licensure (as applicable) of
a drug or biological product (including in
accordance with section 506(c)) under section 505
of this Act or section 351 of the Public Health
Service Act.
``(2) Relation to trade secrets act.--Information made
publicly available by the Secretary under paragraph (1) shall be
considered a disclosure authorized by law for purposes of
section 1905 of title 18, United States Code.
``(3) Applicability.--Nothing in this section shall be
construed as authorizing the Secretary to disclose any
information contained in an application submitted under section
505 of this Act or section 351 of the Public Health Service Act
that is confidential commercial or trade secret information
subject to section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
``(d) Rule of Construction.--Nothing in this section shall be
construed--
``(1) to alter the standards of evidence under subsection
(c) or (d) of section 505, including the substantial evidence
standard in such subsection (d), or under section 351 of the
Public Health Service Act (as applicable); or
``(2) to limit the authority of the Secretary to approve or
license products under this Act or the Public Health Service
Act, as applicable (as in effect before the date of the
enactment of the 21st Century Cures Act).
``(e) Definitions.--In this section:
``(1) Biomarker.--The term `biomarker'--
[[Page 130 STAT. 1089]]
``(A) means a characteristic (such as a physiologic,
pathologic, or anatomic characteristic or measurement)
that is objectively measured and evaluated as an
indicator of normal biologic processes, pathologic
processes, or biological responses to a therapeutic
intervention; and
``(B) includes a surrogate endpoint.
``(2) Biomedical research consortia.--The term `biomedical
research consortia' means collaborative groups that may take the
form of public-private partnerships and may include government
agencies, institutions of higher education (as defined in
section 101(a) of the Higher Education Act of 1965), patient
advocacy groups, industry representatives, clinical and
scientific experts, and other relevant entities and individuals.
``(3) Clinical outcome assessment.--The term `clinical
outcome assessment' means--
``(A) a measurement of a patient's symptoms, overall
mental state, or the effects of a disease or condition
on how the patient functions; and
``(B) includes a patient-reported outcome.
``(4) Context of use.--The term `context of use' means, with
respect to a drug development tool, the circumstances under
which the drug development tool is to be used in drug
development and regulatory review.
``(5) Drug development tool.--The term `drug development
tool' includes--
``(A) a biomarker;
``(B) a clinical outcome assessment; and
``(C) any other method, material, or measure that
the Secretary determines aids drug development and
regulatory review for purposes of this section.
``(6) Patient-reported outcome.--The term `patient-reported
outcome' means a measurement based on a report from a patient
regarding the status of the patient's health condition without
amendment or interpretation of the patient's report by a
clinician or any other person.
``(7) Qualification.--The terms `qualification' and
`qualified' mean a determination by the Secretary that a drug
development tool and its proposed context of use can be relied
upon to have a specific interpretation and application in drug
development and regulatory review under this Act.
``(8) Requestor.--The term `requestor' means an entity or
entities, including a drug sponsor or a biomedical research
consortia, seeking to qualify a drug development tool for a
proposed context of use under this section.
``(9) Surrogate endpoint.--The term `surrogate endpoint'
means a marker, such as a laboratory measurement, radiographic
image, physical sign, or other measure, that is not itself a
direct measurement of clinical benefit, and--
``(A) is known to predict clinical benefit and could
be used to support traditional approval of a drug or
biological product; or
``(B) is reasonably likely to predict clinical
benefit and could be used to support the accelerated
approval of a drug or biological product in accordance
with section 506(c).''.
(b) <<NOTE: 21 USC 357 note.>> Guidance.--
[[Page 130 STAT. 1090]]
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, in
consultation with biomedical research consortia (as defined in
subsection (e) of section 507 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)) and other interested
parties through a collaborative public process, issue guidance
to implement such section 507 that--
(A) provides a conceptual framework describing
appropriate standards and scientific approaches to
support the development of biomarkers delineated under
the taxonomy established under paragraph (3);
(B) with respect to the qualification process under
such section 507--
(i) describes the requirements that entities
seeking to qualify a drug development tool under
such section shall observe when engaging in such
process;
(ii) outlines reasonable timeframes for the
Secretary's review of letters, qualification
plans, or full qualification packages submitted
under such process; and
(iii) establishes a process by which such
entities or the Secretary may consult with
biomedical research consortia and other
individuals and entities with expert knowledge and
insights that may assist the Secretary in the
review of qualification plans and full
qualification submissions under such section; and
(C) includes such other information as the Secretary
determines appropriate.
(2) Timing.--Not later than 3 years after the date of the
enactment of this Act, the Secretary shall issue draft guidance
under paragraph (1) on the implementation of section 507 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)). The Secretary shall issue final guidance on the
implementation of such section not later than 6 months after the
date on which the comment period for the draft guidance closes.
(3) Taxonomy.--
(A) In general.--For purposes of informing guidance
under this subsection, the Secretary shall, in
consultation with biomedical research consortia and
other interested parties through a collaborative public
process, establish a taxonomy for the classification of
biomarkers (and related scientific concepts) for use in
drug development.
(B) Public availability.--Not later than 2 years
after the date of the enactment of this Act, the
Secretary shall make such taxonomy publicly available in
draft form for public comment. The Secretary shall
finalize the taxonomy not later than 1 year after the
close of the public comment period.
(c) Meeting and Report.--
(1) Meeting.--Not later than 2 years after the date of the
enactment of this Act, the Secretary shall convene a public
meeting to describe and solicit public input regarding the
qualification process under section 507 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a).
[[Page 130 STAT. 1091]]
(2) Report.--Not later than 5 years after the date of the
enactment of this Act, the Secretary shall make publicly
available on the Internet website of the Food and Drug
Administration a report. Such report shall include, with respect
to the qualification process under section 507 of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a),
information on--
(A) the number of requests submitted, as a letter of
intent, for qualification of a drug development tool (as
defined in subsection (e) of such section 507);
(B) the number of such requests accepted and
determined to be eligible for submission of a
qualification plan or full qualification package (as
such terms are defined in subsection (e) of such section
507), respectively;
(C) the number of such requests for which external
scientific experts were utilized in the development of a
qualification plan or review of a full qualification
package;
(D) the number of qualification plans and full
qualification packages, respectively, submitted to the
Secretary; and
(E) the drug development tools qualified through
such qualification process, specified by type of tool,
such as a biomarker or clinical outcome assessment (as
such terms are defined in subsection (e) of such section
507).
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.
Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529
the following:
``SEC. 529A. <<NOTE: 21 USC 360ff-1.>> TARGETED DRUGS FOR RARE
DISEASES.
``(a) Purpose.--The purpose of this section, through the approach
provided for in subsection (b), is to--
``(1) facilitate the development, review, and approval of
genetically targeted drugs and variant protein targeted drugs to
address an unmet medical need in one or more patient subgroups,
including subgroups of patients with different mutations of a
gene, with respect to rare diseases or conditions that are
serious or life-threatening; and
``(2) maximize the use of scientific tools or methods,
including surrogate endpoints and other biomarkers, for such
purposes.
``(b) Leveraging of Data From Previously Approved Drug Application
or Applications.--The Secretary may, consistent with applicable
standards for approval under this Act or section 351(a) of the Public
Health Service Act, allow the sponsor of an application under section
505(b)(1) of this Act or section 351(a) of the Public Health Service Act
for a genetically targeted drug or a variant protein targeted drug to
rely upon data and information--
``(1) previously developed by the same sponsor (or another
sponsor that has provided the sponsor with a contractual right
of reference to such data and information); and
``(2) submitted by a sponsor described in paragraph (1) in
support of one or more previously approved applications that
were submitted under section 505(b)(1) of this Act or section
351(a) of the Public Health Service Act,
for a drug that incorporates or utilizes the same or similar genetically
targeted technology as the drug or drugs that are the subject
[[Page 130 STAT. 1092]]
of an application or applications described in paragraph (2) or for a
variant protein targeted drug that is the same or incorporates or
utilizes the same variant protein targeted drug, as the drug or drugs
that are the subject of an application or applications described in
paragraph (2).
``(c) Definitions.--For purposes of this section--
``(1) the term `genetically targeted drug' means a drug
that--
``(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public
Health Service Act for the treatment of a rare disease
or condition (as such term is defined in section 526)
that is serious or life-threatening;
``(B) may result in the modulation (including
suppression, up-regulation, or activation) of the
function of a gene or its associated gene product; and
``(C) incorporates or utilizes a genetically
targeted technology;
``(2) the term `genetically targeted technology' means a
technology comprising non-replicating nucleic acid or analogous
compounds with a common or similar chemistry that is intended to
treat one or more patient subgroups, including subgroups of
patients with different mutations of a gene, with the same
disease or condition, including a disease or condition due to
other variants in the same gene; and
``(3) the term `variant protein targeted drug' means a drug
that--
``(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public
Health Service Act for the treatment of a rare disease
or condition (as such term is defined in section 526)
that is serious or life-threatening;
``(B) modulates the function of a product of a
mutated gene where such mutation is responsible in whole
or in part for a given disease or condition; and
``(C) is intended to treat one or more patient
subgroups, including subgroups of patients with
different mutations of a gene, with the same disease or
condition.
``(d) Rule of Construction.--Nothing in this section shall be
construed to--
``(1) alter the authority of the Secretary to approve drugs
pursuant to this Act or section 351 of the Public Health Service
Act (as authorized prior to the date of enactment of the 21st
Century Cures Act), including the standards of evidence, and
applicable conditions, for approval under such applicable Act;
or
``(2) confer any new rights, beyond those authorized under
this Act or the Public Health Service Act prior to enactment of
this section, with respect to the permissibility of a sponsor
referencing information contained in another application
submitted under section 505(b)(1) of this Act or section 351(a)
of the Public Health Service Act.''.
[[Page 130 STAT. 1093]]
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR
RARE PEDIATRIC DISEASES.
(a) In General.--Section 529(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5)
and inserting the following:
``(5) Termination of authority.--The Secretary may not award
any priority review vouchers under paragraph (1) after September
30, 2020, unless the rare pediatric disease product
application--
``(A) is for a drug that, not later than September
30, 2020, is designated under subsection (d) as a drug
for a rare pediatric disease; and
``(B) is, not later than September 30, 2022,
approved under section 505(b)(1) of this Act or section
351(a) of the Public Health Service Act.''.
(b) Report.--The Advancing Hope Act of 2016 (Public Law 114-229) is
amended by striking section 3.
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.
(a) Study.--The Comptroller General of the United States (referred
to in this section as the ``Comptroller General'') shall conduct a study
addressing the effectiveness and overall impact of the following
priority review voucher programs, including any such programs amended or
established by this Act:
(1) The neglected tropical disease priority review voucher
program under section 524 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n).
(2) The rare pediatric disease priority review voucher
program under section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff).
(3) The medical countermeasure priority review voucher
program under section 565A of the Federal Food, Drug, and
Cosmetic Act, as added by section 3086.
(b) Issuance of Report.--Not later than January 31, 2020, the
Comptroller General shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report containing the results
of the study under subsection (a).
(c) Contents of Reports.--The report submitted under subsection (b)
shall address--
(1) for each drug for which a priority review voucher has
been awarded as of initiation of the study--
(A) the indications for which the drug is approved
under section 505(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
application under section 505(b)(1) of such Act, or
licensed under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a));
(B) whether, and to what extent, the voucher
impacted the sponsor's decision to develop the drug; and
(C) whether, and to what extent, the approval or
licensure of the drug, as applicable and appropriate--
(i) addressed a global unmet need related to
the treatment or prevention of a neglected
tropical disease, including whether the sponsor of
a drug coordinated with international development
organizations;
[[Page 130 STAT. 1094]]
(ii) addressed an unmet need related to the
treatment of a rare pediatric disease; or
(iii) affected the Nation's preparedness
against a chemical, biological, radiological, or
nuclear threat, including naturally occurring
threats;
(2) for each drug for which a priority review voucher has
been used--
(A) the indications for which such drug is approved
under section 505(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)), pursuant to an
application under section 505(b)(1) of such Act, or
licensed under section 351(a) of the Public Health
Service Act (42 U.S.C. 262);
(B) the value of the voucher, if transferred; and
(C) the length of time between the date on which the
voucher was awarded and the date on which the voucher
was used; and
(3) an analysis of the priority review voucher programs
described in subsection (a), including--
(A) the resources used by the Food and Drug
Administration in reviewing drugs for which vouchers
were used, including the effect of the programs on the
Food and Drug Administration's review of drugs for which
priority review vouchers were not awarded or used;
(B) whether any improvements to such programs are
necessary to appropriately target incentives for the
development of drugs that would likely not otherwise be
developed, or developed in as timely a manner, and, as
applicable and appropriate--
(i) address global unmet needs related to the
treatment or prevention of neglected tropical
diseases, including in countries in which
neglected tropical diseases are endemic; or
(ii) address unmet needs related to the
treatment of rare pediatric diseases; and
(C) whether the sunset of the rare pediatric disease
program and medical countermeasure program has had an
impact on the program, including any potential
unintended consequences.
(d) Protection of National Security.--The Comptroller General shall
conduct the study and issue reports under this section in a manner that
does not compromise national security.
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
(1) in subsection (a), by striking paragraph (1) and
inserting the following: ``(1) defraying the costs of developing
drugs for rare diseases or conditions, including qualified
testing expenses,''; and
(2) in subsection (b)(1)--
(A) in subparagraph (A)(ii), by striking ``and''
after the semicolon;
(B) in subparagraph (B), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
[[Page 130 STAT. 1095]]
``(C) prospectively planned and designed
observational studies and other analyses conducted to
assist in the understanding of the natural history of a
rare disease or condition and in the development of a
therapy, including studies and analyses to--
``(i) develop or validate a drug development
tool related to a rare disease or condition; or
``(ii) understand the full spectrum of the
disease manifestations, including describing
genotypic and phenotypic variability and
identifying and defining distinct subpopulations
affected by a rare disease or condition.''.
SEC. 3016. <<NOTE: 21 USC 399h.>> GRANTS FOR STUDYING CONTINUOUS
DRUG MANUFACTURING.
(a) In General.--The Secretary of Health and Human Services may
award grants to institutions of higher education and nonprofit
organizations for the purpose of studying and recommending improvements
to the process of continuous manufacturing of drugs and biological
products and similar innovative monitoring and control techniques.
(b) Definitions.--In this section--
(1) the term ``drug'' has the meaning given such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(2) the term ``biological product'' has the meaning given
such term in section 351(i) of the Public Health Service Act (42
U.S.C. 262(i)); and
(3) the term ``institution of higher education'' has the
meaning given such term in section 101(a) of the Higher
Education Act of 1965 (20 U.S.C. 1001(a)).
Subtitle C--Modern Trial Design and Evidence Development
SEC. 3021. <<NOTE: 21 USC 355 note.>> NOVEL CLINICAL TRIAL
DESIGNS.
(a) Proposals for Use of Novel Clinical Trial Designs for Drugs and
Biological Products.--For purposes of assisting sponsors in
incorporating complex adaptive and other novel trial designs into
proposed clinical protocols and applications for new drugs under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and
biological products under section 351 of the Public Health Service Act
(42 U.S.C. 262), the Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') shall conduct a public meeting and
issue guidance in accordance with subsection (b).
(b) Guidance Addressing Use of Novel Clinical Trial Designs.--
(1) In general.--The Secretary, acting through the
Commissioner of Food and Drugs, shall update or issue guidance
addressing the use of complex adaptive and other novel trial
design in the development and regulatory review and approval or
licensure for drugs and biological products.
(2) Contents.--The guidance under paragraph (1) shall
address--
[[Page 130 STAT. 1096]]
(A) the use of complex adaptive and other novel
trial designs, including how such clinical trials
proposed or submitted help to satisfy the substantial
evidence standard under section 505(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
(B) how sponsors may obtain feedback from the
Secretary on technical issues related to modeling and
simulations prior to--
(i) completion of such modeling or
simulations; or
(ii) the submission of resulting information
to the Secretary;
(C) the types of quantitative and qualitative
information that should be submitted for review; and
(D) recommended analysis methodologies.
(3) Public meeting.--Prior to updating or issuing the
guidance required by paragraph (1), the Secretary shall consult
with stakeholders, including representatives of regulated
industry, academia, patient advocacy organizations, consumer
groups, and disease research foundations, through a public
meeting to be held not later than 18 months after the date of
enactment of this Act.
(4) Timing.--The Secretary shall update or issue a draft
version of the guidance required by paragraph (1) not later than
18 months after the date of the public meeting required by
paragraph (3) and finalize such guidance not later than 1 year
after the date on which the public comment period for the draft
guidance closes.
SEC. 3022. REAL WORLD EVIDENCE.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505E (21 U.S.C. 355f) the following:
``SEC. 505F. <<NOTE: 21 USC 355g.>> UTILIZING REAL WORLD
EVIDENCE.
``(a) In General.--The Secretary shall establish a program to
evaluate the potential use of real world evidence--
``(1) to help to support the approval of a new indication
for a drug approved under section 505(c); and
``(2) to help to support or satisfy postapproval study
requirements.
``(b) Real World Evidence Defined.--In this section, the term `real
world evidence' means data regarding the usage, or the potential
benefits or risks, of a drug derived from sources other than randomized
clinical trials.
``(c) Program Framework.--
``(1) In general.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary shall
establish a draft framework for implementation of the program
under this section.
``(2) Contents of framework.--The framework shall include
information describing--
``(A) the sources of real world evidence, including
ongoing safety surveillance, observational studies,
registries, claims, and patient-centered outcomes
research activities;
``(B) the gaps in data collection activities;
[[Page 130 STAT. 1097]]
``(C) the standards and methodologies for collection
and analysis of real world evidence; and
``(D) the priority areas, remaining challenges, and
potential pilot opportunities that the program
established under this section will address.
``(3) Consultation.--
``(A) In general.--In developing the program
framework under this subsection, the Secretary shall
consult with regulated industry, academia, medical
professional organizations, representatives of patient
advocacy organizations, consumer organizations, disease
research foundations, and other interested parties.
``(B) Process.--The consultation under subparagraph
(A) may be carried out through approaches such as--
``(i) a public-private partnership with the
entities described in such subparagraph in which
the Secretary may participate;
``(ii) a contract, grant, or other
arrangement, as the Secretary determines
appropriate, with such a partnership or an
independent research organization; or
``(iii) public workshops with the entities
described in such subparagraph.
``(d) Program Implementation.--The Secretary shall, not later than 2
years after the date of enactment of the 21st Century Cures Act and in
accordance with the framework established under subsection (c),
implement the program to evaluate the potential use of real world
evidence.
``(e) Guidance for Industry.--The Secretary shall--
``(1) utilize the program established under subsection (a),
its activities, and any subsequent pilots or written reports, to
inform a guidance for industry on--
``(A) the circumstances under which sponsors of
drugs and the Secretary may rely on real world evidence
for the purposes described in paragraphs (1) and (2) of
subsection (a); and
``(B) the appropriate standards and methodologies
for collection and analysis of real world evidence
submitted for such purposes;
``(2) not later than 5 years after the date of enactment of
the 21st Century Cures Act, issue draft guidance for industry as
described in paragraph (1); and
``(3) not later than 18 months after the close of the public
comment period for the draft guidance described in paragraph
(2), issue revised draft guidance or final guidance.
``(f) Rule of Construction.--
``(1) In general.--Subject to paragraph (2), nothing in this
section prohibits the Secretary from using real world evidence
for purposes not specified in this section, provided the
Secretary determines that sufficient basis exists for any such
nonspecified use.
``(2) Standards of evidence and secretary's authority.--This
section shall not be construed to alter--
``(A) the standards of evidence under--
``(i) subsection (c) or (d) of section 505,
including the substantial evidence standard in
such subsection (d); or
[[Page 130 STAT. 1098]]
``(ii) section 351(a) of the Public Health
Service Act; or
``(B) the Secretary's authority to require
postapproval studies or clinical trials, or the
standards of evidence under which studies or trials are
evaluated.''.
SEC. 3023. <<NOTE: 42 USC 289 note.>> PROTECTION OF HUMAN
RESEARCH SUBJECTS.
(a) In General.--In order to simplify and facilitate compliance by
researchers with applicable regulations for the protection of human
subjects in research, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, to the extent
practicable and consistent with other statutory provisions, harmonize
differences between the HHS Human Subject Regulations and the FDA Human
Subject Regulations in accordance with subsection (b).
(b) Avoiding Regulatory Duplication and Unnecessary Delays.--The
Secretary shall, as appropriate--
(1) make such modifications to the provisions of the HHS
Human Subject Regulations, the FDA Human Subject Regulations,
and the vulnerable populations rules as may be necessary--
(A) to reduce regulatory duplication and unnecessary
delays;
(B) to modernize such provisions in the context of
multisite and cooperative research projects; and
(C) to protect vulnerable populations, incorporate
local considerations, and support community engagement
through mechanisms such as consultation with local
researchers and human research protection programs, in a
manner consistent with subparagraph (B); and
(2) ensure that human subject research that is subject to
the HHS Human Subject Regulations and to the FDA Human Subject
Regulations may--
(A) use joint or shared review;
(B) rely upon the review of--
(i) an independent institutional review board;
or
(ii) an institutional review board of an
entity other than the sponsor of the research; or
(C) use similar arrangements to avoid duplication of
effort.
(c) Consultation.--In harmonizing or modifying regulations or
guidance under this section, the Secretary shall consult with
stakeholders (including researchers, academic organizations, hospitals,
institutional research boards, pharmaceutical, biotechnology, and
medical device developers, clinical research organizations, patient
groups, and others).
(d) Timing.--The Secretary shall complete the harmonization
described in subsection (a) not later than 3 years after the date of
enactment of this Act.
(e) Progress Report.--Not later than 2 years after the date of
enactment of this Act, the Secretary shall submit to Congress a report
on the progress made toward completing such harmonization.
(f) Definitions.--
(1) Human subject regulations.--In this section:
(A) FDA human subject regulations.--The term ``FDA
Human Subject Regulations'' means the provisions
[[Page 130 STAT. 1099]]
of parts 50, 56, 312, and 812 of title 21, Code of
Federal Regulations (or any successor regulations).
(B) HHS human subject regulations.--The term ``HHS
Human Subject Regulations'' means the provisions of
subpart A of part 46 of title 45, Code of Federal
Regulations (or any successor regulations).
(C) Vulnerable population rules.--The term
``vulnerable population rules'' means--
(i) except in the case of research described
in clause (ii), the provisions of subparts B
through D of part 46, Code of Federal Regulations
(or any successor regulations); and
(ii) in the case of research that is subject
to FDA Human Subject Regulations, the provisions
applicable to vulnerable populations under part 56
of title 21, Code of Federal Regulations (or any
successor regulations) and subpart D of part 50 of
such title 21 (or any successor regulations).
(2) Institutional review board defined.--In this section,
the term ``institutional review board'' has the meaning that
applies to the term ``institutional review board'' under the HHS
Human Subject Regulations.
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL
INVESTIGATIONS.
(a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
(1) in subparagraph (D), by striking ``except where subject
to such conditions as the Secretary may prescribe, the
investigator'' and inserting the following: ``except where,
subject to such conditions as the Secretary may prescribe--
``(i) the proposed clinical testing poses no more
than minimal risk to the human subject and includes
appropriate safeguards to protect the rights, safety,
and welfare of the human subject; or
``(ii) the investigator''; and
(2) in the matter following subparagraph (D), by striking
``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
(b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where
it is not feasible or it is contrary to the best interests of such human
beings'' and inserting ``except where it is not feasible, it is contrary
to the best interests of such human beings, or the proposed clinical
testing poses no more than minimal risk to such human beings and
includes appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings''.
Subtitle D--Patient Access to Therapies and Information
SEC. 3031. SUMMARY LEVEL REVIEW.
(a) FFDCA.--Section 505(c) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(c)) is amended by adding at the end the following:
``(5)(A) The Secretary may rely upon qualified data summaries to
support the approval of a supplemental application, with respect
[[Page 130 STAT. 1100]]
to a qualified indication for a drug, submitted under subsection (b), if
such supplemental application complies with subparagraph (B).
``(B) A supplemental application is eligible for review as described
in subparagraph (A) only if--
``(i) there is existing data available and acceptable to the
Secretary demonstrating the safety of the drug; and
``(ii) all data used to develop the qualified data summaries
are submitted to the Secretary as part of the supplemental
application.
``(C) The Secretary shall post on the Internet website of the Food
and Drug Administration and update annually--
``(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
``(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
``(iii) the average time for review of supplemental
applications where the Secretary did not use review flexibility
under subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act; and
``(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act for which the Secretary made use of full data sets
in addition to the qualified data summary.
``(D) In this paragraph--
``(i) the term `qualified indication' means an indication
for a drug that the Secretary determines to be appropriate for
summary level review under this paragraph; and
``(ii) the term `qualified data summary' means a summary of
clinical data that demonstrates the safety and effectiveness of
a drug with respect to a qualified indication.''.
(b) PHSA.--Section 351(a)(2) of the Public Health Service Act (42
U.S.C. 262(a)(2)) is amended by adding at the end the following:
``(E)(i) The Secretary may rely upon qualified data summaries to
support the approval of a supplemental application, with respect to a
qualified indication for a drug, submitted under this subsection, if
such supplemental application complies with the requirements of
subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and
Cosmetic Act.
``(ii) In this subparagraph, the terms `qualified indication' and
`qualified data summary' have the meanings given such terms in section
505(c)(5) of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 3032. EXPANDED ACCESS POLICY.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 561 (21 U.S.C. 360bbb) the following:
``SEC. 561A. <<NOTE: 21 USC 360bbb-0.>> EXPANDED ACCESS POLICY
REQUIRED FOR INVESTIGATIONAL DRUGS.
``(a) In General.--The manufacturer or distributor of one or more
investigational drugs for the diagnosis, monitoring, or treatment of one
or more serious diseases or conditions shall make available the policy
of the manufacturer or distributor on evaluating and responding to
requests submitted under section 561(b) for provision of such a drug.
[[Page 130 STAT. 1101]]
``(b) Public Availability of Expanded Access Policy.--The policies
under subsection (a) shall be made public and readily available, such as
by posting such policies on a publicly available Internet website. Such
policies may be generally applicable to all investigational drugs of
such manufacturer or distributor.
``(c) Content of Policy.--A policy described in subsection (a) shall
include--
``(1) contact information for the manufacturer or
distributor to facilitate communication about requests described
in subsection (a);
``(2) procedures for making such requests;
``(3) the general criteria the manufacturer or distributor
will use to evaluate such requests for individual patients, and
for responses to such requests;
``(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests; and
``(5) a hyperlink or other reference to the clinical trial
record containing information about the expanded access for such
drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of
the Public Health Service Act.
``(d) No Guarantee of Access.--The posting of policies by
manufacturers and distributors under subsection (a) shall not serve as a
guarantee of access to any specific investigational drug by any
individual patient.
``(e) Revised Policy.--Nothing in this section shall prevent a
manufacturer or distributor from revising a policy required under this
section at any time.
``(f) Application.--This section shall apply to a manufacturer or
distributor with respect to an investigational drug beginning on the
later of--
``(1) the date that is 60 calendar days after the date of
enactment of the 21st Century Cures Act; or
``(2) the first initiation of a phase 2 or phase 3 study (as
such terms are defined in section 312.21(b) and (c) of title 21,
Code of Federal Regulations (or any successor regulations)) with
respect to such investigational drug.''.
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
THERAPIES.
(a) In General.--Section 506 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356) is amended--
(1) by transferring subsection (e) (relating to
construction) so that it appears before subsection (f) (relating
to awareness efforts); and
(2) by adding at the end the following:
``(g) Regenerative Advanced Therapy.--
``(1) In general.--The Secretary, at the request of the
sponsor of a drug, shall facilitate an efficient development
program for, and expedite review of, such drug if the drug
qualifies as a regenerative advanced therapy under the criteria
described in paragraph (2).
``(2) Criteria.--A drug is eligible for designation as a
regenerative advanced therapy under this subsection if--
``(A) the drug is a regenerative medicine therapy
(as defined in paragraph (8));
[[Page 130 STAT. 1102]]
``(B) the drug is intended to treat, modify,
reverse, or cure a serious or life-threatening disease
or condition; and
``(C) preliminary clinical evidence indicates that
the drug has the potential to address unmet medical
needs for such a disease or condition.
``(3) Request for designation.--The sponsor of a drug may
request the Secretary to designate the drug as a regenerative
advanced therapy concurrently with, or at any time after,
submission of an application for the investigation of the drug
under section 505(i) of this Act or section 351(a)(3) of the
Public Health Service Act.
``(4) Designation.--Not later than 60 calendar days after
the receipt of a request under paragraph (3), the Secretary
shall determine whether the drug that is the subject of the
request meets the criteria described in paragraph (2). If the
Secretary determines that the drug meets the criteria, the
Secretary shall designate the drug as a regenerative advanced
therapy and shall take such actions as are appropriate under
paragraph (1). If the Secretary determines that a drug does not
meet the criteria for such designation, the Secretary shall
include with the determination a written description of the
rationale for such determination.
``(5) Actions.--The sponsor of a regenerative advanced
therapy shall be eligible for the actions to expedite
development and review of such therapy under subsection
(a)(3)(B), including early interactions to discuss any potential
surrogate or intermediate endpoint to be used to support the
accelerated approval of an application for the product under
subsection (c).
``(6) Access to expedited approval pathways.--An application
for a regenerative advanced therapy under section 505(b)(1) of
this Act or section 351(a) of the Public Health Service Act may
be--
``(A) eligible for priority review, as described in
the Manual of Policies and Procedures of the Food and
Drug Administration and goals identified in the letters
described in section 101(b) of the Prescription Drug
User Fee Amendments of 2012; and
``(B) eligible for accelerated approval under
subsection (c), as agreed upon pursuant to subsection
(a)(3)(B), through, as appropriate--
``(i) surrogate or intermediate endpoints
reasonably likely to predict long-term clinical
benefit; or
``(ii) reliance upon data obtained from a
meaningful number of sites, including through
expansion to additional sites, as appropriate.
``(7) Postapproval requirements.--The sponsor of a
regenerative advanced therapy that is granted accelerated
approval and is subject to the postapproval requirements under
subsection (c) may, as appropriate, fulfill such requirements,
as the Secretary may require, through--
``(A) the submission of clinical evidence, clinical
studies, patient registries, or other sources of real
world evidence, such as electronic health records;
``(B) the collection of larger confirmatory data
sets, as agreed upon pursuant to subsection (a)(3)(B);
or
[[Page 130 STAT. 1103]]
``(C) postapproval monitoring of all patients
treated with such therapy prior to approval of the
therapy.
``(8) Definition.--For purposes of this section, the term
`regenerative medicine therapy' includes cell therapy,
therapeutic tissue engineering products, human cell and tissue
products, and combination products using any such therapies or
products, except for those regulated solely under section 361 of
the Public Health Service Act and part 1271 of title 21, Code of
Federal Regulations.''.
(b) <<NOTE: 21 USC 356 note.>> Rule of Construction.--Nothing in
this section and the amendments made by this section shall be construed
to alter the authority of the Secretary of Health and Human Services--
(1) to approve drugs pursuant to the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the
Public Health Service Act (42 U.S.C. 262) as authorized prior to
the date of enactment of the 21st Century Cures Act, including
the standards of evidence, and applicable conditions, for
approval under such Acts; or
(2) to alter the authority of the Secretary to require
postapproval studies pursuant to such Acts, as authorized prior
to the date of enactment of the 21st Century Cures Act.
(c) Conforming Amendment.--Section 506(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting
``and the 21st Century Cures Act'' after ``Food and Drug Administration
Safety and Innovation Act''.
SEC. 3034. <<NOTE: 21 USC 356g note.>> GUIDANCE REGARDING DEVICES
USED IN THE RECOVERY, ISOLATION, OR
DELIVERY OF REGENERATIVE ADVANCED
THERAPIES.
(a) Draft Guidance.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary of Health and
Human Services, acting through the Commissioner of Food and Drugs, shall
issue draft guidance clarifying how, in the context of regenerative
advanced therapies, the Secretary will evaluate devices used in the
recovery, isolation, or delivery of regenerative advanced therapies. In
doing so, the Secretary shall specifically address--
(1) how the Food and Drug Administration intends to simplify
and streamline regulatory requirements for combination device
and cell or tissue products;
(2) what, if any, intended uses or specific attributes would
result in a device used with a regenerative therapy product to
be classified as a class III device;
(3) when the Food and Drug Administration considers it is
necessary, if ever, for the intended use of a device to be
limited to a specific intended use with only one particular type
of cell; and
(4) application of the least burdensome approach to
demonstrate how a device may be used with more than one cell
type.
(b) Final Guidance.--Not later than 12 months after the close of the
period for public comment on the draft guidance under subsection (a),
the Secretary of Health and Human Services shall finalize such guidance.
SEC. 3035. <<NOTE: 21 USC 356 note.>> REPORT ON REGENERATIVE
ADVANCED THERAPIES.
(a) Report to Congress.--Before March 1 of each calendar year, the
Secretary of Health and Human Services shall, with
[[Page 130 STAT. 1104]]
respect to the previous calendar year, submit a report to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives on--
(1) the number and type of applications for approval of
regenerative advanced therapies filed, approved or licensed as
applicable, withdrawn, or denied; and
(2) how many of such applications or therapies, as
applicable, were granted accelerated approval or priority
review.
(b) Regenerative Advanced Therapy.--In this section, the term
``regenerative advanced therapy'' has the meaning given such term in
section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by
section 3033 of this Act.
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE
ADVANCED THERAPIES.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F
the following:
``SEC. 506G. <<NOTE: 21 USC 356g.>> STANDARDS FOR REGENERATIVE
MEDICINE AND REGENERATIVE ADVANCED
THERAPIES.
``(a) In General.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary, in consultation
with the National Institute of Standards and Technology and stakeholders
(including regenerative medicine and advanced therapies manufacturers
and clinical trial sponsors, contract manufacturers, academic
institutions, practicing clinicians, regenerative medicine and advanced
therapies industry organizations, and standard setting organizations),
shall facilitate an effort to coordinate and prioritize the development
of standards and consensus definition of terms, through a public
process, to support, through regulatory predictability, the development,
evaluation, and review of regenerative medicine therapies and
regenerative advanced therapies, including with respect to the
manufacturing processes and controls of such products.
``(b) Activities.--
``(1) In general.--In carrying out this section, the
Secretary shall continue to--
``(A) identity opportunities to help advance the
development of regenerative medicine therapies and
regenerative advanced therapies;
``(B) identify opportunities for the development of
laboratory regulatory science research and documentary
standards that the Secretary determines would help
support the development, evaluation, and review of
regenerative medicine therapies and regenerative
advanced therapies through regulatory predictability;
and
``(C) work with stakeholders, such as those
described in subsection (a), as appropriate, in the
development of such standards.
``(2) Regulations and guidance.--Not later than 1 year after
the development of standards as described in subsection (a), the
Secretary shall review relevant regulations and guidance and,
through a public process, update such regulations and guidance
as the Secretary determines appropriate.
[[Page 130 STAT. 1105]]
``(c) Definitions.--For purposes of this section, the terms
`regenerative medicine therapy' and `regenerative advanced therapy' have
the meanings given such terms in section 506(g).''.
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.
Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(a)) is amended--
(1) by striking ``(a) If its'' and inserting ``(a)(1) If
its'';
(2) by striking ``a formulary committee, or other similar
entity, in the course of the committee or the entity carrying
out its responsibilities for the selection of drugs for managed
care or other similar organizations'' and inserting ``a payor,
formulary committee, or other similar entity with knowledge and
expertise in the area of health care economic analysis, carrying
out its responsibilities for the selection of drugs for coverage
or reimbursement'';
(3) by striking ``directly relates'' and inserting
``relates'';
(4) by striking ``and is based on competent and reliable
scientific evidence. The requirements set forth in section
505(a) or in section 351(a) of the Public Health Service Act
shall not apply to health care economic information provided to
such a committee or entity in accordance with this paragraph''
and inserting ``, is based on competent and reliable scientific
evidence, and includes, where applicable, a conspicuous and
prominent statement describing any material differences between
the health care economic information and the labeling approved
for the drug under section 505 or under section 351 of the
Public Health Service Act. The requirements set forth in section
505(a) or in subsections (a) and (k) of section 351 of the
Public Health Service Act shall not apply to health care
economic information provided to such a payor, committee, or
entity in accordance with this paragraph''; and
(5) by striking ``In this paragraph, the term'' and all that
follows and inserting the following:
``(2)(A) For purposes of this paragraph, the term `health care
economic information' means any analysis (including the clinical data,
inputs, clinical or other assumptions, methods, results, and other
components underlying or comprising the analysis) that identifies,
measures, or describes the economic consequences, which may be based on
the separate or aggregated clinical consequences of the represented
health outcomes, of the use of a drug. Such analysis may be comparative
to the use of another drug, to another health care intervention, or to
no intervention.
``(B) Such term does not include any analysis that relates only to
an indication that is not approved under section 505 or under section
351 of the Public Health Service Act for such drug.''.
SEC. 3038. COMBINATION PRODUCT INNOVATION.
(a) In General.--Section 503(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(g)) is amended--
(1) by striking paragraph (3);
(2) by redesignating paragraph (2) as paragraph (7);
(3) by redesignating paragraphs (4) and (5) as paragraphs
(8) and (9), respectively;
(4) by striking ``(g)(1)'' and all that follows through the
end of paragraph (1) and inserting the following:
[[Page 130 STAT. 1106]]
``(g)(1)(A) The Secretary shall, in accordance with this subsection,
assign a primary agency center to regulate products that constitute a
combination of a drug, device, or biological product.
``(B) The Secretary shall conduct the premarket review of any
combination product under a single application, whenever appropriate.
``(C) For purposes of this subsection, the term `primary mode of
action' means the single mode of action of a combination product
expected to make the greatest contribution to the overall intended
therapeutic effects of the combination product.
``(D) The Secretary shall determine the primary mode of action of
the combination product. If the Secretary determines that the primary
mode of action is that of--
``(i) a drug (other than a biological product), the agency
center charged with premarket review of drugs shall have primary
jurisdiction;
``(ii) a device, the agency center charged with premarket
review of devices shall have primary jurisdiction; or
``(iii) a biological product, the agency center charged with
premarket review of biological products shall have primary
jurisdiction.
``(E) In determining the primary mode of action of a combination
product, the Secretary shall not determine that the primary mode of
action is that of a drug or biological product solely because the
combination product has any chemical action within or on the human body.
``(F) If a sponsor of a combination product disagrees with the
determination under subparagraph (D)--
``(i) such sponsor may request, and the Secretary shall
provide, a substantive rationale to such sponsor that references
scientific evidence provided by the sponsor and any other
scientific evidence relied upon by the Secretary to support such
determination; and
``(ii)(I) the sponsor of the combination product may propose
one or more studies (which may be nonclinical, clinical, or
both) to establish the relevance, if any, of the chemical action
in achieving the primary mode of action of such product;
``(II) if the sponsor proposes any such studies, the
Secretary and the sponsor of such product shall collaborate and
seek to reach agreement, within a reasonable time of such
proposal, not to exceed 90 calendar days, on the design of such
studies; and
``(III) if an agreement is reached under subclause (II) and
the sponsor conducts one or more of such studies, the Secretary
shall consider the data resulting from any such study when
reevaluating the determination of the primary mode of action of
such product, and unless and until such reevaluation has
occurred and the Secretary issues a new determination, the
determination of the Secretary under subparagraph (D) shall
remain in effect.
``(2)(A)(i) To establish clarity and certainty for the sponsor, the
sponsor of a combination product may request a meeting on such
combination product. If the Secretary concludes that a determination of
the primary mode of action pursuant to paragraph (1)(D) is necessary,
the sponsor may request such meeting only after the Secretary makes such
determination. If the sponsor submits a written meeting request, the
Secretary shall, not later than
[[Page 130 STAT. 1107]]
75 calendar days after receiving such request, meet with the sponsor of
such combination product.
``(ii) A meeting under clause (i) may--
``(I) address the standards and requirements for market
approval or clearance of the combination product;
``(II) address other issues relevant to such combination
product, such as requirements related to postmarket modification
of such combination product and good manufacturing practices
applicable to such combination product; and
``(III) identify elements under subclauses (I) and (II) that
may be more appropriate for discussion and agreement with the
Secretary at a later date given that scientific or other
information is not available, or agreement is otherwise not
feasible regarding such elements, at the time a request for such
meeting is made.
``(iii) Any agreement under this subparagraph shall be in writing
and made part of the administrative record by the Secretary.
``(iv) Any such agreement shall remain in effect, except--
``(I) upon the written agreement of the Secretary and the
sponsor or applicant; or
``(II) pursuant to a decision by the director of the
reviewing division of the primary agency center, or a person
more senior than such director, in consultation with consulting
centers and the Office, as appropriate, that an issue essential
to determining whether the standard for market clearance or
other applicable standard under this Act or the Public Health
Service Act applicable to the combination product has been
identified since the agreement was reached, or that deviating
from the agreement is otherwise justifiable based on scientific
evidence, for public health reasons.
``(3) For purposes of conducting the premarket review of a
combination product that contains an approved constituent part described
in paragraph (4), the Secretary may require that the sponsor of such
combination product submit to the Secretary only data or information
that the Secretary determines is necessary to meet the standard for
clearance or approval, as applicable, under this Act or the Public
Health Service Act, including any incremental risks and benefits posed
by such combination product, using a risk-based approach and taking into
account any prior finding of safety and effectiveness or substantial
equivalence for the approved constituent part relied upon by the
applicant in accordance with paragraph (5).
``(4) For purposes of paragraph (3), an approved constituent part
is--
``(A) a drug constituent part of a combination product being
reviewed in a single application or request under section 515,
510(k), or 513(f)(2) (submitted in accordance with paragraph
(5)), that is an approved drug, provided such application or
request complies with paragraph (5);
``(B) a device constituent part approved under section 515
that is referenced by the sponsor and that is available for use
by the Secretary under section 520(h)(4); or
``(C) any constituent part that was previously approved,
cleared, or classified under section 505, 510(k), 513(f)(2), or
515 of this Act for which the sponsor has a right of reference
or any constituent part that is a nonprescription drug, as
defined in section 760(a)(2).
[[Page 130 STAT. 1108]]
``(5)(A) If an application is submitted under section 515 or 510(k)
or a request is submitted under section 513(f)(2), consistent with any
determination made under paragraph (1)(D), for a combination product
containing as a constituent part an approved drug--
``(i) the application or request shall include the
certification or statement described in section 505(b)(2); and
``(ii) the applicant or requester shall provide notice as
described in section 505(b)(3).
``(B) For purposes of this paragraph and paragraph (4), the term
`approved drug' means an active ingredient--
``(i) that was in an application previously approved under
section 505(c);
``(ii) where such application is relied upon by the
applicant submitting the application or request described in
subparagraph (A);
``(iii) for which full reports of investigations that have
been made to show whether such drug is safe for use and whether
such drug is effective in use were not conducted by or for the
applicant submitting the application or request described in
subparagraph (A); and
``(iv) for which the applicant submitting the application or
request described in subparagraph (A) has not obtained a right
of reference or use from the person by or for whom the
investigations described in clause (iii) were conducted.
``(C) The following provisions shall apply with respect to an
application or request described in subparagraph (A) to the same extent
and in the same manner as if such application or request were an
application described in section 505(b)(2) that referenced the approved
drug:
``(i) Subparagraphs (A), (B), (C), and (D) of section
505(c)(3).
``(ii) Clauses (ii), (iii), and (iv) of section
505(c)(3)(E).
``(iii) Subsections (b) and (c) of section 505A.
``(iv) Section 505E(a).
``(v) Section 527(a).
``(D) Notwithstanding any other provision of this subsection, an
application or request for classification for a combination product
described in subparagraph (A) shall be considered an application
submitted under section 505(b)(2) for purposes of section 271(e)(2)(A)
of title 35, United States Code.
``(6) Nothing in this subsection shall be construed as prohibiting a
sponsor from submitting separate applications for the constituent parts
of a combination product, unless the Secretary determines that a single
application is necessary.'';
(5) in paragraph (8) (as redesignated by paragraph (3))--
(A) in subparagraph (C)--
(i) by amending clause (i) to read as follows:
``(i) In carrying out this subsection, the Office shall help to
ensure timely and effective premarket review that involves more than one
agency center by coordinating such reviews, overseeing the timeliness of
such reviews, and overseeing the alignment of feedback regarding such
reviews.'';
(ii) in clause (ii), by inserting ``and
alignment'' after ``the timeliness'' each place it
appears; and
(iii) by adding at the end the following new
clauses:
``(iii) The Office shall ensure that, with respect to a combination
product, a designated person or persons in the primary agency
[[Page 130 STAT. 1109]]
center is the primary point or points of contact for the sponsor of such
combination product. The Office shall also coordinate communications to
and from any consulting center involved in such premarket review, if
requested by such primary agency center or any such consulting center.
Agency communications and commitments, to the extent consistent with
other provisions of law and the requirements of all affected agency
centers, from the primary agency center shall be considered as
communication from the Secretary on behalf of all agency centers
involved in the review.
``(iv) The Office shall, with respect to the premarket review of a
combination product--
``(I) ensure that any meeting between the Secretary and the
sponsor of such product is attended by each agency center
involved in the review, as appropriate;
``(II) ensure that each consulting agency center has
completed its premarket review and provided the results of such
review to the primary agency center in a timely manner; and
``(III) ensure that each consulting center follows the
guidance described in clause (vi) and advises, as appropriate,
on other relevant regulations, guidances, and policies.
``(v) In seeking agency action with respect to a combination
product, the sponsor of such product--
``(I) shall identify the product as a combination product;
and
``(II) may request in writing the participation of
representatives of the Office in meetings related to such
combination product, or to have the Office otherwise engage on
such regulatory matters concerning the combination product.
``(vi) Not later than 4 years after the date of enactment of the
21st Century Cures Act, and after a public comment period of not less
than 60 calendar days, the Secretary shall issue a final guidance that
describes--
``(I) the structured process for managing pre-submission
interactions with sponsors developing combination products;
``(II) the best practices for ensuring that the feedback in
such pre-submission interactions represents the Agency's best
advice based on the information provided during such pre-
submission interactions;
``(III) the information that is required to be submitted
with a meeting request under paragraph (2), how such meetings
relate to other types of meetings in the Food and Drug
Administration, and the form and content of any agreement
reached through a meeting under such paragraph (2);''; and
(B) in subparagraph (G)--
(i) in the matter preceding clause (i), by
inserting ``(except with respect to clause (iv),
beginning not later than one year after the date
of the enactment of the 21st Century Cures Act)''
after ``enactment of this paragraph'';
(ii) in clause (ii), by striking ``and'' at
the end;
(iii) in clause (iii), by striking the period
at the end and inserting ``; and''; and
(iv) by adding at the end the following new
clause:
``(iv) identifying the percentage of combination products
for which a dispute resolution, with respect to premarket
review, was requested by the combination product's sponsor.'';
and
[[Page 130 STAT. 1110]]
(6) in paragraph (9) (as redesignated by paragraph (3))--
(A) in subparagraph (C)--
(i) in clause (i), by striking the comma at
the end and inserting a semicolon;
(ii) in clause (ii), by striking ``, and'' at
the end and inserting a semicolon;
(iii) in clause (iii), by striking the period
at the end and inserting ``; and''; and
(iv) by adding at the end the following:
``(iv) de novo classification under section
513(a)(1).''; and
(B) by adding at the end the following:
``(D) The terms `premarket review' and `reviews' include all
activities of the Food and Drug Administration conducted prior
to approval or clearance of an application, notification, or
request for classification submitted under section 505, 510(k),
513(f)(2), 515, or 520 of this Act or under section 351 of the
Public Health Service Act, including with respect to
investigational use of the product.''.
(b) Information for Approval of Combination Products.--Section
520(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(h)(4)) is amended--
(1) in subparagraph (A), by striking ``Any information'' and
inserting ``Subject to subparagraph (C), any information''; and
(2) by adding at the end the following new subparagraph:
``(C) No information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c) may be used
to approve or clear any application submitted under section 515 or
510(k) or to classify a product under section 513(f)(2) for a
combination product containing as a constituent part an approved drug
(as defined in section 503(g)(5)(B)) unless--
``(i) the application includes the certification or
statement referenced in section 503(g)(5)(A);
``(ii) the applicant provides notice as described in section
503(g)(5)(A); and
``(iii) the Secretary's approval of such application is
subject to the provisions in section 503(g)(5)(C).''.
(c) <<NOTE: 21 USC 355 note.>> Variations From CGMP Streamlined
Approach.--Not later than 18 months after the date of enactment of this
Act, the Secretary of Health and Human Services (referred to in this
subsection as the ``Secretary'') shall identify types of combination
products and manufacturing processes with respect to which the Secretary
proposes that good manufacturing processes may be adopted that vary from
the requirements set forth in section 4.4 of title 21, Code of Federal
Regulations (or any successor regulations) or that the Secretary
proposes can satisfy the requirements in section 4.4 through alternative
or streamlined mechanisms. The Secretary shall identify such types,
variations from such requirements, and such mechanisms, in a proposed
list published in the Federal Register. After a public comment period
regarding the appropriate good manufacturing practices for such types,
the Secretary shall publish a final list in the Federal Register,
notwithstanding section 553 of title 5, United States Code. The
Secretary shall evaluate such types, variations, and mechanisms using a
risk-based approach. The Secretary shall periodically review such final
list.
[[Page 130 STAT. 1111]]
Subtitle E--Antimicrobial Innovation and Stewardship
SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.
(a) In General.--Section 319E of the Public Health Service Act (42
U.S.C. 247d-5) is amended--
(1) by redesignating subsections (f) and (g) as subsections
(l) and (m), respectively; and
(2) by inserting after subsection (e), the following:
``(f) Monitoring at Federal Health Care Facilities.--The Secretary
shall encourage reporting on aggregate antimicrobial drug use and
antimicrobial resistance to antimicrobial drugs and the implementation
of antimicrobial stewardship programs by health care facilities of the
Department of Defense, the Department of Veterans Affairs, and the
Indian Health Service and shall provide technical assistance to the
Secretary of Defense and the Secretary of Veterans Affairs, as
appropriate and upon request.
``(g) Report on Antimicrobial Resistance in Humans and Use of
Antimicrobial Drugs.--Not later than 1 year after the date of enactment
of the 21st Century Cures Act, and annually thereafter, the Secretary
shall prepare and make publicly available data and information
concerning--
``(1) aggregate national and regional trends of
antimicrobial resistance in humans to antimicrobial drugs,
including such drugs approved under section 506(h) of the
Federal Food, Drug, and Cosmetic Act;
``(2) antimicrobial stewardship, which may include summaries
of State efforts to address antimicrobial resistance in humans
to antimicrobial drugs and antimicrobial stewardship; and
``(3) coordination between the Director of the Centers for
Disease Control and Prevention and the Commissioner of Food and
Drugs with respect to the monitoring of--
``(A) any applicable resistance under paragraph (1);
and
``(B) drugs approved under section 506(h) of the
Federal Food, Drug, and Cosmetic Act.
``(h) Information Related to Antimicrobial Stewardship Programs.--
The Secretary shall, as appropriate, disseminate guidance, educational
materials, or other appropriate materials related to the development and
implementation of evidence-based antimicrobial stewardship programs or
practices at health care facilities, such as nursing homes and other
long-term care facilities, ambulatory surgical centers, dialysis
centers, outpatient clinics, and hospitals, including community and
rural hospitals.
``(i) Supporting State-Based Activities To Combat Antimicrobial
Resistance.--The Secretary shall continue to work with State and local
public health departments on statewide or regional programs related to
antimicrobial resistance. Such efforts may include activities to related
to--
``(1) identifying patterns of bacterial and fungal
resistance in humans to antimicrobial drugs;
``(2) preventing the spread of bacterial and fungal
infections that are resistant to antimicrobial drugs; and
``(3) promoting antimicrobial stewardship.
[[Page 130 STAT. 1112]]
``(j) Antimicrobial Resistance and Stewardship Activities.--
``(1) In general.--For the purposes of supporting
stewardship activities, examining changes in antimicrobial
resistance, and evaluating the effectiveness of section 506(h)
of the Federal Food, Drug, and Cosmetic Act, the Secretary
shall--
``(A) provide a mechanism for facilities to report
data related to their antimicrobial stewardship
activities (including analyzing the outcomes of such
activities); and
``(B) evaluate--
``(i) antimicrobial resistance data using a
standardized approach; and
``(ii) trends in the utilization of drugs
approved under such section 506(h) with respect to
patient populations.
``(2) Use of systems.--The Secretary shall use available
systems, including the National Healthcare Safety Network or
other systems identified by the Secretary, to fulfill the
requirements or conduct activities under this section.
``(k) Antimicrobial.--For purposes of subsections (f) through (j),
the term `antimicrobial' includes any antibacterial or antifungal drugs,
and may include drugs that eliminate or inhibit the growth of other
microorganisms, as appropriate.''.
(b) <<NOTE: 42 USC 247d-5 note.>> Availability of Data.--The
Secretary shall make the data collected pursuant to this subsection
public. Nothing in this subsection shall be construed as authorizing the
Secretary to disclose any information that is a trade secret or
confidential information subject to section 552(b)(4) of title 5, United
States Code, or section 1905 of title 18, United States Code.
SEC. 3042. LIMITED POPULATION PATHWAY.
Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356), as amended by section 3033, is further amended by adding at the
end the following:
``(h) Limited Population Pathway for Antibacterial and Antifungal
Drugs.--
``(1) In general.--The Secretary may approve an
antibacterial or antifungal drug, alone or in combination with
one or more other drugs, as a limited population drug pursuant
to this subsection only if--
``(A) the drug is intended to treat a serious or
life-threatening infection in a limited population of
patients with unmet needs;
``(B) the standards for approval under section
505(c) and (d), or the standards for licensure under
section 351 of the Public Health Service Act, as
applicable, are met; and
``(C) the Secretary receives a written request from
the sponsor to approve the drug as a limited population
drug pursuant to this subsection.
``(2) Benefit-risk consideration.--The Secretary's
determination of safety and effectiveness of an antibacterial or
antifungal drug shall reflect the benefit-risk profile of such
drug in the intended limited population, taking into account the
severity, rarity, or prevalence of the infection the drug is
intended to treat and the availability or lack of alternative
treatment in such limited population. Such drug may be
[[Page 130 STAT. 1113]]
approved under this subsection notwithstanding a lack of
evidence to fully establish a favorable benefit-risk profile in
a population that is broader than the intended limited
population.
``(3) Additional requirements.--A drug approved under this
subsection shall be subject to the following requirements, in
addition to any other applicable requirements of this Act:
``(A) Labeling.--To indicate that the safety and
effectiveness of a drug approved under this subsection
has been demonstrated only with respect to a limited
population--
``(i) all labeling and advertising of an
antibacterial or antifungal drug approved under
this subsection shall contain the statement
`Limited Population' in a prominent manner and
adjacent to, and not more prominent than--
``(I) the proprietary name of such
drug, if any; or
``(II) if there is no proprietary
name, the established name of the drug,
if any, as defined in section 503(e)(3),
or, in the case of a drug that is a
biological product, the proper name, as
defined by regulation; and
``(ii) the prescribing information for the
drug required by section 201.57 of title 21, Code
of Federal Regulations (or any successor
regulation) shall also include the following
statement: `This drug is indicated for use in a
limited and specific population of patients.'.
``(B) Promotional material.--The sponsor of an
antibacterial or antifungal drug subject to this
subsection shall submit to the Secretary copies of all
promotional materials related to such drug at least 30
calendar days prior to dissemination of the materials.
``(4) Other programs.--A sponsor of a drug that seeks
approval of a drug under this subsection may also seek
designation or approval, as applicable, of such drug under other
applicable sections or subsections of this Act or the Public
Health Service Act.
``(5) Guidance.--Not later than 18 months after the date of
enactment of the 21st Century Cures Act, the Secretary shall
issue draft guidance describing criteria, processes, and other
general considerations for demonstrating the safety and
effectiveness of limited population antibacterial and antifungal
drugs. The Secretary shall publish final guidance within 18
months of the close of the public comment period on such draft
guidance. The Secretary may approve antibacterial and antifungal
drugs under this subsection prior to issuing guidance under this
paragraph.
``(6) Advice.--The Secretary shall provide prompt advice to
the sponsor of a drug for which the sponsor seeks approval under
this subsection to enable the sponsor to plan a development
program to obtain the necessary data for such approval, and to
conduct any additional studies that would be required to gain
approval of such drug for use in a broader population.
``(7) Termination of limitations.--If, after approval of a
drug under this subsection, the Secretary approves a broader
indication for such drug under section 505(b) or section 351(a)
of the Public Health Service Act, the Secretary may remove
[[Page 130 STAT. 1114]]
any postmarketing conditions, including requirements with
respect to labeling and review of promotional materials under
paragraph (3), applicable to the approval of the drug under this
subsection.
``(8) Rules of construction.--Nothing in this subsection
shall be construed to alter the authority of the Secretary to
approve drugs pursuant to this Act or section 351 of the Public
Health Service Act, including the standards of evidence and
applicable conditions for approval under such Acts, the
standards of approval of a drug under such Acts, or to alter the
authority of the Secretary to monitor drugs pursuant to such
Acts.
``(9) Reporting and accountability.--
``(A) Biennial reporting.--The Secretary shall
report to Congress not less often than once every 2
years on the number of requests for approval, and the
number of approvals, of an antibacterial or antifungal
drug under this subsection.
``(B) GAO report.--Not later than December 2021, the
Comptroller General of the United States shall submit to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor and Pensions of the Senate a report on the
coordination of activities required under section 319E
of the Public Health Service Act. Such report shall
include a review of such activities, and the extent to
which the use of the pathway established under this
subsection has streamlined premarket approval for
antibacterial or antifungal drugs for limited
populations, if such pathway has functioned as intended,
if such pathway has helped provide for safe and
effective treatment for patients, if such premarket
approval would be appropriate for other categories of
drugs, and if the authorities under this subsection have
affected antibacterial or antifungal resistance.''.
SEC. 3043. <<NOTE: 21 USC 356 note.>> PRESCRIBING AUTHORITY.
Nothing in this subtitle, or an amendment made by this subtitle,
shall be construed to restrict the prescribing of antimicrobial drugs or
other products, including drugs approved under subsection (h) of section
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as
added by section 3042), by health care professionals, or to limit the
practice of health care.
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS; ANTIMICROBIAL
SUSCEPTIBILITY TESTING DEVICES.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 511 the following:
``SEC. 511A. <<NOTE: 21 USC 360a-2.>> SUSCEPTIBILITY TEST
INTERPRETIVE CRITERIA FOR
MICROORGANISMS.
``(a) Purpose; Identification of Criteria.--
``(1) Purpose.--The purpose of this section is to clarify
the Secretary's authority to--
``(A) efficiently update susceptibility test
interpretive criteria for antimicrobial drugs when
necessary for public
[[Page 130 STAT. 1115]]
health, due to, among other things, the constant
evolution of microorganisms that leads to the
development of resistance to drugs that have been
effective in decreasing morbidity and mortality for
patients, which warrants unique management of
antimicrobial drugs that is inappropriate for most other
drugs in order to delay or prevent the development of
further resistance to existing therapies;
``(B) provide for public notice of the availability
of recognized interpretive criteria and interpretive
criteria standards; and
``(C) clear under section 510(k), classify under
section 513(f)(2), or approve under section 515,
antimicrobial susceptibility testing devices utilizing
updated, recognized susceptibility test interpretive
criteria to characterize the in vitro susceptibility of
particular bacteria, fungi, or other microorganisms, as
applicable, to antimicrobial drugs.
``(2) Identification of criteria.--The Secretary shall
identify appropriate susceptibility test interpretive criteria
with respect to antimicrobial drugs--
``(A) if such criteria are available on the date of
approval of the drug under section 505 of this Act or
licensure of the drug under section 351 of the Public
Health Service Act (as applicable), upon such approval
or licensure; or
``(B) if such criteria are unavailable on such date,
on the date on which such criteria are available for
such drug.
``(3) Bases for initial identification.--The Secretary shall
identify appropriate susceptibility test interpretive criteria
under paragraph (2), based on the Secretary's review of, to the
extent available and relevant--
``(A) preclinical and clinical data, including
pharmacokinetic, pharmacodynamic, and epidemiological
data;
``(B) the relationship of susceptibility test
interpretive criteria to morbidity and mortality
associated with the disease or condition for which such
drug is used; and
``(C) such other evidence and information as the
Secretary considers appropriate.
``(b) Susceptibility Test Interpretive Criteria Website.--
``(1) In general.--Not later than 1 year after the date of
the enactment of the 21st Century Cures Act, the Secretary shall
establish, and maintain thereafter, on the website of the Food
and Drug Administration, a dedicated website that contains a
list of any appropriate new or updated susceptibility test
interpretive criteria standards and interpretive criteria in
accordance with paragraph (2) (referred to in this section as
the `Interpretive Criteria Website').
``(2) Listing of susceptibility test interpretive criteria
standards and interpretive criteria.--
``(A) In general.--The list described in paragraph
(1) shall consist of any new or updated susceptibility
test interpretive criteria standards that are--
``(i) established by a nationally or
internationally recognized standard development
organization that--
``(I) establishes and maintains
procedures to address potential
conflicts of interest and ensure
transparent decisionmaking;
[[Page 130 STAT. 1116]]
``(II) holds open meetings to ensure
that there is an opportunity for public
input by interested parties, and
establishes and maintains processes to
ensure that such input is considered in
decisionmaking; and
``(III) permits its standards to be
made publicly available, through the
National Library of Medicine or another
similar source acceptable to the
Secretary; and
``(ii) recognized in whole, or in part, by the
Secretary under subsection (c).
``(B) Other list.--The Interpretive Criteria Website
shall, in addition to the list described in subparagraph
(A), include a list of interpretive criteria, if any,
that the Secretary has determined to be appropriate with
respect to legally marketed antimicrobial drugs, where--
``(i) the Secretary does not recognize, in
whole or in part, an interpretive criteria
standard described under subparagraph (A)
otherwise applicable to such a drug;
``(ii) the Secretary withdraws under
subsection (c)(1)(A) recognition of a standard, in
whole or in part, otherwise applicable to such a
drug;
``(iii) the Secretary approves an application
under section 505 of this Act or section 351 of
the Public Health Service Act, as applicable, with
respect to marketing of such a drug for which
there are no relevant interpretive criteria
included in a standard recognized by the Secretary
under subsection (c); or
``(iv) because the characteristics of such a
drug differ from other drugs with the same active
ingredient, the interpretive criteria with respect
to such drug--
``(I) differ from otherwise
applicable interpretive criteria
included in a standard listed under
subparagraph (A) or interpretive
criteria otherwise listed under this
subparagraph; and
``(II) are determined by the
Secretary to be appropriate for the
drug.
``(C) Required statements.--The Interpretive
Criteria Website shall include statements conveying--
``(i) that the website provides information
about the in vitro susceptibility of bacteria,
fungi, or other microorganisms, as applicable to a
certain drug (or drugs);
``(ii) that--
``(I) the safety and efficacy of
such drugs in treating clinical
infections due to such bacteria, fungi,
or other microorganisms, as applicable,
may or may not have been established in
adequate and well-controlled clinical
trials in order for the susceptibility
information described in clause (i) to
be included on the website; and
``(II) the clinical significance of
such susceptibility information in such
instances is unknown;
``(iii) that the approved product labeling for
specific drugs provides the uses for which the
Secretary has approved the product; and
[[Page 130 STAT. 1117]]
``(iv) any other information that the
Secretary determines appropriate to adequately
convey the meaning of the data supporting the
recognition or listing of susceptibility test
interpretive criteria standards or susceptibility
test interpretive criteria included on the
website.
``(3) Notice.--Not later than the date on which the
Interpretive Criteria Website is established, the Secretary
shall publish a notice of that establishment in the Federal
Register.
``(4) Inapplicability of misbranding provision.--The
inclusion in the approved labeling of an antimicrobial drug of a
reference or hyperlink to the Interpretive Criteria Website, in
and of itself, shall not cause the drug to be misbranded in
violation of section 502.
``(5) Trade secrets and confidential information.--Nothing
in this section shall be construed as authorizing the Secretary
to disclose any information that is a trade secret or
confidential information subject to section 552(b)(4) of title
5, United States Code.
``(c) Recognition of Susceptibility Test Interpretive Criteria.--
``(1) Evaluation and publication.--
``(A) In general.--Beginning on the date of the
establishment of the Interpretive Criteria Website, and
at least every 6 months thereafter, the Secretary
shall--
``(i) evaluate any appropriate new or updated
susceptibility test interpretive criteria
standards established by a nationally or
internationally recognized standard development
organization described in subsection (b)(2)(A)(i);
and
``(ii) publish on the public website of the
Food and Drug Administration a notice--
``(I) withdrawing recognition of any
different susceptibility test
interpretive criteria standard, in whole
or in part;
``(II) recognizing the new or
updated standards;
``(III) recognizing one or more
parts of the new or updated interpretive
criteria specified in such a standard
and declining to recognize the remainder
of such standard; and
``(IV) making any necessary updates
to the lists under subsection (b)(2).
``(B) Upon approval of a drug.--Upon the approval of
an initial or supplemental application for an
antimicrobial drug under section 505 of this Act or
section 351 of the Public Health Service Act, as
applicable, where such approval is based on
susceptibility test interpretive criteria which differ
from those contained in a standard recognized, or from
those otherwise listed, by the Secretary pursuant to
this subsection, or for which there are no relevant
interpretive criteria standards recognized, or
interpretive criteria otherwise listed, by the Secretary
pursuant to this subsection, the Secretary shall update
the lists under subparagraphs (A) and (B) of subsection
(b)(2) to include the susceptibility test interpretive
criteria upon which such approval was based.
[[Page 130 STAT. 1118]]
``(2) Bases for updating interpretive criteria standards.--
In evaluating new or updated susceptibility test interpretive
criteria standards under paragraph (1)(A), the Secretary may
consider--
``(A) the Secretary's determination that such a
standard is not applicable to a particular drug because
the characteristics of the drug differ from other drugs
with the same active ingredient;
``(B) information provided by interested third
parties, including public comment on the annual
compilation of notices published under paragraph (3);
``(C) any bases used to identify susceptibility test
interpretive criteria under subsection (a)(2); and
``(D) such other information or factors as the
Secretary determines appropriate.
``(3) Annual compilation of notices.--Each year, the
Secretary shall compile the notices published under paragraph
(1)(A) and publish such compilation in the Federal Register and
provide for public comment. If the Secretary receives comments,
the Secretary shall review such comments and, if the Secretary
determines appropriate, update pursuant to this subsection
susceptibility test interpretive criteria standards or
criteria--
``(A) recognized by the Secretary under this
subsection; or
``(B) otherwise listed on the Interpretive Criteria
Website under subsection (b)(2).
``(4) Relation to section 514(c).--Any susceptibility test
interpretive standard recognized under this subsection or any
criteria otherwise listed under subsection (b)(2)(B) shall be
deemed to be recognized as a standard by the Secretary under
section 514(c)(1).
``(5) Voluntary use of interpretive criteria.--Nothing in
this section prohibits a person from seeking approval or
clearance of a drug or device, or changes to the drug or the
device, on the basis of susceptibility test interpretive
criteria which differ from those contained in a standard
recognized, or from those otherwise listed, by the Secretary
pursuant to subsection (b)(2).
``(d) Antimicrobial Drug Labeling.--
``(1) Drugs marketed prior to establishment of interpretive
criteria website.--
``(A) In general.--With respect to an antimicrobial
drug lawfully introduced or delivered for introduction
into interstate commerce for commercial distribution
before the establishment of the Interpretive Criteria
Website, a holder of an approved application under
section 505 of this Act or section 351 of the Public
Health Service Act, as applicable, for each such drug,
not later than 1 year after establishment of the
Interpretive Criteria Website described in subsection
(b)(1), shall remove susceptibility test interpretive
criteria, if any, and related information from the
approved drug labeling and replace it with a reference
to the Interpretive Criteria Website.
``(B) Labeling changes.--The labeling changes
required by this section shall be considered a minor
change
[[Page 130 STAT. 1119]]
under section 314.70 of title 21, Code of Federal
Regulations (or any successor regulations) that may be
implemented through documentation in the next applicable
annual report.
``(2) Drugs marketed subsequent to establishment of
interpretive criteria website.--With respect to antimicrobial
drugs approved on or after the date of the establishment of the
Interpretive Criteria Website described in subsection (b)(1),
the labeling for such a drug shall include, in lieu of
susceptibility test interpretive criteria and related
information, a reference to such Website.
``(e) Special Condition for Marketing of Antimicrobial
Susceptibility Testing Devices.--
``(1) In general.--Notwithstanding sections 501, 502, 505,
510, 513, and 515, if the conditions specified in paragraph (2)
are met (in addition to other applicable provisions under this
chapter) with respect to an antimicrobial susceptibility testing
device described in subsection (f)(1), the Secretary may
authorize the marketing of such device for a use described in
such subsection.
``(2) Conditions applicable to antimicrobial susceptibility
testing devices.--The conditions specified in this paragraph are
the following:
``(A) The device is used to make a determination of
susceptibility using susceptibility test interpretive
criteria that are--
``(i) included in a standard recognized by the
Secretary under subsection (c); or
``(ii) otherwise listed on the Interpretive
Criteria Website under subsection (b)(2).
``(B) The labeling of such device includes
statements conveying--
``(i) that the device provides information
about the in vitro susceptibility of bacteria,
fungi, or other microorganisms, as applicable to
antimicrobial drugs;
``(ii) that--
``(I) the safety and efficacy of
such drugs in treating clinical
infections due to such bacteria, fungi,
or other microorganisms, as applicable,
may or may not have been established in
adequate and well-controlled clinical
trials in order for the device to report
the susceptibility of such bacteria,
fungi, or other microorganisms, as
applicable, to such drugs; and
``(II) the clinical significance of
such susceptibility information in those
instances is unknown;
``(iii) that the approved labeling for drugs
tested using such a device provides the uses for
which the Secretary has approved such drugs; and
``(iv) any other information the Secretary
determines appropriate to adequately convey the
meaning of the data supporting the recognition or
listing of susceptibility test interpretive
criteria standards or susceptibility test
interpretive criteria described in subparagraph
(A).
``(C) The antimicrobial susceptibility testing
device meets all other requirements to be cleared under
section
[[Page 130 STAT. 1120]]
510(k), classified under section 513(f)(2), or approved
under section 515.
``(f) Definitions.--In this section:
``(1) The term `antimicrobial susceptibility testing device'
means a device that utilizes susceptibility test interpretive
criteria to determine and report the in vitro susceptibility of
certain microorganisms to a drug (or drugs).
``(2) The term `qualified infectious disease product' means
a qualified infectious disease product designated under section
505E(d).
``(3) The term `susceptibility test interpretive criteria'
means--
``(A) one or more specific numerical values which
characterize the susceptibility of bacteria or other
microorganisms to the drug tested; and
``(B) related categorizations of such
susceptibility, including categorization of the drug as
susceptible, intermediate, resistant, or such other term
as the Secretary determines appropriate.
``(4)(A) The term `antimicrobial drug' means, subject to
subparagraph (B), a systemic antibacterial or antifungal drug
that--
``(i) is intended for human use in the treatment of
a disease or condition caused by a bacterium or fungus;
``(ii) may include a qualified infectious disease
product designated under section 505E(d); and
``(iii) is subject to section 503(b)(1).
``(B) If provided by the Secretary through regulations, such
term may include--
``(i) drugs other than systemic antibacterial and
antifungal drugs; and
``(ii) biological products (as such term is defined
in section 351 of the Public Health Service Act) to the
extent such products exhibit antimicrobial activity.
``(5) The term `interpretive criteria standard' means a
compilation of susceptibility test interpretive criteria
developed by a standard development organization that meets the
criteria set forth in subsection (b)(2)(A)(i).
``(g) Rule of Construction.--Nothing in this section shall be
construed to--
``(1) alter the standards of evidence under subsection (c)
or (d) of section 505 (including the substantial evidence
standard under section 505(d)) or under section 351 of the
Public Health Service Act (as applicable); or
``(2) with respect to clearing devices under section 510(k),
classifying devices under section 513(f)(2), or approving
devices under section 515--
``(A) apply with respect to any drug, device, or
biological product, in any context other than an
antimicrobial drug and an antimicrobial susceptibility
testing device that uses susceptibility test
interpretive criteria to characterize and report the
susceptibility of certain bacteria, fungi, or other
microorganisms, as applicable, to such drug to reflect
patient morbidity and mortality in accordance with this
section; or
[[Page 130 STAT. 1121]]
``(B) unless specifically stated, have any effect on
authorities provided under other sections of this Act,
including any regulations issued under such sections.''.
(b) Conforming Amendments.--
(1) Repeal of prior related authority.--Section 1111 of the
Food and Drug Administration Amendments Act of 2007 (42 U.S.C.
247d-5a), relating to identification of clinically susceptible
concentrations of antimicrobials, is repealed.
(2) Addition to categories of misbranded drugs.--Section 502
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is
amended by adding at the end the following:
``(dd) If it is an antimicrobial drug, as defined in section
511A(f), and its labeling fails to conform with the requirements under
section 511A(d).''.
(3) Recognition of interpretive criteria standard as device
standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting
after ``the Secretary shall, by publication in the Federal
Register'' the following: ``(or, with respect to a
susceptibility test interpretive criteria standard under section
511A, by posting on the Interpretive Criteria Website in
accordance with such section)''.
(c) Report to Congress.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report on the progress made in implementing section
511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as
added by subsection (a).
(d) <<NOTE: 21 USC 360a-2 note.>> Requests for Updates to
Interpretive Criteria Website.--Chapter 35 of title 44, United States
Code, shall not apply to the collection of information from interested
parties regarding updating the lists established under section 511A(b)
of the Federal Food, Drug, and Cosmetic Act and posted on the
Interpretive Criteria Website established under section 511A(c) of such
Act.
Subtitle F--Medical Device Innovations
SEC. 3051. BREAKTHROUGH DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B,
as added by section 3034(b), the following:
``SEC. 515C. <<NOTE: 21 USC 360e-3.>> BREAKTHROUGH DEVICES.
``(a) Purpose.--The purpose of this section is to encourage the
Secretary, and provide the Secretary with sufficient authority, to apply
efficient and flexible approaches to expedite the development of, and
prioritize the Food and Drug Administration's review of, devices that
represent breakthrough technologies.
``(b) Establishment of Program.--The Secretary shall establish a
program to expedite the development of, and provide for the priority
review for, devices, as determined by the Secretary--
[[Page 130 STAT. 1122]]
``(1) that provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human disease
or conditions; and
``(2)(A) that represent breakthrough technologies;
``(B) for which no approved or cleared alternatives exist;
``(C) that offer significant advantages over existing
approved or cleared alternatives, including the potential,
compared to existing approved alternatives, to reduce or
eliminate the need for hospitalization, improve patient quality
of life, facilitate patients' ability to manage their own care
(such as through self-directed personal assistance), or
establish long-term clinical efficiencies; or
``(D) the availability of which is in the best interest of
patients.
``(c) Request for Designation.--A sponsor of a device may request
that the Secretary designate such device for expedited development and
priority review under this section. Any such request for designation may
be made at any time prior to the submission of an application under
section 515(c), a notification under section 510(k), or a petition for
classification under section 513(f)(2).
``(d) Designation Process.--
``(1) In general.--Not later than 60 calendar days after the
receipt of a request under subsection (c), the Secretary shall
determine whether the device that is the subject of the request
meets the criteria described in subsection (b). If the Secretary
determines that the device meets the criteria, the Secretary
shall designate the device for expedited development and
priority review.
``(2) Review.--Review of a request under subsection (c)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
``(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of the
criteria under subsection (b) no longer applying because of the
subsequent clearance or approval of another device that--
``(A) was designated under this section; or
``(B) was given priority review under section
515(d)(5), as in effect prior to the date of enactment
of the 21st Century Cures Act.
``(e) Expedited Development and Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (d) the
Secretary shall--
``(A) assign a team of staff, including a team
leader with appropriate subject matter expertise and
experience, for each device for which a request is
submitted under subsection (c);
``(B) provide for oversight of the team by senior
agency personnel to facilitate the efficient development
of the device and the efficient review of any submission
described in subsection (c) for the device;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive and timely
communication with the sponsor of the device during the
development program and review process;
[[Page 130 STAT. 1123]]
``(E) expedite the Secretary's review of
manufacturing and quality systems compliance, as
applicable;
``(F) disclose to the sponsor, not less than 5
business days in advance, the topics of any consultation
the Secretary intends to undertake with external experts
or an advisory committee concerning the sponsor's device
and provide the sponsor the opportunity to recommend
such external experts;
``(G) provide for advisory committee input, as the
Secretary determines appropriate (including in response
to the request of the sponsor) for applications
submitted under section 515(c); and
``(H) assign staff to be available within a
reasonable time to address questions by institutional
review committees concerning the conditions and clinical
testing requirements applicable to the investigational
use of the device pursuant to an exemption under section
520(g).
``(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting the
development and review of devices designated under subsection
(d), the Secretary, in collaboration with the device sponsor,
may, as appropriate--
``(A) coordinate with the sponsor regarding early
agreement on a data development plan;
``(B) take steps to ensure that the design of
clinical trials is as efficient and flexible as
practicable, when scientifically appropriate;
``(C) facilitate, when scientifically appropriate,
expedited and efficient development and review of the
device through utilization of timely postmarket data
collection with regard to application for approval under
section 515(c); and
``(D) agree in writing to clinical protocols that
the Secretary will consider binding on the Secretary and
the sponsor, subject to--
``(i) changes to such protocols agreed to in
writing by the sponsor and the Secretary; or
``(ii) a decision, made by the director of the
office responsible for reviewing the device
submission, that a substantial scientific issue
essential to determining the safety or
effectiveness of such device exists, provided that
such decision is in writing, and is made only
after the Secretary provides to the device sponsor
or applicant an opportunity for a meeting at which
the director and the sponsor or applicant are
present and at which the director documents the
substantial scientific issue.
``(f) Priority Review Guidance.--
``(1) Content.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
issue guidance on the implementation of this section. Such
guidance shall--
``(A) set forth the process by which a person may
seek a designation under subsection (d);
``(B) provide a template for requests under
subsection (c);
[[Page 130 STAT. 1124]]
``(C) identify the criteria the Secretary will use
in evaluating a request for designation under this
section; and
``(D) identify the criteria and processes the
Secretary will use to assign a team of staff, including
team leaders, to review devices designated for expedited
development and priority review, including any training
required for such personnel to ensure effective and
efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment on a
proposed guidance.
``(g) Rule of Construction.--Nothing in this section shall be
construed to affect--
``(1) the criteria and standards for evaluating an
application pursuant to section 515(c), a report and request for
classification under section 513(f)(2), or a report under
section 510(k), including the recognition of valid scientific
evidence as described in section 513(a)(3)(B) and consideration
and application of the least burdensome means of evaluating
device effectiveness or demonstrating substantial equivalence
between devices with differing technological characteristics, as
applicable;
``(2) the authority of the Secretary with respect to
clinical holds under section 520(g)(8)(A);
``(3) the authority of the Secretary to act on an
application pursuant to section 515(d) before completion of an
establishment inspection, as the Secretary determines
appropriate; or
``(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and 522.''.
(b) Documentation and Review of Significant Decisions.--Section
517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)(1)) is amended by inserting ``a request for designation under
section 515C,'' after ``application under section 515,''.
(c) Termination of Previous Program.--
(1) In general.--Section 515(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph (5).
(2) Conforming amendment.--Section 737(5) of the Federal
Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by
striking ``515(d)(6)'' and inserting ``515(d)(5)''.
(d) Report.--On January 1, 2019, the Secretary of Health and Human
Services shall issue a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives--
(1) on the program under section 515C of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), in bringing
safe and effective devices included in such program to patients
as soon as possible; and
(2) that includes recommendations, if any, to strengthen the
program to better meet patient device needs in a manner as
timely as possible.
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.
(a) In General.--Section 520(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) is amended--
[[Page 130 STAT. 1125]]
(1) in paragraph (1) by striking ``fewer than 4,000'' and
inserting ``not more than 8,000'';
(2) in paragraph (2)(A) by striking ``fewer than 4,000'' and
inserting ``not more than 8,000''; and
(3) in paragraph (6)(A)(ii), by striking ``4,000'' and
inserting ``8,000''.
(b) <<NOTE: 21 USC 360j note.>> Guidance Document on Probable
Benefit.--Not later than 18 months after the date of enactment of this
Act, the Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall publish a draft guidance that
defines the criteria for establishing ``probable benefit'' as that term
is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(m)(2)(C)).
SEC. 3053. RECOGNITION OF STANDARDS.
(a) In General.--Section 514(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (B)
the following new subparagraphs:
``(C)(i) Any person may submit a request for recognition under
subparagraph (A) of all or part of an appropriate standard established
by a nationally or internationally recognized standard organization.
``(ii) Not later than 60 calendar days after the Secretary receives
such a request, the Secretary shall--
``(I) make a determination to recognize all, part, or none
of the standard that is the subject of the request; and
``(II) issue to the person who submitted such request a
response in writing that states the Secretary's rationale for
that determination, including the scientific, technical,
regulatory, or other basis for such determination.
``(iii) The Secretary shall make a response issued under clause
(ii)(II) publicly available, in such a manner as the Secretary
determines appropriate.
``(iv) The Secretary shall take such actions as may be necessary to
implement all or part of a standard recognized under clause (ii)(I), in
accordance with subparagraph (A).
``(D) The Secretary shall make publicly available, in such manner as
the Secretary determines appropriate, the rationale for recognition
under subparagraph (A) of all, part, or none of a standard, including
the scientific, technical, regulatory, or other basis for the decision
regarding such recognition.''; and
(2) by adding at the end the following:
``(4) The Secretary shall provide to all employees of the Food and
Drug Administration who review premarket submissions for devices
periodic training on the concept and use of recognized standards for
purposes of meeting a premarket submission requirement or other
applicable requirement under this Act, including standards relevant to
an employee's area of device review.''.
(b) <<NOTE: 21 USC 360d note.>> Guidance.--The Secretary of Health
and Human Services, acting through the Commissioner of Food and Drugs,
shall review and update, if necessary, previously published guidance and
standard operating procedures identifying the principles for recognizing
standards, and for withdrawing the recognition of standards, under
section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360d(c)), taking into account the experience with and reliance on a
standard by foreign regulatory authorities and the
[[Page 130 STAT. 1126]]
device industry, and whether recognition of a standard will promote
harmonization among regulatory authorities in the regulation of devices.
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.
(a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(l)) is amended--
(1) by striking ``A report under subsection (k)'' and
inserting ``(1) A report under subsection (k)''; and
(2) by adding at the end the following new paragraph:
``(2) Not later than 120 calendar days after the date of enactment
of the 21st Century Cures Act and at least once every 5 years
thereafter, as the Secretary determines appropriate, the Secretary shall
identify, through publication in the Federal Register, any type of class
I device that the Secretary determines no longer requires a report under
subsection (k) to provide reasonable assurance of safety and
effectiveness. Upon such publication--
``(A) each type of class I device so identified shall be
exempt from the requirement for a report under subsection (k);
and
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
(b) Class II Devices.--Section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) is amended--
(1) by striking ``(m)(1)'' and all that follows through ``by
the Secretary.'' and inserting the following:
``(m)(1) The Secretary shall--
``(A) not later than 90 days after the date of enactment of
the 21st Century Cures Act and at least once every 5 years
thereafter, as the Secretary determines appropriate--
``(i) publish in the Federal Register a notice that
contains a list of each type of class II device that the
Secretary determines no longer requires a report under
subsection (k) to provide reasonable assurance of safety
and effectiveness; and
``(ii) provide for a period of not less than 60
calendar days for public comment beginning on the date
of the publication of such notice; and
``(B) not later than 210 calendar days after the date of
enactment of the 21st Century Cures Act, publish in the Federal
Register a list representing the Secretary's final determination
with respect to the devices contained in the list published
under subparagraph (A).''; and
(2) in paragraph (2)--
(A) by striking ``1 day after the date of
publication of a list under this subsection,'' and
inserting ``1 calendar day after the date of publication
of the final list under paragraph (1)(B),''; and
(B) by striking ``30-day period'' and inserting
``60-calendar-day period''; and
(C) by adding at the end the following new
paragraph:
``(3) Upon the publication of the final list under paragraph
(1)(B)--
``(A) each type of class II device so listed shall be exempt
from the requirement for a report under subsection (k); and
[[Page 130 STAT. 1127]]
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
SEC. 3055. CLASSIFICATION PANELS.
(a) Classification Panels.--Paragraph (5) of section 513(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
(1) by striking ``(5)'' and inserting ``(5)(A)''; and
(2) by adding at the end the following:
``(B) When a device is specifically the subject of review by a
classification panel, the Secretary shall--
``(i) ensure that adequate expertise is represented on the
classification panel to assess--
``(I) the disease or condition which the device is
intended to cure, treat, mitigate, prevent, or diagnose;
and
``(II) the technology of the device; and
``(ii) provide an opportunity for the person whose device is
specifically the subject of panel review to provide
recommendations on the expertise needed among the voting members
of the panel.
``(C) For purposes of subparagraph (B)(i), the term `adequate
expertise' means that the membership of the classification panel
includes--
``(i) two or more voting members, with a specialty or other
expertise clinically relevant to the device under review; and
``(ii) at least one voting member who is knowledgeable about
the technology of the device.
``(D) The Secretary shall provide an annual opportunity for
patients, representatives of patients, and sponsors of medical device
submissions to provide recommendations for individuals with appropriate
expertise to fill voting member positions on classification panels.''.
(b) Panel Review Process.--Section 513(b)(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
(1) in subparagraph (A)(iii), by inserting before the period
at the end ``, including, subject to the discretion of the panel
chairperson, by designating a representative who will be
provided a time during the panel meeting to address the panel
for the purpose of correcting misstatements of fact or providing
clarifying information, and permitting the person or
representative to call on experts within the person's
organization to address such specific issues in the time
provided''; and
(2) by striking subparagraph (B) and inserting the following
new subparagraph:
``(B)(i) Any meeting of a classification panel with respect to the
review of a device shall--
``(I) provide adequate time for initial presentations by the
person whose device is specifically the subject of such review
and by the Secretary; and
``(II) encourage free and open participation by all
interested persons.
``(ii) Following the initial presentations described in clause (i),
the panel may--
``(I) pose questions to a designated representative
described in subparagraph (A)(iii); and
[[Page 130 STAT. 1128]]
``(II) consider the responses to such questions in the
panel's review of the device.''.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j) is amended--
(1) in subsection (g)(3)--
(A) in subparagraph (A)(i)--
(i) by striking ``local''; and
(ii) by striking ``which has been''; and
(B) in subparagraph (B), by striking ``a local
institutional'' and inserting ``an institutional''; and
(2) in subsection (m)(4)--
(A) by striking subparagraph (A) and inserting the
following:
``(A) in facilities in which clinical testing of devices is
supervised by an institutional review committee established in
accordance with the regulations of the Secretary; and'';
(B) in subparagraph (B), by striking ``a local
institutional'' and inserting ``an institutional''; and
(C) in the matter following subparagraph (B), by
striking ``local''.
SEC. 3057. <<NOTE: 42 USC 263a note.>> CLIA WAIVER IMPROVEMENTS.
(a) Draft Revised Guidance.--Not later than 1 year after the date of
the enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall publish a draft
guidance that--
(1) revises ``Section V. Demonstrating Insignificant Risk of
an Erroneous Result - Accuracy'' of the guidance entitled
``Recommendations for Clinical Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices'' and dated January 30, 2008; and
(2) includes the appropriate use of comparable performance
between a waived user and a moderately complex laboratory user
to demonstrate accuracy.
(b) Final Revised Guidance.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs, shall
finalize the draft guidance published under subsection (a) not later
than 1 year after the comment period for such draft guidance closes.
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.
(a) In General.--Section 513 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c) is amended by adding at the end the following:
``(j) Training and Oversight of Least Burdensome Requirements.--
``(1) The Secretary shall--
``(A) ensure that each employee of the Food and Drug
Administration who is involved in the review of
premarket submissions, including supervisors, receives
training regarding the meaning and implementation of the
least burdensome requirements under subsections
(a)(3)(D) and (i)(1)(D) of this section and section
515(c)(5); and
``(B) periodically assess the implementation of the
least burdensome requirements, including the employee
training
[[Page 130 STAT. 1129]]
under subparagraph (A), to ensure that the least
burdensome requirements are fully and consistently
applied.
``(2) Not later than 18 months after the date of enactment
of the 21st Century Cures Act, the ombudsman for any
organizational unit of the Food and Drug Administration
responsible for the premarket review of devices shall--
``(A) conduct an audit of the training described in
paragraph (1)(A), including the effectiveness of such
training in implementing the least burdensome
requirements;
``(B) include in such audit interviews of persons
who are representatives of the device industry regarding
their experiences in the device premarket review
process, including with respect to the application of
least burdensome concepts to premarket review and
decisionmaking;
``(C) include in such audit a list of the
measurement tools the Secretary uses to assess the
implementation of the least burdensome requirements,
including under paragraph (1)(B) and section 517A(a)(3),
and may also provide feedback on the effectiveness of
such tools in the implementation of the least burdensome
requirements;
``(D) summarize the findings of such audit in a
final audit report; and
``(E) within 30 calendar days of completion of such
final audit report, make such final audit report
available--
``(i) to the Committee on Health, Education,
Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives; and
``(ii) on the Internet website of the Food and
Drug Administration.''.
(b) Premarket Applications.--Section 515(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the
end the following:
``(5)(A) In requesting additional information with respect to an
application under this section, the Secretary shall consider the least
burdensome appropriate means necessary to demonstrate a reasonable
assurance of device safety and effectiveness.
``(B) For purposes of subparagraph (A), the term `necessary' means
the minimum required information that would support a determination by
the Secretary that an application provides a reasonable assurance of the
safety and effectiveness of the device.
``(C) For purposes of this paragraph, the Secretary shall consider
the role of postmarket information in determining the least burdensome
means of demonstrating a reasonable assurance of device safety and
effectiveness.
``(D) Nothing in this paragraph alters the standards for premarket
approval of a device.''.
(c) Rationale for Significant Decisions Regarding Devices.--Section
517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)) is amended by adding at the end the following:
``(3) Application of least burdensome requirements.--The
substantive summary required under this subsection shall include
a brief statement regarding how the least burdensome
requirements were considered and applied consistent with section
513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as
applicable.''.
[[Page 130 STAT. 1130]]
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT.
(a) In General.--Section 510 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360) is amended by adding at the end the following:
``(q) Reusable Medical Devices.--
``(1) In general.--Not later than 180 days after the date of
enactment of the 21st Century Cures Act, the Secretary shall
identify and publish a list of reusable device types for which
reports under subsection (k) are required to include--
``(A) instructions for use, which have been
validated in a manner specified by the Secretary; and
``(B) validation data, the types of which shall be
specified by the Secretary;
regarding cleaning, disinfection, and sterilization, and for
which a substantial equivalence determination may be based.
``(2) Revision of list.--The Secretary shall revise the list
under paragraph (2), as the Secretary determines appropriate,
with notice in the Federal Register.
``(3) Content of reports.--Reports under subsection (k) that
are submitted after the publication of the list described in
paragraph (1), for devices or types of devices included on such
list, shall include such instructions for use and validation
data.''.
(b) <<NOTE: 21 USC 360 note.>> Device Modifications.--The Secretary
of Health and Human Services, acting through the Commissioner of Food
and Drugs, shall issue final guidance regarding when a premarket
notification under section 510(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a
modification or change to a legally marketed device. Such final guidance
shall be issued not later than 1 year after the date on which the
comment period closes for the draft guidance on such subject.
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
(a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j) is amended by adding at the end the following:
``(o) Regulation of Medical and Certain Decisions Support
Software.--
``(1) The term device, as defined in section 201(h), shall
not include a software function that is intended--
``(A) for administrative support of a health care
facility, including the processing and maintenance of
financial records, claims or billing information,
appointment schedules, business analytics, information
about patient populations, admissions, practice and
inventory management, analysis of historical claims data
to predict future utilization or cost-effectiveness,
determination of health benefit eligibility, population
health management, and laboratory workflow;
``(B) for maintaining or encouraging a healthy
lifestyle and is unrelated to the diagnosis, cure,
mitigation, prevention, or treatment of a disease or
condition;
``(C) to serve as electronic patient records,
including patient-provided information, to the extent
that such records are intended to transfer, store,
convert formats,
[[Page 130 STAT. 1131]]
or display the equivalent of a paper medical chart, so
long as--
``(i) such records were created, stored,
transferred, or reviewed by health care
professionals, or by individuals working under
supervision of such professionals;
``(ii) such records are part of health
information technology that is certified under
section 3001(c)(5) of the Public Health Service
Act; and
``(iii) such function is not intended to
interpret or analyze patient records, including
medical image data, for the purpose of the
diagnosis, cure, mitigation, prevention, or
treatment of a disease or condition;
``(D) for transferring, storing, converting formats,
or displaying clinical laboratory test or other device
data and results, findings by a health care professional
with respect to such data and results, general
information about such findings, and general background
information about such laboratory test or other device,
unless such function is intended to interpret or analyze
clinical laboratory test or other device data, results,
and findings; or
``(E) unless the function is intended to acquire,
process, or analyze a medical image or a signal from an
in vitro diagnostic device or a pattern or signal from a
signal acquisition system, for the purpose of--
``(i) displaying, analyzing, or printing
medical information about a patient or other
medical information (such as peer-reviewed
clinical studies and clinical practice
guidelines);
``(ii) supporting or providing recommendations
to a health care professional about prevention,
diagnosis, or treatment of a disease or condition;
and
``(iii) enabling such health care professional
to independently review the basis for such
recommendations that such software presents so
that it is not the intent that such health care
professional rely primarily on any of such
recommendations to make a clinical diagnosis or
treatment decision regarding an individual
patient.
``(2) In the case of a product with multiple functions that
contains--
``(A) at least one software function that meets the
criteria under paragraph (1) or that otherwise does not
meet the definition of device under section 201(h); and
``(B) at least one function that does not meet the
criteria under paragraph (1) and that otherwise meets
the definition of a device under section 201(h),
the Secretary shall not regulate the software function of such
product described in subparagraph (A) as a device.
Notwithstanding the preceding sentence, when assessing the
safety and effectiveness of the device function or functions of
such product described in subparagraph (B), the Secretary may
assess the impact that the software function or functions
described in subparagraph (A) have on such device function or
functions.
``(3)(A) Notwithstanding paragraph (1), a software function
described in subparagraph (C), (D), or (E) of paragraph (1)
[[Page 130 STAT. 1132]]
shall not be excluded from the definition of device under
section 201(h) if--
``(i) the Secretary makes a finding that use of such
software function would be reasonably likely to have
serious adverse health consequences; and
``(ii) the software function has been identified in
a final order issued by the Secretary under subparagraph
(B).
``(B) Subparagraph (A) shall apply only if the Secretary--
``(i) publishes a notification and proposed order in
the Federal Register;
``(ii) includes in such notification the Secretary's
finding, including the rationale and identification of
the evidence on which such finding was based, as
described in subparagraph (A)(i); and
``(iii) provides for a period of not less than 30
calendar days for public comment before issuing a final
order or withdrawing such proposed order.
``(C) In making a finding under subparagraph (A)(i) with
respect to a software function, the Secretary shall consider--
``(i) the likelihood and severity of patient harm if
the software function were to not perform as intended;
``(ii) the extent to which the software function is
intended to support the clinical judgment of a health
care professional;
``(iii) whether there is a reasonable opportunity
for a health care professional to review the basis of
the information or treatment recommendation provided by
the software function; and
``(iv) the intended user and user environment, such
as whether a health care professional will use a
software function of a type described in subparagraph
(E) of paragraph (1).
``(4) Nothing in this subsection shall be construed as
limiting the authority of the Secretary to--
``(A) exercise enforcement discretion as to any
device subject to regulation under this Act;
``(B) regulate software used in the manufacture and
transfusion of blood and blood components to assist in
the prevention of disease in humans; or
``(C) regulate software as a device under this Act
if such software meets the criteria under section
513(a)(1)(C).''.
(b) <<NOTE: 21 USC 360j note.>> Reports.--The Secretary of Health
and Human Services (referred to in this subsection as the
``Secretary''), after consultation with agencies and offices of the
Department of Health and Human Services involved in health information
technology, shall publish a report, not later than 2 years after the
date of enactment of this Act and every 2 years thereafter, that--
(1) includes input from outside experts, such as
representatives of patients, consumers, health care providers,
startup companies, health plans or other third-party payers,
venture capital investors, information technology vendors,
health information technology vendors, small businesses,
purchasers, employers, and other stakeholders with relevant
expertise, as determined by the Secretary;
[[Page 130 STAT. 1133]]
(2) examines information available to the Secretary on any
risks and benefits to health associated with software functions
described in section 520(o)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a));
and
(3) summarizes findings regarding the impact of such
software functions on patient safety, including best practices
to promote safety, education, and competency related to such
functions.
(c) Classification of Accessories.--Section 513(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding at
the end the following:
``(9) The Secretary shall classify an accessory under this section
based on the intended use of the accessory, notwithstanding the
classification of any other device with which such accessory is intended
to be used.''.
(d) Conforming Amendment.--Section 201(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the
following: ``The term `device' does not include software functions
excluded pursuant to section 520(o).''.
Subtitle G--Improving Scientific Expertise and Outreach at FDA
SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND
BIOMEDICAL PRODUCT ASSESSMENT SERVICE.
(a) Hiring and Retention Authority.--Section 228 of the Public
Health Service Act (42 U.S.C. 237) is amended--
(1) in the section heading, by inserting ``and biomedical
product assessment'' after ``research'';
(2) in subsection (a)--
(A) in paragraph (1), by striking ``Silvio O. Conte
Senior Biomedical Research Service, not to exceed 500
members'' and inserting ``Silvio O. Conte Senior
Biomedical Research and Biomedical Product Assessment
Service (in this section referred to as the `Service'),
not to exceed 2,000 members, the purpose of which is to
recruit and retain outstanding and qualified scientific
and technical experts in the fields of biomedical
research, clinical research evaluation, and biomedical
product assessment'';
(B) by amending paragraph (2) to read as follows:
``(2) The authority established in paragraph (1) may not be
construed to require the Secretary to reduce the number of employees
serving under any other employment system in order to offset the number
of members serving in the Service.''; and
(C) by adding at the end the following:
``(3) The Secretary shall assign experts under this section to
agencies within the Department of Health and Human Services taking into
account the need for the expertise of such expert.'';
(3) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``or clinical research evaluation'' and
inserting ``, clinical research evaluation, or
biomedical product assessment''; and
[[Page 130 STAT. 1134]]
(B) in paragraph (1), by inserting ``or a doctoral
or master's level degree in engineering, bioinformatics,
or a related or emerging field,'' after the comma;
(4) in subsection (d)(2), by striking ``and shall not exceed
the rate payable for level I of the Executive Schedule unless
approved by the President under section 5377(d)(2) of title 5,
United States Code'' and inserting ``and shall not exceed the
amount of annual compensation (excluding expenses) specified in
section 102 of title 3, United States Code'';
(5) by striking subsection (e); and
(6) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
(b) GAO Study.--
(1) In general.--The Comptroller General of the United
States shall conduct a study of the effectiveness of the
amendments to section 228 of the Public Health Service Act (42
U.S.C. 237) made by subsection (a) and the impact of such
amendments, if any, on all agencies or departments of the
Department of Health and Human Services, and, not later than 4
years after the date of enactment of this Act, shall submit a
report based on such study to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives.
(2) Content of study and report.--The study and report under
paragraph (1) shall include an examination of the extent to
which recruitment and retention of outstanding and qualified
scientific, medical, or technical experts in the fields of
biomedical research, clinical research evaluation, and
biomedical product assessment have improved or otherwise have
been affected by the amendments to section 228 of the Public
Health Service Act (42 U.S.C. 237) made by subsection (a),
including by determining, during the period between the date of
enactment of this Act and the completion of the study--
(A) the total number of members recruited and
retained under the Senior Biomedical Research and
Biomedical Product Assessment Service under such section
228, and the effect of increasing the number of members
eligible for such Service;
(B) the number of members of such Senior Biomedical
Research and Biomedical Product Assessment Service hired
with a doctoral level degree in biomedicine or a related
field, and the number of such members hired with a
doctoral or master's level degree in engineering,
bioinformatics, or a related or emerging field; and
(C) the number of Senior Biomedical Research and
Biomedical Product Assessment Service members that have
been hired by each agency or department of the
Department of Health and Human Services, and how such
Department assigns such members to each agency or
department.
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is amended
by inserting after section 714 (21 U.S.C. 379d-3) the following:
[[Page 130 STAT. 1135]]
``SEC. 714A. <<NOTE: 21 USC 379d-3a.>> HIRING AUTHORITY FOR
SCIENTIFIC, TECHNICAL, AND PROFESSIONAL
PERSONNEL.
``(a) In General.--The Secretary may, notwithstanding title 5,
United States Code, governing appointments in the competitive service,
appoint outstanding and qualified candidates to scientific, technical,
or professional positions that support the development, review, and
regulation of medical products. Such positions shall be within the
competitive service.
``(b) Compensation.--
``(1) In general.--Notwithstanding any other provision of
law, including any requirement with respect to General Schedule
pay rates under subchapter III of chapter 53 of title 5, United
States Code, and consistent with the requirements of paragraph
(2), the Commissioner of Food and Drugs may determine and set--
``(A) the annual rate of pay of any individual
appointed under subsection (a); and
``(B) for purposes of retaining qualified employees,
the annual rate of pay for any qualified scientific,
technical, or professional personnel appointed to a
position described in subsection (a) before the date of
enactment of the 21st Century Cures Act.
``(2) Limitation.--The annual rate of pay established
pursuant to paragraph (1) may not exceed the amount of annual
compensation (excluding expenses) specified in section 102 of
title 3, United States Code.
``(3) Public availability.--The annual rate of pay provided
to an individual in accordance with this section shall be
publicly available information.
``(c) Rule of Construction.--The authorities under this section
shall not be construed to affect the authority provided under section
714.
``(d) Report on Workforce Planning.--
``(1) In general.--Not later than 18 months after the date
of enactment of the 21st Century Cures Act, the Secretary shall
submit a report on workforce planning to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives
that examines the extent to which the Food and Drug
Administration has a critical need for qualified individuals for
scientific, technical, or professional positions, including--
``(A) an analysis of the workforce needs at the Food
and Drug Administration and the Secretary's strategic
plan for addressing such needs, including through use of
the authority under this section; and
``(B) a recruitment and retention plan for hiring
qualified scientific, technical, and professional
candidates, which may include the use of--
``(i) recruitment through nongovernmental
recruitment or placement agencies;
``(ii) recruitment through academic
institutions;
``(iii) recruitment or hiring bonuses, if
applicable;
``(iv) recruitment using targeted direct
hiring authorities; and
``(v) retention of qualified scientific,
technical, and professional employees using the
authority under this section, or other applicable
authorities of the Secretary.
[[Page 130 STAT. 1136]]
``(2) Recommendations.--The report under paragraph (1) may
include the recommendations of the Commissioner of Food and
Drugs that would help the Food and Drug Administration to better
recruit and retain qualified individuals for scientific,
technical, or professional positions at the agency.''.
(b) GAO Study and Report.--
(1) In general.--The Comptroller General of the United
States shall conduct a study of the ability of the Food and Drug
Administration to hire, train, and retain qualified scientific,
technical, and professional staff, not including contractors,
necessary to fulfill the mission of the Food and Drug
Administration to protect and promote public health. Not later
than January 1, 2022, the Comptroller General shall submit a
report on such study to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives.
(2) Contents of study.--The Comptroller General shall
include in the study and report under paragraph (1)--
(A) information about the progress of the Food and
Drug Administration in recruiting and retaining
qualified scientific, technical, and professional staff
outstanding in the field of biomedical research,
clinical research evaluation, and biomedical product
assessment;
(B) the extent to which critical staffing needs
exist at the Food and Drug Administration, and barriers
to hiring, training, and retaining qualified staff, if
any;
(C) an examination of the recruitment and retention
strategies of the Food and Drug Administration,
including examining any strategic workforce plan,
focused on improving scientific, technical, and
professional staff recruitment and retention; and
(D) recommendations for potential improvements that
would address staffing needs of the Food and Drug
Administration.
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION
INTERCENTER INSTITUTES.
(a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1014. <<NOTE: 21 USC 399g.>> FOOD AND DRUG ADMINISTRATION
INTERCENTER INSTITUTES.
``(a) In General.--The Secretary shall establish one or more
Intercenter Institutes within the Food and Drug Administration (referred
to in this section as an `Institute') for a major disease area or areas.
With respect to the major disease area of focus of an Institute, such
Institute shall develop and implement processes for coordination of
activities, as applicable to such major disease area or areas, among the
Center for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and Radiological
Health (for the purposes of this section, referred to as the `Centers').
Such activities may include--
``(1) coordination of staff from the Centers with diverse
product expertise in the diagnosis, cure, mitigation, treatment,
or prevention of the specific diseases relevant to the major
disease area of focus of the Institute;
[[Page 130 STAT. 1137]]
``(2) streamlining, where appropriate, the review of medical
products to diagnose, cure, mitigate, treat, or prevent the
specific diseases relevant to the major disease area of focus of
the Institute, applying relevant standards under sections 505,
510(k), 513(f)(2), and 515 of this Act and section 351 of the
Public Health Service Act, and other applicable authorities;
``(3) promotion of scientific programs within the Centers
related to the major disease area of focus of the Institute;
``(4) development of programs and enhancement of strategies
to recruit, train, and provide continuing education
opportunities for the personnel of the Centers with expertise
related to the major disease area of focus of the Institute;
``(5) enhancement of the interactions of the Centers with
patients, sponsors, and the external biomedical community
regarding the major disease area of focus of the Institute; and
``(6) facilitation of the collaborative relationships of the
Centers with other agencies within the Department of Health and
Human Services regarding the major disease area of focus of the
Institute.
``(b) Public Process.--The Secretary shall provide a period for
public comment during the time that each Institute is being implemented.
``(c) Timing.--The Secretary shall establish at least one Institute
under subsection (a) before the date that is 1 year after the date of
enactment of the 21st Century Cures Act.
``(d) Termination of Institutes.--The Secretary may terminate any
Institute established pursuant to this section if the Secretary
determines such Institute is no longer benefitting the public health.
Not less than 60 days prior to so terminating an Institute, the
Secretary shall provide public notice, including the rationale for such
termination.''.
(b) Technical Amendments.--Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
(1) by redesignating section 1012 as section 1013; and
(2) by redesignating the second section 1011 (with respect
to improving the training of State, local, territorial, and
tribal food safety officials), as added by section 209(a) of the
FDA Food Safety Modernization Act (Public Law 111-353), as
section 1012.
SEC. 3074. <<NOTE: 42 USC 3506a.>> SCIENTIFIC ENGAGEMENT.
(a) In General.--Scientific meetings that are attended by scientific
or medical personnel, or other professionals, of the Department of
Health and Human Services for whom attendance at such meeting is
directly related to their professional duties and the mission of the
Department--
(1) shall not be considered conferences for the purposes of
complying with Federal reporting requirements contained in
annual appropriations Acts or in this section; and
(2) shall not be considered conferences for purposes of a
restriction contained in an annual appropriations Act, based on
Office of Management and Budget Memorandum M-12-12 or any other
regulation restricting travel to such meeting.
(b) Limitation.--Nothing in this section shall be construed to
exempt travel for scientific meetings from Federal regulations relating
to travel.
[[Page 130 STAT. 1138]]
(c) Reports.--Not later than 90 days after the end of the fiscal
year, each operating division of the Department of Health and Human
Services shall prepare, and post on an Internet website of the operating
division, an annual report on scientific meeting attendance and related
travel spending for each fiscal year. Such report shall include--
(1) general information concerning the scientific meeting
activities involved;
(2) information concerning the total amount expended for
such meetings;
(3) a description of all such meetings that were attended by
scientific or medical personnel, or other professionals, of each
such operating division where the total amount expended by the
operating division associated with each such meeting were in
excess of $30,000, including--
(A) the total amount of meeting expenses incurred by
the operating division for such meeting;
(B) the location of such meeting;
(C) the date of such meeting;
(D) a brief explanation on how such meeting advanced
the mission of the operating division; and
(E) the total number of individuals whose travel
expenses or other scientific meeting expenses were paid
by the operating division; and
(4) with respect to any such meeting where the total
expenses to the operating division exceeded $150,000, a
description of the exceptional circumstances that necessitated
the expenditure of such amounts.
SEC. 3075. DRUG SURVEILLANCE.
(a) New Drugs.--Section 505(k)(5) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 2074, is
further amended--
(1) in subparagraph (A), by striking ``, bi-weekly
screening'' and inserting ``screenings'';
(2) in subparagraph (B), as redesignated by section
2074(1)(C), by striking the period at the end and inserting ``;
and''; and
(3) by adding at the end the following:
``(C) make available on the Internet website of the Food and
Drug Administration--
``(i) guidelines, developed with input from experts
qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, that
detail best practices for drug safety surveillance using
the Adverse Event Reporting System; and
``(ii) criteria for public posting of adverse event
signals.''.
(b) FAERS Revision.--Section 505(r)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking ``, by
18 months'' and all that follows through the semicolon at the end of the
subparagraph and inserting ``and making publicly available on the
Internet website established under paragraph (1) best practices for drug
safety surveillance activities for drugs approved under this section or
section 351 of the Public Health Service Act;''.
[[Page 130 STAT. 1139]]
(c) Risk Evaluation and Mitigation Strategies.--Section 505-1(f)(5)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is
amended--
(1) in the matter preceding subparagraph (A), by inserting
``or other advisory committee'' after ``(or successor
committee)''; and
(2) in subparagraph (B), by striking ``at least annually,''
and inserting ``periodically''.
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) Board of Directors.--
(1) Composition and size.--Section 770(d)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C))
is amended--
(A) by redesignating clause (ii) as clause (iii);
(B) by inserting after clause (i) the following:
``(ii) Additional members.--The Board, through
amendments to the bylaws of the Foundation, may
provide that the number of voting members of the
Board shall be a number (to be specified in such
amendment) greater than 14. Any Board positions
that are established by any such amendment shall
be appointed (by majority vote) by the individuals
who, as of the date of such amendment, are voting
members of the Board and persons so appointed may
represent any of the categories specified in
subclauses (I) through (V) of clause (i), so long
as no more than 30 percent of the total voting
members of the Board (including members whose
positions are established by such amendment) are
representatives of the general pharmaceutical,
device, food, cosmetic, and biotechnology
industries.''; and
(C) in clause (iii)(I), as redesignated by
subparagraph (A), by striking ``The ex officio members
shall ensure'' and inserting ``The ex officio members,
acting pursuant to clause (i), and the Board, acting
pursuant to clause (ii), shall ensure''.
(2) Federal employees allowed to serve on board.--Clause
(iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by
paragraph (1)(A), is amended by adding at the end the following:
``For purposes of this section, the term `employee of the
Federal Government' does not include a special Government
employee, as that term is defined in section 202(a) of title 18,
United States Code.''.
(3) Staggered terms.--Subparagraph (A) of section 770(d)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(d)(3)) is amended to read as follows:
``(A) Term.--The term of office of each member of
the Board appointed under paragraph (1)(C)(i), and the
term of office of any member of the Board whose position
is established pursuant to paragraph (1)(C)(ii), shall
be 4 years, except that--
``(i) the terms of offices for the members of
the Board initially appointed under paragraph
(1)(C)(i)
[[Page 130 STAT. 1140]]
shall expire on a staggered basis as determined by
the ex officio members; and
``(ii) the terms of office for the persons
initially appointed to positions established
pursuant to paragraph (1)(C)(ii) may be made to
expire on a staggered basis, as determined by the
individuals who, as of the date of the amendment
establishing such positions, are members of the
Board.''.
(b) Executive Director Compensation.--Section 770(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended
by striking ``but shall not be greater than the compensation of the
Commissioner''.
(c) Separation of Funds.--Section 770(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ``are held
in separate accounts from funds received from entities under subsection
(i)'' and inserting ``are managed as individual programmatic funds under
subsection (i), according to best accounting practices''.
Subtitle H--Medical Countermeasures Innovation
SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in subsection (a), by adding at the end the following:
``(3) Utilization guidelines.--The Secretary shall ensure
timely and accurate recommended utilization guidelines for
qualified countermeasures (as defined in section 319F-1),
qualified pandemic and epidemic products (as defined in section
319F-3), and security countermeasures (as defined in subsection
(c)), including for such products in the stockpile.''; and
(2) in subsection (g)--
(A) by amending paragraph (4) to read as follows:
``(4) Report on security countermeasure procurement.--Not
later than March 1 of each year in which the Secretary
determines that the amount of funds available for procurement of
security countermeasures is less than $1,500,000,000, the
Secretary shall submit to the Committee on Appropriations and
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Appropriations and the Committee on
Energy and Commerce of the House of Representatives a report
detailing the amount of such funds available for procurement and
the impact such amount of funding will have--
``(A) in meeting the security countermeasure needs
identified under this section; and
``(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).''.
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.
(a) In General.--Section 319F-2(g) of the Public Health Service Act
(42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
[[Page 130 STAT. 1141]]
``(5) Clarification on contracting authority.--The
Secretary, acting through the Director of the Biomedical
Advanced Research and Development Authority, shall carry out the
programs funded by the special reserve fund (for the procurement
of security countermeasures under subsection (c) and for
carrying out section 319L), including the execution of
procurement contracts, grants, and cooperative agreements
pursuant to this section and section 319L.''.
(b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public
Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``,
including the execution of procurement contracts, grants, and
cooperative agreements pursuant to this section'' before the period.
SEC. 3083. COUNTERMEASURE BUDGET PLAN.
Section 2811(b)(7) of the Public Health Service Act (42 U.S.C.
300hh-10(b)(7)) is amended--
(1) in the matter preceding subparagraph (A), by striking
the first sentence and inserting ``Develop, and update not later
than March 1 of each year, a coordinated 5-year budget plan
based on the medical countermeasure priorities described in
subsection (d), including with respect to chemical, biological,
radiological, and nuclear agent or agents that may present a
threat to the Nation, including such agents that are novel or
emerging infectious diseases, and the corresponding efforts to
develop qualified countermeasures (as defined in section 319F-
1), security countermeasures (as defined in section 319F-2), and
qualified pandemic or epidemic products (as defined in section
319F-3) for each such threat.'';
(2) in subparagraph (C), by striking ``; and'' and inserting
a semicolon;
(3) in subparagraph (D), by striking ``to the appropriate
committees of Congress upon request.'' and inserting ``, not
later than March 15 of each year, to the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Appropriations
and the Committee on Energy and Commerce of the House of
Representatives; and''; and
(4) by adding at the end the following:
``(E) not later than March 15 of each year, be made
publicly available in a manner that does not compromise
national security.''.
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
7e(c)(4)) is amended by adding at the end the following:
``(E) Medical countermeasures innovation partner.--
``(i) In general.--To support the purposes
described in paragraph (2), the Secretary, acting
through the Director of BARDA, may enter into an
agreement (including through the use of grants,
contracts, cooperative agreements, or other
transactions as described in paragraph (5)) with
an independent, nonprofit entity to--
``(I) foster and accelerate the
development and innovation of medical
countermeasures and technologies that
may assist advanced research and
[[Page 130 STAT. 1142]]
the development of qualified
countermeasures and qualified pandemic
or epidemic products, including through
the use of strategic venture capital
practices and methods;
``(II) promote the development of
new and promising technologies that
address urgent medical countermeasure
needs, as identified by the Secretary;
``(III) address unmet public health
needs that are directly related to
medical countermeasure requirements,
such as novel antimicrobials for
multidrug resistant organisms and
multiuse platform technologies for
diagnostics, prophylaxis, vaccines, and
therapeutics; and
``(IV) provide expert consultation
and advice to foster viable medical
countermeasure innovators, including
helping qualified countermeasure
innovators navigate unique industry
challenges with respect to developing
chemical, biological, radiological, and
nuclear countermeasure products.
``(ii) Eligibility.--
``(I) In general.--To be eligible to
enter into an agreement under clause (i)
an entity shall--
``(aa) be an independent,
nonprofit entity;
``(bb) have a demonstrated
record of being able to create
linkages between innovators and
investors and leverage such
partnerships and resources for
the purpose of addressing
identified strategic needs of
the Federal Government;
``(cc) have experience in
promoting novel technology
innovation;
``(dd) be problem-driven and
solution-focused based on the
needs, requirements, and
problems identified by the
Secretary under clause (iv);
``(ee) demonstrate the
ability, or the potential
ability, to promote the
development of medical
countermeasure products;
``(ff) demonstrate
expertise, or the capacity to
develop or acquire expertise,
related to technical and
regulatory considerations with
respect to medical
countermeasures; and
``(gg) not be within the
Department of Health and Human
Services.
``(II) Partnering experience.--In
selecting an entity with which to enter
into an agreement under clause (i), the
Secretary shall place a high value on
the demonstrated experience of the
entity in partnering with the Federal
Government to meet identified strategic
needs.
``(iii) Not agency.--An entity that enters
into an agreement under clause (i) shall not be
deemed to be a Federal agency for any purpose,
including for any purpose under title 5, United
States Code.
[[Page 130 STAT. 1143]]
``(iv) Direction.--Pursuant to an agreement
entered into under this subparagraph, the
Secretary, acting through the Director of BARDA,
shall provide direction to the entity that enters
into an agreement under clause (i). As part of
this agreement the Director of BARDA shall--
``(I) communicate the medical
countermeasure needs, requirements, and
problems to be addressed by the entity
under the agreement;
``(II) develop a description of work
to be performed by the entity under the
agreement;
``(III) provide technical feedback
and appropriate oversight over work
carried out by the entity under the
agreement, including subsequent
development and partnerships consistent
with the needs and requirements set
forth in this subparagraph;
``(IV) ensure fair consideration of
products developed under the agreement
in order to maintain competition to the
maximum practical extent, as applicable
and appropriate under applicable
provisions of this section; and
``(V) ensure, as a condition of the
agreement that the entity--
``(aa) has in place a
comprehensive set of policies
that demonstrate a commitment to
transparency and accountability;
``(bb) protects against
conflicts of interest through a
comprehensive set of policies
that address potential conflicts
of interest, ethics, disclosure,
and reporting requirements;
``(cc) provides monthly
accounting on the use of funds
provided under such agreement;
and
``(dd) provides on a
quarterly basis, reports
regarding the progress made
toward meeting the identified
needs set forth in the
agreement.
``(v) Supplement not supplant.--Activities
carried out under this subparagraph shall
supplement, and not supplant, other activities
carried out under this section.
``(vi) No establishment of entity.--To prevent
unnecessary duplication and target resources
effectively, nothing in this subparagraph shall be
construed to authorize the Secretary to establish
within the Department of Health and Human Services
an entity for the purposes of carrying out this
subparagraph.
``(vii) Transparency and oversight.--Upon
request, the Secretary shall provide to Congress
the information provided to the Secretary under
clause (iv)(V)(dd).
``(viii) Independent evaluation.--Not later
than 4 years after the date of enactment of the
21st Century Cures Act, the Comptroller General of
the United States shall conduct an independent
evaluation, and submit to the Secretary and the
appropriate committees of Congress a report,
concerning the activities
[[Page 130 STAT. 1144]]
conducted under this subparagraph. Such report
shall include recommendations with respect to any
agreement or activities carried out pursuant to
this subparagraph.
``(ix) Sunset.--This subparagraph shall have
no force or effect after September 30, 2022.''.
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.
Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended--
(1) in paragraph (4)(A)(ii), by striking ``make a
recommendation under paragraph (6) that the special reserve fund
as defined in subsection (h) be made available for the
procurement of such countermeasure'' and inserting ``and subject
to the availability of appropriations, make available the
special reserve fund as defined in subsection (h) for
procurement of such countermeasure, as applicable'';
(2) in paragraph (6)--
(A) by striking subparagraphs (A), (B), and (E);
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (A) and (B), respectively;
(C) by amending subparagraph (A), as so
redesignated, to read as follows:
``(A) Notice to appropriate congressional
committees.--The Secretary shall notify the Committee on
Appropriations and the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Appropriations and the Committee on Energy and Commerce
of the House of Representatives of each decision to make
available the special reserve fund as defined in
subsection (h) for procurement of a security
countermeasure, including, where available, the number
of, the nature of, and other information concerning
potential suppliers of such countermeasure, and whether
other potential suppliers of the same or similar
countermeasures were considered and rejected for
procurement under this section and the reasons for each
such rejection.''; and
(D) in the heading, by striking ``Recommendation for
president's approval'' and inserting ``Recommendations
for procurement''; and
(3) in paragraph (7)--
(A) by striking subparagraphs (A) and (B) and
inserting the following:
``(A) Payments from special reserve fund.--The
special reserve fund as defined in subsection (h) shall
be available for payments made by the Secretary to a
vendor for procurement of a security countermeasure in
accordance with the provisions of this paragraph.''; and
(B) by redesignating subparagraph (C) as
subparagraph (B).
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A
NATIONAL SECURITY THREAT.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565
the following:
[[Page 130 STAT. 1145]]
``SEC. 565A. <<NOTE: 21 USC 360bbb-4a.>> PRIORITY REVIEW TO
ENCOURAGE TREATMENTS FOR AGENTS THAT
PRESENT NATIONAL SECURITY THREATS.
``(a) Definitions.--In this section:
``(1) Human drug application.--The term `human drug
application' has the meaning given such term in section 735(1).
``(2) Priority review.--The term `priority review', with
respect to a human drug application, means review and action by
the Secretary on such application not later than 6 months after
receipt by the Secretary of such application, as described in
the Manual of Policies and Procedures in the Food and Drug
Administration and goals identified in the letters described in
section 101(b) of the Food and Drug Administration Safety and
Innovation Act.
``(3) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the sponsor
of a material threat medical countermeasure application that
entitles the holder of such voucher to priority review of a
single human drug application submitted under section 505(b)(1)
or section 351(a) of the Public Health Service Act after the
date of approval of the material threat medical countermeasure
application.
``(4) Material threat medical countermeasure application.--
The term `material threat medical countermeasure application'
means an application that--
``(A) is a human drug application for a drug
intended for use--
``(i) to prevent, or treat harm from a
biological, chemical, radiological, or nuclear
agent identified as a material threat under
section 319F-2(c)(2)(A)(ii) of the Public Health
Service Act; or
``(ii) to mitigate, prevent, or treat harm
from a condition that may result in adverse health
consequences or death and may be caused by
administering a drug, or biological product
against such agent; and
``(B) the Secretary determines eligible for priority
review;
``(C) is approved after the date of enactment of the
21st Century Cures Act; and
``(D) is for a human drug, no active ingredient
(including any ester or salt of the active ingredient)
of which has been approved in any other application
under section 505(b)(1) or section 351(a) of the Public
Health Service Act.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a material threat medical
countermeasure application upon approval by the Secretary of
such material threat medical countermeasure application.
``(2) Transferability.--The sponsor of a material threat
medical countermeasure application that receives a priority
review voucher under this section may transfer (including by
sale) the entitlement to such voucher to a sponsor of a human
drug for which an application under section 505(b)(1) or section
351(a) of the Public Health Service Act will be submitted after
the date of the approval of the material threat medical
countermeasure application. There is no limit on the number of
times
[[Page 130 STAT. 1146]]
a priority review voucher may be transferred before such voucher
is used.
``(3) Notification.--
``(A) In general.--The sponsor of a human drug
application shall notify the Secretary not later than 90
calendar days prior to submission of the human drug
application that is the subject of a priority review
voucher of an intent to submit the human drug
application, including the date on which the sponsor
intends to submit the application. Such notification
shall be a legally binding commitment to pay for the
user fee to be assessed in accordance with this section.
``(B) Transfer after notice.--The sponsor of a human
drug application that provides notification of the
intent of such sponsor to use the voucher for the human
drug application under subparagraph (A) may transfer the
voucher after such notification is provided, if such
sponsor has not yet submitted the human drug application
described in the notification.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application that
is the subject of a priority review voucher shall pay to the
Secretary a fee determined under paragraph (2). Such fee shall
be in addition to any fee required to be submitted by the
sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the review
of a human drug application subject to priority review in the
previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2016, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The priority review user fee
required by this subsection shall be due upon the
submission of a human drug application under section
505(b)(1) or section 351(a) of the Public Health Service
Act for which the priority review voucher is used.
``(B) Complete application.--An application
described under subparagraph (A) for which the sponsor
requests the use of a priority review voucher shall be
considered incomplete if the fee required by this
subsection and all other applicable user fees are not
paid in accordance with the Secretary's procedures for
paying such fees.
``(C) No waivers, exemptions, reductions, or
refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due and
payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to
the Food and Drug Administration; and
[[Page 130 STAT. 1147]]
``(6) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.
``(d) Notice of Issuance of Voucher and Approval of Products Under
Voucher.--The Secretary shall publish a notice in the Federal Register
and on the Internet website of the Food and Drug Administration not
later than 30 calendar days after the occurrence of each of the
following:
``(1) The Secretary issues a priority review voucher under
this section.
``(2) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher issued
under this section.
``(e) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a priority review voucher under this
section from participating in any other incentive program, including
under this Act, except that no sponsor of a material threat medical
countermeasure application may receive more than one priority review
voucher issued under any section of this Act with respect to such drug.
``(f) Relation to Other Provisions.--The provisions of this section
shall supplement, not supplant, any other provisions of this Act or the
Public Health Service Act that encourage the development of medical
countermeasures.
``(g) Sunset.--The Secretary may not award any priority review
vouchers under subsection (b) after October 1, 2023.''.
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH
EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(f) Determination With Respect to Paperwork Reduction Act Waiver
During a Public Health Emergency.--
``(1) Determination.--If the Secretary determines, after
consultation with such public health officials as may be
necessary, that--
``(A)(i) the criteria set forth for a public health
emergency under paragraph (1) or (2) of subsection (a)
has been met; or
``(ii) a disease or disorder, including a novel and
emerging public health threat, is significantly likely
to become a public health emergency; and
``(B) the circumstances of such public health
emergency, or potential for such significantly likely
public health emergency, including the specific
preparation for and response to such public health
emergency or threat, necessitate a waiver from the
requirements of subchapter I of chapter 35 of title 44,
United States Code (commonly referred to as the
Paperwork Reduction Act),
then the requirements of such subchapter I with respect to
voluntary collection of information shall not be applicable
during the immediate investigation of, and response to, such
public health emergency during the period of such public health
emergency or the period of time necessary to determine if a
disease or disorder, including a novel and emerging public
[[Page 130 STAT. 1148]]
health threat, will become a public health emergency as provided
for in this paragraph. The requirements of such subchapter I
with respect to voluntary collection of information shall not be
applicable during the immediate postresponse review regarding
such public health emergency if such immediate postresponse
review does not exceed a reasonable length of time.
``(2) Transparency.--If the Secretary determines that a
waiver is necessary under paragraph (1), the Secretary shall
promptly post on the Internet website of the Department of
Health and Human Services a brief justification for such waiver,
the anticipated period of time such waiver will be in effect,
and the agencies and offices within the Department of Health and
Human Services to which such waiver shall apply, and update such
information posted on the Internet website of the Department of
Health and Human Services, as applicable.
``(3) Effectiveness of waiver.--Any waiver under this
subsection shall take effect on the date on which the Secretary
posts information on the Internet website as provided for in
this subsection.
``(4) Termination of waiver.--Upon determining that the
circumstances necessitating a waiver under paragraph (1) no
longer exist, the Secretary shall promptly update the Internet
website of the Department of Health and Human Services to
reflect the termination of such waiver.
``(5) Limitations.--
``(A) Period of waiver.--The period of a waiver
under paragraph (1) shall not exceed the period of time
for the related public health emergency, including a
public health emergency declared pursuant to subsection
(a), and any immediate postresponse review regarding the
public health emergency consistent with the requirements
of this subsection.
``(B) Subsequent compliance.--An initiative subject
to a waiver under paragraph (1) that is ongoing after
the date on which the waiver expires, shall be subject
to the requirements of subchapter I of chapter 35 of
title 44, United States Code, and the Secretary shall
ensure that compliance with such requirements occurs in
as timely a manner as possible based on the applicable
circumstances, but not to exceed 30 calendar days after
the expiration of the applicable waiver.''.
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE
AUTHORIZATION.
(a) Authorization for Medical Products for Use in Emergencies.--
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3) is amended--
(1) in subsection (a)(2)--
(A) in subparagraph (A)--
(i) by striking ``or 515'' and inserting
``512, or 515''; and
(ii) by inserting ``or conditionally approved
under section 571 of this Act'' after ``Public
Health Service Act''; and
[[Page 130 STAT. 1149]]
(B) in subparagraph (B), by inserting
``conditionally approved under section 571,'' after
``approved,'' each place the term appears;
(2) in subsection (b)(4), by striking the second comma after
``determination'';
(3) in subsection (e)(3)(B), by striking ``section 503(b)''
and inserting ``subsection (b) or (f) of section 503 or under
section 504'';
(4) in subsection (f)(2)--
(A) by inserting ``, or an animal to which,'' after
``to a patient to whom''; and
(B) by inserting ``or by the veterinarian caring for
such animal, as applicable'' after ``attending
physician'';
(5) in subsection (g)(1), by inserting ``conditional
approval under section 571,'' after ``approval,'';
(6) in subsection (h)(1), by striking ``or section
520(g)''and inserting ``512(j), or 520(g)''; and
(7) in subsection (k), by striking ``section 520(g),''and
inserting ``512(j), or 520(g)''.
(b) New Animal Drugs.--Section 512(a)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended--
(1) in subparagraph (B), by striking ``or'' at the end;
(2) in subparagraph (C), by striking the period and
inserting ``; or''; and
(3) by inserting after subparagraph (C) the following:
``(D) there is in effect an authorization pursuant to
section 564 with respect to such use or intended use of such
drug, and such drug, its labeling, and such use conform to any
conditions of such authorization.''.
(c) Emergency Use of Medical Products.--Section 564A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
(1) in subsection (a)(1)(A), by inserting ``, conditionally
approved under section 571,'' after ``chapter''; and
(2) in subsection (d), by striking ``sections 503(b) and
520(e)'' and inserting ``subsections (b) and (f) of section 503,
section 504, and section 520(e)''.
(d) Products Held for Emergency Use.--Section 564B(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is amended--
(1) in subparagraph (A)--
(A) by inserting ``or conditionally approved under
section 571 of this Act'' after ``Public Health Service
Act''; and
(B) by striking ``or 515'' and inserting ``512, or
515''; and
(2) in subparagraph (B), by striking ``or 520'' and
inserting ``512, or 520''.
Subtitle I--Vaccine Access, Certainty, and Innovation
SEC. 3091. <<NOTE: 21 USC 360bbb-4 note.>> PREDICTABLE REVIEW
TIMELINES OF VACCINES BY THE ADVISORY
COMMITTEE ON IMMUNIZATION PRACTICES.
(a) Consideration of New Vaccines.--Upon the licensure of any
vaccine or any new indication for a vaccine, the Advisory
[[Page 130 STAT. 1150]]
Committee on Immunization Practices (in this section referred to as the
``Advisory Committee'') shall, as appropriate, consider the use of the
vaccine at its next regularly scheduled meeting.
(b) Additional Information.--If the Advisory Committee does not make
a recommendation with respect to the use of a vaccine at the Advisory
Committee's first regularly scheduled meeting after the licensure of the
vaccine or any new indication for the vaccine, the Advisory Committee
shall provide an update on the status of such committee's review.
(c) Consideration for Breakthrough Therapies and for Potential Use
During Public Health Emergency.--The Advisory Committee shall make
recommendations with respect to the use of certain vaccines in a timely
manner, as appropriate, including vaccines that--
(1) are designated as a breakthrough therapy under section
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356)
and licensed under section 351 of the Public Health Service Act
(42 U.S.C. 262); or
(2) could be used in a public health emergency.
(d) Definition.--In this section, the terms ``Advisory Committee on
Immunization Practices'' and ``Advisory Committee'' mean the Advisory
Committee on Immunization Practices established by the Secretary
pursuant to section 222 of the Public Health Service Act (42 U.S.C.
217a), acting through the Director of the Centers for Disease Control
and Prevention.''.
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY
COMMITTEE ON IMMUNIZATION PRACTICES
RECOMMENDATIONS.
(a) Review.--The Director of the Centers for Disease Control and
Prevention shall conduct a review of the processes used by the Advisory
Committee on Immunization Practices in formulating and issuing
recommendations pertaining to vaccines, including with respect to
consistency.
(b) Considerations.--The review under subsection (a) shall include
an assessment of--
(1) the criteria used to evaluate new and existing vaccines,
including the identification of any areas for which flexibility
in evaluating such criteria is necessary and the reason for such
flexibility;
(2) the Grading of Recommendations, Assessment, Development,
and Evaluation (GRADE) approach to the review and analysis of
scientific and economic data, including the scientific basis for
such approach; and
(3) the extent to which the processes used by the work
groups of the Advisory Committee on Immunization Practices are
consistent among such groups, including the identification of
reasons for any variation.
(c) Stakeholders.--In carrying out the review under subsection (a),
the Director of the Centers for Disease Control and Prevention shall
solicit input from vaccine stakeholders.
(d) Report.--Not later than 18 months after the date of enactment of
this Act, the Director of the Centers for Disease Control and Prevention
shall submit to the appropriate committees of the Congress, and make
publicly available, a report on the results of the review under
subsection (a), including any recommendations
[[Page 130 STAT. 1151]]
on improving the consistency of the processes described in such
subsection.
(e) Definition.--In this section, the term ``Advisory Committee on
Immunization Practices'' means the Advisory Committee on Immunization
Practices established by the Secretary of Health and Human Services
pursuant to section 222 of the Public Health Service Act (42 U.S.C.
217a), acting through the Director of the Centers for Disease Control
and Prevention.
SEC. 3093. <<NOTE: 42 USC 300aa-2 note.>> ENCOURAGING VACCINE
INNOVATION.
(a) Vaccine Meetings.--The Director of the Centers for Disease
Control and Prevention shall ensure that appropriate staff within the
relevant centers and divisions of the Office of Infectious Diseases, and
others, as appropriate, coordinate with respect to the public health
needs, epidemiology, and program planning and implementation
considerations related to immunization, including with regard to
meetings with stakeholders related to such topics.
(b) Report on Vaccine Innovation.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary''), in
collaboration with appropriate agencies or offices within the
Department of Health and Human Services, including the National
Institutes of Health, the Centers for Disease Control and
Prevention, the Food and Drug Administration, and the Biomedical
Advanced Research and Development Authority, shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives, and post publicly on the Internet website of
the Department of Health and Human Services, a report on ways to
promote innovation in the development of vaccines that minimize
the burden of infectious disease.
(2) Contents.--The report described in paragraph (1) shall
review the current status of vaccine development and, as
appropriate--
(A) consider the optimal process to determine which
vaccines would be beneficial to public health and how
information on such vaccines is disseminated to key
stakeholders;
(B) examine and identify whether obstacles exist
that inhibit the development of beneficial vaccines; and
(C) make recommendations about how best to remove
any obstacles identified under subparagraph (B) in order
to promote and incentivize vaccine innovation and
development.
(3) Consultation.--In preparing the report under this
subsection, the Secretary may consult with--
(A) representatives of relevant Federal agencies and
departments, including the Department of Defense and the
Department of Veterans Affairs;
(B) academic researchers;
(C) developers and manufacturers of vaccines;
(D) medical and public health practitioners;
(E) representatives of patient, policy, and advocacy
organizations; and
[[Page 130 STAT. 1152]]
(F) representatives of other entities, as the
Secretary determines appropriate.
(c) Updates Related to Maternal Immunization.--
(1) Additional vaccines.--Section 2114(e) of the Public
Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding
at the end the following:
``(3) Vaccines recommended for use in pregnant women.--The
Secretary shall revise the Vaccine Injury Table included in
subsection (a), through the process described in subsection (c),
to include vaccines recommended by the Centers for Disease
Control and Prevention for routine administration in pregnant
women and the information described in subparagraphs (B) and (C)
of paragraph (2) with respect to such vaccines.''.
(2) Petition content.--Section 2111 of the Public Health
Service Act (42 U.S.C. 300aa-11) is amended by adding at the end
the following:
``(f) Maternal Immunization.--
``(1) In general.--Notwithstanding any other provision of
law, for purposes of this subtitle, both a woman who received a
covered vaccine while pregnant and any child who was in utero at
the time such woman received the vaccine shall be considered
persons to whom the covered vaccine was administered and persons
who received the covered vaccine.
``(2) Definition.--As used in this subsection, the term
`child' shall have the meaning given that term by subsections
(a) and (b) of section 8 of title 1, United States Code, except
that, for purposes of this subsection, such section 8 shall be
applied as if the term `include' in subsection (a) of such
section were replaced with the term `mean'.''.
(3) Petitioners.--Section 2111(b)(2) of the Public Health
Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A
covered vaccine administered to a pregnant woman shall
constitute more than one administration, one to the mother and
one to each child (as such term is defined in subsection (f)(2))
who was in utero at the time such woman was administered the
vaccine.'' at the end.
Subtitle J--Technical Corrections
SEC. 3101. TECHNICAL CORRECTIONS.
(a) FFDCA.--
(1) References.--Except as otherwise expressly provided,
whenever in this subsection an amendment is expressed in terms
of an amendment to a section or other provision, the reference
shall be considered to be made to that section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(2) Amendments.--
(A) Prohibited acts.--Section 301(r) (21 U.S.C.
331(r)) is amended by inserting ``, drug,'' after
``device'' each place the term appears.
(B) New drugs.--Section 505 (21 U.S.C. 355) is
amended--
[[Page 130 STAT. 1153]]
(i) in subsection (d), in the last sentence,
by striking ``premarket approval'' and inserting
``marketing approval''; and
(ii) in subsection (q)(5)(A), by striking
``subsection (b)(2) or (j) of the Act or 351(k)''
and inserting ``subsection (b)(2) or (j) of this
section or section 351(k)''.
(C) Risk evaluation and mitigation strategies.--
Section 505-1(h)(21 U.S.C. 355-1(h)) is amended--
(i) in paragraph (2)(A)(iii)--
(I) in the clause heading, by
striking ``label'' and inserting
``labeling'';
(II) by striking ``label'' each
place the term appears and inserting
``labeling''; and
(III) by striking ``sponsor'' and
inserting ``responsible person''; and
(ii) in paragraph (8), by striking ``and
(7).'' and inserting ``and (7)''.
(D) Pediatric study plans.--Section 505B (21 U.S.C.
355c) is amended--
(i) in subsection (e)--
(I) in paragraph (2)--
(aa) in subparagraph (A), by
inserting ``study'' after
``initial pediatric'' each place
the term appears; and
(bb) in subparagraph (B), in
the subparagraph heading, by
striking ``initial plan'' and
inserting ``initial pediatric
study plan'';
(II) in paragraph (5), in the
paragraph heading, by inserting ``agreed
initial pediatric study'' before
``plan''; and
(III) in paragraph (6), by striking
``agreed initial pediatric plan'' and
inserting ``agreed initial pediatric
study plan''; and
(ii) in subsection (f)(1), by inserting ``and
any significant amendments to such plans,'' after
``agreed initial pediatric study plans,''.
(E) Discontinuance or interruption in the production
of live-saving drugs.--Section 506C (21 U.S.C. 356c) is
amended--
(i) in subsection (c), by striking
``discontinuation'' and inserting
``discontinuance''; and
(ii) in subsection (g)(1), by striking
``section 505(j) that could help'' and inserting
``section 505(j), that could help''.
(F) Annual reporting on drug shortages.--Section
506C-1(a) (21 U.S.C. 331(a)) is amended, in the matter
before paragraph (1)--
(i) by striking ``Not later than the end of
calendar year 2013, and not later than the end of
each calendar year thereafter,'' and inserting
``Not later than March 31 of each calendar
year,''; and
(ii) by inserting ``, with respect to the
preceding calendar year,'' after ``a report''.
(G) Drug shortage list.--Section 506E(b)(3)(E) (21
U.S.C. 356e(b)(3)(E)) is amended by striking
``discontinuation'' and inserting ``discontinuance''.
[[Page 130 STAT. 1154]]
(H) Inspections of establishments.--Section 510(h)
(21 U.S.C. 360(h)) is amended--
(i) in paragraph (4), in the matter preceding
subparagraph (A), by striking ``establishing the
risk-based scheduled'' and inserting
``establishing a risk-based schedule''; and
(ii) in paragraph (6)--
(I) in subparagraph (A), by striking
``fiscal'' and inserting ``calendar''
each place the term appears; and
(II) in subparagraph (B), by
striking ``an active ingredient of a
drug, a finished drug product, or an
excipient of a drug'' and inserting ``an
active ingredient of a drug or a
finished drug product''.
(I) Classification of devices intended for human
use.--Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is
amended--
(i) in clause (i), by striking ``within 30
days''; and
(ii) in clause (iv), by striking ``low-
moderate'' and inserting ``low to moderate''.
(J) Premarket approval.--Section 515(a)(1) (21
U.S.C. 360e(a)(1)) is amended by striking ``subject to a
an order'' and inserting ``subject to an order''.
(K) Program to improve the device recall system.--
Section 518A (21 U.S.C. 360h-1) is amended--
(i) by striking subsection (c); and
(ii) by redesignating subsection (d) as
subsection (c).
(L) Unique device identifier.--Section 519(f) (21
U.S.C. 360i(f)) is amended by striking ``and life
sustaining'' and inserting ``or life sustaining''.
(M) Priority review to encourage treatments for
tropical diseases.--Section 524(c)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A))
is amended by striking ``Services Act'' and inserting
``Service Act''.
(N) Priority review for qualified infectious disease
products.--Section 524A (21 U.S.C. 360n-1) is amended--
(i) by striking ``If the Secretary'' and
inserting the following:
``(a) In General.--If the Secretary'';
(ii) by striking ``any'' and inserting ``the
first''; and
(iii) by adding at the end the following:
``(b) Construction.--Nothing in this section shall prohibit the
Secretary from giving priority review to a human drug application or
efficacy supplement submitted for approval under section 505(b) that
otherwise meets the criteria for the Secretary to grant priority
review.''.
(O) Consultation with external experts on rare
diseases, targeted therapies, and genetic targeting of
treatments.--Section 569(a)(2)(A) (21 U.S.C. 360bbb-
8(a)(2)(A)) is amended, in the first sentence, by
striking ``subsection (c)'' and inserting ``subsection
(b)''.
(P) Optimizing global clinical trials.--Section
569A(c) (21 U.S.C. 360bbb-8a(c)) is amended by inserting
``or under the Public Health Service Act'' after ``this
Act''.
[[Page 130 STAT. 1155]]
(Q) Use of clinical investigation data from outside
the united states.--Section 569B (21 U.S.C. 360bbb-8b)
is amended by striking ``drug or device'' and inserting
``drug, biological product, or device'' each place the
term appears.
(R) Medical gases definitions.--Section 575(1)(H)
(21 U.S.C. 360ddd(1)(H)) is amended--
(i) by inserting ``for a new drug'' after
``any period of exclusivity''; and
(ii) by inserting ``or any period of
exclusivity for a new animal drug under section
512(c)(2)(F),'' after ``section 505A,''.
(S) Regulation of medical gases.--Section 576(a) (21
U.S.C. 360ddd-1(a)) is amended--
(i) in the matter preceding subparagraph (A)
of paragraph (1), by inserting ``who seeks to
initially introduce or deliver for introduction a
designated medical gas into interstate commerce''
after ``any person''; and
(ii) in paragraph (3)--
(I) in subparagraph (A)--
(aa) in clause (i)(VIII), by
inserting ``for a new drug''
after ``any period of
exclusivity''; and
(bb) in clause (ii), in the
matter preceding subclause (I),
by inserting ``the'' before
``final use''; and
(II) in subparagraph (B)--
(aa) in clause (i), by
inserting ``for a new drug''
after ``any period of
exclusivity''; and
(bb) in clause (ii), by
inserting a comma after ``drug
product''.
(T) Inapplicability of drug fees to designated
medical gases.--Section 577 (21 U.S.C. 360ddd-2) is
amended by inserting ``or 740(a)'' after ``section
736(a)''.
(U) Conflicts of interest.--Section 712(e)(1)(B) (21
U.S.C. 379d-1(e)(1)(B)) is amended by striking
``services'' and inserting ``service''.
(V) Authority to assess and use biosimilar
biological product fees.--Section 744H(a) (21 U.S.C.
379j-52(a)) is amended--
(i) in paragraph (1)(A)(v), by striking
``Biosimilars User Fee Act of 2012'' and inserting
``Biosimilar User Fee Act of 2012''; and
(ii) in paragraph (2)(B), by striking
``Biosimilars User Fee Act of 2012'' and inserting
``Biosimilar User Fee Act of 2012''.
(W) Registration of commercial importers.--
(i) Amendment.--Section 801(s)(2) (21 U.S.C.
381(s)(2)) is amended by adding at the end the
following:
``(D) Effective date.--In establishing the effective
date of the regulations under subparagraph (A), the
Secretary shall, in consultation with the Secretary of
Homeland Security acting through U.S. Customs and Border
Protection, as determined appropriate by the Secretary
of Health and Human Services, provide a reasonable
period of time for an importer of a drug to comply with
good
[[Page 130 STAT. 1156]]
importer practices, taking into account differences
among importers and types of imports, including based on
the level of risk posed by the imported product.''.
(ii) Conforming amendment.--Section 714 of the
Food and Drug Administration Safety and Innovation
Act (Public Law 112-144; 126 Stat. 1074) is
amended by striking subsection (d).
(X) Recognition of foreign government inspections.--
Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by
striking ``conduction'' and inserting ``conducting''.
(b) FDASIA.--
(1) Findings relating to drug approval.--Section
901(a)(1)(A) of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is
amended by striking ``serious and life-threatening diseases''
and inserting ``serious or life-threatening diseases''.
(2) Reporting of inclusion of demographic subgroups.--
Section 907 of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is
amended--
(A) in the section heading, by striking
``biologics'' in the heading and inserting ``biological
products''; and
(B) in subsection (a)(2)(B), by striking
``applications for new drug applications'' and inserting
``new drug applications''.
(3) Combating prescription drug abuse.--Section 1122 of the
Food and Drug Administration Safety and Innovation Act (Public
Law 112-144; 126 Stat. 1112, 1113) is amended--
(A) in subsection (a)(2), by striking ``dependance''
and inserting ``dependence''; and
(B) in subsection (c), by striking ``promulgate''
and inserting ``issue''.
SEC. 3102. COMPLETED STUDIES.
The Federal Food, Drug, and Cosmetic Act is amended--
(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
(A) in subparagraph (A), by inserting ``and'' after
the semicolon;
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as
subparagraph (B);
(2) in section 505A (21 U.S.C. 355a), by striking subsection
(p);
(3) in section 505B (21 U.S.C. 355c)--
(A) by striking subsection (l); and
(B) by redesignating subsection (m) as subsection
(l); and
(4) in section 523 (21 U.S.C. 360m), by striking subsection
(d).
[[Page 130 STAT. 1157]]
TITLE IV--DELIVERY
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF
CARE FOR PATIENTS.
(a) In General.--The Health Information Technology for Economic and
Clinical Health Act (title XIII of division A of Public Law 111-5) is
amended--
(1) by adding at the end of part 1 of subtitle A the
following:
``SEC. 13103. <<NOTE: 42 USC 300jj-11 note.>> ASSISTING DOCTORS
AND HOSPITALS IN IMPROVING QUALITY OF
CARE FOR PATIENTS.
``(a) Reduction in Burdens Goal.--The Secretary of Health and Human
Services (referred to in this section as the `Secretary'), in
consultation with providers of health services, health care suppliers of
services, health care payers, health professional societies, health
information technology developers, health care quality organizations,
health care accreditation organizations, public health entities, States,
and other appropriate entities, shall, in accordance with subsection
(b)--
``(1) establish a goal with respect to the reduction of
regulatory or administrative burdens (such as documentation
requirements) relating to the use of electronic health records;
``(2) develop a strategy for meeting the goal established
under paragraph (1); and
``(3) develop recommendations for meeting the goal
established under paragraph (1).
``(b) Strategy and Recommendations.--
``(1) In general.--To achieve the goal established under
subsection (a)(1), the Secretary, in consultation with the
entities described in such subsection, shall, not later than 1
year after the date of enactment of the 21st Century Cures Act,
develop a strategy and recommendations to meet the goal in
accordance with this subsection.
``(2) Strategy.--The strategy developed under paragraph (1)
shall address the regulatory and administrative burdens (such as
documentation requirements) relating to the use of electronic
health records. Such strategy shall include broad public comment
and shall prioritize--
``(A)(i) incentives for meaningful use of certified
EHR technology for eligible professionals and hospitals
under sections 1848(a)(7) and 1886(b)(3)(B)(ix),
respectively, of the Social Security Act (42 U.S.C.
1395w-4(a)(7), 1395ww(b)(3)(B)(ix));
``(ii) the program for making payments under section
1903(a)(3)(F) of the Social Security Act (42 U.S.C.
1396b(a)(3)(F)) to encourage the adoption and use of
certified EHR technology by Medicaid providers;
``(iii) the Merit-based Incentive Payment System
under section 1848(q) of the Social Security Act (42
U.S.C. 1395w-4(q));
``(iv) alternative payment models (as defined in
section 1833(z)(3)(C) of the Social Security Act (42
U.S.C. 1395l(z)(3)(C));
``(v) the Hospital Value-Based Purchasing Program
under section 1886(o) of the Social Security Act (42
U.S.C. 1395ww(o)); and
[[Page 130 STAT. 1158]]
``(vi) other value-based payment programs, as the
Secretary determines appropriate;
``(B) health information technology certification;
``(C) standards and implementation specifications,
as appropriate;
``(D) activities that provide individuals access to
their electronic health information;
``(E) activities related to protecting the privacy
of electronic health information;
``(F) activities related to protecting the security
of electronic health information;
``(G) activities related to facilitating health and
clinical research;
``(H) activities related to public health;
``(I) activities related to aligning and simplifying
quality measures across Federal programs and other
payers;
``(J) activities related to reporting clinical data
for administrative purposes; and
``(K) other areas, as the Secretary determines
appropriate.
``(3) Recommendations.--The recommendations developed under
paragraph (1) shall address--
``(A) actions that improve the clinical
documentation experience;
``(B) actions that improve patient care;
``(C) actions to be taken by the Secretary and by
other entities; and
``(D) other areas, as the Secretary determines
appropriate, to reduce the reporting burden required of
health care providers.
``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the development of the goal,
strategies, or recommendations described in this section.
``(c) Application of Certain Regulatory Requirements.--A physician
(as defined in section 1861(r)(1) of the Social Security Act), to the
extent consistent with applicable State law, may delegate electronic
medical record documentation requirements specified in regulations
promulgated by the Centers for Medicare & Medicaid Services to a person
performing a scribe function who is not such physician if such physician
has signed and verified the documentation.''; and
(2) in the table of contents in section 13001(b), by
inserting after the item relating to section 13102 the
following:
``13103. Assisting doctors and hospitals in improving the quality and
care for patients.''.
(b) Certification of Health Information Technology for Medical
Specialties and Sites of Service.--Section 3001(c)(5) of the Public
Health Service Act (42 U.S.C. 300jj-11(c)(5)) is amended by adding at
the end the following:
``(C) Health information technology for medical
specialties and sites of service.--
``(i) In general.--The National Coordinator
shall encourage, keep, or recognize, through
existing authorities, the voluntary certification
of health information technology under the program
developed under
[[Page 130 STAT. 1159]]
subparagraph (A) for use in medical specialties
and sites of service for which no such technology
is available or where more technological
advancement or integration is needed.
``(ii) Specific medical specialties.--The
Secretary shall accept public comment on specific
medical specialties and sites of service, in
addition to those described in clause (i), for the
purpose of selecting additional specialties and
sites of service as necessary.
``(iii) Health information technology for
pediatrics.--Not later than 18 months after the
date of enactment of the 21st Century Cures Act,
the Secretary, in consultation with relevant
stakeholders, shall make recommendations for the
voluntary certification of health information
technology for use by pediatric health providers
to support the health care of children. Not later
than 2 years after the date of enactment of the
21st Century Cures Act, the Secretary shall adopt
certification criteria under section 3004 to
support the voluntary certification of health
information technology for use by pediatric health
providers to support the health care of
children.''.
(c) Meaningful Use Statistics.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the HIT Advisory Committee of the
Office of the National Coordinator for Health Information
Technology, a report concerning attestation statistics for the
Medicare and Medicaid EHR Meaningful Use Incentive programs to
assist in informing standards adoption and related practices.
Such statistics shall include attestation information delineated
by State, including, to the extent practicable, the number of
providers who did not meet the minimum criteria necessary to
attest for the Medicare and Medicaid EHR Meaningful Use
Incentive programs for a calendar year, and shall be made
publicly available on the Internet website of the Secretary on
at least a quarterly basis.
(2) Authority to alter format.--The Secretary of Health and
Human Services may alter the format of the reports on the
attestation of eligible health care professionals following the
first performance year of the Merit-based Incentive Payment
System to account for changes arising from the implementation of
such payment system.
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND
FUNCTIONALITY.
(a) Enhancements to Certification.--Section 3001(c)(5) of the Public
Health Service Act (42 U.S.C. 300jj-11), as amended by section 4001(b),
is further amended by adding at the end the following:
``(D) Conditions of certification.--Not later than 1
year after the date of enactment of the 21st Century
Cures Act, the Secretary, through notice and comment
rulemaking, shall require, as a condition of
certification and maintenance of certification for
programs maintained or recognized under this paragraph,
consistent with other
[[Page 130 STAT. 1160]]
conditions and requirements under this title, that the
health information technology developer or entity--
``(i) does not take any action that
constitutes information blocking as defined in
section 3022(a);
``(ii) provides assurances satisfactory to the
Secretary that such developer or entity, unless
for legitimate purposes specified by the
Secretary, will not take any action described in
clause (i) or any other action that may inhibit
the appropriate exchange, access, and use of
electronic health information;
``(iii) does not prohibit or restrict
communication regarding--
``(I) the usability of the health
information technology;
``(II) the interoperability of the
health information technology;
``(III) the security of the health
information technology;
``(IV) relevant information
regarding users' experiences when using
the health information technology;
``(V) the business practices of
developers of health information
technology related to exchanging
electronic health information; and
``(VI) the manner in which a user of
the health information technology has
used such technology;
``(iv) has published application programming
interfaces and allows health information from such
technology to be accessed, exchanged, and used
without special effort through the use of
application programming interfaces or successor
technology or standards, as provided for under
applicable law, including providing access to all
data elements of a patient's electronic health
record to the extent permissible under applicable
privacy laws;
``(v) has successfully tested the real world
use of the technology for interoperability (as
defined in section 3000) in the type of setting in
which such technology would be marketed;
``(vi) provides to the Secretary an
attestation that the developer or entity--
``(I) has not engaged in any of the
conduct described in clause (i);
``(II) has provided assurances
satisfactory to the Secretary in
accordance with clause (ii);
``(III) does not prohibit or
restrict communication as described in
clause (iii);
``(IV) has published information in
accordance with clause (iv);
``(V) ensures that its technology
allows for health information to be
exchanged, accessed, and used, in the
manner described in clause (iv); and
``(VI) has undertaken real world
testing as described in clause (v); and
``(vii) submits reporting criteria in
accordance with section 3009A(b).''.
[[Page 130 STAT. 1161]]
``(E) Compliance with conditions of certification.--
The Secretary may encourage compliance with the
conditions of certification described in subparagraph
(D) and take action to discourage noncompliance, as
appropriate.''.
(b) EHR Significant Hardship Exception.--
(1) Application to eligible professionals.--
(A) In case of decertification.--Section
1848(a)(7)(B) of the Social Security Act (42 U.S.C.
1395w-4(a)(7)(B)) is amended by inserting after the
first sentence the following new sentence: ``The
Secretary shall exempt an eligible professional from the
application of the payment adjustment under subparagraph
(A) with respect to a year, subject to annual renewal,
if the Secretary determines that compliance with the
requirement for being a meaningful EHR user is not
possible because the certified EHR technology used by
such professional has been decertified under a program
kept or recognized pursuant to section 3001(c)(5) of the
Public Health Service Act.''.
(B) Continued application under mips.--Section
1848(o)(2)(D) of the Social Security Act (42 U.S.C.
1395w-4(o)(2)(D)) is amended by adding at the end the
following new sentence: ``The provisions of
subparagraphs (B) and (D) of subsection (a)(7), shall
apply to assessments of MIPS eligible professionals
under subsection (q) with respect to the performance
category described in subsection (q)(2)(A)(iv) in an
appropriate manner which may be similar to the manner in
which such provisions apply with respect to payment
adjustments made under subsection (a)(7)(A).''.
(2) Application to eligible hospitals.--Section
1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first
sentence the following new sentence: ``The Secretary shall
exempt an eligible hospital from the application of the payment
adjustment under subclause (I) with respect to a fiscal year,
subject to annual renewal, if the Secretary determines that
compliance with the requirement for being a meaningful EHR user
is not possible because the certified EHR technology used by
such hospital is decertified under a program kept or recognized
pursuant to section 3001(c)(5) of the Public Health Service
Act.''.
(c) Electronic Health Record Reporting Program.--Subtitle A of title
XXX of the Public Health Service Act (42 U.S.C. 300jj-11 et seq.) is
amended by adding at the end the following:
``SEC. 3009A. <<NOTE: 42 USC 300jj-19a.>> ELECTRONIC HEALTH
RECORD REPORTING PROGRAM.
``(a) Reporting Criteria.--
``(1) Convening of stakeholders.--Not later than 1 year
after the date of enactment of the 21st Century Cures Act, the
Secretary shall convene stakeholders, as described in paragraph
(2), for the purpose of developing the reporting criteria in
accordance with paragraph (3).
``(2) Development of reporting criteria.--The reporting
criteria under this subsection shall be developed through a
public, transparent process that reflects input from relevant
stakeholders, including--
[[Page 130 STAT. 1162]]
``(A) health care providers, including primary care
and specialty care health care professionals;
``(B) hospitals and hospital systems;
``(C) health information technology developers;
``(D) patients, consumers, and their advocates;
``(E) data sharing networks, such as health
information exchanges;
``(F) authorized certification bodies and testing
laboratories;
``(G) security experts;
``(H) relevant manufacturers of medical devices;
``(I) experts in health information technology
market economics;
``(J) public and private entities engaged in the
evaluation of health information technology performance;
``(K) quality organizations, including the consensus
based entity described in section 1890 of the Social
Security Act;
``(L) experts in human factors engineering and the
measurement of user-centered design; and
``(M) other entities or individuals, as the
Secretary determines appropriate.
``(3) Considerations for reporting criteria.--The reporting
criteria developed under this subsection--
``(A) shall include measures that reflect categories
including--
``(i) security;
``(ii) usability and user-centered design;
``(iii) interoperability;
``(iv) conformance to certification testing;
and
``(v) other categories, as appropriate to
measure the performance of electronic health
record technology;
``(B) may include categories such as--
``(i) enabling the user to order and view the
results of laboratory tests, imaging tests, and
other diagnostic tests;
``(ii) submitting, editing, and retrieving
data from registries such as clinician-led
clinical data registries;
``(iii) accessing and exchanging information
and data from and through health information
exchanges;
``(iv) accessing and exchanging information
and data from medical devices;
``(v) accessing and exchanging information and
data held by Federal, State, and local agencies
and other applicable entities useful to a health
care provider or other applicable user in the
furtherance of patient care;
``(vi) accessing and exchanging information
from other health care providers or applicable
users;
``(vii) accessing and exchanging patient
generated information;
``(viii) providing the patient or an
authorized designee with a complete copy of their
health information from an electronic record in a
computable format;
``(ix) providing accurate patient information
for the correct patient, including exchanging such
information, and avoiding the duplication of
patients records; and
[[Page 130 STAT. 1163]]
``(x) other categories regarding performance,
accessibility, as the Secretary determines
appropriate; and
``(C) shall be designed to ensure that small and
startup health information technology developers are not
unduly disadvantaged by the reporting criteria.
``(4) Modifications.--After the reporting criteria have been
developed under paragraph (3), the Secretary may convene
stakeholders and conduct a public comment period for the purpose
of modifying the reporting criteria developed under such
paragraph.
``(b) Participation.--As a condition of maintaining certification
under section 3001(c)(5)(D), a developer of certified electronic health
records shall submit to an appropriate recipient of a grant, contract,
or agreement under subsection (c)(1) responses to the criteria developed
under subsection (a), with respect to all certified technology offered
by such developer.
``(c) Reporting Program.--
``(1) In general.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
award grants, contracts, or agreements to independent entities
on a competitive basis to support the convening of stakeholders
as described in subsection (a)(2), collect the information
required to be reported in accordance with the criteria
established as described subsection (a)(3), and develop and
implement a process in accordance with paragraph (5) and report
such information to the Secretary.
``(2) Applications.--An independent entity that seeks a
grant, contract, or agreement under this subsection shall submit
an application to the Secretary at such time, in such manner,
and containing such information as the Secretary may reasonably
require, including a description of--
``(A) the proposed method for reviewing and
summarizing information gathered based on reporting
criteria established under subsection (a);
``(B) if applicable, the intended focus on a
specific subset of certified electronic health record
technology users, such as health care providers,
including primary care, specialty care, and care
provided in rural settings; hospitals and hospital
systems; and patients, consumers, and patients and
consumer advocates;
``(C) the plan for widely distributing reports
described in paragraph (6);
``(D) the period for which the grant, contract, or
agreement is requested, which may be up to 2 years; and
``(E) the budget for reporting program
participation, and whether the eligible independent
entity intends to continue participation after the
period of the grant, contract, or agreement.
``(3) Considerations for independent entities.--In awarding
grants, contracts, and agreements under paragraph (1), the
Secretary shall give priority to independent entities with
appropriate expertise in health information technology
usability, interoperability, and security (especially entities
with such expertise in electronic health records) with respect
to--
``(A) health care providers, including primary care,
specialty care, and care provided in rural settings;
``(B) hospitals and hospital systems; and
[[Page 130 STAT. 1164]]
``(C) patients, consumers, and patient and consumer
advocates.
``(4) Limitations.--
``(A) Assessment and redetermination.--Not later
than 4 years after the date of enactment of the 21st
Century Cures Act and every 2 years thereafter, the
Secretary, in consultation with stakeholders, shall--
``(i) assess performance of the recipients of
the grants, contracts, and agreements under
paragraph (1) based on quality and usability of
reports described in paragraph (6); and
``(ii) re-determine grants, contracts, and
agreements as necessary.
``(B) Prohibitions on participation.--The Secretary
may not award a grant, contract, or cooperative
agreement under paragraph (1) to--
``(i) a proprietor of certified health
information technology or a business affiliate of
such a proprietor;
``(ii) a developer of certified health
information technology; or
``(iii) a State or local government agency.
``(5) Feedback.--Based on reporting criteria established
under subsection (a), the recipients of grants, contracts, and
agreements under paragraph (1) shall develop and implement a
process to collect and verify confidential feedback on such
criteria from--
``(A) health care providers, patients, and other
users of certified electronic health record technology;
and
``(B) developers of certified electronic health
record technology.
``(6) Reports.--
``(A) Development of reports.--Each recipient of a
grant, contract, or agreement under paragraph (1) shall
report on the information reported to such recipient
pursuant to subsection (a) and the user feedback
collected under paragraph (5) by preparing summary
reports and detailed reports of such information.
``(B) Distribution of reports.--Each recipient of a
grant, contract, or agreement under paragraph (1) shall
submit the reports prepared under subparagraph (A) to
the Secretary for public distribution in accordance with
subsection (d).
``(d) Publication.--The Secretary shall distribute widely, as
appropriate, and publish, on the Internet website of the Office of the
National Coordinator--
``(1) the reporting criteria developed under subsection (a);
and
``(2) the summary and detailed reports under subsection
(c)(6).
``(e) Review.--Each recipient of a grant, contract, or agreement
under paragraph (1) shall develop and implement a process through which
participating electronic health record technology developers may review
and recommend changes to the reports created under subsection (c)(6) for
products developed by such developer prior to the publication of such
report under subsection (d).
``(f) Additional Resources.--The Secretary may provide additional
resources on the Internet website of the Office of the National
[[Page 130 STAT. 1165]]
Coordinator to better inform consumers of health information technology.
Such reports may be carried out through partnerships with private
organizations with appropriate expertise.''.
(d) Authorization of Appropriations.--There is authorized to be
appropriated $15,000,000 for purposes of carrying out subparagraph (D)
of section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-
11) (as added by subsection (a)) and section 3009A of the Public Health
Service Act (as added by subsection (b)), including for purposes of
administering any contracts, grants, or agreements, to remain available
until expended.
SEC. 4003. INTEROPERABILITY.
(a) Definition.--Section 3000 of the Public Health Service Act (42
U.S.C. 300jj) is amended--
(1) by redesignating paragraphs (10) through (14), as
paragraphs (11) through (15), respectively; and
(2) by inserting after paragraph (9) the following:
``(10) Interoperability.--The term `interoperability', with
respect to health information technology, means such health
information technology that--
``(A) enables the secure exchange of electronic
health information with, and use of electronic health
information from, other health information technology
without special effort on the part of the user;
``(B) allows for complete access, exchange, and use
of all electronically accessible health information for
authorized use under applicable State or Federal law;
and
``(C) does not constitute information blocking as
defined in section 3022(a).''.
(b) Support for Interoperable Network Exchange.--Section 3001(c) of
the Public Health Service Act (42 U.S.C. 300jj-11(c)) is amended by
adding at the end the following:
``(9) Support for interoperable networks exchange.--
``(A) In general.--The National Coordinator shall,
in collaboration with the National Institute of
Standards and Technology and other relevant agencies
within the Department of Health and Human Services, for
the purpose of ensuring full network-to-network exchange
of health information, convene public-private and
public-public partnerships to build consensus and
develop or support a trusted exchange framework,
including a common agreement among health information
networks nationally. Such convention may occur at a
frequency determined appropriate by the Secretary.
``(B) Establishing a trusted exchange framework.--
``(i) In general.--Not later than 6 months
after the date of enactment of the 21st Century
Cures Act, the National Coordinator shall convene
appropriate public and private stakeholders to
develop or support a trusted exchange framework
for trust policies and practices and for a common
agreement for exchange between health information
networks. The common agreement may include--
``(I) a common method for
authenticating trusted health
information network participants;
[[Page 130 STAT. 1166]]
``(II) a common set of rules for
trusted exchange;
``(III) organizational and
operational policies to enable the
exchange of health information among
networks, including minimum conditions
for such exchange to occur; and
``(IV) a process for filing and
adjudicating noncompliance with the
terms of the common agreement.
``(ii) Technical assistance.--The National
Coordinator, in collaboration with the National
Institute of Standards and Technology, shall
provide technical assistance on how to implement
the trusted exchange framework and common
agreement under this paragraph.
``(iii) Pilot testing.--The National
Coordinator, in consultation with the National
Institute of Standards and Technology, shall
provide for the pilot testing of the trusted
exchange framework and common agreement
established or supported under this subsection (as
authorized under section 13201 of the Health
Information Technology for Economic and Clinical
Health Act). The National Coordinator, in
consultation with the National Institute of
Standards and Technology, may delegate pilot
testing activities under this clause to
independent entities with appropriate expertise.
``(C) Publication of a trusted exchange framework
and common agreement.--Not later than 1 year after
convening stakeholders under subparagraph (A), the
National Coordinator shall publish on its public
Internet website, and in the Federal register, the
trusted exchange framework and common agreement
developed or supported under subparagraph (B). Such
trusted exchange framework and common agreement shall be
published in a manner that protects proprietary and
security information, including trade secrets and any
other protected intellectual property.
``(D) Directory of participating health information
networks.--
``(i) In general.--Not later than 2 years
after convening stakeholders under subparagraph
(A), and annually thereafter, the National
Coordinator shall publish on its public Internet
website a list of the health information networks
that have adopted the common agreement and are
capable of trusted exchange pursuant to the common
agreement developed or supported under paragraph
(B).
``(ii) Process.--The Secretary shall, through
notice and comment rulemaking, establish a process
for health information networks that voluntarily
elect to adopt the trusted exchange framework and
common agreement to attest to such adoption of the
framework and agreement.
``(E) Application of the trusted exchange framework
and common agreement.--As appropriate, Federal agencies
contracting or entering into agreements with
[[Page 130 STAT. 1167]]
health information exchange networks may require that as
each such network upgrades health information technology
or trust and operational practices, such network may
adopt, where available, the trusted exchange framework
and common agreement published under subparagraph (C).
``(F) Rule of construction.--
``(i) General adoption.--Nothing in this
paragraph shall be construed to require a health
information network to adopt the trusted exchange
framework or common agreement.
``(ii) Adoption when exchange of information
is within network.--Nothing in this paragraph
shall be construed to require a health information
network to adopt the trusted exchange framework or
common agreement for the exchange of electronic
health information between participants of the
same network.
``(iii) Existing frameworks and agreements.--
The trusted exchange framework and common
agreement published under subparagraph (C) shall
take into account existing trusted exchange
frameworks and agreements used by health
information networks to avoid the disruption of
existing exchanges between participants of health
information networks.
``(iv) Application by federal agencies.--
Notwithstanding clauses (i), (ii), and (iii),
Federal agencies may require the adoption of the
trusted exchange framework and common agreement
published under subparagraph (C) for health
information exchanges contracting with or entering
into agreements pursuant to subparagraph (E).
``(v) Consideration of ongoing work.--In
carrying out this paragraph, the Secretary shall
ensure the consideration of activities carried out
by public and private organizations related to
exchange between health information exchanges to
avoid duplication of efforts.''.
(c) <<NOTE: 42 USC 300jj-11 note.>> Provider Digital Contact
Information Index.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the ``Secretary'')
shall, directly or through a partnership with a private entity,
establish a provider digital contact information index to
provide digital contact information for health professionals and
health facilities.
(2) Use of existing index.--In establishing the initial
index under paragraph (1), the Secretary may utilize an existing
provider directory to make such digital contact information
available.
(3) Contact information.--An index established under this
subsection shall ensure that contact information is available at
the individual health care provider level and at the health
facility or practice level.
(4) Rule of construction.--
(A) In general.--The purpose of this subsection is
to encourage the exchange of electronic health
information by providing the most useful, reliable, and
comprehensive
[[Page 130 STAT. 1168]]
index of providers possible. In furthering such purpose,
the Secretary shall include all health professionals and
health facilities applicable to provide a useful,
reliable, and comprehensive index for use in the
exchange of health information.
(B) Limitation.--In no case shall exclusion from the
index of providers be used as a measure to achieve
objectives other the objectives described in
subparagraph (A).
(d) Standards Development Organizations.--Section 3004 of the Public
Health Service Act (42 U.S.C. 300jj-14) is amended by adding at the end
the following:
``(c) Deference to Standards Development Organizations.--In adopting
and implementing standards under this section, the Secretary shall give
deference to standards published by standards development organizations
and voluntary consensus-based standards bodies.''.
(e) Health Information Technology Advisory Committee.--
(1) In general.--Title XXX of the Public Health Service Act
(42 U.S.C. 300jj et seq.) is amended by striking sections 3002
(42 U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and inserting
the following:
``SEC. 3002. <<NOTE: 42 USC 300jj-12.>> HEALTH INFORMATION
TECHNOLOGY ADVISORY COMMITTEE.
``(a) Establishment.--There is established a Health Information
Technology Advisory Committee (referred to in this section as the `HIT
Advisory Committee') to recommend to the National Coordinator,
consistent with the implementation of the strategic plan described in
section 3001(c)(3), policies, and, for purposes of adoption under
section 3004, standards, implementation specifications, and
certification criteria, relating to the implementation of a health
information technology infrastructure, nationally and locally, that
advances the electronic access, exchange, and use of health information.
Such Committee shall serve to unify the roles of, and replace, the HIT
Policy Committee and the HIT Standards Committee, as in existence before
the date of the enactment of the 21st Century Cures Act.
``(b) Duties.--
``(1) Recommendations on policy framework to advance an
interoperable health information technology infrastructure.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator a policy framework
for adoption by the Secretary consistent with the
strategic plan under section 3001(c)(3) for advancing
the target areas described in this subsection. Such
policy framework shall seek to prioritize achieving
advancements in the target areas specified in
subparagraph (B) of paragraph (2) and may, to the extent
consistent with this section, incorporate policy
recommendations made by the HIT Policy Committee, as in
existence before the date of the enactment of the 21st
Century Cures Act.
``(B) Updates.--The HIT Advisory Committee shall
propose updates to such recommendations to the policy
framework and make new recommendations, as appropriate.
[[Page 130 STAT. 1169]]
``(2) General duties and target areas.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator for purposes of
adoption under section 3004, standards, implementation
specifications, and certification criteria and an order
of priority for the development, harmonization, and
recognition of such standards, specifications, and
certification criteria. Such recommendations shall
include recommended standards, architectures, and
software schemes for access to electronic individually
identifiable health information across disparate systems
including user vetting, authentication, privilege
management, and access control.
``(B) Priority target areas.--For purposes of this
section, the HIT Advisory Committee shall make
recommendations under subparagraph (A) with respect to
at least each of the following target areas:
``(i) Achieving a health information
technology infrastructure, nationally and locally,
that allows for the electronic access, exchange,
and use of health information, including through
technology that provides accurate patient
information for the correct patient, including
exchanging such information, and avoids the
duplication of patient records.
``(ii) The promotion and protection of privacy
and security of health information in health
information technology, including technologies
that allow for an accounting of disclosures and
protections against disclosures of individually
identifiable health information made by a covered
entity for purposes of treatment, payment, and
health care operations (as such terms are defined
for purposes of the regulation promulgated under
section 264(c) of the Health Insurance Portability
and Accountability Act of 1996), including for the
segmentation and protection from disclosure of
specific and sensitive individually identifiable
health information with the goal of minimizing the
reluctance of patients to seek care.
``(iii) The facilitation of secure access by
an individual to such individual's protected
health information and access to such information
by a family member, caregiver, or guardian acting
on behalf of a patient, including due to age-
related and other disability, cognitive
impairment, or dementia.
``(iv) Subject to subparagraph (D), any other
target area that the HIT Advisory Committee
identifies as an appropriate target area to be
considered under this subparagraph.
``(C) Additional target areas.--For purposes of this
section, the HIT Advisory Committee may make
recommendations under subparagraph (A), in addition to
areas described in subparagraph (B), with respect to any
of the following areas:
``(i) The use of health information technology
to improve the quality of health care, such as by
promoting the coordination of health care and
improving continuity of health care among health
care providers, reducing medical errors, improving
population health,
[[Page 130 STAT. 1170]]
reducing chronic disease, and advancing research
and education.
``(ii) The use of technologies that address
the needs of children and other vulnerable
populations.
``(iii) The use of electronic systems to
ensure the comprehensive collection of patient
demographic data, including at a minimum, race,
ethnicity, primary language, and gender
information.
``(iv) The use of self-service, telemedicine,
home health care, and remote monitoring
technologies.
``(v) The use of technologies that meet the
needs of diverse populations.
``(vi) The use of technologies that support--
``(I) data for use in quality and
public reporting programs;
``(II) public health; or
``(III) drug safety.
``(vii) The use of technologies that allow
individually identifiable health information to be
rendered unusable, unreadable, or indecipherable
to unauthorized individuals when such information
is transmitted in a health information network or
transported outside of the secure facilities or
systems where the disclosing covered entity is
responsible for security conditions.
``(viii) The use of a certified health
information technology for each individual in the
United States.
``(D) Authority for temporary additional priority
target areas.--For purposes of subparagraph (B)(iv), the
HIT Advisory Committee may identify an area to be
considered for purposes of recommendations under this
subsection as a target area described in subparagraph
(B) if--
``(i) the area is so identified for purposes
of responding to new circumstances that have
arisen in the health information technology
community that affect the interoperability,
privacy, or security of health information, or
affect patient safety; and
``(ii) at least 30 days prior to treating such
area as if it were a target area described in
subparagraph (B), the National Coordinator
provides adequate notice to Congress of the intent
to treat such area as so described.
``(E) Focus of committee work.--It is the sense of
Congress that the HIT Advisory Committee shall focus its
work on the priority areas described in subparagraph (B)
before proceeding to other work under subparagraph (C).
``(3) Rules relating to recommendations for standards,
implementation specifications, and certification criteria.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator standards,
implementation specifications, and certification
criteria described in subsection (a), which may include
standards, implementation specifications, and
certification criteria that have been developed,
harmonized, or recognized by the HIT Advisory Committee
or predecessor committee.
[[Page 130 STAT. 1171]]
The HIT Advisory Committee shall update such
recommendations and make new recommendations as
appropriate, including in response to a notification
sent under section 3004(a)(2)(B). Such recommendations
shall be consistent with the latest recommendations made
by the Committee.
``(B) Harmonization.--The HIT Advisory Committee may
recognize harmonized or updated standards from an entity
or entities for the purpose of harmonizing or updating
standards and implementation specifications in order to
achieve uniform and consistent implementation of the
standards and implementation specification.
``(C) Pilot testing of standards and implementation
specifications.--In the development, harmonization, or
recognition of standards and implementation
specifications, the HIT Advisory Committee for purposes
of recommendations under paragraph (2)(B), shall, as
appropriate, provide for the testing of such standards
and specifications by the National Institute for
Standards and Technology under section 13201(a) of the
Health Information Technology for Economic and Clinical
Health Act.
``(D) Consistency.--The standards, implementation
specifications, and certification criteria recommended
under paragraph (2)(B) shall be consistent with the
standards for information transactions and data elements
adopted pursuant to section 1173 of the Social Security
Act.
``(E) Special rule related to interoperability.--Any
recommendation made by the HIT Advisory Committee after
the date of the enactment of this subparagraph with
respect to interoperability of health information
technology shall be consistent with interoperability as
described in section 3000.
``(4) Forum.--The HIT Advisory Committee shall serve as a
forum for the participation of a broad range of stakeholders
with specific expertise in policies, including technical
expertise, relating to the matters described in paragraphs (1),
(2), and (3) to provide input on the development, harmonization,
and recognition of standards, implementation specifications, and
certification criteria necessary for the development and
adoption of health information technology infrastructure
nationally and locally that allows for the electronic access,
exchange, and use of health information.
``(5) Schedule.--Not later than 30 days after the date on
which the HIT Advisory Committee first meets, such HIT Advisory
Committee shall develop a schedule for the assessment of policy
recommendations developed under paragraph (1). The HIT Advisory
Committee shall update such schedule annually. The Secretary
shall publish such schedule in the Federal Register.
``(6) Public input.--The HIT Advisory Committee shall
conduct open public meetings and develop a process to allow for
public comment on the schedule described in paragraph (5) and
recommendations described in this subsection. Under such process
comments shall be submitted in a timely manner after the date of
publication of a recommendation under this subsection.
``(c) Measured Progress in Advancing Priority Areas.--
[[Page 130 STAT. 1172]]
``(1) In general.--For purposes of this section, the
National Coordinator, in collaboration with the Secretary, shall
establish, and update as appropriate, objectives and benchmarks
for advancing and measuring the advancement of the priority
target areas described in subsection (b)(2)(B).
``(2) Annual progress reports on advancing
interoperability.--
``(A) In general.--The HIT Advisory Committee, in
consultation with the National Coordinator, shall
annually submit to the Secretary and Congress a report
on the progress made during the preceding fiscal year
in--
``(i) achieving a health information
technology infrastructure, nationally and locally,
that allows for the electronic access, exchange,
and use of health information; and
``(ii) meeting the objectives and benchmarks
described in paragraph (1).
``(B) Content.--Each such report shall include, for
a fiscal year--
``(i) a description of the work conducted by
the HIT Advisory Committee during the preceding
fiscal year with respect to the areas described in
subsection (b)(2)(B);
``(ii) an assessment of the status of the
infrastructure described in subparagraph (A),
including the extent to which electronic health
information is appropriately and readily available
to enhance the access, exchange, and the use of
electronic health information between users and
across technology offered by different developers;
``(iii) the extent to which advancements have
been achieved with respect to areas described in
subsection (b)(2)(B);
``(iv) an analysis identifying existing gaps
in policies and resources for--
``(I) achieving the objectives and
benchmarks established under paragraph
(1); and
``(II) furthering interoperability
throughout the health information
technology infrastructure;
``(v) recommendations for addressing the gaps
identified in clause (iii); and
``(vi) a description of additional initiatives
as the HIT Advisory Committee and National
Coordinator determine appropriate.
``(3) Significant advancement determination.--The Secretary
shall periodically, based on the reports submitted under this
subsection, review the target areas described in subsection
(b)(2)(B), and, based on the objectives and benchmarks
established under paragraph (1), the Secretary shall determine
if significant advancement has been achieved with respect to
such an area. Such determination shall be taken into
consideration by the HIT Advisory Committee when determining to
what extent the Committee makes recommendations for an area
other than an area described in subsection (b)(2)(B).
``(d) Membership and Operations.--
[[Page 130 STAT. 1173]]
``(1) In general.--The National Coordinator shall take a
leading position in the establishment and operations of the HIT
Advisory Committee.
``(2) Membership.--The membership of the HIT Advisory
Committee shall--
``(A) include at least 25 members, of which--
``(i) no fewer than 2 members are advocates
for patients or consumers of health information
technology;
``(ii) 3 members are appointed by the
Secretary, 1 of whom shall be appointed to
represent the Department of Health and Human
Services and 1 of whom shall be a public health
official;
``(iii) 2 members are appointed by the
majority leader of the Senate;
``(iv) 2 members are appointed by the minority
leader of the Senate;
``(v) 2 members are appointed by the Speaker
of the House of Representatives;
``(vi) 2 members are appointed by the minority
leader of the House of Representatives; and
``(vii) such other members are appointed by
the Comptroller General of the United States; and
``(B) at least reflect providers, ancillary health
care workers, consumers, purchasers, health plans,
health information technology developers, researchers,
patients, relevant Federal agencies, and individuals
with technical expertise on health care quality, system
functions, privacy, security, and on the electronic
exchange and use of health information, including the
use standards for such activity.
``(3) Participation.--The members of the HIT Advisory
Committee shall represent a balance among various sectors of the
health care system so that no single sector unduly influences
the recommendations of the Committee.
``(4) Terms.--
``(A) In general.--The terms of the members of the
HIT Advisory Committee shall be for 3 years, except that
the Secretary shall designate staggered terms of the
members first appointed.
``(B) Vacancies.--Any member appointed to fill a
vacancy in the membership of the HIT Advisory Committee
that occurs prior to the expiration of the term for
which the member's predecessor was appointed shall be
appointed only for the remainder of that term. A member
may serve after the expiration of that member's term
until a successor has been appointed. A vacancy in the
HIT Advisory Committee shall be filled in the manner in
which the original appointment was made.
``(C) Limits.--Members of the HIT Advisory Committee
shall be limited to two 3-year terms, for a total of not
to exceed 6 years of service on the Committee.
``(5) Outside involvement.--The HIT Advisory Committee shall
ensure an opportunity for the participation in activities of the
Committee of outside advisors, including individuals with
expertise in the development of policies and standards for the
electronic exchange and use of health information,
[[Page 130 STAT. 1174]]
including in the areas of health information privacy and
security.
``(6) Quorum.--A majority of the members of the HIT Advisory
Committee shall constitute a quorum for purposes of voting, but
a lesser number of members may meet and hold hearings.
``(7) Consideration.--The National Coordinator shall ensure
that the relevant and available recommendations and comments
from the National Committee on Vital and Health Statistics are
considered in the development of policies.
``(8) Assistance.--For the purposes of carrying out this
section, the Secretary may provide or ensure that financial
assistance is provided by the HIT Advisory Committee to defray
in whole or in part any membership fees or dues charged by such
Committee to those consumer advocacy groups and not-for-profit
entities that work in the public interest as a party of their
mission.
``(e) Application of FACA.--The Federal Advisory Committee Act (5
U.S.C. App.), other than section 14 of such Act, shall apply to the HIT
Advisory Committee.
``(f) Publication.--The Secretary shall provide for publication in
the Federal Register and the posting on the Internet website of the
Office of the National Coordinator for Health Information Technology of
all policy recommendations made by the HIT Advisory Committee under this
section.''.
(2) Technical and conforming amendments.--Title XXX of the
Public Health Service Act (42 U.S.C. 300jj et seq.) is amended--
(A) by striking--
(i) ``HIT Policy Committee'' and ``HIT
Standards Committee'' each place that such terms
appear (other than within the term ``HIT Policy
Committee and the HIT Standards Committee'' or
within the term ``HIT Policy Committee or the HIT
Standards Committee'') and inserting ``HIT
Advisory Committee'';
(ii) ``HIT Policy Committee and the HIT
Standards Committee'' each place that such term
appears and inserting ``HIT Advisory Committee'';
and
(iii) ``HIT Policy Committee or the HIT
Standards Committee'' each place that such term
appears and inserting ``HIT Advisory Committee'';
(B) in section 3000 (42 U.S.C. 300jj)--
(i) by striking paragraphs (7) and (8) and
redesignating paragraphs (9) through (14) as
paragraphs (8) through (13), respectively; and
(ii) by inserting after paragraph (6) the
following paragraph:
``(7) Hit advisory committee.--The term `HIT Advisory
Committee' means such Committee established under section
3002(a).'';
(C) in section 3001(c) (42 U.S.C. 300jj-11(c))--
(i) in paragraph (1)(A), by striking ``under
section 3003'' and inserting ``under section
3002'';
(ii) in paragraph (2), by striking
subparagraph (B) and inserting the following:
``(B) Hit advisory committee.--The National
Coordinator shall be a leading member in the
establishment
[[Page 130 STAT. 1175]]
and operations of the HIT Advisory Committee and shall
serve as a liaison between that Committee and the
Federal Government.'';
(D) in section 3004(b)(3) (42 U.S.C. 300jj-
14(b)(3)), by striking ``3003(b)(2)'' and inserting
``3002(b)(4)'';
(E) in section 3007(b) (42 U.S.C. 300jj-17(b)), by
striking ``3003(a)'' and inserting ``3002(a)(2)''; and
(F) in section 3008 (42 U.S.C. 300jj-18)--
(i) in subsection (b), by striking ``or
3003''; and
(ii) in subsection (c), by striking
``3003(b)(1)(A)'' and inserting ``3002(b)(2)''.
(3) <<NOTE: 42 USC 300jj-12 note.>> Transition to the hit
advisory committee.--The Secretary of Health and Human Services
shall provide for an orderly and timely transition to the HIT
Advisory Committee established under amendments made by this
section.
(f) Priorities for Adoption of Standards, Implementation
Specifications, and Certification Criteria.--Title XXX of the Public
Health Service Act (42 U.S.C. 300jj et seq.), as amended by subsection
(e), is further amended by inserting after section 3002 the following:
``SEC. 3003. <<NOTE: 42 USC 300jj-13.>> SETTING PRIORITIES FOR
STANDARDS ADOPTION.
``(a) Identifying Priorities.--
``(1) In general.--Not later than 6 months after the date on
which the HIT Advisory Committee first meets, the National
Coordinator shall periodically convene the HIT Advisory
Committee to--
``(A) identify priority uses of health information
technology, focusing on priorities--
``(i) arising from the implementation of the
incentive programs for the meaningful use of
certified EHR technology, the Merit-based
Incentive Payment System, Alternative Payment
Models, the Hospital Value-Based Purchasing
Program, and any other value-based payment program
determined appropriate by the Secretary;
``(ii) related to the quality of patient care;
``(iii) related to public health;
``(iv) related to clinical research;
``(v) related to the privacy and security of
electronic health information;
``(vi) related to innovation in the field of
health information technology;
``(vii) related to patient safety;
``(viii) related to the usability of health
information technology;
``(ix) related to individuals' access to
electronic health information; and
``(x) other priorities determined appropriate
by the Secretary;
``(B) identify existing standards and implementation
specifications that support the use and exchange of
electronic health information needed to meet the
priorities identified in subparagraph (A); and
``(C) publish a report summarizing the findings of
the analysis conducted under subparagraphs (A) and (B)
and make appropriate recommendations.
[[Page 130 STAT. 1176]]
``(2) Prioritization.--In identifying such standards and
implementation specifications under paragraph (1)(B), the HIT
Advisory Committee shall prioritize standards and implementation
specifications developed by consensus-based standards
development organizations.
``(3) Guidelines for review of existing standards and
specifications.--In consultation with the consensus-based entity
described in section 1890 of the Social Security Act and other
appropriate Federal agencies, the analysis of existing standards
under paragraph (1)(B) shall include an evaluation of the need
for a core set of common data elements and associated value sets
to enhance the ability of certified health information
technology to capture, use, and exchange structured electronic
health information.
``(b) Review of Adopted Standards.--
``(1) In general.--Beginning 5 years after the date of
enactment of the 21st Century Cures Act and every 3 years
thereafter, the National Coordinator shall convene stakeholders
to review the existing set of adopted standards and
implementation specifications and make recommendations with
respect to whether to--
``(A) maintain the use of such standards and
implementation specifications; or
``(B) phase out such standards and implementation
specifications.
``(2) Priorities.--The HIT Advisory Committee, in
collaboration with the National Institute for Standards and
Technology, shall annually and through the use of public input,
review and publish priorities for the use of health information
technology, standards, and implementation specifications to
support those priorities.
``(c) Rule of Construction.--Nothing in this section shall be
construed to prevent the use or adoption of novel standards that improve
upon the existing health information technology infrastructure and
facilitate the secure exchange of health information.''.
SEC. 4004. INFORMATION BLOCKING.
Subtitle C of title XXX of the Public Health Service Act (42 U.S.C.
300jj-51 et seq.) is amended by adding at the end the following:
``SEC. 3022. <<NOTE: 42 USC 300jj-52.>> INFORMATION BLOCKING.
``(a) Definition.--
``(1) In general.--In this section, the term `information
blocking' means a practice that--
``(A) except as required by law or specified by the
Secretary pursuant to rulemaking under paragraph (3), is
likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health
information; and
``(B)(i) if conducted by a health information
technology developer, exchange, or network, such
developer, exchange, or network knows, or should know,
that such practice is likely to interfere with, prevent,
or materially discourage the access, exchange, or use of
electronic health information; or
``(ii) if conducted by a health care provider, such
provider knows that such practice is unreasonable and is
[[Page 130 STAT. 1177]]
likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health
information.
``(2) Practices described.--The information blocking
practices described in paragraph (1) may include--
``(A) practices that restrict authorized access,
exchange, or use under applicable State or Federal law
of such information for treatment and other permitted
purposes under such applicable law, including
transitions between certified health information
technologies;
``(B) implementing health information technology in
nonstandard ways that are likely to substantially
increase the complexity or burden of accessing,
exchanging, or using electronic health information; and
``(C) implementing health information technology in
ways that are likely to--
``(i) restrict the access, exchange, or use of
electronic health information with respect to
exporting complete information sets or in
transitioning between health information
technology systems; or
``(ii) lead to fraud, waste, or abuse, or
impede innovations and advancements in health
information access, exchange, and use, including
care delivery enabled by health information
technology.
``(3) Rulemaking.--The Secretary, through rulemaking, shall
identify reasonable and necessary activities that do not
constitute information blocking for purposes of paragraph (1).
``(4) No enforcement before exception identified.--The term
`information blocking' does not include any practice or conduct
occurring prior to the date that is 30 days after the date of
enactment of the 21st Century Cures Act.
``(5) Consultation.--The Secretary may consult with the
Federal Trade Commission in promulgating regulations under this
subsection, to the extent that such regulations define practices
that are necessary to promote competition and consumer welfare.
``(6) Application.--The term `information blocking', with
respect to an individual or entity, shall not include an act or
practice other than an act or practice committed by such
individual or entity.
``(7) Clarification.--In carrying out this section, the
Secretary shall ensure that health care providers are not
penalized for the failure of developers of health information
technology or other entities offering health information
technology to such providers to ensure that such technology
meets the requirements to be certified under this title.
``(b) Inspector General Authority.--
``(1) In general.--The inspector general of the Department
of Health and Human Services (referred to in this section as the
`Inspector General') may investigate any claim that--
``(A) a health information technology developer of
certified health information technology or other entity
offering certified health information technology--
``(i) submitted a false attestation under
section 3001(c)(5)(D)(vii); or
``(ii) engaged in information blocking;
``(B) a health care provider engaged in information
blocking; or
[[Page 130 STAT. 1178]]
``(C) a health information exchange or network
engaged in information blocking.
``(2) Penalties.--
``(A) Developers, networks, and exchanges.--Any
individual or entity described in subparagraph (A) or
(C) of paragraph (1) that the Inspector General,
following an investigation conducted under this
subsection, determines to have committed information
blocking shall be subject to a civil monetary penalty
determined by the Secretary for all such violations
identified through such investigation, which may not
exceed $1,000,000 per violation. Such determination
shall take into account factors such as the nature and
extent of the information blocking and harm resulting
from such information blocking, including, where
applicable, the number of patients affected, the number
of providers affected, and the number of days the
information blocking persisted.
``(B) Providers.--Any individual or entity described
in subparagraph (B) of paragraph (1) determined by the
Inspector General to have committed information blocking
shall be referred to the appropriate agency to be
subject to appropriate disincentives using authorities
under applicable Federal law, as the Secretary sets
forth through notice and comment rulemaking.
``(C) Procedure.--The provisions of section 1128A of
the Social Security Act (other than subsections (a) and
(b) of such section) shall apply to a civil money
penalty applied under this paragraph in the same manner
as such provisions apply to a civil money penalty or
proceeding under such section 1128A(a).
``(D) Recovered penalty funds.--The amounts
recovered under this paragraph shall be allocated as
follows:
``(i) Annual operating expenses.--Each year
following the establishment of the authority under
this subsection, the Office of the Inspector
General shall provide to the Secretary an estimate
of the costs to carry out investigations under
this section. Such estimate may include reasonable
reserves to account for variance in annual amounts
recovered under this paragraph. There is
authorized to be appropriated for purposes of
carrying out this section an amount equal to the
amount specified in such estimate for the fiscal
year.
``(ii) Application to other programs.--The
amounts recovered under this paragraph and
remaining after amounts are made available under
clause (i) shall be transferred to the Federal
Hospital Insurance Trust Fund under section 1817
of the Social Security Act and the Federal
Supplementary Medical Insurance Trust Fund under
section 1841 of such Act, in such proportion as
the Secretary determines appropriate.
``(E) Authorization of appropriations.--There is
authorized to be appropriated to the Office of the
Inspector General to carry out this section $10,000,000,
to remain available until expended.
``(3) Resolution of claims.--
[[Page 130 STAT. 1179]]
``(A) In general.--The Office of the Inspector
General, if such Office determines that a consultation
regarding the health privacy and security rules
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2 note) will resolve an information blocking
claim, may refer such instances of information blocking
to the Office for Civil Rights of the Department of
Health and Human Services for resolution.
``(B) Limitation on liability.--If a health care
provider or health information technology developer
makes information available based on a good faith
reliance on consultations with the Office for Civil
Rights of the Department of Health and Human Services
pursuant to a referral under subparagraph (A), with
respect to such information, the health care provider or
developer shall not be liable for such disclosure or
disclosures made pursuant to subparagraph (A).
``(c) Identifying Barriers To Exchange of Certified Health
Information Technology.--
``(1) Trusted exchange defined.--In this section, the term
`trusted exchange' with respect to certified electronic health
records means that the certified electronic health record
technology has the technical capability to enable secure health
information exchange between users and multiple certified
electronic health record technology systems.
``(2) Guidance.--The National Coordinator, in consultation
with the Office for Civil Rights of the Department of Health and
Human Services, shall issue guidance on common legal,
governance, and security barriers that prevent the trusted
exchange of electronic health information.
``(3) Referral.--The National Coordinator and the Office for
Civil Rights of the Department of Health and Human Services may
refer to the Inspector General instances or patterns of refusal
to exchange health information with an individual or entity
using certified electronic health record technology that is
technically capable of trusted exchange and under conditions
when exchange is legally permissible.
``(d) Additional Provisions.--
``(1) Information sharing provisions.--The National
Coordinator may serve as a technical consultant to the Inspector
General and the Federal Trade Commission for purposes of
carrying out this section. The National Coordinator may,
notwithstanding any other provision of law, share information
related to claims or investigations under subsection (b) with
the Federal Trade Commission for purposes of such investigations
and shall share information with the Inspector General, as
required by law.
``(2) Protection from disclosure of information.--Any
information that is received by the National Coordinator in
connection with a claim or suggestion of possible information
blocking and that could reasonably be expected to facilitate
identification of the source of the information--
``(A) shall not be disclosed by the National
Coordinator except as may be necessary to carry out the
purpose of this section;
[[Page 130 STAT. 1180]]
``(B) shall be exempt from mandatory disclosure
under section 552 of title 5, United States Code, as
provided by subsection (b)(3) of such section; and
``(C) may be used by the Inspector General or
Federal Trade Commission for reporting purposes to the
extent that such information could not reasonably be
expected to facilitate identification of the source of
such information.
``(3) Standardized process.--
``(A) In general.--The National Coordinator shall
implement a standardized process for the public to
submit reports on claims of--
``(i) health information technology products
or developers of such products (or other entities
offering such products to health care providers)
not being interoperable or resulting in
information blocking;
``(ii) actions described in subsection (b)(1)
that result in information blocking as described
in subsection (a); and
``(iii) any other act described in subsection
(a).
``(B) Collection of information.--The standardized
process implemented under subparagraph (A) shall provide
for the collection of such information as the
originating institution, location, type of transaction,
system and version, timestamp, terminating institution,
locations, system and version, failure notice, and other
related information.
``(4) Nonduplication of penalty structures.--In carrying out
this subsection, the Secretary shall, to the extent possible,
ensure that penalties do not duplicate penalty structures that
would otherwise apply with respect to information blocking and
the type of individual or entity involved as of the day before
the date of the enactment of this section.''.
SEC. 4005. <<NOTE: 42 USC 300jj-14 note.>> LEVERAGING ELECTRONIC
HEALTH RECORDS TO IMPROVE PATIENT CARE.
(a) Requirement Relating to Registries.--
(1) In general.--To be certified in accordance with title
XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.),
electronic health records shall be capable of transmitting to,
and where applicable, receiving and accepting data from,
registries in accordance with standards recognized by the Office
of the National Coordinator for Health Information Technology,
including clinician-led clinical data registries, that are also
certified to be technically capable of receiving and accepting
from, and where applicable, transmitting data to certified
electronic health record technology in accordance with such
standards.
(2) Rule of construction.--Nothing in this subsection shall
be construed to require the certification of registries beyond
the technical capability to exchange data in accordance with
applicable recognized standards.
(b) Definition.--For purposes of this Act, the term ``clinician-led
clinical data registry'' means a clinical data repository--
(1) that is established and operated by a clinician-led or
controlled, tax-exempt (pursuant to section 501(c) of the
Internal Revenue Code of 1986), professional society or other
similar clinician-led or -controlled organization, or such
[[Page 130 STAT. 1181]]
organization's controlled affiliate, devoted to the care of a
population defined by a particular disease, condition, exposure
or therapy;
(2) that is designed to collect detailed, standardized data
on an ongoing basis for medical procedures, services, or
therapies for particular diseases, conditions, or exposures;
(3) that provides feedback to participants who submit
reports to the repository;
(4) that meets standards for data quality including--
(A) systematically collecting clinical and other
health care data, using standardized data elements and
having procedures in place to verify the completeness
and validity of those data; and
(B) being subject to regular data checks or audits
to verify completeness and validity; and
(5) that provides ongoing participant training and support.
(c) Treatment of Health Information Technology Developers With
Respect to Patient Safety Organizations.--
(1) In general.--In applying part C of title IX of the
Public Health Service Act (42 U.S.C. 299b-21 et seq.), a health
information technology developer shall be treated as a provider
(as defined in section 921 of such Act) for purposes of
reporting and conducting patient safety activities concerning
improving clinical care through the use of health information
technology that could result in improved patient safety, health
care quality, or health care outcomes.
(2) Report.--Not later than 4 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
concerning best practices and current trends voluntarily
provided, without identifying individual providers or disclosing
or using protected health information or individually
identifiable information, by patient safety organizations to
improve the integration of health information technology into
clinical practice.
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS TO
THEIR ELECTRONIC HEALTH INFORMATION.
(a) Use of Health Information Exchanges for Patient Access.--Section
3009 of the Public Health Service Act (42 U.S.C. 300jj-19) is amended by
adding at the end the following:
``(c) Promoting Patient Access to Electronic Health Information
Through Health Information Exchanges .--
``(1) In general.--The Secretary shall use existing
authorities to encourage partnerships between health information
exchange organizations and networks and health care providers,
health plans, and other appropriate entities with the goal of
offering patients access to their electronic health information
in a single, longitudinal format that is easy to understand,
secure, and may be updated automatically.
``(2) Education of providers.--The Secretary, in
coordination with the Office for Civil Rights of the Department
of Health and Human Services, shall--
``(A) educate health care providers on ways of
leveraging the capabilities of health information
exchanges
[[Page 130 STAT. 1182]]
(or other relevant platforms) to provide patients with
access to their electronic health information;
``(B) clarify misunderstandings by health care
providers about using health information exchanges (or
other relevant platforms) for patient access to
electronic health information; and
``(C) to the extent practicable, educate providers
about health information exchanges (or other relevant
platforms) that employ some or all of the capabilities
described in paragraph (1).
``(3) Requirements.--In carrying out paragraph (1), the
Secretary, in coordination with the Office for Civil Rights,
shall issue guidance to health information exchanges related to
best practices to ensure that the electronic health information
provided to patients is--
``(A) private and secure;
``(B) accurate;
``(C) verifiable; and
``(D) where a patient's authorization to exchange
information is required by law, easily exchanged
pursuant to such authorization.
``(4) Rule of construction.--Nothing in this subsection
shall be construed to preempt State laws applicable to patient
consent for the access of information through a health
information exchange (or other relevant platform) that provide
protections to patients that are greater than the protections
otherwise provided for under applicable Federal law.
``(d) Efforts To Promote Access to Health Information.--The National
Coordinator and the Office for Civil Rights of the Department of Health
and Human Services shall jointly promote patient access to health
information in a manner that would ensure that such information is
available in a form convenient for the patient, in a reasonable manner,
without burdening the health care provider involved.
``(e) Accessibility of Patient Records.--
``(1) Accessibility and updating of information.--
``(A) In general.--The Secretary, in consultation
with the National Coordinator, shall promote policies
that ensure that a patient's electronic health
information is accessible to that patient and the
patient's designees, in a manner that facilitates
communication with the patient's health care providers
and other individuals, including researchers, consistent
with such patient's consent.
``(B) Updating education on accessing and exchanging
personal health information.--To promote awareness that
an individual has a right of access to inspect, obtain a
copy of, and transmit to a third party a copy of such
individual's protected health information pursuant to
the Health Information Portability and Accountability
Act, Privacy Rule (subpart E of part 164 of title 45,
Code of Federal Regulations), the Director of the Office
for Civil Rights, in consultation with the National
Coordinator, shall assist individuals and health care
providers in understanding a patient's rights to access
and protect personal health information under the Health
Insurance Portability and Accountability Act of 1996
(Public Law 104-191), including providing best practices
[[Page 130 STAT. 1183]]
for requesting personal health information in a
computable format, including using patient portals or
third-party applications and common cases when a
provider is permitted to exchange and provide access to
health information.''.
``(2) Certifying usability for patients.--In carrying out
certification programs under section 3001(c)(5), the National
Coordinator may require that--
``(A) the certification criteria support--
``(i) patient access to their electronic
health information, including in a single
longitudinal format that is easy to understand,
secure, and may be updated automatically;
``(ii) the patient's ability to electronically
communicate patient-reported information (such as
family history and medical history); and
``(iii) patient access to their personal
electronic health information for research at the
option of the patient; and
``(B) the HIT Advisory Committee develop and
prioritize standards, implementation specifications, and
certification criteria required to help support patient
access to electronic health information, patient
usability, and support for technologies that offer
patients access to their electronic health information
in a single, longitudinal format that is easy to
understand, secure, and may be updated automatically.''.
(b) Access to Information in an Electronic Format.--Section 13405(e)
of the Health Information Technology for Economic and Clinical Health
Act (42 U.S.C. 17935) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) by redesignating paragraph (2) as paragraph (3); and
(3) by inserting after paragraph (1), the following:
``(2) if the individual makes a request to a business
associate for access to, or a copy of, protected health
information about the individual, or if an individual makes a
request to a business associate to grant such access to, or
transmit such copy directly to, a person or entity designated by
the individual, a business associate may provide the individual
with such access or copy, which may be in an electronic form, or
grant or transmit such access or copy to such person or entity
designated by the individual; and''.
SEC. 4007. GAO STUDY ON PATIENT MATCHING.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Comptroller General of the United States shall conduct
a study to--
(1) review the policies and activities of the Office of the
National Coordinator for Health Information Technology and other
relevant stakeholders, which may include standards development
organizations, experts in the technical aspects of health
information technology, health information technology
developers, providers of health services, health care suppliers,
health care payers, health care quality organizations, States,
health information technology policy experts, and other
appropriate entities, to ensure appropriate patient matching to
protect patient privacy and security with respect to electronic
[[Page 130 STAT. 1184]]
health records and the exchange of electronic health
information; and
(2) survey ongoing efforts related to the policies and
activities described in paragraph (1) and the effectiveness of
such efforts occurring in the private sector.
(b) Areas of Concentration.--In conducting the study under
subsection (a), the Comptroller General shall--
(1) evaluate current methods used in certified electronic
health records for patient matching based on performance related
to factors such as--
(A) the privacy of patient information;
(B) the security of patient information;
(C) improving matching rates;
(D) reducing matching errors; and
(E) reducing duplicate records; and
(2) determine whether the Office of the National Coordinator
for Health Information Technology could improve patient matching
by taking steps including--
(A) defining additional data elements to assist in
patient data matching;
(B) agreeing on a required minimum set of elements
that need to be collected and exchanged;
(C) requiring electronic health records to have the
ability to make certain fields required and use specific
standards; and
(D) other options recommended by the relevant
stakeholders consulted pursuant to subsection (a).
(c) Report.--Not later than 2 years after the date of enactment of
this Act, the Comptroller General shall submit to the appropriate
committees of Congress a report concerning the findings of the study
conducted under subsection (a).
SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (referred to in this section as the ``Comptroller
General'') shall build on prior Government Accountability Office
studies and other literature review and conduct a study to
review patient access to their own protected health information,
including barriers to such patient access and complications or
difficulties providers experience in providing access to
patients. In conducting such study, the Comptroller General
shall consider the increase in adoption of health information
technology and the increasing prevalence of protected health
information that is maintained electronically.
(2) Areas of concentration.--In conducting the review under
paragraph (1), the Comptroller General shall consider--
(A) instances when covered entities charge
individuals, including patients, third parties, and
health care providers, for record requests, including
records that are requested in an electronic format;
(B) examples of the amounts and types of fees
charged to individuals for record requests, including
instances when the record is requested to be transmitted
to a third party;
(C) the extent to which covered entities are unable
to provide the access requested by individuals in the
form
[[Page 130 STAT. 1185]]
and format requested by the individual, including
examples of such instances;
(D) instances in which third parties may request
protected health information through patients'
individual right of access, including instances where
such requests may be used to circumvent appropriate fees
that may be charged to third parties;
(E) opportunities that permit covered entities to
charge appropriate fees to third parties for patient
records while providing patients with access to their
protected health information at low or no cost;
(F) the ability of providers to distinguish between
requests originating from an individual that require
limitation to a cost-based fee and requests originating
from third parties that may not be limited to cost-based
fees; and
(G) other circumstances that may inhibit the ability
of providers to provide patients with access to their
records, and the ability of patients to gain access to
their records.
(b) Report.--Not later than 18 months after the date of enactment of
this Act, the Comptroller General shall submit a report to Congress on
the findings of the study conducted under subsection (a).
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
(a) In General.--Section 1862(l)(5) of the Social Security Act (42
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new
subparagraph:
``(D) Local coverage determinations.--The Secretary
shall require each Medicare administrative contractor
that develops a local coverage determination to make
available on the Internet website of such contractor and
on the Medicare Internet website, at least 45 days
before the effective date of such determination, the
following information:
``(i) Such determination in its entirety.
``(ii) Where and when the proposed
determination was first made public.
``(iii) Hyperlinks to the proposed
determination and a response to comments submitted
to the contractor with respect to such proposed
determination.
``(iv) A summary of evidence that was
considered by the contractor during the
development of such determination and a list of
the sources of such evidence.
``(v) An explanation of the rationale that
supports such determination.''.
(b) <<NOTE: 42 USC 1395y note.>> Effective Date.--The amendment
made by subsection (a) shall apply with respect to local coverage
determinations that are proposed or revised on or after the date that is
180 days after the date of enactment of this Act.
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
Section 1808 of the Social Security Act (42 U.S.C. 1395b-9) is
amended by adding at the end the following new subsection:
``(d) Pharmaceutical and Technology Ombudsman.--
``(1) In general.--Not later than 12 months after the date
of enactment of this paragraph, the Secretary shall provide
[[Page 130 STAT. 1186]]
for a pharmaceutical and technology ombudsman within the Centers
for Medicare & Medicaid Services who shall receive and respond
to complaints, grievances, and requests that--
``(A) are from entities that manufacture
pharmaceutical, biotechnology, medical device, or
diagnostic products that are covered or for which
coverage is being sought under this title; and
``(B) are with respect to coverage, coding, or
payment under this title for such products.
``(2) Application.--The second sentence of subsection (c)(2)
shall apply to the ombudsman under subparagraph (A) in the same
manner as such sentence applies to the Medicare Beneficiary
Ombudsman under subsection (c).''.
SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended
by adding at the end the following new subsection:
``(t) Site-of-Service Price Transparency.--
``(1) In general.--In order to facilitate price transparency
with respect to items and services for which payment may be made
either to a hospital outpatient department or to an ambulatory
surgical center under this title, the Secretary shall, for 2018
and each year thereafter, make available to the public via a
searchable Internet website, with respect to an appropriate
number of such items and services--
``(A) the estimated payment amount for the item or
service under the outpatient department fee schedule
under subsection (t) of section 1833 and the ambulatory
surgical center payment system under subsection (i) of
such section; and
``(B) the estimated amount of beneficiary liability
applicable to the item or service.
``(2) Calculation of estimated beneficiary liability.--For
purposes of paragraph (1)(B), the estimated amount of
beneficiary liability, with respect to an item or service, is
the amount for such item or service for which an individual who
does not have coverage under a Medicare supplemental policy
certified under section 1882 or any other supplemental insurance
coverage is responsible.
``(3) Implementation.--In carrying out this subsection, the
Secretary--
``(A) shall include in the notice described in
section 1804(a) a notification of the availability of
the estimated amounts made available under paragraph
(1); and
``(B) may utilize mechanisms in existence on the
date of enactment of this subsection, such as the
portion of the Internet website of the Centers for
Medicare & Medicaid Services on which information
comparing physician performance is posted (commonly
referred to as the Physician Compare Internet website),
to make available such estimated amounts under such
paragraph.
``(4) Funding.--For purposes of implementing this
subsection, the Secretary shall provide for the transfer, from
the Federal Supplementary Medical Insurance Trust Fund under
section 1841 to the Centers for Medicare & Medicaid Services
Program Management Account, of $6,000,000 for fiscal year 2017,
to remain available until expended.''.
[[Page 130 STAT. 1187]]
SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.
(a) Provision of Information by Centers for Medicare & Medicaid
Services.--Not later than 1 year after the date of enactment of this
Act, the Administrator of the Centers for Medicare & Medicaid Services
shall provide to the committees of jurisdiction of the House of
Representatives and the Senate information on the following:
(1) The populations of Medicare beneficiaries, such as those
who are dually eligible for the Medicare program under title
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and
the Medicaid program under title XIX of such Act (42 U.S.C. 1396
et seq.) and those with chronic conditions, whose care may be
improved most in terms of quality and efficiency by the
expansion, in a manner that meets or exceeds the existing in-
person standard of care under the Medicare program under such
title XVIII, of telehealth services under section 1834(m)(4) of
such Act (42 U.S.C. 1395m(m)(4)).
(2) Activities by the Center for Medicare and Medicaid
Innovation which examine the use of telehealth services in
models, projects, or initiatives funded through section 1115A of
such Act (42 U.S.C. 1315a).
(3) The types of high-volume services (and related
diagnoses) under such title XVIII which might be suitable to be
furnished using telehealth.
(4) Barriers that might prevent the expansion of telehealth
services under section 1834(m)(4) of the Social Security Act (42
U.S.C. 1395m(m)(4)) beyond such services that are in effect as
of the date of enactment of this Act.
(b) Provision of Information by MedPAC.--Not later than March 15,
2018, the Medicare Payment Advisory Commission established under section
1805 of the Social Security Act (42 U.S.C. 1395b-6) shall, using
quantitative and qualitative research methods, provide information to
the committees of jurisdiction of the House of Representatives and the
Senate that identifies--
(1) the telehealth services for which payment can be made,
as of the date of enactment of this Act, under the fee-for-
service program under parts A and B of title XVIII of such Act;
(2) the telehealth services for which payment can be made,
as of such date, under private health insurance plans; and
(3) with respect to services identified under paragraph (2)
but not under paragraph (1), ways in which payment for such
services might be incorporated into such fee-for-service program
(including any recommendations for ways to accomplish this
incorporation).
(c) Sense of Congress.--It is the sense of Congress that--
(1) eligible originating sites should be expanded beyond
those originating sites described in section 1834(m)(4)(C) of
the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
(2) any expansion of telehealth services under the Medicare
program under title XVIII of such Act should--
(A) recognize that telemedicine is the delivery of
safe, effective, quality health care services, by a
health care provider, using technology as the mode of
care delivery;
(B) meet or exceed the conditions of coverage and
payment with respect to the Medicare program if the
service
[[Page 130 STAT. 1188]]
was furnished in person, including standards of care,
unless specifically addressed in subsequent legislation;
and
(C) involve clinically appropriate means to furnish
such services.
TITLE V--SAVINGS
SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)), as amended by section 704(h) of the Comprehensive
Addiction and Recovery Act of 2016, is amended by striking
``$140,000,000'' and inserting ``$270,000,000''.
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE MEDICAL
EQUIPMENT.
Section 1903(i)(27) of the Social Security Act (42 U.S.C.
1396b(i)(27)) is amended by striking ``January 1, 2019'' and inserting
``January 1, 2018''.
SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND
OTHER AGREEMENTS.
(a) In General.--Section 1128A of the Social Security Act (42 U.S.C.
1320a-7a) is amended by adding at the end the following new subsections:
``(o) Any person (including an organization, agency, or other
entity, but excluding a program beneficiary, as defined in subsection
(q)(4)) that, with respect to a grant, contract, or other agreement for
which the Secretary provides funding--
``(1) knowingly presents or causes to be presented a
specified claim (as defined in subsection (r)) under such grant,
contract, or other agreement that the person knows or should
know is false or fraudulent;
``(2) knowingly makes, uses, or causes to be made or used
any false statement, omission, or misrepresentation of a
material fact in any application, proposal, bid, progress
report, or other document that is required to be submitted in
order to directly or indirectly receive or retain funds provided
in whole or in part by such Secretary pursuant to such grant,
contract, or other agreement;
``(3) knowingly makes, uses, or causes to be made or used, a
false record or statement material to a false or fraudulent
specified claim under such grant, contract, or other agreement;
``(4) knowingly makes, uses, or causes to be made or used, a
false record or statement material to an obligation (as defined
in subsection (s)) to pay or transmit funds or property to such
Secretary with respect to such grant, contract, or other
agreement, or knowingly conceals or knowingly and improperly
avoids or decreases an obligation to pay or transmit funds or
property to such Secretary with respect to such grant, contract,
or other agreement; or
``(5) fails to grant timely access, upon reasonable request
(as defined by such Secretary in regulations), to the Inspector
General of the Department, for the purpose of audits,
investigations, evaluations, or other statutory functions of
such Inspector General in matters involving such grants,
contracts, or other agreements;
[[Page 130 STAT. 1189]]
shall be subject, in addition to any other penalties that may be
prescribed by law, to a civil money penalty in cases under paragraph
(1), of not more than $10,000 for each specified claim; in cases under
paragraph (2), not more than $50,000 for each false statement, omission,
or misrepresentation of a material fact; in cases under paragraph (3),
not more than $50,000 for each false record or statement; in cases under
paragraph (4), not more than $50,000 for each false record or statement
or $10,000 for each day that the person knowingly conceals or knowingly
and improperly avoids or decreases an obligation to pay; or in cases
under paragraph (5), not more than $15,000 for each day of the failure
described in such paragraph. In addition, in cases under paragraphs (1)
and (3), such a person shall be subject to an assessment of not more
than 3 times the amount claimed in the specified claim described in such
paragraph in lieu of damages sustained by the United States or a
specified State agency because of such specified claim, and in cases
under paragraphs (2) and (4), such a person shall be subject to an
assessment of not more than 3 times the total amount of the funds
described in paragraph (2) or (4), respectively (or, in the case of an
obligation to transmit property to the Secretary described in paragraph
(4), of the value of the property described in such paragraph) in lieu
of damages sustained by the United States or a specified State agency
because of such case. In addition, the Secretary may make a
determination in the same proceeding to exclude the person from
participation in the Federal health care programs (as defined in section
1128B(f)(1)) and to direct the appropriate State agency to exclude the
person from participation in any State health care program.
``(p) The provisions of subsections (c), (d), (g), and (h) shall
apply to a civil money penalty or assessment under subsection (o) in the
same manner as such provisions apply to a penalty, assessment, or
proceeding under subsection (a). In applying subsection (d), each
reference to a claim under such subsection shall be treated as including
a reference to a specified claim (as defined in subsection (r)).
``(q) For purposes of this subsection and subsections (o) and (p):
``(1) The term `Department' means the Department of Health
and Human Services.
``(2) The term `material' means having a natural tendency to
influence, or be capable of influencing, the payment or receipt
of money or property.
``(3) The term `other agreement' includes a cooperative
agreement, scholarship, fellowship, loan, subsidy, payment for a
specified use, donation agreement, award, or subaward
(regardless of whether one or more of the persons entering into
the agreement is a contractor or subcontractor).
``(4) The term `program beneficiary' means, in the case of a
grant, contract, or other agreement designed to accomplish the
objective of awarding or otherwise furnishing benefits or
assistance to individuals and for which the Secretary provides
funding, an individual who applies for, or who receives, such
benefits or assistance from such grant, contract, or other
agreement. Such term does not include, with respect to such
grant, contract, or other agreement, an officer, employee, or
agent of a person or entity that receives such grant or that
enters into such contract or other agreement.
[[Page 130 STAT. 1190]]
``(5) The term `recipient' includes a subrecipient or
subcontractor.
``(6) The term `specified State agency' means an agency of a
State government established or designated to administer or
supervise the administration of a grant, contract, or other
agreement funded in whole or in part by the Secretary.
``(r) For purposes of this section, the term `specified claim' means
any application, request, or demand under a grant, contract, or other
agreement for money or property, whether or not the United States or a
specified State agency has title to the money or property, that is not a
claim (as defined in subsection (i)(2)) and that--
``(1) is presented or caused to be presented to an officer,
employee, or agent of the Department or agency thereof, or of
any specified State agency; or
``(2) is made to a contractor, grantee, or any other
recipient if the money or property is to be spent or used on the
Department's behalf or to advance a Department program or
interest, and if the Department--
``(A) provides or has provided any portion of the
money or property requested or demanded; or
``(B) will reimburse such contractor, grantee, or
other recipient for any portion of the money or property
which is requested or demanded.
``(s) For purposes of subsection (o), the term `obligation' means an
established duty, whether or not fixed, arising from an express or
implied contractual, grantor-grantee, or licensor-licensee relationship,
for a fee-based or similar relationship, from statute or regulation, or
from the retention of any overpayment.''.
(b) Conforming Amendments.--Section 1128A of the Social Security Act
(42 U.S.C. 1320a-7a) is amended--
(1) in subsection (e), by inserting ``or specified claim''
after ``claim'' in the first sentence; and
(2) in subsection (f)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``or specified claim (as
defined in subsection (r))'' after ``district
where the claim''; and
(ii) by inserting ``(or, with respect to a
person described in subsection (o), the person)''
after ``claimant''; and
(B) in the matter following paragraph (4), by
inserting ``(or, in the case of a penalty or assessment
under subsection (o), by a specified State agency (as
defined in subsection (q)(6)),'' after ``or a State
agency''.
SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
(a) Treatment of Infusion Drugs Furnished Through Durable Medical
Equipment.--Section 1842(o)(1) of the Social Security Act (42 U.S.C.
1395u(o)(1)) is amended--
(1) in subparagraph (C), by inserting ``(and including a
drug or biological described in subparagraph (D)(i) furnished on
or after January 1, 2017)'' after ``2005''; and
(2) in subparagraph (D)--
(A) by striking ``infusion drugs'' and inserting
``infusion drugs or biologicals'' each place it appears;
and
(B) in clause (i)--
[[Page 130 STAT. 1191]]
(i) by striking ``2004'' and inserting ``2004,
and before January 1, 2017''; and
(ii) by striking ``for such drug''.
(b) Noninclusion of DME Infusion Drugs Under DME Competitive
Acquisition Programs.--
(1) In general.--Section 1847(a)(2)(A) of the Social
Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
(A) by striking ``and excluding'' and inserting ``,
excluding''; and
(B) by inserting before the period at the end the
following: ``, and excluding drugs and biologicals
described in section 1842(o)(1)(D)''.
(2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the
Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by
striking ``2007'' and inserting ``2007, and before the date of
the enactment of the 21st Century Cures Act.''.
SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID
PROVIDERS.
(a) Increased Oversight and Reporting.--
(1) State reporting requirements.--Section 1902(kk) of the
Social Security Act (42 U.S.C. 1396a(kk)) is amended--
(A) by redesignating paragraph (8) as paragraph (9);
and
(B) by inserting after paragraph (7) the following
new paragraph:
``(8) Provider terminations.--
``(A) In general.--Beginning on July 1, 2018, in the
case of a notification under subsection (a)(41) with
respect to a termination for a reason specified in
section 455.101 of title 42, Code of Federal Regulations
(as in effect on November 1, 2015) or for any other
reason specified by the Secretary, of the participation
of a provider of services or any other person under the
State plan (or under a waiver of the plan), the State,
not later than 30 days after the effective date of such
termination, submits to the Secretary with respect to
any such provider or person, as appropriate--
``(i) the name of such provider or person;
``(ii) the provider type of such provider or
person;
``(iii) the specialty of such provider's or
person's practice;
``(iv) the date of birth, Social Security
number, national provider identifier (if
applicable), Federal taxpayer identification
number, and the State license or certification
number of such provider or person (if applicable);
``(v) the reason for the termination;
``(vi) a copy of the notice of termination
sent to the provider or person;
``(vii) the date on which such termination is
effective, as specified in the notice; and
``(viii) any other information required by the
Secretary.
``(B) Effective date defined.--For purposes of this
paragraph, the term `effective date' means, with respect
[[Page 130 STAT. 1192]]
to a termination described in subparagraph (A), the
later of--
``(i) the date on which such termination is
effective, as specified in the notice of such
termination; or
``(ii) the date on which all appeal rights
applicable to such termination have been exhausted
or the timeline for any such appeal has
expired.''.
(2) Contract requirement for managed care entities.--Section
1932(d) of the Social Security Act (42 U.S.C. 1396u-2(d)) is
amended by adding at the end the following new paragraph:
``(5) Contract requirement for managed care entities.--With
respect to any contract with a managed care entity under section
1903(m) or 1905(t)(3) (as applicable), no later than July 1,
2018, such contract shall include a provision that providers of
services or persons terminated (as described in section
1902(kk)(8)) from participation under this title, title XVIII,
or title XXI shall be terminated from participating under this
title as a provider in any network of such entity that serves
individuals eligible to receive medical assistance under this
title.''.
(3) Termination notification database.--Section 1902 of the
Social Security Act (42 U.S.C. 1396a) is amended by adding at
the end the following new subsection:
``(ll) Termination Notification Database.--In the case of a provider
of services or any other person whose participation under this title or
title XXI is terminated (as described in subsection (kk)(8)), the
Secretary shall, not later than 30 days after the date on which the
Secretary is notified of such termination under subsection (a)(41) (as
applicable), review such termination and, if the Secretary determines
appropriate, include such termination in any database or similar system
developed pursuant to section 6401(b)(2) of the Patient Protection and
Affordable Care Act (42 U.S.C. 1395cc note; Public Law 111-148).''.
(4) No federal funds for items and services furnished by
terminated providers.--Section 1903 of the Social Security Act
(42 U.S.C. 1396b) is amended--
(A) in subsection (i)(2)--
(i) in subparagraph (A), by striking the comma
at the end and inserting a semicolon;
(ii) in subparagraph (B), by striking ``or''
at the end; and
(iii) by adding at the end the following new
subparagraph:
``(D) beginning on July 1, 2018, under the plan by
any provider of services or person whose participation
in the State plan is terminated (as described in section
1902(kk)(8)) after the date that is 60 days after the
date on which such termination is included in the
database or other system under section 1902(ll); or'';
and
(B) in subsection (m), by inserting after paragraph
(2) the following new paragraph:
``(3) No payment shall be made under this title to a State with
respect to expenditures incurred by the State for payment for services
provided by a managed care entity (as defined under section 1932(a)(1))
under the State plan under this title (or under a waiver of the plan)
unless the State--
[[Page 130 STAT. 1193]]
``(A) beginning on July 1, 2018, has a contract with such
entity that complies with the requirement specified in section
1932(d)(5); and
``(B) beginning on January 1, 2018, complies with the
requirement specified in section 1932(d)(6)(A).''.
(5) <<NOTE: 42 USC 1396a note.>> Development of uniform
terminology for reasons for provider termination.--Not later
than July 1, 2017, the Secretary of Health and Human Services
shall, in consultation with the heads of State agencies
administering State Medicaid plans (or waivers of such plans),
issue regulations establishing uniform terminology to be used
with respect to specifying reasons under subparagraph (A)(v) of
paragraph (8) of section 1902(kk) of the Social Security Act (42
U.S.C. 1396a(kk)), as added by paragraph (1), for the
termination (as described in such paragraph (8)) of the
participation of certain providers in the Medicaid program under
title XIX of such Act or the Children's Health Insurance Program
under title XXI of such Act.
(6) Conforming amendment.--Section 1902(a)(41) of the Social
Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking
``provide that whenever'' and inserting ``provide, in accordance
with subsection (kk)(8) (as applicable), that whenever''.
(b) Increasing Availability of Medicaid Provider Information.--
(1) FFS provider enrollment.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)) is amended by inserting after
paragraph (77) the following new paragraph:
``(78) provide that, not later than January 1, 2017, in the
case of a State that pursuant to its State plan or waiver of the
plan for medical assistance pays for medical assistance on a
fee-for-service basis, the State shall require each provider
furnishing items and services to, or ordering, prescribing,
referring, or certifying eligibility for, services for
individuals eligible to receive medical assistance under such
plan to enroll with the State agency and provide to the State
agency the provider's identifying information, including the
name, specialty, date of birth, Social Security number, national
provider identifier (if applicable), Federal taxpayer
identification number, and the State license or certification
number of the provider (if applicable);''.
(2) Managed care provider enrollment.--Section 1932(d) of
the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by
subsection (a)(2), is amended by adding at the end the following
new paragraph:
``(6) Enrollment of participating providers.--
``(A) In general.--Beginning not later than January
1, 2018, a State shall require that, in order to
participate as a provider in the network of a managed
care entity that provides services to, or orders,
prescribes, refers, or certifies eligibility for
services for, individuals who are eligible for medical
assistance under the State plan under this title (or
under a waiver of the plan) and who are enrolled with
the entity, the provider is enrolled consistent with
section 1902(kk) with the State agency administering the
State plan under this title. Such enrollment shall
[[Page 130 STAT. 1194]]
include providing to the State agency the provider's
identifying information, including the name, specialty,
date of birth, Social Security number, national provider
identifier, Federal taxpayer identification number, and
the State license or certification number of the
provider.
``(B) Rule of construction.--Nothing in subparagraph
(A) shall be construed as requiring a provider described
in such subparagraph to provide services to individuals
who are not enrolled with a managed care entity under
this title.''.
(c) Coordination With CHIP.--
(1) In general.--Section 2107(e)(1) of the Social Security
Act (42 U.S.C. 1397gg(e)(1)) is amended--
(A) by redesignating subparagraphs (B), (C), (D),
(E), (F), (G), (H), (I), (J), (K), (L), (M), (N), and
(O) as subparagraphs (D), (E), (F), (G), (H), (I), (J),
(K), (M), (N), (O), (P), (Q), and (R), respectively;
(B) by inserting after subparagraph (A) the
following new subparagraphs:
``(B) Section 1902(a)(39) (relating to termination
of participation of certain providers).
``(C) Section 1902(a)(78) (relating to enrollment of
providers participating in State plans providing medical
assistance on a fee-for-service basis).'';
(C) by inserting after subparagraph (K) (as
redesignated by subparagraph (A)) the following new
subparagraph:
``(L) Section 1903(m)(3) (relating to limitation on
payment with respect to managed care).''; and
(D) in subparagraph (P) (as redesignated by
subparagraph (A)), by striking ``(a)(2)(C) and (h)'' and
inserting ``(a)(2)(C) (relating to Indian enrollment),
(d)(5) (relating to contract requirement for managed
care entities), (d)(6) (relating to enrollment of
providers participating with a managed care entity), and
(h) (relating to special rules with respect to Indian
enrollees, Indian health care providers, and Indian
managed care entities)''.
(2) Excluding from medicaid providers excluded from chip.--
Section 1902(a)(39) of the Social Security Act (42 U.S.C.
1396a(a)(39)) is amended by striking ``title XVIII or any other
State plan under this title'' and inserting ``title XVIII, any
other State plan under this title (or waiver of the plan), or
any State child health plan under title XXI (or waiver of the
plan) and such termination is included by the Secretary in any
database or similar system developed pursuant to section
6401(b)(2) of the Patient Protection and Affordable Care Act''.
(d) <<NOTE: 42 USC 1396a note.>> Rule of Construction.--Nothing in
this section shall be construed as changing or limiting the appeal
rights of providers or the process for appeals of States under the
Social Security Act.
(e) OIG Report.--Not later than March 31, 2020, the Inspector
General of the Department of Health and Human Services shall submit to
Congress a report on the implementation of the amendments made by this
section. Such report shall include the following:
(1) An assessment of the extent to which providers who are
included under subsection (ll) of section 1902 of the Social
Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3))
[[Page 130 STAT. 1195]]
in the database or similar system referred to in such subsection
are terminated (as described in paragraph (8) of subsection (kk)
of such section, as added by subsection (a)(1)) from
participation in all State plans under title XIX of such Act (or
waivers of such plans).
(2) Information on the amount of Federal financial
participation paid to States under section 1903 of such Act in
violation of the limitation on such payment specified in
subparagraph (D) of subsection (i)(2) of such section and
paragraph (3) of subsection (m) of such section, as added by
subsection (a)(4).
(3) An assessment of the extent to which contracts with
managed care entities under title XIX of such Act comply with
the requirement specified in paragraph (5) of section 1932(d) of
such Act, as added by subsection (a)(2).
(4) An assessment of the extent to which providers have been
enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such Act
(42 U.S.C. 1396a(a)(78), 1396u-2(d)(6)(A)) with State agencies
administering State plans under title XIX of such Act (or
waivers of such plans).
SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER
DIRECTORY.
(a) In General.--Section 1902(a) of the Social Security Act (42
U.S.C. 1396a(a)) is amended--
(1) in paragraph (81), by striking ``and'' at the end;
(2) in paragraph (82), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after paragraph (82) the following new
paragraph:
``(83) provide that, not later than January 1, 2017, in the
case of a State plan (or waiver of the plan) that provides
medical assistance on a fee-for-service basis or through a
primary care case-management system described in section
1915(b)(1) (other than a primary care case management entity (as
defined by the Secretary)), the State shall publish (and update
on at least an annual basis) on the public website of the State
agency administering the State plan, a directory of the
physicians described in subsection (mm) and, at State option,
other providers described in such subsection that--
``(A) includes--
``(i) with respect to each such physician or
provider--
``(I) the name of the physician or
provider;
``(II) the specialty of the
physician or provider;
``(III) the address at which the
physician or provider provides services;
and
``(IV) the telephone number of the
physician or provider; and
``(ii) with respect to any such physician or
provider participating in such a primary care
case-management system, information regarding--
``(I) whether the physician or
provider is accepting as new patients
individuals who receive medical
assistance under this title; and
``(II) the physician's or provider's
cultural and linguistic capabilities,
including the languages spoken by the
physician or provider or by the
[[Page 130 STAT. 1196]]
skilled medical interpreter providing
interpretation services at the
physician's or provider's office; and
``(B) may include, at State option, with respect to
each such physician or provider--
``(i) the Internet website of such physician
or provider; or
``(ii) whether the physician or provider is
accepting as new patients individuals who receive
medical assistance under this title.''.
(b) Directory Physician or Provider Described.--Section 1902 of the
Social Security Act (42 U.S.C. 1396a), as amended by section 5005(a)(3),
is further amended by adding at the end the following new subsection:
``(mm) Directory Physician or Provider Described.--A physician or
provider described in this subsection is--
``(1) in the case of a physician or provider of a provider
type for which the State agency, as a condition on receiving
payment for items and services furnished by the physician or
provider to individuals eligible to receive medical assistance
under the State plan, requires the enrollment of the physician
or provider with the State agency, a physician or a provider
that--
``(A) is enrolled with the agency as of the date on
which the directory is published or updated (as
applicable) under subsection (a)(83); and
``(B) received payment under the State plan in the
12-month period preceding such date; and
``(2) in the case of a physician or provider of a provider
type for which the State agency does not require such
enrollment, a physician or provider that received payment under
the State plan (or a waiver of the plan) in the 12-month period
preceding the date on which the directory is published or
updated (as applicable) under subsection (a)(83).''.
(c) <<NOTE: 42 USC 1396a note.>> Rule of Construction.--
(1) In general.--The amendment made by subsection (a) shall
not be construed to apply in the case of a State (as defined for
purposes of title XIX of the Social Security Act) in which all
the individuals enrolled in the State plan under such title (or
under a waiver of such plan), other than individuals described
in paragraph (2), are enrolled with a medicaid managed care
organization (as defined in section 1903(m)(1)(A) of such Act
(42 U.S.C. 1396b(m)(1)(A))), including prepaid inpatient health
plans and prepaid ambulatory health plans (as defined by the
Secretary of Health and Human Services).
(2) Individuals described.--An individual described in this
paragraph is an individual who is an Indian (as defined in
section 4 of the Indian Health Care Improvement Act (25 U.S.C.
1603)) or an Alaska Native.
(d) <<NOTE: 42 USC 1396a note.>> Exception for State Legislation.--
In the case of a State plan under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.), which the Secretary of Health and Human
Services determines requires State legislation in order for the
respective plan to meet one or more additional requirements imposed by
amendments made by this section, the respective plan shall not be
regarded as failing to comply with the requirements of such title
[[Page 130 STAT. 1197]]
solely on the basis of its failure to meet such an additional
requirement before the first day of the first calendar quarter beginning
after the close of the first regular session of the State legislature
that begins after the date of enactment of this Act. For purposes of the
previous sentence, in the case of a State that has a 2-year legislative
session, each year of the session shall be considered to be a separate
regular session of the State legislature.
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.
(a) In General.--Section 1917(d)(4)(A) of the Social Security Act
(42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ``the individual,''
after ``for the benefit of such individual by''.
(b) <<NOTE: 42 USC 1396p note.>> Effective Date.--The amendment
made by subsection (a) shall apply to trusts established on or after the
date of the enactment of this Act.
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH
RESPECT TO EXPENDITURES UNDER MEDICAID
FOR AGENTS USED FOR COSMETIC PURPOSES OR
HAIR GROWTH.
(a) In General.--Section 1903(i)(21) of the Social Security Act (42
U.S.C. 1396b(i)(21)) is amended by inserting ``section 1927(d)(2)(C)
(relating to drugs when used for cosmetic purposes or hair growth),
except where medically necessary, and'' after ``drugs described in''.
(b) <<NOTE: 42 USC 1396b note.>> Effective Date.--The amendment
made by subsection (a) shall apply with respect to calendar quarters
beginning on or after the date of the enactment of this Act.
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH FUND.
Section 4002(b) of the Patient Protection and Affordable Care Act
(42 U.S.C. 300u-11(b)) is amended--
(1) in paragraph (3), by striking ``$1,250,000,000'' and
inserting ``$900,000,000'';
(2) in paragraph (4), by striking ``$1,500,000,000'' and
inserting ``$1,000,000,000''; and
(3) by striking paragraph (5) and inserting the following:
``(5) for fiscal year 2022, $1,500,000,000;
``(6) for fiscal year 2023, $1,000,000,000;
``(7) for fiscal year 2024, $1,700,000,000; and
``(8) for fiscal year 2025 and each fiscal year thereafter,
$2,000,000,000.''.
SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.
(a) <<NOTE: 42 USC 6241 note.>> Drawdown and Sale.--
(1) In general.--Notwithstanding section 161 of the Energy
Policy and Conservation Act (42 U.S.C. 6241), except as provided
in subsections (b) and (c), the Secretary of Energy shall
drawdown and sell from the Strategic Petroleum Reserve--
(A) 10,000,000 barrels of crude oil during fiscal
year 2017;
(B) 9,000,000 barrels of crude oil during fiscal
year 2018; and
(C) 6,000,000 barrels of crude oil during fiscal
year 2019.
[[Page 130 STAT. 1198]]
(2) Deposit of amounts received from sale.--Amounts received
from a sale under paragraph (1) shall be deposited in the
general fund of the Treasury during the fiscal year in which the
sale occurs.
(b) <<NOTE: 42 USC 6241 note.>> Emergency Protection.--The
Secretary shall not draw down and sell crude oil under this section in
quantities that would limit the authority to sell petroleum products
under section 161(h) of the Energy Policy and Conservation Act (42
U.S.C. 6241(h)) in the full quantity authorized by that subsection.
(c) Strategic Petroleum Drawdown Limitations.--Subparagraphs (C) and
(D) of section 161(h)(2) of the Energy Policy and Conservation Act (42
U.S.C. 6241(h)(2)(C) and (D)) are both amended by striking
``500,000,000'' and inserting ``450,000,000''.
SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.
Of the unobligated amounts available under section 1323(c)(1) of the
Patient Protection and Affordable Care Act (42 U.S.C. 18043(c)(1)),
$464,000,000 is rescinded immediately upon the date of the enactment of
this Act.
SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
(a) In General.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended--
(1) in subsection (s)(2)--
(A) by striking ``and'' at the end of subparagraph
(EE);
(B) by inserting ``and'' at the end of subparagraph
(FF); and
(C) by inserting at the end the following new
subparagraph:
``(GG) home infusion therapy (as defined in subsection
(iii)(1));''; and
(2) by adding at the end the following new subsection:
``(iii) Home Infusion Therapy.--(1) The term `home infusion therapy'
means the items and services described in paragraph (2) furnished by a
qualified home infusion therapy supplier (as defined in paragraph
(3)(D)) which are furnished in the individual's home (as defined in
paragraph (3)(B)) to an individual--
``(A) who is under the care of an applicable provider (as
defined in paragraph (3)(A)); and
``(B) with respect to whom a plan prescribing the type,
amount, and duration of infusion therapy services that are to be
furnished such individual has been established by a physician
(as defined in subsection (r)(1)) and is periodically reviewed
by a physician (as so defined) in coordination with the
furnishing of home infusion drugs (as defined in paragraph
(3)(C)) under part B.
``(2) The items and services described in this paragraph are the
following:
``(A) Professional services, including nursing services,
furnished in accordance with the plan.
``(B) Training and education (not otherwise paid for as
durable medical equipment (as defined in subsection (n)), remote
monitoring, and monitoring services for the provision of home
infusion therapy and home infusion drugs furnished by a
qualified home infusion therapy supplier.
``(3) For purposes of this subsection:
``(A) The term `applicable provider' means--
``(i) a physician;
[[Page 130 STAT. 1199]]
``(ii) a nurse practitioner; and
``(iii) a physician assistant.
``(B) The term `home' means a place of residence used as the
home of an individual (as defined for purposes of subsection
(n)).
``(C) The term `home infusion drug' means a parenteral drug
or biological administered intravenously, or subcutaneously for
an administration period of 15 minutes or more, in the home of
an individual through a pump that is an item of durable medical
equipment (as defined in subsection (n)). Such term does not
include the following:
``(i) Insulin pump systems.
``(ii) A self-administered drug or biological on a
self-administered drug exclusion list.
``(D)(i) The term `qualified home infusion therapy supplier'
means a pharmacy, physician, or other provider of services or
supplier licensed by the State in which the pharmacy, physician,
or provider or services or supplier furnishes items or services
and that--
``(I) furnishes infusion therapy to individuals with
acute or chronic conditions requiring administration of
home infusion drugs;
``(II) ensures the safe and effective provision and
administration of home infusion therapy on a 7-day-a-
week, 24-hour-a-day basis;
``(III) is accredited by an organization designated
by the Secretary pursuant to section 1834(u)(5); and
``(IV) meets such other requirements as the
Secretary determines appropriate, taking into account
the standards of care for home infusion therapy
established by Medicare Advantage plans under part C and
in the private sector.
``(ii) A qualified home infusion therapy supplier may
subcontract with a pharmacy, physician, provider of services, or
supplier to meet the requirements of this subparagraph.''.
(b) Payment and Related Requirements for Home Infusion Therapy.--
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by
section 4011, is further amended by adding at the end the following new
subsection:
``(u) Payment and Related Requirements for Home Infusion Therapy.--
``(1) Payment.--
``(A) Single payment.--
``(i) In general.--Subject to clause (iii) and
subparagraphs (B) and (C), the Secretary shall
implement a payment system under which a single
payment is made under this title to a qualified
home infusion therapy supplier for items and
services described in subparagraphs (A) and (B) of
section 1861(iii)(2)) furnished by a qualified
home infusion therapy supplier (as defined in
section 1861(iii)(3)(D)) in coordination with the
furnishing of home infusion drugs (as defined in
section 1861(iii)(3)(C)) under this part.
``(ii) Unit of single payment.--A unit of
single payment under the payment system
implemented under this subparagraph is for each
infusion drug administration calendar day in the
individual's home. The Secretary shall, as
appropriate, establish single
[[Page 130 STAT. 1200]]
payment amounts for types of infusion therapy,
including to take into account variation in
utilization of nursing services by therapy type.
``(iii) Limitation.--The single payment amount
determined under this subparagraph after
application of subparagraph (B) and paragraph (3)
shall not exceed the amount determined under the
fee schedule under section 1848 for infusion
therapy services furnished in a calendar day if
furnished in a physician office setting, except
such single payment shall not reflect more than 5
hours of infusion for a particular therapy in a
calendar day.
``(B) Required adjustments.--The Secretary shall
adjust the single payment amount determined under
subparagraph (A) for home infusion therapy services
under section 1861(iii)(1) to reflect other factors such
as--
``(i) a geographic wage index and other costs
that may vary by region; and
``(ii) patient acuity and complexity of drug
administration.
``(C) Discretionary adjustments.--
``(i) In general.--Subject to clause (ii), the
Secretary may adjust the single payment amount
determined under subparagraph (A) (after
application of subparagraph (B)) to reflect
outlier situations and other factors as the
Secretary determines appropriate.
``(ii) Requirement of budget neutrality.--Any
adjustment under this subparagraph shall be made
in a budget neutral manner.
``(2) Considerations.--In developing the payment system
under this subsection, the Secretary may consider the costs of
furnishing infusion therapy in the home, consult with home
infusion therapy suppliers, consider payment amounts for similar
items and services under this part and part A, and consider
payment amounts established by Medicare Advantage plans under
part C and in the private insurance market for home infusion
therapy (including average per treatment day payment amounts by
type of home infusion therapy).
``(3) Annual updates.--
``(A) In general.--Subject to subparagraph (B), the
Secretary shall update the single payment amount under
this subsection from year to year beginning in 2022 by
increasing the single payment amount from the prior year
by the percentage increase in the Consumer Price Index
for all urban consumers (United States city average) for
the 12-month period ending with June of the preceding
year.
``(B) Adjustment.--For each year, the Secretary
shall reduce the percentage increase described in
subparagraph (A) by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II). The
application of the preceding sentence may result in a
percentage being less than 0.0 for a year, and may
result in payment being less than such payment rates for
the preceding year.
``(4) Authority to apply prior authorization.--The Secretary
may, as determined appropriate by the Secretary, apply
[[Page 130 STAT. 1201]]
prior authorization for home infusion therapy services under
section 1861(iii)(1).
``(5) Accreditation of qualified home infusion therapy
suppliers.--
``(A) Factors for designation of accreditation
organizations.--The Secretary shall consider the
following factors in designating accreditation
organizations under subparagraph (B) and in reviewing
and modifying the list of accreditation organizations
designated pursuant to subparagraph (C):
``(i) The ability of the organization to
conduct timely reviews of accreditation
applications.
``(ii) The ability of the organization to take
into account the capacities of suppliers located
in a rural area (as defined in section
1886(d)(2)(D)).
``(iii) Whether the organization has
established reasonable fees to be charged to
suppliers applying for accreditation.
``(iv) Such other factors as the Secretary
determines appropriate.
``(B) Designation.--Not later than January 1, 2021,
the Secretary shall designate organizations to accredit
suppliers furnishing home infusion therapy. The list of
accreditation organizations so designated may be
modified pursuant to subparagraph (C).
``(C) Review and modification of list of
accreditation organizations.--
``(i) In general.--The Secretary shall review
the list of accreditation organizations designated
under subparagraph (B) taking into account the
factors under subparagraph (A). Taking into
account the results of such review, the Secretary
may, by regulation, modify the list of
accreditation organizations designated under
subparagraph (B).
``(ii) Special rule for accreditations done
prior to removal from list of designated
accreditation organizations.--In the case where
the Secretary removes an organization from the
list of accreditation organizations designated
under subparagraph (B), any supplier that is
accredited by the organization during the period
beginning on the date on which the organization is
designated as an accreditation organization under
subparagraph (B) and ending on the date on which
the organization is removed from such list shall
be considered to have been accredited by an
organization designated by the Secretary under
subparagraph (B) for the remaining period such
accreditation is in effect.
``(D) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2021, by an accreditation
organization designated by the Secretary under
subparagraph (B) as of January 1, 2019, such supplier
shall be considered to have been accredited by an
organization designated by the Secretary under such
paragraph as of January 1, 2023, for the remaining
period such accreditation is in effect.
[[Page 130 STAT. 1202]]
``(6) Notification of infusion therapy options available
prior to furnishing home infusion therapy.--Prior to the
furnishing of home infusion therapy to an individual, the
physician who establishes the plan described in section
1861(iii)(1) for the individual shall provide notification (in a
form, manner, and frequency determined appropriate by the
Secretary) of the options available (such as home, physician's
office, hospital outpatient department) for the furnishing of
infusion therapy under this part.''.
(c) Conforming Amendments.--
(1) Payment reference.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and'' before ``(AA)''; and
(B) by inserting before the semicolon at the end the
following: ``, and (BB) with respect to home infusion
therapy, the amount paid shall be an amount equal to 80
percent of the lesser of the actual charge for the
services or the amount determined under section
1834(u)''.
(2) Direct payment.--The first sentence of section
1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is
amended--
(A) by striking ``and'' before ``(H)''; and
(B) by inserting before the period at the end the
following: ``, and (I) in the case of home infusion
therapy, payment shall be made to the qualified home
infusion therapy supplier''.
(3) Exclusion from home health services.--Section 1861(m) of
the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the
first sentence, by inserting the following before the period at
the end: ``and home infusion therapy (as defined in subsection
(iii)(i))''.
(d) <<NOTE: 42 USC 13951 note.>> Effective Date.--The amendments
made by this section shall apply to items and services furnished on or
after January 1, 2021.
DIVISION <<NOTE: Helping Families in Mental Health Crisis Reform Act of
2016.>> B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
SEC. 6000. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This division may be cited as the ``Helping Families in Mental
Health Crisis Reform Act of 2016''.
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A--Leadership
SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE
USE.
(a) Assistant Secretary.--Section 501(c) of the Public Health
Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
``(c) Assistant Secretary and Deputy Assistant Secretary.--
[[Page 130 STAT. 1203]]
``(1) Assistant secretary.--The Administration shall be
headed by an official to be known as the Assistant Secretary for
Mental Health and Substance Use (hereinafter in this title
referred to as the `Assistant Secretary') who shall be appointed
by the President, by and with the advice and consent of the
Senate.
``(2) Deputy assistant secretary.--The Assistant Secretary,
with the approval of the Secretary, may appoint a Deputy
Assistant Secretary and may employ and prescribe the functions
of such officers and employees, including attorneys, as are
necessary to administer the activities to be carried out through
the Administration.''.
(b) <<NOTE: 42 USC 290aa note.>> Transfer of Authorities.--The
Secretary of Health and Human Services shall delegate to the Assistant
Secretary for Mental Health and Substance Use all duties and authorities
that--
(1) as of the day before the date of enactment of this Act,
were vested in the Administrator of the Substance Abuse and
Mental Health Services Administration; and
(2) are not terminated by this Act.
(c) Conforming Amendments.--Title V of the Public Health Service Act
(42 U.S.C. 290aa et seq.), as amended by the previous provisions of this
section, is further amended--
(1) by striking ``Administrator of the Substance Abuse and
Mental Health Services Administration'' each place it appears
and inserting ``Assistant Secretary for Mental Health and
Substance Use''; and
(2) by striking ``Administrator'' or ``Administrator'' each
place it appears (including in any headings) and inserting
``Assistant Secretary'' or ``Assistant Secretary'',
respectively, except where the term ``Administrator'' appears--
(A) in each of subsections (e) and (f) of section
501 of such Act (42 U.S.C. 290aa), including the
headings of such subsections, within the term
``Associate Administrator'';
(B) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ``Administrator of the
Health Resources and Services Administration'';
(C) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ``Administrator of the
Centers for Medicare & Medicaid Services'';
(D) in section 519B(c)(1)(B) of such Act (42 U.S.C.
290bb-25b(c)(1)(B)), within the term ``Administrator of
the National Highway Traffic Safety Administration''; or
(E) in each of sections 519B(c)(1)(B), 520C(a), and
520D(a) of such Act (42 U.S.C. 290bb-25b(c)(1)(B),
290bb-34(a), 290bb-35(a)), within the term
``Administrator of the Office of Juvenile Justice and
Delinquency Prevention''.
(d) <<NOTE: 42 USC 290aa note.>> References.--After executing
subsections (a), (b), and (c), any reference in statute, regulation, or
guidance to the Administrator of the Substance Abuse and Mental Health
Services Administration shall be construed to be a reference to the
Assistant Secretary for Mental Health and Substance Use.
[[Page 130 STAT. 1204]]
SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND
MENTAL HEALTH SERVICES ADMINISTRATION.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
amended by section 6001, is further amended--
(1) in subsection (b)--
(A) in the subsection heading, by striking
``Agencies'' and inserting ``Centers''; and
(B) in the matter preceding paragraph (1), by
striking ``entities'' and inserting ``Centers'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) by striking ``agencies'' each place the
term appears and inserting ``Centers''; and
(ii) by striking ``such agency'' and inserting
``such Center'';
(B) in paragraph (2)--
(i) by striking ``agencies'' and inserting
``Centers'';
(ii) by striking ``with respect to substance
abuse'' and inserting ``with respect to substance
use disorders''; and
(iii) by striking ``and individuals who are
substance abusers'' and inserting ``and
individuals with substance use disorders'';
(C) in paragraph (5), by striking ``substance
abuse'' and inserting ``substance use disorder'';
(D) in paragraph (6)--
(i) by striking ``the Centers for Disease
Control'' and inserting ``the Centers for Disease
Control and Prevention,'';
(ii) by striking ``Administration develop''
and inserting ``Administration, develop'';
(iii) by striking ``HIV or tuberculosis among
substance abusers and individuals with mental
illness'' and inserting ``HIV, hepatitis,
tuberculosis, and other communicable diseases
among individuals with mental or substance use
disorders,''; and
(iv) by striking ``illnesses'' at the end and
inserting ``diseases or disorders'';
(E) in paragraph (7), by striking ``abuse utilizing
anti-addiction medications, including methadone'' and
inserting ``use disorders, including services that
utilize drugs or devices approved or cleared by the Food
and Drug Administration for the treatment of substance
use disorders'';
(F) in paragraph (8)--
(i) by striking ``Agency for Health Care
Policy Research'' and inserting ``Agency for
Healthcare Research and Quality''; and
(ii) by striking ``treatment and prevention''
and inserting ``prevention and treatment'';
(G) in paragraph (9)--
(i) by inserting ``and maintenance'' after
``development'';
(ii) by striking ``Agency for Health Care
Policy Research'' and inserting ``Agency for
Healthcare Research and Quality''; and
[[Page 130 STAT. 1205]]
(iii) by striking ``treatment and prevention
services'' and inserting ``prevention, treatment,
and recovery support services and are
appropriately incorporated into programs carried
out by the Administration'';
(H) in paragraph (10), by striking ``abuse'' and
inserting ``use disorder'';
(I) by striking paragraph (11) and inserting the
following:
``(11) work with relevant agencies of the Department of
Health and Human Services on integrating mental health promotion
and substance use disorder prevention with general health
promotion and disease prevention and integrating mental and
substance use disorders treatment services with physical health
treatment services;'';
(J) in paragraph (13)--
(i) in the matter preceding subparagraph (A),
by striking ``this title, assure that'' and
inserting ``this title or part B of title XIX, or
grant programs otherwise funded by the
Administration'';
(ii) in subparagraph (A)--
(I) by inserting ``require that''
before ``all grants''; and
(II) by striking ``and'' at the end;
(iii) by redesignating subparagraph (B) as
subparagraph (C);
(iv) by inserting after subparagraph (A) the
following:
``(B) ensure that the director of each Center of the
Administration consistently documents the application of
criteria when awarding grants and the ongoing oversight
of grantees after such grants are awarded;'';
(v) in subparagraph (C), as so redesignated--
(I) by inserting ``require that''
before ``all grants''; and
(II) in clause (ii), by inserting
``and'' after the semicolon at the end;
and
(vi) by adding at the end the following:
``(D) inform a State when any funds are awarded
through such a grant to any entity within such State;'';
(K) in paragraph (16), by striking ``abuse and
mental health information'' and inserting ``use disorder
information, including evidence-based and promising best
practices for prevention, treatment, and recovery
support services for individuals with mental and
substance use disorders,'';
(L) in paragraph (17)--
(i) by striking ``substance abuse'' and
inserting ``substance use disorder''; and
(ii) by striking ``and'' at the end;
(M) in paragraph (18), by striking the period and
inserting a semicolon; and
(N) by adding at the end the following:
``(19) consult with State, local, and tribal governments,
nongovernmental entities, and individuals with mental illness,
particularly adults with a serious mental illness, children with
a serious emotional disturbance, and the family members of
[[Page 130 STAT. 1206]]
such adults and children, with respect to improving community-
based and other mental health services;
``(20) collaborate with the Secretary of Defense and the
Secretary of Veterans Affairs to improve the provision of mental
and substance use disorder services provided by the Department
of Defense and the Department of Veterans Affairs to members of
the Armed Forces, veterans, and the family members of such
members and veterans, including through the provision of
services using the telehealth capabilities of the Department of
Defense and the Department of Veterans Affairs;
``(21) collaborate with the heads of relevant Federal
agencies and departments, States, communities, and
nongovernmental experts to improve mental and substance use
disorders services for chronically homeless individuals,
including by designing strategies to provide such services in
supportive housing;
``(22) work with States and other stakeholders to develop
and support activities to recruit and retain a workforce
addressing mental and substance use disorders;
``(23) collaborate with the Attorney General and
representatives of the criminal justice system to improve mental
and substance use disorders services for individuals who have
been arrested or incarcerated;
``(24) after providing an opportunity for public input, set
standards for grant programs under this title for mental and
substance use disorders services and prevention programs, which
standards may address--
``(A) the capacity of the grantee to implement the
award;
``(B) requirements for the description of the
program implementation approach;
``(C) the extent to which the grant plan submitted
by the grantee as part of its application must explain
how the grantee will reach the population of focus and
provide a statement of need, which may include
information on how the grantee will increase access to
services and a description of measurable objectives for
improving outcomes;
``(D) the extent to which the grantee must collect
and report on required performance measures; and
``(E) the extent to which the grantee is proposing
to use evidence-based practices; and
``(25) advance, through existing programs, the use of
performance metrics, including those based on the
recommendations on performance metrics from the Assistant
Secretary for Planning and Evaluation under section 6021(d) of
the Helping Families in Mental Health Crisis Reform Act of
2016.''; and
(3) in subsection (m), by adding at the end the following:
``(4) Emergency response.--Amounts made available for
carrying out this subsection shall remain available through the
end of the fiscal year following the fiscal year for which such
amounts are appropriated.''.
SEC. 6003. CHIEF MEDICAL OFFICER.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
amended by sections 6001 and 6002, is further amended--
[[Page 130 STAT. 1207]]
(1) by redesignating subsections (g) through (j) and
subsections (k) through (o) as subsections (h) through (k) and
subsections (m) through (q), respectively;
(2) in subsection (e)(3)(C), by striking ``subsection (k)''
and inserting ``subsection (m)'';
(3) in subsection (f)(2)(C)(iii), by striking ``subsection
(k)'' and inserting ``subsection (m)''; and
(4) by inserting after subsection (f) the following:
``(g) Chief Medical Officer.--
``(1) In general.--The Assistant Secretary, with the
approval of the Secretary, shall appoint a Chief Medical Officer
to serve within the Administration.
``(2) Eligible candidates.--The Assistant Secretary shall
select the Chief Medical Officer from among individuals who--
``(A) have a doctoral degree in medicine or
osteopathic medicine;
``(B) have experience in the provision of mental or
substance use disorder services;
``(C) have experience working with mental or
substance use disorder programs;
``(D) have an understanding of biological,
psychosocial, and pharmaceutical treatments of mental or
substance use disorders; and
``(E) are licensed to practice medicine in one or
more States.
``(3) Duties.--The Chief Medical Officer shall--
``(A) serve as a liaison between the Administration
and providers of mental and substance use disorders
prevention, treatment, and recovery services;
``(B) assist the Assistant Secretary in the
evaluation, organization, integration, and coordination
of programs operated by the Administration;
``(C) promote evidence-based and promising best
practices, including culturally and linguistically
appropriate practices, as appropriate, for the
prevention and treatment of, and recovery from, mental
and substance use disorders, including serious mental
illness and serious emotional disturbances;
``(D) participate in regular strategic planning with
the Administration;
``(E) coordinate with the Assistant Secretary for
Planning and Evaluation to assess the use of performance
metrics to evaluate activities within the Administration
related to mental and substance use disorders; and
``(F) coordinate with the Assistant Secretary to
ensure mental and substance use disorders grant programs
within the Administration consistently utilize
appropriate performance metrics and evaluation
designs.''.
SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), as
amended by section 6001(c), is amended--
(1) by striking the section designation and heading and
inserting the following:
[[Page 130 STAT. 1208]]
``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND
QUALITY.'';
(2) by redesignating subsections (a) through (d) as
subsections (b) through (e), respectively;
(3) before subsection (b), as redesignated by paragraph (2),
by inserting the following:
``(a) In General.--The Assistant Secretary shall maintain within the
Administration a Center for Behavioral Health Statistics and Quality (in
this section referred to as the `Center'). The Center shall be headed by
a Director (in this section referred to as the `Director') appointed by
the Secretary from among individuals with extensive experience and
academic qualifications in research and analysis in behavioral health
care or related fields.'';
(4) in subsection (b), as redesignated by paragraph (2)--
(A) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(B) by striking ``The Secretary, acting'' and all
that follows through ``year on--'' and inserting ``The
Director shall--
``(1) coordinate the Administration's integrated data
strategy, including by collecting data each year on--'';
(C) in the subparagraph (B), as redesignated by
subparagraph (A), by striking ``Assistant Secretary''
and inserting ``Director''; and
(D) by adding at the end the following new
paragraphs:
``(2) provide statistical and analytical support for
activities of the Administration;
``(3) recommend a core set of performance metrics to
evaluate activities supported by the Administration; and
``(4) coordinate with the Assistant Secretary, the Assistant
Secretary for Planning and Evaluation, and the Chief Medical
Officer appointed under section 501(g), as appropriate, to
improve the quality of services provided by programs of the
Administration and the evaluation of activities carried out by
the Administration.''.
(5) in subsection (c), as so redesignated--
(A) by striking ``With respect to the activities''
and inserting ``Mental Health.--With respect to the
activities'';
(B) by striking ``Assistant Secretary'' each place
it appears and inserting ``Director''; and
(C) by striking ``subsection (a)'' and inserting
``subsection (b)(1)'';
(6) in subsection (d), as so redesignated--
(A) by striking the subsection designation and all
that follows through ``With respect to the activities''
and inserting the following:
``(d) Substance Abuse.--
``(1) In general.--With respect to the activities'';
(B) in paragraph (1)--
(i) in the matter before subparagraph (A)--
(I) by striking ``subsection (a)''
and inserting ``subsection (b)(1)''; and
(II) by striking ``Assistant
Secretary'' each place it appears and
inserting ``Director''; and
[[Page 130 STAT. 1209]]
(ii) in subparagraph (B), by inserting ``in
coordination with the Centers for Disease Control
and Prevention'' before the semicolon at the end;
and
(C) in paragraph (2), by striking ``Annual surveys''
and inserting ``Annual surveys; public availability of
data.--Annual surveys''; and
(7) in subsection (e), as so redesignated--
(A) by striking ``After consultation'' and inserting
``Consultation.--After consultation''; and
(B) by striking ``Assistant Secretary shall
develop'' and inserting ``Assistant Secretary shall use
existing standards and best practices to develop''.
SEC. 6005. STRATEGIC PLAN.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as
amended by sections 6001 through 6003, is further amended by inserting
after subsection (k), as redesignated by section 6003, the following:
``(l) Strategic Plan.--
``(1) In general.--Not later than September 30, 2018, and
every 4 years thereafter, the Assistant Secretary shall develop
and carry out a strategic plan in accordance with this
subsection for the planning and operation of activities carried
out by the Administration, including evidence-based programs.
``(2) Coordination.--In developing and carrying out the
strategic plan under this subsection, the Assistant Secretary
shall take into consideration the findings and recommendations
of the Assistant Secretary for Planning and Evaluation under
section 6021(d) of the Helping Families in Mental Health Crisis
Reform Act of 2016 and the report of the Interdepartmental
Serious Mental Illness Coordinating Committee under section 6031
of such Act.
``(3) Publication of plan.--Not later than September 30,
2018, and every 4 years thereafter, the Assistant Secretary
shall--
``(A) submit the strategic plan developed under
paragraph (1) to the Committee on Energy and Commerce
and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate; and
``(B) post such plan on the Internet website of the
Administration.
``(4) Contents.--The strategic plan developed under
paragraph (1) shall--
``(A) identify strategic priorities, goals, and
measurable objectives for mental and substance use
disorders activities and programs operated and supported
by the Administration, including priorities to prevent
or eliminate the burden of mental and substance use
disorders;
``(B) identify ways to improve the quality of
services for individuals with mental and substance use
disorders, and to reduce homelessness, arrest,
incarceration, violence, including self-directed
violence, and unnecessary hospitalization of individuals
with a mental or substance use disorder, including
adults with a serious mental illness or children with a
serious emotional disturbance;
[[Page 130 STAT. 1210]]
``(C) ensure that programs provide, as appropriate,
access to effective and evidence-based prevention,
diagnosis, intervention, treatment, and recovery
services, including culturally and linguistically
appropriate services, as appropriate, for individuals
with a mental or substance use disorder;
``(D) identify opportunities to collaborate with the
Health Resources and Services Administration to develop
or improve--
``(i) initiatives to encourage individuals to
pursue careers (especially in rural and
underserved areas and with rural and underserved
populations) as psychiatrists, including child and
adolescent psychiatrists, psychologists,
psychiatric nurse practitioners, physician
assistants, clinical social workers, certified
peer support specialists, licensed professional
counselors, or other licensed or certified mental
health or substance use disorder professionals,
including such professionals specializing in the
diagnosis, evaluation, or treatment of adults with
a serious mental illness or children with a
serious emotional disturbance; and
``(ii) a strategy to improve the recruitment,
training, and retention of a workforce for the
treatment of individuals with mental or substance
use disorders, or co-occurring disorders;
``(E) identify opportunities to improve
collaboration with States, local governments,
communities, and Indian tribes and tribal organizations
(as such terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act); and
``(F) specify a strategy to disseminate evidence-
based and promising best practices related to
prevention, diagnosis, early intervention, treatment,
and recovery services related to mental illness,
particularly for adults with a serious mental illness
and children with a serious emotional disturbance, and
for individuals with a substance use disorder.''.
SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
(a) In General.--Section 501 of the Public Health Service Act (42
U.S.C. 290aa), as so amended, is further amended by amending subsection
(m), as redesignated by section 6003, to read as follows:
``(m) Biennial Report Concerning Activities and Progress.--Not later
than September 30, 2020, and every 2 years thereafter, the Assistant
Secretary shall prepare and submit to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate, and post on
the Internet website of the Administration, a report containing at a
minimum--
``(1) a review of activities conducted or supported by the
Administration, including progress toward strategic priorities,
goals, and objectives identified in the strategic plan developed
under subsection (l);
[[Page 130 STAT. 1211]]
``(2) an assessment of programs and activities carried out
by the Assistant Secretary, including the extent to which
programs and activities under this title and part B of title XIX
meet identified goals and performance measures developed for the
respective programs and activities;
``(3) a description of the progress made in addressing gaps
in mental and substance use disorders prevention, treatment, and
recovery services and improving outcomes by the Administration,
including with respect to serious mental illnesses, serious
emotional disturbances, and co-occurring disorders;
``(4) a description of the manner in which the
Administration coordinates and partners with other Federal
agencies and departments related to mental and substance use
disorders, including activities related to--
``(A) the implementation and dissemination of
research findings into improved programs, including with
respect to how advances in serious mental illness and
serious emotional disturbance research have been
incorporated into programs;
``(B) the recruitment, training, and retention of a
mental and substance use disorders workforce;
``(C) the integration of mental disorder services,
substance use disorder services, and physical health
services;
``(D) homelessness; and
``(E) veterans;
``(5) a description of the manner in which the
Administration promotes coordination by grantees under this
title, and part B of title XIX, with State or local agencies;
and
``(6) a description of the activities carried out under
section 501A(e), with respect to mental and substance use
disorders, including--
``(A) the number and a description of grants
awarded;
``(B) the total amount of funding for grants
awarded;
``(C) a description of the activities supported
through such grants, including outcomes of programs
supported; and
``(D) information on how the National Mental Health
and Substance Use Policy Laboratory is consulting with
the Assistant Secretary for Planning and Evaluation and
collaborating with the Center for Substance Abuse
Treatment, the Center for Substance Abuse Prevention,
the Center for Behavioral Health Statistics and Quality,
and the Center for Mental Health Services to carry out
such activities; and
``(7) recommendations made by the Assistant Secretary for
Planning and Evaluation under section 6021 of the Helping
Families in Mental Health Crisis Reform Act of 2016 to improve
programs within the Administration, and actions taken in
response to such recommendations to improve programs within the
Administration.
The Assistant Secretary may meet reporting requirements established
under this title by providing the contents of such reports as an
addendum to the biennial report established under this subsection,
notwithstanding the timeline of other reporting requirements in this
title. Nothing in this subsection shall be construed to alter the
content requirements of such reports or authorize the Assistant
Secretary to alter the timeline of any such reports
[[Page 130 STAT. 1212]]
to be less frequent than biennially, unless as specified in this
title.''.
(b) Conforming Amendment.--Section 508(p) of the Public Health
Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section
501(k)'' and inserting ``section 501(m)''.
SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
SUBSTANCE ABUSE PREVENTION, AND
SUBSTANCE ABUSE TREATMENT.
(a) Center for Mental Health Services.--Section 520(b) of the Public
Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
(1) by redesignating paragraphs (3) through (15) as
paragraphs (4) through (16), respectively;
(2) by inserting after paragraph (2) the following:
``(3) collaborate with the Director of the National
Institute of Mental Health and the Chief Medical Officer,
appointed under section 501(g), to ensure that, as appropriate,
programs related to the prevention and treatment of mental
illness and the promotion of mental health and recovery support
are carried out in a manner that reflects the best available
science and evidence-based practices, including culturally and
linguistically appropriate services, as appropriate;'';
(3) in paragraph (5), as so redesignated, by inserting ``,
including through programs that reduce risk and promote
resiliency'' before the semicolon;
(4) in paragraph (6), as so redesignated, by inserting ``in
collaboration with the Director of the National Institute of
Mental Health,'' before ``develop'';
(5) in paragraph (8), as so redesignated, by inserting ``,
increase meaningful participation of individuals with mental
illness in programs and activities of the Administration,''
before ``and protect the legal'';
(6) in paragraph (10), as so redesignated, by striking
``professional and paraprofessional personnel pursuant to
section 303'' and inserting ``health paraprofessional personnel
and health professionals'';
(7) in paragraph (11), as so redesignated, by inserting
``and tele-mental health'' after ``rural mental health'';
(8) in paragraph (12), as so redesignated, by striking
``establish a clearinghouse for mental health information to
assure the widespread dissemination of such information'' and
inserting ``disseminate mental health information, including
evidence-based practices,'';
(9) in paragraph (15), as so redesignated, by striking
``and'' at the end;
(10) in paragraph (16), as so redesignated, by striking the
period and inserting ``; and''; and
(11) by adding at the end the following:
``(17) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded.''.
(b) Director of the Center for Substance Abuse Prevention.--Section
515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
(1) in the section heading, by striking ``office'' and
inserting ``center'';
[[Page 130 STAT. 1213]]
(2) in subsection (a)--
(A) by striking ``an Office'' and inserting ``a
Center''; and
(B) by striking ``The Office'' and inserting ``The
Prevention Center''; and
(3) in subsection (b)--
(A) in paragraph (1), by inserting ``through the
reduction of risk and the promotion of resiliency''
before the semicolon;
(B) by redesignating paragraphs (3) through (11) as
paragraphs (4) through (12), respectively;
(C) by inserting after paragraph (2) the following:
``(3) collaborate with the Director of the National
Institute on Drug Abuse, the Director of the National Institute
on Alcohol Abuse and Alcoholism, and States to promote the study
of substance abuse prevention and the dissemination and
implementation of research findings that will improve the
delivery and effectiveness of substance abuse prevention
activities;'';
(D) in paragraph (4), as so redesignated, by
striking ``literature on the adverse effects of cocaine
free base (known as crack)'' and inserting ``educational
information on the effects of drugs abused by
individuals, including drugs that are emerging as abused
drugs'';
(E) in paragraph (6), as so redesignated--
(i) by striking ``substance abuse counselors''
and inserting ``health professionals who provide
substance use and misuse prevention and treatment
services''; and
(ii) by striking ``drug abuse education,
prevention,'' and inserting ``illicit drug use
education and prevention'';
(F) by amending paragraph (7), as so redesignated,
to read as follows:
``(7) in cooperation with the Director of the Centers for
Disease Control and Prevention, develop and disseminate
educational materials to increase awareness for individuals at
greatest risk for substance use disorders to prevent the
transmission of communicable diseases, such as HIV, hepatitis,
tuberculosis, and other communicable diseases;'';
(G) in paragraph (9), as so redesignated--
(i) by striking ``to discourage'' and
inserting ``that reduce the risk of''; and
(ii) by inserting before the semicolon ``and
promote resiliency'';
(H) in paragraph (11), as so redesignated, by
striking ``and'' after the semicolon;
(I) in paragraph (12), as so redesignated, by
striking the period and inserting a semicolon; and
(J) by adding at the end the following:
``(13) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded; and
``(14) assist and support States in preventing illicit drug
use, including emerging illicit drug use issues.''.
[[Page 130 STAT. 1214]]
(c) Director of the Center for Substance Abuse Treatment.--Section
507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
(1) in subsection (a)--
(A) by striking ``treatment of substance abuse'' and
inserting ``treatment of substance use disorders''; and
(B) by striking ``abuse treatment systems'' and
inserting ``use disorder treatment systems''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and
inserting ``use disorder'';
(B) in paragraph (3), by striking ``abuse'' and
inserting ``use disorder'';
(C) in paragraph (4), by striking ``individuals who
abuse drugs'' and inserting ``individuals who illicitly
use drugs'';
(D) in paragraph (9), by striking ``carried out by
the Director'';
(E) by striking paragraph (10);
(F) by redesignating paragraphs (11) through (14) as
paragraphs (10) through (13), respectively;
(G) in paragraph (12), as so redesignated, by
striking ``; and'' and inserting a semicolon; and
(H) by striking paragraph (13), as so redesignated,
and inserting the following:
``(13) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded; and
``(14) work with States, providers, and individuals in
recovery, and their families, to promote the expansion of
recovery support services and systems of care oriented toward
recovery.''.
SEC. 6008. ADVISORY COUNCILS.
Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
1(b)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (E), by striking ``and'' after
the semicolon;
(B) by redesignating subparagraph (F) as
subparagraph (J); and
(C) by inserting after subparagraph (E), the
following:
``(F) the Chief Medical Officer, appointed under
section 501(g);
``(G) the Director of the National Institute of
Mental Health for the advisory councils appointed under
subsections (a)(1)(A) and (a)(1)(D);
``(H) the Director of the National Institute on Drug
Abuse for the advisory councils appointed under
subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
``(I) the Director of the National Institute on
Alcohol Abuse and Alcoholism for the advisory councils
appointed under subsections (a)(1)(A), (a)(1)(B), and
(a)(1)(C); and''; and
(2) in paragraph (3), by adding at the end the following:
``(C) Not less than half of the members of the
advisory council appointed under subsection (a)(1)(D)--
``(i) shall--
[[Page 130 STAT. 1215]]
``(I) have a medical degree;
``(II) have a doctoral degree in
psychology; or
``(III) have an advanced degree in
nursing or social work from an
accredited graduate school or be a
certified physician assistant; and
``(ii) shall specialize in the mental health
field.
``(D) Not less than half of the members of the
advisory councils appointed under subsections (a)(1)(B)
and (a)(1)(C)--
``(i) shall--
``(I) have a medical degree;
``(II) have a doctoral degree; or
``(III) have an advanced degree in
nursing, public health, behavioral or
social sciences, or social work from an
accredited graduate school or be a
certified physician assistant; and
``(ii) shall have experience in the provision
of substance use disorder services or the
development and implementation of programs to
prevent substance misuse.''.
SEC. 6009. PEER REVIEW.
Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
3(b)) is amended by adding at the end the following: ``In the case of
any such peer review group that is reviewing a grant, cooperative
agreement, or contract related to mental illness treatment, not less
than half of the members of such peer review group shall be licensed and
experienced professionals in the prevention, diagnosis, or treatment of,
or recovery from, mental illness or co-occurring mental illness and
substance use disorders and have a medical degree, a doctoral degree in
psychology, or an advanced degree in nursing or social work from an
accredited program, and the Secretary, in consultation with the
Assistant Secretary, shall, to the extent possible, ensure such peer
review groups include broad geographic representation, including both
urban and rural representatives.''.
Subtitle B--Oversight and Accountability
SEC. 6021. <<NOTE: 42 USC 290aa note.>> IMPROVING OVERSIGHT OF
MENTAL AND SUBSTANCE USE DISORDERS
PROGRAMS THROUGH THE ASSISTANT SECRETARY
FOR PLANNING AND EVALUATION.
(a) In General.--The Secretary of Health and Human Services, acting
through the Assistant Secretary for Planning and Evaluation, shall
ensure efficient and effective planning and evaluation of mental and
substance use disorders prevention and treatment programs and related
activities.
(b) Evaluation Strategy.--In carrying out subsection (a), the
Assistant Secretary for Planning and Evaluation shall, not later than
180 days after the date of enactment of this Act, develop a strategy for
conducting ongoing evaluations that identifies priority programs to be
evaluated by the Assistant Secretary for Planning and Evaluation and
priority programs to be evaluated by other relevant offices and agencies
within the Department of Health and Human Services. The strategy shall--
[[Page 130 STAT. 1216]]
(1) include a plan for evaluating programs related to mental
and substance use disorders, including co-occurring disorders,
across agencies, as appropriate, including programs related to--
(A) prevention, intervention, treatment, and
recovery support services, including such services for
adults with a serious mental illness or children with a
serious emotional disturbance;
(B) the reduction of homelessness and incarceration
among individuals with a mental or substance use
disorder; and
(C) public health and health services; and
(2) include a plan for assessing the use of performance
metrics to evaluate activities carried out by entities receiving
grants, contracts, or cooperative agreements related to mental
and substance use disorders prevention and treatment services
under title V or title XIX of the Public Health Service Act (42
U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
(c) Consultation.--In carrying out this section, the Assistant
Secretary for Planning and Evaluation shall consult, as appropriate,
with the Assistant Secretary for Mental Health and Substance Use, the
Chief Medical Officer of the Substance Abuse and Mental Health Services
Administration appointed under section 501(g) of the Public Health
Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
Behavioral Health Coordinating Council of the Department of Health and
Human Services, other agencies within the Department of Health and Human
Services, and other relevant Federal departments and agencies.
(d) Recommendations.--In carrying out this section, the Assistant
Secretary for Planning and Evaluation shall provide recommendations to
the Secretary of Health and Human Services, the Assistant Secretary for
Mental Health and Substance Use, and the Congress on improving the
quality of prevention and treatment programs and activities related to
mental and substance use disorders, including recommendations for the
use of performance metrics. The Assistant Secretary for Mental Health
and Substance Use shall include such recommendations in the biennial
report required by subsection 501(m) of the Public Health Service Act,
as redesignated by section 6003 of this Act.
SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
(a) Public Availability of Reports.--Section 105(a)(7) of the
Protection and Advocacy for Individuals with Mental Illness Act (42
U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and
inserting ``is located, and make publicly available, a report''.
(b) Detailed Accounting.--Section 114(a) of the Protection and
Advocacy for Individuals with Mental Illness Act (42 U.S.C. 10824(a)) is
amended--
(1) in paragraph (3), by striking ``and'' at the end;
(2) in paragraph (4), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(5) using data from the existing required annual program
progress reports submitted by each system funded under this
title, a detailed accounting for each such system of how funds
are spent, disaggregated according to whether the funds were
[[Page 130 STAT. 1217]]
received from the Federal Government, the State government, a
local government, or a private entity.''.
SEC. 6023. GAO STUDY.
(a) In General.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United States, in
consultation with the Secretary of Health and Human Services and the
Assistant Secretary for Mental Health and Substance Use, shall conduct
an independent evaluation, and submit a report, to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, on programs
funded by allotments made under title I of the Protection and Advocacy
for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
(b) Contents.--The report and evaluation required under subsection
(a) shall include--
(1) a review of the programs described in such subsection
that are carried out by State agencies and such programs that
are carried out by private, nonprofit organizations; and
(2) a review of the compliance of the programs described in
subsection (a) with statutory and regulatory responsibilities,
such as--
(A) responsibilities relating to family engagement;
(B) responsibilities relating to the grievance
procedure for clients or prospective clients of the
system to assure that individuals with mental illness
have full access to the services of the system, for
individuals who have received or are receiving mental
health services, and for family members of such
individuals with mental illness, or representatives of
such individuals or family members, to assure that the
eligible system is operating in compliance with the
provisions of the Protection and Advocacy for
Individuals with Mental Illness Act, as required to be
established by section 105(a)(9) of such Act (42 U.S.C.
10805(a)(9));
(C) investigation of alleged abuse and neglect of
persons with mental illness;
(D) availability of adequate medical and behavioral
health treatment;
(E) denial of rights for persons with mental
illness; and
(F) compliance with the Federal prohibition on
lobbying.
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
COMMITTEE.
(a) Establishment.--
(1) In general.--Not later than 3 months after the date of
enactment of this Act, the Secretary of Health and Human
Services, or the designee of the Secretary, shall establish a
committee to be known as the Interdepartmental Serious Mental
Illness Coordinating Committee (in this section referred to as
the ``Committee'').
[[Page 130 STAT. 1218]]
(2) Federal advisory committee act.--Except as provided in
this section, the provisions of the Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Committee.
(b) Meetings.--The Committee shall meet not fewer than 2 times each
year.
(c) Responsibilities.--Not later than 1 year after the date of
enactment of this Act, and 5 years after such date of enactment, the
Committee shall submit to Congress and any other relevant Federal
department or agency a report including--
(1) a summary of advances in serious mental illness and
serious emotional disturbance research related to the prevention
of, diagnosis of, intervention in, and treatment and recovery of
serious mental illnesses, serious emotional disturbances, and
advances in access to services and support for adults with a
serious mental illness or children with a serious emotional
disturbance;
(2) an evaluation of the effect Federal programs related to
serious mental illness have on public health, including public
health outcomes such as--
(A) rates of suicide, suicide attempts, incidence
and prevalence of serious mental illnesses, serious
emotional disturbances, and substance use disorders,
overdose, overdose deaths, emergency hospitalizations,
emergency room boarding, preventable emergency room
visits, interaction with the criminal justice system,
homelessness, and unemployment;
(B) increased rates of employment and enrollment in
educational and vocational programs;
(C) quality of mental and substance use disorders
treatment services; or
(D) any other criteria as may be determined by the
Secretary; and
(3) specific recommendations for actions that agencies can
take to better coordinate the administration of mental health
services for adults with a serious mental illness or children
with a serious emotional disturbance.
(d) Committee Extension.--Upon the submission of the second report
under subsection (c), the Secretary shall submit a recommendation to
Congress on whether to extend the operation of the Committee.
(e) Membership.--
(1) Federal members.--The Committee shall be composed of the
following Federal representatives, or the designees of such
representatives--
(A) the Secretary of Health and Human Services, who
shall serve as the Chair of the Committee;
(B) the Assistant Secretary for Mental Health and
Substance Use;
(C) the Attorney General;
(D) the Secretary of Veterans Affairs;
(E) the Secretary of Defense;
(F) the Secretary of Housing and Urban Development;
(G) the Secretary of Education;
(H) the Secretary of Labor;
(I) the Administrator of the Centers for Medicare &
Medicaid Services; and
(J) the Commissioner of Social Security.
[[Page 130 STAT. 1219]]
(2) Non-federal members.--The Committee shall also include
not less than 14 non-Federal public members appointed by the
Secretary of Health and Human Services, of which--
(A) at least 2 members shall be an individual who
has received treatment for a diagnosis of a serious
mental illness;
(B) at least 1 member shall be a parent or legal
guardian of an adult with a history of a serious mental
illness or a child with a history of a serious emotional
disturbance;
(C) at least 1 member shall be a representative of a
leading research, advocacy, or service organization for
adults with a serious mental illness;
(D) at least 2 members shall be--
(i) a licensed psychiatrist with experience in
treating serious mental illnesses;
(ii) a licensed psychologist with experience
in treating serious mental illnesses or serious
emotional disturbances;
(iii) a licensed clinical social worker with
experience treating serious mental illnesses or
serious emotional disturbances; or
(iv) a licensed psychiatric nurse, nurse
practitioner, or physician assistant with
experience in treating serious mental illnesses or
serious emotional disturbances;
(E) at least 1 member shall be a licensed mental
health professional with a specialty in treating
children and adolescents with a serious emotional
disturbance;
(F) at least 1 member shall be a mental health
professional who has research or clinical mental health
experience in working with minorities;
(G) at least 1 member shall be a mental health
professional who has research or clinical mental health
experience in working with medically underserved
populations;
(H) at least 1 member shall be a State certified
mental health peer support specialist;
(I) at least 1 member shall be a judge with
experience in adjudicating cases related to criminal
justice or serious mental illness;
(J) at least 1 member shall be a law enforcement
officer or corrections officer with extensive experience
in interfacing with adults with a serious mental
illness, children with a serious emotional disturbance,
or individuals in a mental health crisis; and
(K) at least 1 member shall have experience
providing services for homeless individuals and working
with adults with a serious mental illness, children with
a serious emotional disturbance, or individuals in a
mental health crisis.
(3) Terms.--A member of the Committee appointed under
subsection (e)(2) shall serve for a term of 3 years, and may be
reappointed for 1 or more additional 3-year terms. Any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A member may serve
after the expiration of the member's term until a successor has
been appointed.
[[Page 130 STAT. 1220]]
(f) Working Groups.--In carrying out its functions, the Committee
may establish working groups. Such working groups shall be composed of
Committee members, or their designees, and may hold such meetings as are
necessary.
(g) Sunset.--The Committee shall terminate on the date that is 6
years after the date on which the Committee is established under
subsection (a)(1).
TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
is amended by inserting after section 501 (42 U.S.C. 290aa) the
following:
``SEC. 501A. <<NOTE: 42 USC 290aa-0.>> NATIONAL MENTAL HEALTH AND
SUBSTANCE USE POLICY LABORATORY.
``(a) In General.--There shall be established within the
Administration a National Mental Health and Substance Use Policy
Laboratory (referred to in this section as the `Laboratory').
``(b) Responsibilities.--The Laboratory shall--
``(1) continue to carry out the authorities and activities
that were in effect for the Office of Policy, Planning, and
Innovation as such Office existed prior to the date of enactment
of the Helping Families in Mental Health Crisis Reform Act of
2016;
``(2) identify, coordinate, and facilitate the
implementation of policy changes likely to have a significant
effect on mental health, mental illness, recovery supports, and
the prevention and treatment of substance use disorder services;
``(3) work with the Center for Behavioral Health Statistics
and Quality to collect, as appropriate, information from
grantees under programs operated by the Administration in order
to evaluate and disseminate information on evidence-based
practices, including culturally and linguistically appropriate
services, as appropriate, and service delivery models;
``(4) provide leadership in identifying and coordinating
policies and programs, including evidence-based programs,
related to mental and substance use disorders;
``(5) periodically review programs and activities operated
by the Administration relating to the diagnosis or prevention
of, treatment for, and recovery from, mental and substance use
disorders to--
``(A) identify any such programs or activities that
are duplicative;
``(B) identify any such programs or activities that
are not evidence-based, effective, or efficient; and
``(C) formulate recommendations for coordinating,
eliminating, or improving programs or activities
identified
[[Page 130 STAT. 1221]]
under subparagraph (A) or (B) and merging such programs
or activities into other successful programs or
activities; and
``(6) carry out other activities as deemed necessary to
continue to encourage innovation and disseminate evidence-based
programs and practices.
``(c) Evidence-Based Practices and Service Delivery Models.--
``(1) In general.--In carrying out subsection (b)(3), the
Laboratory--
``(A) may give preference to models that improve--
``(i) the coordination between mental health
and physical health providers;
``(ii) the coordination among such providers
and the justice and corrections system; and
``(iii) the cost effectiveness, quality,
effectiveness, and efficiency of health care
services furnished to adults with a serious mental
illness, children with a serious emotional
disturbance, or individuals in a mental health
crisis; and
``(B) may include clinical protocols and practices
that address the needs of individuals with early serious
mental illness.
``(2) Consultation.--In carrying out this section, the
Laboratory shall consult with--
``(A) the Chief Medical Officer appointed under
section 501(g);
``(B) representatives of the National Institute of
Mental Health, the National Institute on Drug Abuse, and
the National Institute on Alcohol Abuse and Alcoholism,
on an ongoing basis;
``(C) other appropriate Federal agencies;
``(D) clinical and analytical experts with expertise
in psychiatric medical care and clinical psychological
care, health care management, education, corrections
health care, and mental health court systems, as
appropriate; and
``(E) other individuals and agencies as determined
appropriate by the Assistant Secretary.
``(d) Deadline for Beginning Implementation.--The Laboratory shall
begin implementation of this section not later than January 1, 2018.
``(e) Promoting Innovation.--
``(1) In general.--The Assistant Secretary, in coordination
with the Laboratory, may award grants to States, local
governments, Indian tribes or tribal organizations (as such
terms are defined in section 4 of the Indian Self-Determination
and Education Assistance Act), educational institutions, and
nonprofit organizations to develop evidence-based interventions,
including culturally and linguistically appropriate services, as
appropriate, for--
``(A) evaluating a model that has been
scientifically demonstrated to show promise, but would
benefit from further applied development, for--
[[Page 130 STAT. 1222]]
``(i) enhancing the prevention, diagnosis,
intervention, and treatment of, and recovery from,
mental illness, serious emotional disturbances,
substance use disorders, and co-occurring illness
or disorders; or
``(ii) integrating or coordinating physical
health services and mental and substance use
disorders services; and
``(B) expanding, replicating, or scaling evidence-
based programs across a wider area to enhance effective
screening, early diagnosis, intervention, and treatment
with respect to mental illness, serious mental illness,
serious emotional disturbances, and substance use
disorders, primarily by--
``(i) applying such evidence-based programs to
the delivery of care, including by training staff
in effective evidence-based treatments; or
``(ii) integrating such evidence-based
programs into models of care across specialties
and jurisdictions.
``(2) Consultation.--In awarding grants under this
subsection, the Assistant Secretary shall, as appropriate,
consult with the Chief Medical Officer, appointed under section
501(g), the advisory councils described in section 502, the
National Institute of Mental Health, the National Institute on
Drug Abuse, and the National Institute on Alcohol Abuse and
Alcoholism, as appropriate.
``(3) Authorization of appropriations.--There are authorized
to be appropriated--
``(A) to carry out paragraph (1)(A), $7,000,000 for
the period of fiscal years 2018 through 2020; and
``(B) to carry out paragraph (1)(B), $7,000,000 for
the period of fiscal years 2018 through 2020.''.
SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
PROGRAMS AND PRACTICES.
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
et seq.) is amended by inserting after section 543 of such Act (42
U.S.C. 290dd-2) the following:
``SEC. 543A. <<NOTE: 42 USC 290dd-2a.>> PROMOTING ACCESS TO
INFORMATION ON EVIDENCE-BASED PROGRAMS
AND PRACTICES.
``(a) In General.--The Assistant Secretary shall, as appropriate,
improve access to reliable and valid information on evidence-based
programs and practices, including information on the strength of
evidence associated with such programs and practices, related to mental
and substance use disorders for States, local communities, nonprofit
entities, and other stakeholders, by posting on the Internet website of
the Administration information on evidence-based programs and practices
that have been reviewed by the Assistant Secretary in accordance with
the requirements of this section.
``(b) Applications.--
``(1) Application period.--In carrying out subsection (a),
the Assistant Secretary may establish a period for the
submission of applications for evidence-based programs and
practices to be posted publicly in accordance with subsection
(a).
``(2) Notice.--In establishing the application period under
paragraph (1), the Assistant Secretary shall provide for the
public notice of such application period in the Federal
Register.
[[Page 130 STAT. 1223]]
Such notice may solicit applications for evidence-based programs
and practices to address gaps in information identified by the
Assistant Secretary, the National Mental Health and Substance
Use Policy Laboratory established under section 501A, or the
Assistant Secretary for Planning and Evaluation, including
pursuant to the evaluation and recommendations under section
6021 of the Helping Families in Mental Health Crisis Reform Act
of 2016 or priorities identified in the strategic plan under
section 501(l).
``(c) Requirements.--The Assistant Secretary may establish minimum
requirements for the applications submitted under subsection (b),
including applications related to the submission of research and
evaluation.
``(d) Review and Rating.--
``(1) In general.--The Assistant Secretary shall review
applications prior to public posting in accordance with
subsection (a), and may prioritize the review of applications
for evidence-based programs and practices that are related to
topics included in the notice provided under subsection (b)(2).
``(2) System.--In carrying out paragraph (1), the Assistant
Secretary may utilize a rating and review system, which may
include information on the strength of evidence associated with
the evidence-based programs and practices and a rating of the
methodological rigor of the research supporting the
applications.
``(3) Public access to metrics and rating.--The Assistant
Secretary shall make the metrics used to evaluate applications
under this section, and any resulting ratings of such
applications, publicly available.''.
SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
SIGNIFICANCE.
Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32)
is amended--
(1) in subsection (a)--
(A) in paragraph (4), by inserting before the period
``, which may include technical assistance centers'';
and
(B) in the flush sentence following paragraph (4)--
(i) by inserting ``, contracts,'' before ``or
cooperative agreements''; and
(ii) by striking ``Indian tribes and tribal
organizations'' and inserting ``Indian tribes or
tribal organizations (as such terms are defined in
section 4 of the Indian Self-Determination and
Education Assistance Act), health facilities, or
programs operated by or in accordance with a
contract or grant with the Indian Health Service,
or''; and
(2) by amending subsection (f) to read as follows:
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $394,550,000 for each of fiscal
years 2018 through 2022.''.
SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
amended--
(1) in subsection (a)--
[[Page 130 STAT. 1224]]
(A) in the matter preceding paragraph (1), by
striking ``abuse'' and inserting ``use disorder'';
(B) in paragraph (3), by inserting before the period
``that permit States, local governments, communities,
and Indian tribes and tribal organizations (as the terms
`Indian tribes' and `tribal organizations' are defined
in section 4 of the Indian Self-Determination and
Education Assistance Act) to focus on emerging trends in
substance abuse and co-occurrence of substance use
disorders with mental illness or other conditions''; and
(C) in the flush sentence following paragraph (3)--
(i) by inserting ``, contracts,'' before ``or
cooperative agreements''; and
(ii) by striking ``Indian tribes and tribal
organizations,'' and inserting ``Indian tribes or
tribal organizations (as such terms are defined in
section 4 of the Indian Self-Determination and
Education Assistance Act), health facilities, or
programs operated by or in accordance with a
contract or grant with the Indian Health Service,
or'';
(2) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and
inserting ``use disorder''; and
(B) in paragraph (2), by striking ``abuse'' and
inserting ``use disorder'';
(3) in subsection (e), by striking ``abuse'' and inserting
``use disorder''; and
(4) in subsection (f), by striking ``$300,000,000'' and all
that follows through the period and inserting ``$333,806,000 for
each of fiscal years 2018 through 2022.''.
SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
amended--
(1) in the section heading, by striking ``abuse'' and
inserting ``use disorder'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``abuse'' and inserting ``use disorder'';
(B) in paragraph (3), by inserting before the period
``, including such programs that focus on emerging drug
abuse issues''; and
(C) in the flush sentence following paragraph (3)--
(i) by inserting ``, contracts,'' before ``or
cooperative agreements''; and
(ii) by striking ``Indian tribes and tribal
organizations,'' and inserting ``Indian tribes or
tribal organizations (as such terms are defined in
section 4 of the Indian Self-Determination and
Education Assistance Act), health facilities, or
programs operated by or in accordance with a
contract or grant with the Indian Health
Service,'';
(3) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and
inserting ``use disorder''; and
(B) in paragraph (2)--
[[Page 130 STAT. 1225]]
(i) in subparagraph (A), by striking ``; and''
at the end and inserting ``;'';
(ii) in subparagraph (B)--
(I) by striking ``abuse'' and
inserting ``use disorder''; and
(II) by striking the period and
inserting ``; and''; and
(iii) by adding at the end the following:
``(C) substance use disorder prevention among high-
risk groups.'';
(4) in subsection (e), by striking ``abuse'' and inserting
``use disorder''; and
(5) in subsection (f), by striking ``$300,000,000'' and all
that follows through the period and inserting ``$211,148,000 for
each of fiscal years 2018 through 2022.''.
TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
(a) Formula Grants.--Section 1911(b) of the Public Health Service
Act (42 U.S.C. 300x(b)) is amended--
(1) by redesignating paragraphs (1) through (3) as
paragraphs (2) through (4), respectively; and
(2) by inserting before paragraph (2) (as so redesignated)
the following:
``(1) providing community mental health services for adults
with a serious mental illness and children with a serious
emotional disturbance as defined in accordance with section
1912(c);''.
(b) State Plan.--Section 1912(b) of the Public Health Service Act
(42 U.S.C. 300x-1(b)) is amended--
(1) in paragraph (3), by redesignating subparagraphs (A)
through (C) as clauses (i) through (iii), respectively, and
realigning the margins accordingly;
(2) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively, and realigning the
margins accordingly;
(3) in the matter preceding subparagraph (A) (as so
redesignated), by striking ``With respect to'' and all that
follows through ``are as follows:'' and inserting ``In
accordance with subsection (a), a State shall submit to the
Secretary a plan every two years that, at a minimum, includes
each of the following:'';
(4) by inserting before subparagraph (A) (as so
redesignated) the following:
``(1) System of care.--A description of the State's system
of care that contains the following:'';
(5) by striking subparagraph (A) (as so redesignated) and
inserting the following:
``(A) Comprehensive community-based health
systems.--The plan shall--
[[Page 130 STAT. 1226]]
``(i) identify the single State agency to be
responsible for the administration of the program
under the grant, including any third party who
administers mental health services and is
responsible for complying with the requirements of
this part with respect to the grant;
``(ii) provide for an organized community-
based system of care for individuals with mental
illness, and describe available services and
resources in a comprehensive system of care,
including services for individuals with co-
occurring disorders;
``(iii) include a description of the manner in
which the State and local entities will coordinate
services to maximize the efficiency,
effectiveness, quality, and cost-effectiveness of
services and programs to produce the best possible
outcomes (including health services,
rehabilitation services, employment services,
housing services, educational services, substance
use disorder services, legal services, law
enforcement services, social services, child
welfare services, medical and dental care
services, and other support services to be
provided with Federal, State, and local public and
private resources) with other agencies to enable
individuals receiving services to function outside
of inpatient or residential institutions, to the
maximum extent of their capabilities, including
services to be provided by local school systems
under the Individuals with Disabilities Education
Act;
``(iv) include a description of how the State
promotes evidence-based practices, including those
evidence-based programs that address the needs of
individuals with early serious mental illness
regardless of the age of the individual at onset,
provide comprehensive individualized treatment, or
integrate mental and physical health services;
``(v) include a description of case management
services;
``(vi) include a description of activities
that seek to engage adults with a serious mental
illness or children with a serious emotional
disturbance and their caregivers where appropriate
in making health care decisions, including
activities that enhance communication among
individuals, families, caregivers, and treatment
providers; and
``(vii) as appropriate to, and reflective of,
the uses the State proposes for the block grant
funds, include--
``(I) a description of the
activities intended to reduce
hospitalizations and hospital stays
using the block grant funds;
``(II) a description of the
activities intended to reduce incidents
of suicide using the block grant funds;
``(III) a description of how the
State integrates mental health and
primary care using the block grant
funds, which may include providing, in
the case of individuals with co-
occurring mental and
[[Page 130 STAT. 1227]]
substance use disorders, both mental and
substance use disorders services in
primary care settings or arrangements to
provide primary and specialty care
services in community-based mental and
substance use disorders settings; and
``(IV) a description of recovery and
recovery support services for adults
with a serious mental illness and
children with a serious emotional
disturbance.'';
(6) in subparagraph (B) (as so redesignated)--
(A) by striking ``The plan contains'' and inserting
``The plan shall contain''; and
(B) by striking ``presents quantitative targets to
be achieved in the implementation of the system
described in paragraph (1)'' and inserting ``present
quantitative targets and outcome measures for programs
and services provided under this subpart'';
(7) in subparagraph (C) (as so redesignated)--
(A) by striking ``serious emotional disturbance'' in
the matter preceding clause (i) (as so redesignated) and
all that follows through ``substance abuse services'' in
clause (i) (as so redesignated) and inserting the
following: ``a serious emotional disturbance (as defined
pursuant to subsection (c)), the plan shall provide for
a system of integrated social services, educational
services, child welfare services, juvenile justice
services, law enforcement services, and substance use
disorder services'';
(B) by striking ``Education Act);'' and inserting
``Education Act).''; and
(C) by striking clauses (ii) and (iii) (as so
redesignated);
(8) in subparagraph (D) (as so redesignated), by striking
``plan describes'' and inserting ``plan shall describe'';
(9) in subparagraph (E) (as so redesignated)--
(A) in the subparagraph heading by striking
``systems'' and inserting ``services'';
(B) in the first sentence, by striking ``plan
describes'' and all that follows through ``and provides
for'' and inserting ``plan shall describe the financial
resources available, the existing mental health
workforce, and the workforce trained in treating
individuals with co-occurring mental and substance use
disorders, and shall provide for''; and
(C) in the second sentence--
(i) by striking ``further describes'' and
inserting ``shall further describe''; and
(ii) by striking ``involved.'' and inserting
``involved, and the manner in which the State
intends to comply with each of the funding
agreements in this subpart and subpart III.'';
(10) by striking the flush matter at the end; and
(11) by adding at the end the following:
``(2) Goals and objectives.--The establishment of goals and
objectives for the period of the plan, including targets and
milestones that are intended to be met, and the activities that
will be undertaken to achieve those targets.''.
[[Page 130 STAT. 1228]]
(c) Early Serious Mental Illness.--Section 1920 of the Public Health
Service Act (42 U.S.C. 300x-9) is amended by adding at the end the
following:
``(c) Early Serious Mental Illness.--
``(1) In general.--Except as provided in paragraph (2), a
State shall expend not less than 10 percent of the amount the
State receives for carrying out this section for each fiscal
year to support evidence-based programs that address the needs
of individuals with early serious mental illness, including
psychotic disorders, regardless of the age of the individual at
onset.
``(2) State flexibility.--In lieu of expending 10 percent of
the amount the State receives under this section for a fiscal
year as required under paragraph (1), a State may elect to
expend not less than 20 percent of such amount by the end of
such succeeding fiscal year.''.
(d) Additional Provisions.--Section 1915(b) of the Public Health
Service Act (42 U.S.C. 300x-4(b)) is amended--
(1) in paragraph (3)--
(A) by striking ``The Secretary'' and inserting the
following:
``(A) In general.--The Secretary'';
(B) by striking ``paragraph (1) if'' and inserting
``paragraph (1) in whole or in part if'';
(C) by striking ``State justify the waiver.'' and
inserting ``State in the fiscal year involved or in the
previous fiscal year justify the waiver''; and
(D) by adding at the end the following:
``(B) Date certain for action upon request.--The
Secretary shall approve or deny a request for a waiver
under this paragraph not later than 120 days after the
date on which the request is made.
``(C) Applicability of waiver.--A waiver provided by
the Secretary under this paragraph shall be applicable
only to the fiscal year involved.''; and
(2) in paragraph (4)--
(A) in subparagraph (A)--
(i) by inserting after the subparagraph
designation the following: ``In general.--'';
(ii) by striking ``In making a grant'' and
inserting the following:
``(i) Determination.--In making a grant''; and
(iii) by inserting at the end the following:
``(ii) Alternative.--A State that has failed
to comply with paragraph (1) and would otherwise
be subject to a reduction in the State's allotment
under section 1911 may, upon request by the State,
in lieu of having the amount of the allotment
under section 1911 for the State reduced for the
fiscal year of the grant, agree to comply with a
negotiated agreement that is approved by the
Secretary and carried out in accordance with
guidelines issued by the Secretary. If a State
fails to enter into or comply with a negotiated
agreement, the Secretary may take action under
this paragraph or the terms of the negotiated
agreement.''; and
(B) in subparagraph (B)--
[[Page 130 STAT. 1229]]
(i) by inserting after the subparagraph
designation the following: ``Submission of
information to the secretary.--''; and
(ii) by striking ``subparagraph (A)'' and
inserting ``subparagraph (A)(i)''.
(e) Application for Grant.--Section 1917(a) of the Public Health
Service Act (42 U.S.C. 300x-6(a)) is amended--
(1) in paragraph (1), by striking ``1941'' and inserting
``1942(a)''; and
(2) in paragraph (5), by striking ``1915(b)(3)(B)'' and
inserting ``1915(b)''.
(f) Funding.--Section 1920 of the Public Health Service Act (42
U.S.C. 300x-9) is amended--
(1) in subsection (a)--
(A) by striking ``section 505'' and inserting
``section 505(c)''; and
(B) by striking ``$450,000,000'' and all that
follows through the period and inserting ``$532,571,000
for each of fiscal years 2018 through 2022.''; and
(2) in subsection (b)(2) by striking ``sections 505 and''
and inserting ``sections 505(c) and''.
SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.
(a) Formula Grants.--Section 1921(b) of the Public Health Service
Act (42 U.S.C. 300x-21(b)) is amended--
(1) by inserting ``carrying out the plan developed in
accordance with section 1932(b) and for'' after ``for the
purpose of''; and
(2) by striking ``abuse'' and inserting ``use disorders''.
(b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the
Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
(1) in the subsection heading, by striking ``Regarding
Intravenous Substance Abuse'' and inserting ``to Persons Who
Inject Drugs''; and
(2) by striking ``for intravenous drug abuse'' and inserting
``for persons who inject drugs''.
(c) Requirements Regarding Tuberculosis and Human Immunodeficiency
Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
24) is amended--
(1) in subsection (a)(1)--
(A) in the matter preceding subparagraph (A), by
striking ``substance abuse'' and inserting ``substance
use disorders''; and
(B) in subparagraph (A), by striking ``such abuse''
and inserting ``such disorders'';
(2) in subsection (b)--
(A) in paragraph (1)(A), by striking ``substance
abuse'' and inserting ``substance use disorders'';
(B) in paragraph (2), by inserting ``and
Prevention'' after ``Disease Control'';
(C) in paragraph (3)--
(i) in the paragraph heading, by striking
``abuse'' and inserting ``use disorders''; and
(ii) by striking ``substance abuse'' and
inserting ``substance use disorders''; and
[[Page 130 STAT. 1230]]
(D) in paragraph (6)(B), by striking ``substance
abuse'' and inserting ``substance use disorders'';
(3) by striking subsection (d); and
(4) by redesignating subsection (e) as subsection (d).
(d) Group Homes.--Section 1925 of the Public Health Service Act (42
U.S.C. 300x-25) is amended--
(1) in the section heading, by striking ``recovering
substance abusers'' and inserting ``persons in recovery from
substance use disorders''; and
(2) in subsection (a), in the matter preceding paragraph
(1), by striking ``recovering substance abusers'' and inserting
``persons in recovery from substance use disorders''.
(e) Additional Agreements.--Section 1928 of the Public Health
Service Act (42 U.S.C. 300x-28) is amended--
(1) in subsection (a), by striking ``(relative to fiscal
year 1992)'';
(2) by striking subsection (b) and inserting the following:
``(b) Professional Development.--A funding agreement for a grant
under section 1921 is that the State involved will ensure that
prevention, treatment, and recovery personnel operating in the State's
substance use disorder prevention, treatment, and recovery systems have
an opportunity to receive training, on an ongoing basis, concerning--
``(1) recent trends in substance use disorders in the State;
``(2) improved methods and evidence-based practices for
providing substance use disorder prevention and treatment
services;
``(3) performance-based accountability;
``(4) data collection and reporting requirements; and
``(5) any other matters that would serve to further improve
the delivery of substance use disorder prevention and treatment
services within the State.''; and
(3) in subsection (d)(1), by striking ``substance abuse''
and inserting ``substance use disorders''.
(f) Repeal.--Section 1929 of the Public Health Service Act (42
U.S.C. 300x-29) is repealed.
(g) Maintenance of Effort.--Section 1930 of the Public Health
Service Act (42 U.S.C. 300x-30) is amended--
(1) in subsection (c)(1), by striking ``in the State justify
the waiver'' and inserting ``exist in the State, or any part of
the State, to justify the waiver''; and
(2) in subsection (d), by inserting at the end the
following:
``(3) Alternative.--A State that has failed to comply with
this section and would otherwise be subject to a reduction in
the State's allotment under section 1921, may, upon request by
the State, in lieu of having the State's allotment under section
1921 reduced, agree to comply with a negotiated agreement that
is approved by the Secretary and carried out in accordance with
guidelines issued by the Secretary. If a State fails to enter
into or comply with a negotiated agreement, the Secretary may
take action under this paragraph or the terms of the negotiated
agreement.''.
(h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public
Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking
``substance abuse'' and inserting ``substance use disorders''.
[[Page 130 STAT. 1231]]
(i) Application.--Section 1932 of the Public Health Service Act (42
U.S.C. 300x-32) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``subsections (c) and (d)(2)'' and inserting
``subsection (c)''; and
(B) in paragraph (5), by striking ``the information
required in section 1929, the information required in
section 1930(c)(2), and'';
(2) in subsection (b)--
(A) by striking paragraph (1) and inserting the
following:
``(1) In general.--In order for a State to be in compliance
with subsection (a)(6), the State shall submit to the Secretary
a plan that, at a minimum, includes the following:
``(A) A description of the State's system of care
that--
``(i) identifies the single State agency
responsible for the administration of the program,
including any third party who administers
substance use disorder services and is responsible
for complying with the requirements of the grant;
``(ii) provides information on the need for
substance use disorder prevention and treatment
services in the State, including estimates on the
number of individuals who need treatment, who are
pregnant women, women with dependent children,
individuals with a co-occurring mental health and
substance use disorder, persons who inject drugs,
and persons who are experiencing homelessness;
``(iii) provides aggregate information on the
number of individuals in treatment within the
State, including the number of such individuals
who are pregnant women, women with dependent
children, individuals with a co-occurring mental
health and substance use disorder, persons who
inject drugs, and persons who are experiencing
homelessness;
``(iv) provides a description of the system
that is available to provide services by modality,
including the provision of recovery support
services;
``(v) provides a description of the State's
comprehensive statewide prevention efforts,
including the number of individuals being served
in the system, target populations, and priority
needs, and provides a description of the amount of
funds from the prevention set-aside expended on
primary prevention;
``(vi) provides a description of the financial
resources available;
``(vii) describes the existing substance use
disorders workforce and workforce trained in
treating co-occurring substance use and mental
disorders;
``(viii) includes a description of how the
State promotes evidence-based practices; and
``(ix) describes how the State integrates
substance use disorder services and primary health
care, which in the case of those individuals with
co-occurring mental health and substance use
disorders may include
[[Page 130 STAT. 1232]]
providing both mental health and substance use
disorder services in primary care settings or
providing primary and specialty care services in
community-based mental health and substance use
disorder service settings.
``(B) The establishment of goals and objectives for
the period of the plan, including targets and milestones
that are intended to be met, and the activities that
will be undertaken to achieve those targets.
``(C) A description of how the State will comply
with each funding agreement for a grant under section
1921 that is applicable to the State, including a
description of the manner in which the State intends to
expend grant funds.''; and
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``authority of secretary regarding modifications''
and inserting ``modifications'';
(ii) by striking ``As a condition'' and
inserting the following:
``(A) Authority of secretary.--As a condition;'';
and
(iii) by adding at the end the following:
``(B) State request for modification.--If the State
determines that a modification to such plan is
necessary, the State may request the Secretary to
approve the modification. Any such modification shall be
in accordance with paragraph (1) and section 1941.'';
and
(C) in paragraph (3), by inserting, ``, including
any modification under paragraph (2)'' after
``subsection (a)(6)''; and
(3) in subsection (e)(2), by striking ``section 1922(c)''
and inserting ``section 1922(b)''.
(j) Definitions.--Section 1934 of the Public Health Service Act (42
U.S.C. 300x-34) is amended--
(1) in paragraph (3), by striking ``substance abuse'' and
inserting ``substance use disorders''; and
(2) in paragraph (7), by striking ``substance abuse'' and
inserting ``substance use disorders''.
(k) Funding.--Section 1935 of the Public Health Service Act (42
U.S.C. 300x-35) is amended--
(1) in subsection (a)--
(A) by striking ``section 505'' and inserting
``section 505(d)''; and
(B) by striking ``$2,000,000,000 for fiscal year
2001, and such sums as may be necessary for each of the
fiscal years 2002 and 2003'' and inserting
``$1,858,079,000 for each of fiscal years 2018 through
2022.''; and
(2) in subsection (b)(1)(B) by striking ``sections 505 and''
and inserting ``sections 505(d) and''.
SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
Subpart III of part B of title XIX of the Public Health Service Act
(42 U.S.C. 300x-51 et seq.) is amended--
(1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
striking ``section 505'' and inserting ``subsections (c) and (d)
of section 505'';
[[Page 130 STAT. 1233]]
(2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
``substance abuse'' and inserting ``substance use disorder'';
and
(3) by adding at the end the following:
``SEC. 1957. <<NOTE: 42 USC 300x-67.>> PUBLIC HEALTH EMERGENCIES.
``In the case of a public health emergency (as determined under
section 319), the Secretary, on a State by State basis, may, as the
circumstances of the emergency reasonably require and for the period of
the emergency, grant an extension, or waive application deadlines or
compliance with any other requirement, of a grant authorized under
section 521, 1911, or 1921 or an allotment authorized under Public Law
99-319 (42 U.S.C. 10801 et seq.).
``SEC. 1958. <<NOTE: 42 USC 300x-68.>> JOINT APPLICATIONS.
``The Secretary, acting through the Assistant Secretary for Mental
Health and Substance Use, shall permit a joint application to be
submitted for grants under subpart I and subpart II upon the request of
a State. Such application may be jointly reviewed and approved by the
Secretary with respect to such subparts, consistent with the purposes
and authorized activities of each such grant program. A State submitting
such a joint application shall otherwise meet the requirements with
respect to each such subpart.''.
SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
ABUSE PREVENTION AND TREATMENT BLOCK
GRANT AND THE COMMUNITY MENTAL HEALTH
SERVICES BLOCK GRANT.
(a) In General.--The Secretary of Health and Human Services, acting
through the Assistant Secretary for Mental Health and Substance Use,
shall through a grant or contract, or through an agreement with a third
party, conduct a study on the formulas for distribution of funds under
the substance abuse prevention and treatment block grant, and the
community mental health services block grant, under part B of title XIX
of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend
changes if necessary. Such study shall include--
(1) an analysis of whether the distributions under such
block grants accurately reflect the need for the services under
the grants in the States;
(2) an examination of whether the indices used under the
formulas for distribution of funds under such block grants are
appropriate, and if not, alternatives recommended by the
Secretary;
(3) where recommendations are included under paragraph (2)
for the use of different indices, a description of the variables
and data sources that should be used to determine the indices;
(4) an evaluation of the variables and data sources that are
being used for each of the indices involved, and whether such
variables and data sources accurately represent the need for
services, the cost of providing services, and the ability of the
States to pay for such services;
(5) the effect that the minimum allotment requirements for
each such block grant have on each State's final allotment and
the effect of such requirements, if any, on each State's
formula-based allotment;
[[Page 130 STAT. 1234]]
(6) recommendations for modifications to the minimum
allotment provisions to ensure an appropriate distribution of
funds; and
(7) any other information that the Secretary determines
appropriate.
(b) Report.--Not later than 2 years after the date of enactment of
this Act, the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives, a
report containing the findings and recommendations of the study
conducted under subsection (a) and the study conducted under section
9004(g).
TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
CARE
Subtitle A--Helping Individuals and Families
SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
INDIVIDUALS.
Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is
amended--
(1) in subsection (a), by striking ``substance abuse'' and
inserting ``substance use disorder'';
(2) in subsection (b)--
(A) in paragraphs (1) and (3), by striking
``substance abuse'' each place the term appears and
inserting ``substance use disorder''; and
(B) in paragraph (4), by striking ``substance
abuse'' and inserting ``a substance use disorder'';
(3) in subsection (c)--
(A) in paragraph (1), by striking ``substance abuse
disorder'' and inserting ``substance use disorder''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking
``substance abuse'' and inserting ``a substance
use disorder''; and
(ii) in subparagraph (B), by striking
``substance abuse'' and inserting ``substance use
disorder''; and
(4) in subsection (e), by striking ``, $50,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003'' and inserting ``$41,304,000 for
each of fiscal years 2018 through 2022''.
SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38)
is amended--
(1) by striking ``substance abuse'' each place such term
appears and inserting ``substance use disorder'';
(2) in subsection (a)--
(A) by striking ``Indian tribes, and tribal
organizations'' and inserting ``and Indian tribes and
tribal organizations (as the terms `Indian tribes' and
`tribal organizations' are
[[Page 130 STAT. 1235]]
defined in section 4 of the Indian Self-Determination
and Education Assistance Act)''; and
(B) by inserting ``or a health facility or program
operated by or in accordance with a contract or grant
with the Indian Health Service,'' after ``entities,'';
(3) in subsection (c)(2)(A)(i), by striking ``the best
known'' and inserting ``evidence-based'';
(4) by redesignating subsections (d) through (i) as
subsections (e) through (j), respectively;
(5) by inserting after subsection (c) the following:
``(d) Special Consideration Regarding Veterans.--In awarding grants
under subsection (a), the Secretary shall, as appropriate, give special
consideration to entities proposing to use grant funding to support jail
diversion services for veterans.'';
(6) in subsection (e), as so redesignated--
(A) in paragraph (3), by striking ``; and'' and
inserting a semicolon;
(B) in paragraph (4), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(5) develop programs to divert individuals prior to
booking or arrest.''; and
(7) in subsection (j), as so redesignated, by striking
``$10,000,000 for fiscal year 2001, and such sums as may be
necessary for fiscal years 2002 through 2003'' and inserting
``$4,269,000 for each of fiscal years 2018 through 2022''.
SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH
CARE.
Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42)
is amended to read as follows:
``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
AGREEMENTS.
``(a) Definitions.--In this section:
``(1) Eligible entity.--The term `eligible entity' means a
State, or other appropriate State agency, in collaboration with
1 or more qualified community programs as described in section
1913(b)(1) or 1 or more community health centers as described in
section 330.
``(2) Integrated care.--The term `integrated care' means
collaborative models or practices offering mental and physical
health services, which may include practices that share the same
space in the same facility.
``(3) Special population.--The term `special population'
means--
``(A) adults with a mental illness who have co-
occurring physical health conditions or chronic
diseases;
``(B) adults with a serious mental illness who have
co-occurring physical health conditions or chronic
diseases;
``(C) children and adolescents with a serious
emotional disturbance with co-occurring physical health
conditions or chronic diseases; or
``(D) individuals with a substance use disorder.
``(b) Grants and Cooperative Agreements.--
``(1) In general.--The Secretary may award grants and
cooperative agreements to eligible entities to support the
[[Page 130 STAT. 1236]]
improvement of integrated care for primary care and behavioral
health care in accordance with paragraph (2).
``(2) Purposes.--A grant or cooperative agreement awarded
under this section shall be designed to--
``(A) promote full integration and collaboration in
clinical practices between primary and behavioral health
care;
``(B) support the improvement of integrated care
models for primary care and behavioral health care to
improve the overall wellness and physical health status
of adults with a serious mental illness or children with
a serious emotional disturbance; and
``(C) promote integrated care services related to
screening, diagnosis, prevention, and treatment of
mental and substance use disorders, and co-occurring
physical health conditions and chronic diseases.
``(c) Applications.--
``(1) In general.--An eligible entity seeking a grant or
cooperative agreement under this section shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may require,
including the contents described in paragraph (2).
``(2) Contents.--The contents described in this paragraph
are--
``(A) a description of a plan to achieve fully
collaborative agreements to provide services to special
populations;
``(B) a document that summarizes the policies, if
any, that serve as barriers to the provision of
integrated care, and the specific steps, if applicable,
that will be taken to address such barriers;
``(C) a description of partnerships or other
arrangements with local health care providers to provide
services to special populations;
``(D) an agreement and plan to report to the
Secretary performance measures necessary to evaluate
patient outcomes and facilitate evaluations across
participating projects; and
``(E) a plan for sustainability beyond the grant or
cooperative agreement period under subsection (e).
``(d) Grant and Cooperative Agreement Amounts.--
``(1) Target amount.--The target amount that an eligible
entity may receive for a year through a grant or cooperative
agreement under this section shall be $2,000,000.
``(2) Adjustment permitted.--The Secretary, taking into
consideration the quality of the application and the number of
eligible entities that received grants under this section prior
to the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, may adjust the target amount
that an eligible entity may receive for a year through a grant
or cooperative agreement under this section.
``(3) Limitation.--An eligible entity receiving funding
under this section may not allocate more than 10 percent of
funds awarded under this section to administrative functions,
and the remaining amounts shall be allocated to health
facilities that provide integrated care.
``(e) Duration.--A grant or cooperative agreement under this section
shall be for a period not to exceed 5 years.
[[Page 130 STAT. 1237]]
``(f) Report on Program Outcomes.--An eligible entity receiving a
grant or cooperative agreement under this section shall submit an annual
report to the Secretary that includes--
``(1) the progress made to reduce barriers to integrated
care as described in the entity's application under subsection
(c); and
``(2) a description of functional outcomes of special
populations, including--
``(A) with respect to adults with a serious mental
illness, participation in supportive housing or
independent living programs, attendance in social and
rehabilitative programs, participation in job training
opportunities, satisfactory performance in work
settings, attendance at scheduled medical and mental
health appointments, and compliance with prescribed
medication regimes;
``(B) with respect to individuals with co-occurring
mental illness and physical health conditions and
chronic diseases, attendance at scheduled medical and
mental health appointments, compliance with prescribed
medication regimes, and participation in learning
opportunities related to improved health and lifestyle
practices; and
``(C) with respect to children and adolescents with
a serious emotional disturbance who have co-occurring
physical health conditions and chronic diseases,
attendance at scheduled medical and mental health
appointments, compliance with prescribed medication
regimes, and participation in learning opportunities at
school and extracurricular activities.
``(g) Technical Assistance for Primary-Behavioral Health Care
Integration.--
``(1) In general.--The Secretary may provide appropriate
information, training, and technical assistance to eligible
entities that receive a grant or cooperative agreement under
this section, in order to help such entities meet the
requirements of this section, including assistance with--
``(A) development and selection of integrated care
models;
``(B) dissemination of evidence-based interventions
in integrated care;
``(C) establishment of organizational practices to
support operational and administrative success; and
``(D) other activities, as the Secretary determines
appropriate.
``(2) Additional dissemination of technical information.--
The information and resources provided by the Secretary under
paragraph (1) shall, as appropriate, be made available to
States, political subdivisions of States, Indian tribes or
tribal organizations (as defined in section 4 of the Indian
Self-Determination and Education Assistance Act), outpatient
mental health and addiction treatment centers, community mental
health centers that meet the criteria under section 1913(c),
certified community behavioral health clinics described in
section 223 of the Protecting Access to Medicare Act of 2014,
primary care organizations such as Federally qualified health
centers or rural health clinics as defined in section 1861(aa)
[[Page 130 STAT. 1238]]
of the Social Security Act, other community-based organizations,
or other entities engaging in integrated care activities, as the
Secretary determines appropriate.
``(h) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $51,878,000 for each of fiscal
years 2018 through 2022.''.
SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
HOMELESSNESS.
(a) Formula Grants to States.--Section 521 of the Public Health
Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through
1994'' and inserting ``2018 through 2022''.
(b) Purpose of Grants.--Section 522 of the Public Health Service Act
(42 U.S.C. 290cc-22) is amended--
(1) in subsection (a)(1)(B), by striking ``substance abuse''
and inserting ``a substance use disorder'';
(2) in subsection (b)(6), by striking ``substance abuse''
and inserting ``substance use disorder'';
(3) in subsection (c), by striking ``substance abuse'' and
inserting ``a substance use disorder'';
(4) in subsection (e)--
(A) in paragraph (1), by striking ``substance
abuse'' and inserting ``a substance use disorder''; and
(B) in paragraph (2), by striking ``substance
abuse'' and inserting ``substance use disorder'';
(5) by striking subsection (g) and redesignating subsections
(h) and (i) as (g) and (h), accordingly; and
(6) in subsection (g), as redesignated by paragraph (5), by
striking ``substance abuse'' each place such term appears and
inserting ``substance use disorder''.
(c) Description of Intended Expenditures of Grant.--Section 527 of
the Public Health Service Act (42 U.S.C. 290cc-27) is amended by
striking ``substance abuse'' each place such term appears and inserting
``substance use disorder''.
(d) Technical Assistance.--Section 530 of the Public Health Service
Act (42 U.S.C. 290cc-30) is amended by striking ``through the National
Institute of Mental Health, the National Institute of Alcohol Abuse and
Alcoholism, and the National Institute on Drug Abuse'' and inserting
``acting through the Assistant Secretary''.
(e) Definitions.--Section 534(4) of the Public Health Service Act
(42 U.S.C. 290cc-34(4)) is amended to read as follows:
``(4) Substance use disorder services.--The term `substance
use disorder services' has the meaning given the term `substance
abuse services' in section 330(h)(5)(C).''.
(f) Funding.--Section 535(a) of the Public Health Service Act (42
U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the
fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of
fiscal years 2018 through 2022''.
(g) Study Concerning Formula.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Assistant Secretary for Mental Health
and Substance Use (referred to in this section as the
``Assistant Secretary'') shall conduct a study concerning the
formula used under section 524 of the Public Health Service Act
(42 U.S.C. 290cc-24) for making allotments to States under
section 521 of such Act (42 U.S.C. 290cc-21). Such study shall
include an evaluation of quality indicators of need for purposes
[[Page 130 STAT. 1239]]
of revising the formula for determining the amount of each
allotment for the fiscal years following the submission of the
study.
(2) Report.--In accordance with section 8004(b), the
Assistant Secretary shall submit to the committees of Congress
described in such section a report concerning the results of the
study conducted under paragraph (1).
SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2
(42 U.S.C. 290bb-36b) the following:
``SEC. 520E-3. <<NOTE: 42 USC 290bb-36c.>> NATIONAL SUICIDE
PREVENTION LIFELINE PROGRAM.
``(a) In General.--The Secretary, acting through the Assistant
Secretary, shall maintain the National Suicide Prevention Lifeline
program (referred to in this section as the `program'), authorized under
section 520A and in effect prior to the date of enactment of the Helping
Families in Mental Health Crisis Reform Act of 2016.
``(b) Activities.--In maintaining the program, the activities of the
Secretary shall include--
``(1) coordinating a network of crisis centers across the
United States for providing suicide prevention and crisis
intervention services to individuals seeking help at any time,
day or night;
``(2) maintaining a suicide prevention hotline to link
callers to local emergency, mental health, and social services
resources; and
``(3) consulting with the Secretary of Veterans Affairs to
ensure that veterans calling the suicide prevention hotline have
access to a specialized veterans' suicide prevention hotline.
``(c) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $7,198,000 for each of fiscal
years 2018 through 2022.''.
SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb-31 et seq.), as amended by section 9005, is further amended
by inserting after section 520E-3 the following:
``SEC. 520E-4. <<NOTE: 42 USC 290bb-36d.>> TREATMENT REFERRAL
ROUTING SERVICE.
``(a) In General.--The Secretary, acting through the Assistant
Secretary, shall maintain the National Treatment Referral Routing
Service (referred to in this section as the `Routing Service') to assist
individuals and families in locating mental and substance use disorders
treatment providers.
``(b) Activities of the Secretary.--To maintain the Routing Service,
the activities of the Assistant Secretary shall include administering--
``(1) a nationwide, telephone number providing year-round
access to information that is updated on a regular basis
regarding local behavioral health providers and community-based
organizations in a manner that is confidential, without
requiring individuals to identify themselves, is in languages
that include at least English and Spanish, and is at no cost to
the individual using the Routing Service; and
[[Page 130 STAT. 1240]]
``(2) an Internet website to provide a searchable, online
treatment services locator of behavioral health treatment
providers and community-based organizations, which shall include
information on the name, location, contact information, and
basic services provided by such providers and organizations.
``(c) Removing Practitioner Contact Information.--In the event that
the Internet website described in subsection (b)(2) contains information
on any qualified practitioner that is certified to prescribe medication
for opioid dependency under section 303(g)(2)(B) of the Controlled
Substances Act, the Assistant Secretary--
``(1) shall provide an opportunity to such practitioner to
have the contact information of the practitioner removed from
the website at the request of the practitioner; and
``(2) may evaluate other methods to periodically update the
information displayed on such website.
``(d) Rule of Construction.--Nothing in this section shall be
construed to prevent the Assistant Secretary from using any unobligated
amounts otherwise made available to the Administration to maintain the
Routing Service.''.
SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37)
is amended to read as follows:
``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
``(a) In General.--The Secretary shall award competitive grants to--
``(1) State and local governments and Indian tribes and
tribal organizations, to enhance community-based crisis response
systems; or
``(2) States to develop, maintain, or enhance a database of
beds at inpatient psychiatric facilities, crisis stabilization
units, and residential community mental health and residential
substance use disorder treatment facilities, for adults with a
serious mental illness, children with a serious emotional
disturbance, or individuals with a substance use disorder.
``(b) Applications.--
``(1) In general.--To receive a grant under subsection (a),
an entity shall submit to the Secretary an application, at such
time, in such manner, and containing such information as the
Secretary may require.
``(2) Community-based crisis response plan.--An application
for a grant under subsection (a)(1) shall include a plan for--
``(A) promoting integration and coordination between
local public and private entities engaged in crisis
response, including first responders, emergency health
care providers, primary care providers, law enforcement,
court systems, health care payers, social service
providers, and behavioral health providers;
``(B) developing memoranda of understanding with
public and private entities to implement crisis response
services;
``(C) addressing gaps in community resources for
crisis intervention and prevention; and
[[Page 130 STAT. 1241]]
``(D) developing models for minimizing hospital
readmissions, including through appropriate discharge
planning.
``(3) Beds database plan.--An application for a grant under
subsection (a)(2) shall include a plan for developing,
maintaining, or enhancing a real-time, Internet-based bed
database to collect, aggregate, and display information about
beds in inpatient psychiatric facilities and crisis
stabilization units, and residential community mental health and
residential substance use disorder treatment facilities to
facilitate the identification and designation of facilities for
the temporary treatment of individuals in mental or substance
use disorder crisis.
``(c) Database Requirements.--A bed database described in this
section is a database that--
``(1) includes information on inpatient psychiatric
facilities, crisis stabilization units, and residential
community mental health and residential substance use disorder
facilities in the State involved, including contact information
for the facility or unit;
``(2) provides real-time information about the number of
beds available at each facility or unit and, for each available
bed, the type of patient that may be admitted, the level of
security provided, and any other information that may be
necessary to allow for the proper identification of appropriate
facilities for treatment of individuals in mental or substance
use disorder crisis; and
``(3) enables searches of the database to identify available
beds that are appropriate for the treatment of individuals in
mental or substance use disorder crisis.
``(d) Evaluation.--An entity receiving a grant under subsection
(a)(1) shall submit to the Secretary, at such time, in such manner, and
containing such information as the Secretary may reasonably require, a
report, including an evaluation of the effect of such grant on--
``(1) local crisis response services and measures for
individuals receiving crisis planning and early intervention
supports;
``(2) individuals reporting improved functional outcomes;
and
``(3) individuals receiving regular followup care following
a crisis.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $12,500,000 for the period of
fiscal years 2018 through 2022.''.
SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
(a) Suicide Prevention Technical Assistance Center.--Section 520C of
the Public Health Service Act (42 U.S.C. 290bb-34), as amended by
section 6001, is further amended--
(1) in the section heading, by striking ``youth interagency
research, training, and technical assistance centers'' and
inserting ``suicide prevention technical assistance center'';
(2) in subsection (a), by striking ``acting through the
Assistant Secretary for Mental Health and Substance Use'' and
all that follows through the period at the end of paragraph (2)
and inserting ``acting through the Assistant Secretary, shall
establish a research, training, and technical assistance
resource
[[Page 130 STAT. 1242]]
center to provide appropriate information, training, and
technical assistance to States, political subdivisions of
States, federally recognized Indian tribes, tribal
organizations, institutions of higher education, public
organizations, or private nonprofit organizations regarding the
prevention of suicide among all ages, particularly among groups
that are at a high risk for suicide.'';
(3) by striking subsections (b) and (c);
(4) by redesignating subsection (d) as subsection (b);
(5) in subsection (b), as so redesignated--
(A) in the subsection heading, by striking
``Additional Center'' and inserting ``Responsibilities
of the Center'';
(B) in the matter preceding paragraph (1), by
striking ``The additional research'' and all that
follows through ``nonprofit organizations for'' and
inserting ``The center established under subsection (a)
shall conduct activities for the purpose of'';
(C) by striking ``youth suicide'' each place such
term appears and inserting ``suicide'';
(D) in paragraph (1)--
(i) by striking ``the development or
continuation of'' and inserting ``developing and
continuing''; and
(ii) by inserting ``for all ages, particularly
among groups that are at a high risk for suicide''
before the semicolon at the end;
(E) in paragraph (2), by inserting ``for all ages,
particularly among groups that are at a high risk for
suicide'' before the semicolon at the end;
(F) in paragraph (3), by inserting ``and tribal''
after ``statewide'';
(G) in paragraph (5), by inserting ``and
prevention'' after ``intervention'';
(H) in paragraph (8), by striking ``in youth'';
(I) in paragraph (9), by striking ``and behavioral
health'' and inserting ``health and substance use
disorder''; and
(J) in paragraph (10), by inserting ``conducting''
before ``other''; and
(6) by striking subsection (e) and inserting the following:
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $5,988,000 for
each of fiscal years 2018 through 2022.
``(d) Annual Report.--Not later than 2 years after the date of
enactment of this subsection, the Secretary shall submit to Congress a
report on the activities carried out by the center established under
subsection (a) during the year involved, including the potential effects
of such activities, and the States, organizations, and institutions that
have worked with the center.''.
(b) Youth Suicide Early Intervention and Prevention Strategies.--
Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is
amended--
(1) in paragraph (1) of subsection (a) and in subsection
(c), by striking ``substance abuse'' each place such term
appears and inserting ``substance use disorder'';
(2) in subsection (b)--
(A) in paragraph (2)--
[[Page 130 STAT. 1243]]
(i) by striking ``ensure that each State is
awarded only 1 grant or cooperative agreement
under this section'' and inserting ``ensure that a
State does not receive more than 1 grant or
cooperative agreement under this section at any 1
time''; and
(ii) by striking ``been awarded'' and
inserting ``received''; and
(B) by adding after paragraph (2) the following:
``(3) Consideration.--In awarding grants under this section,
the Secretary shall take into consideration the extent of the
need of the applicant, including the incidence and prevalence of
suicide in the State and among the populations of focus,
including rates of suicide determined by the Centers for Disease
Control and Prevention for the State or population of focus.'';
(3) in subsection (g)(2), by striking ``2 years after the
date of enactment of this section,'' and insert ``2 years after
the date of enactment of Helping Families in Mental Health
Crisis Reform Act of 2016,''; and
(4) by striking subsection (m) and inserting the following:
``(m) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $30,000,000
for each of fiscal years 2018 through 2022.''.
SEC. 9009. <<NOTE: 42 USC 290bb-43.>> ADULT SUICIDE PREVENTION.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
``SEC. 520L. ADULT SUICIDE PREVENTION.
``(a) Grants.--
``(1) In general.--The Assistant Secretary shall award
grants to eligible entities described in paragraph (2) to
implement suicide prevention and intervention programs, for
individuals who are 25 years of age or older, that are designed
to raise awareness of suicide, establish referral processes, and
improve care and outcomes for such individuals who are at risk
of suicide.
``(2) Eligible entities.--To be eligible to receive a grant
under this section, an entity shall be a community-based primary
care or behavioral health care setting, an emergency department,
a State mental health agency (or State health agency with mental
or behavioral health functions), public health agency, a
territory of the United States, or an Indian tribe or tribal
organization (as the terms `Indian tribe' and `tribal
organization' are defined in section 4 of the Indian Self-
Determination and Education Assistance Act).
``(3) Use of funds.--The grants awarded under paragraph (1)
shall be used to implement programs, in accordance with such
paragraph, that include one or more of the following components:
``(A) Screening for suicide risk, suicide
intervention services, and services for referral for
treatment for individuals at risk for suicide.
``(B) Implementing evidence-based practices to
provide treatment for individuals at risk for suicide,
including appropriate followup services.
``(C) Raising awareness and reducing stigma of
suicide.
[[Page 130 STAT. 1244]]
``(b) Evaluations and Technical Assistance.--The Assistant Secretary
shall--
``(1) evaluate the activities supported by grants awarded
under subsection (a), and disseminate, as appropriate, the
findings from the evaluation; and
``(2) provide appropriate information, training, and
technical assistance, as appropriate, to eligible entities that
receive a grant under this section, in order to help such
entities to meet the requirements of this section, including
assistance with selection and implementation of evidence-based
interventions and frameworks to prevent suicide.
``(c) Duration.--A grant under this section shall be for a period of
not more than 5 years.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $30,000,000 for the period of
fiscal years 2018 through 2022.''.
SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
Section 520J of the Public Health Service Act (42 U.S.C. 290bb-41)
is amended--
(1) in the section heading, by inserting ``mental health
awareness'' before ``training''; and
(2) in subsection (b)--
(A) in the subsection heading, by striking
``Illness'' and inserting ``Health'';
(B) in paragraph (1), by inserting ``veterans, law
enforcement, and other categories of individuals, as
determined by the Secretary,'' after ``emergency
services personnel'';
(C) in paragraph (5)--
(i) in the matter preceding subparagraph (A),
by striking ``to'' and inserting ``for evidence-
based programs that provide training and education
in accordance with paragraph (1) on matters
including''; and
(ii) by striking subparagraphs (A) through (C)
and inserting the following:
``(A) recognizing the signs and symptoms of mental
illness; and
``(B)(i) resources available in the community for
individuals with a mental illness and other relevant
resources; or
``(ii) safely de-escalating crisis situations
involving individuals with a mental illness.''; and
(D) in paragraph (7), by striking ``, $25,000,000''
and all that follows through the period at the end and
inserting ``$14,693,000 for each of fiscal years 2018
through 2022.''.
SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND
ALASKA NATIVE YOUTH WITHIN SUICIDE
PREVENTION PROGRAMS.
(a) Findings.--The Congress finds as follows:
(1) Suicide is the eighth leading cause of death among
American Indians and Alaska Natives across all ages.
(2) Among American Indians and Alaska Natives who are 10 to
34 years of age, suicide is the second leading cause of death.
(3) The suicide rate among American Indian and Alaska Native
adolescents and young adults ages 15 to 34 (17.9 per
[[Page 130 STAT. 1245]]
100,000) is approximately 1.3 times higher than the national
average for that age group (13.3 per 100,000).
(b) Sense of Congress.--It is the sense of Congress that the
Secretary of Health and Human Services, in carrying out suicide
prevention and intervention programs, should prioritize programs and
activities for populations with disproportionately high rates of
suicide, such as American Indians and Alaska Natives.
SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
32(e)) is amended by adding at the end the following:
``(3) Geriatric mental disorders.--The Secretary shall, as
appropriate, provide technical assistance to grantees regarding
evidence-based practices for the prevention and treatment of
geriatric mental disorders and co-occurring mental health and
substance use disorders among geriatric populations, as well as
disseminate information about such evidence-based practices to
States and nongrantees throughout the United States.''.
SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
The Secretary of Health and Human Services, acting through the
Director of the Centers for Disease Control and Prevention, is
encouraged to improve, particularly through the inclusion of additional
States, the National Violent Death Reporting System as authorized by
title III of the Public Health Service Act (42 U.S.C. 241 et seq.).
Participation in the system by the States shall be voluntary.
SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
Section 224 of the Protecting Access to Medicare Act of 2014 (42
U.S.C. 290aa note) is amended--
(1) in subsection (e), by striking ``and 2018,'' and
inserting ``2018, 2019, 2020, 2021, and 2022,''; and
(2) in subsection (g)--
(A) in paragraph (1), by striking ``2018'' and
inserting ``2022''; and
(B) in paragraph (2), by striking ``is authorized to
be appropriated to carry out this section $15,000,000
for each of fiscal years 2015 through 2018'' and
inserting ``are authorized to be appropriated to carry
out this section $15,000,000 for each of fiscal years
2015 through 2017, $20,000,000 for fiscal year 2018,
$19,000,000 for each of fiscal years 2019 and 2020, and
$18,000,000 for each of fiscal years 2021 and 2022''.
SEC. 9015. <<NOTE: 42 USC 290bb-44.>> ASSERTIVE COMMUNITY
TREATMENT GRANT PROGRAM.
Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
et seq.), as amended by section 9009, is further amended by adding at
the end the following:
``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
``(a) In General.--The Assistant Secretary shall award grants to
eligible entities--
``(1) to establish assertive community treatment programs
for adults with a serious mental illness; or
``(2) to maintain or expand such programs.
[[Page 130 STAT. 1246]]
``(b) Eligible Entities.--To be eligible to receive a grant under
this section, an entity shall be a State, political subdivision of a
State, Indian tribe or tribal organization (as such terms are defined in
section 4 of the Indian Self-Determination and Education Assistance
Act), mental health system, health care facility, or any other entity
the Assistant Secretary deems appropriate.
``(c) Special Consideration.--In selecting among applicants for a
grant under this section, the Assistant Secretary may give special
consideration to the potential of the applicant's program to reduce
hospitalization, homelessness, and involvement with the criminal justice
system while improving the health and social outcomes of the patient.
``(d) Additional Activities.--The Assistant Secretary shall--
``(1) not later than the end of fiscal year 2021, submit a
report to the appropriate congressional committees on the grant
program under this section, including an evaluation of--
``(A) any cost savings and public health outcomes
such as mortality, suicide, substance use disorders,
hospitalization, and use of services;
``(B) rates of involvement with the criminal justice
system of patients;
``(C) rates of homelessness among patients; and
``(D) patient and family satisfaction with program
participation; and
``(2) provide appropriate information, training, and
technical assistance to grant recipients under this section to
help such recipients to establish, maintain, or expand their
assertive community treatment programs.
``(e) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there is
authorized to be appropriated $5,000,000 for the period of
fiscal years 2018 through 2022.
``(2) Use of certain funds.--Of the funds appropriated to
carry out this section in any fiscal year, not more than 5
percent shall be available to the Assistant Secretary for
carrying out subsection (d).''.
SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
REAUTHORIZATION.
Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
is amended--
(1) in subsection (c)(3), by striking ``fiscal year 2007''
and all that follows through the period at the end and inserting
``each of the fiscal years 2018 through 2022.'';
(2) in subsection (d)(4), by striking ``fiscal year 2007''
and all that follows through the period at the end and inserting
``each of the fiscal years 2018 through 2022.'';
(3) in subsection (e)(1)(I), by striking ``fiscal year
2007'' and all that follows through the period at the end and
inserting ``each of the fiscal years 2018 through 2022.'';
(4) in subsection (f)(2), by striking ``$6,000,000 for
fiscal year 2007'' and all that follows through the period at
the end and inserting ``$3,000,000 for each of the fiscal years
2018 through 2022''; and
(5) by adding at the end the following new subsection:
``(g) Reducing Underage Drinking Through Screening and Brief
Intervention.--
[[Page 130 STAT. 1247]]
``(1) Grants to pediatric health care providers to reduce
underage drinking.--The Assistant Secretary may make grants to
eligible entities to increase implementation of practices for
reducing the prevalence of alcohol use among individuals under
the age of 21, including college students.
``(2) Purposes.--Grants under this subsection shall be made
to improve--
``(A) screening children and adolescents for alcohol
use;
``(B) offering brief interventions to children and
adolescents to discourage such use;
``(C) educating parents about the dangers of, and
methods of discouraging, such use;
``(D) diagnosing and treating alcohol use disorders;
and
``(E) referring patients, when necessary, to other
appropriate care.
``(3) Use of funds.--An entity receiving a grant under this
subsection may use such funding for the purposes identified in
paragraph (2) by--
``(A) providing training to health care providers;
``(B) disseminating best practices, including
culturally and linguistically appropriate best
practices, as appropriate, and developing and
distributing materials; and
``(C) supporting other activities, as determined
appropriate by the Assistant Secretary.
``(4) Application.--To be eligible to receive a grant under
this subsection, an entity shall submit an application to the
Assistant Secretary at such time, and in such manner, and
accompanied by such information as the Assistant Secretary may
require. Each application shall include--
``(A) a description of the entity;
``(B) a description of activities to be completed;
``(C) a description of how the services specified in
paragraphs (2) and (3) will be carried out and the
qualifications for providing such services; and
``(D) a timeline for the completion of such
activities.
``(5) Definitions.--For the purpose of this subsection:
``(A) Brief intervention.--The term `brief
intervention' means, after screening a patient,
providing the patient with brief advice and other brief
motivational enhancement techniques designed to increase
the insight of the patient regarding the patient's
alcohol use, and any realized or potential consequences
of such use, to effect the desired related behavioral
change.
``(B) Children and adolescents.--The term `children
and adolescents' means any person under 21 years of age.
``(C) Eligible entity.--The term `eligible entity'
means an entity consisting of pediatric health care
providers and that is qualified to support or provide
the activities identified in paragraph (2).
``(D) Pediatric health care provider.--The term
`pediatric health care provider' means a provider of
primary health care to individuals under the age of 21
years.
``(E) Screening.--The term `screening' means using
validated patient interview techniques to identify and
assess the existence and extent of alcohol use in a
patient.''.
[[Page 130 STAT. 1248]]
SEC. 9017. CENTER AND PROGRAM REPEALS.
Part B of title V of the Public Health Service Act (42 U.S.C. 290bb
et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the
second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and
amphetamine treatment initiatives, and each of sections 514A, 517, 519A,
519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).
Subtitle B--Strengthening the Health Care Workforce
SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
GRANTS.
Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``of higher education''; and
(B) by striking paragraphs (1) through (4) and
inserting the following:
``(1) accredited institutions of higher education or
accredited professional training programs that are establishing
or expanding internships or other field placement programs in
mental health in psychiatry, psychology, school psychology,
behavioral pediatrics, psychiatric nursing (which may include
master's and doctoral level programs), social work, school
social work, substance use disorder prevention and treatment,
marriage and family therapy, occupational therapy, school
counseling, or professional counseling, including such programs
with a focus on child and adolescent mental health and
transitional-age youth;
``(2) accredited doctoral, internship, and post-doctoral
residency programs of health service psychology (including
clinical psychology, counseling, and school psychology) for the
development and implementation of interdisciplinary training of
psychology graduate students for providing behavioral health
services, including substance use disorder prevention and
treatment services, as well as the development of faculty in
health service psychology;
``(3) accredited master's and doctoral degree programs of
social work for the development and implementation of
interdisciplinary training of social work graduate students for
providing behavioral health services, including substance use
disorder prevention and treatment services, and the development
of faculty in social work; and
``(4) State-licensed mental health nonprofit and for-profit
organizations to enable such organizations to pay for programs
for preservice or in-service training in a behavioral health-
related paraprofessional field with preference for preservice or
in-service training of paraprofessional child and adolescent
mental health workers.'';
(2) in subsection (b)--
(A) by striking paragraph (5);
[[Page 130 STAT. 1249]]
(B) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(C) by inserting before paragraph (2), as so
redesignated, the following:
``(1) an ability to recruit and place the students described
in subsection (a) in areas with a high need and high demand
population;'';
(D) in paragraph (3), as so redesignated, by
striking ``subsection (a)'' and inserting ``paragraph
(2), especially individuals with mental disorder
symptoms or diagnoses, particularly children and
adolescents, and transitional-age youth'';
(E) in paragraph (4), as so redesignated, by
striking ``;'' and inserting ``; and''; and
(F) in paragraph (5), as so redesignated, by
striking ``; and'' and inserting a period;
(3) in subsection (c), by striking ``authorized under
subsection (a)(1)'' and inserting ``awarded under paragraphs (2)
and (3) of subsection (a)'';
(4) by amending subsection (d) to read as follows:
``(d) Priority.--In selecting grant recipients under this section,
the Secretary shall give priority to--
``(1) programs that have demonstrated the ability to train
psychology, psychiatry, and social work professionals to work in
integrated care settings for purposes of recipients under
paragraphs (1), (2), and (3) of subsection (a); and
``(2) programs for paraprofessionals that emphasize the role
of the family and the lived experience of the consumer and
family-paraprofessional partnerships for purposes of recipients
under subsection (a)(4).''; and
(5) by striking subsection (e) and inserting the following:
``(e) Report to Congress.--Not later than 4 years after the date of
enactment of the Helping Families in Mental Health Crisis Reform Act of
2016, the Secretary shall include in the biennial report submitted to
Congress under section 501(m) an assessment on the effectiveness of the
grants under this section in--
``(1) providing graduate students support for experiential
training (internship or field placement);
``(2) recruiting students interested in behavioral health
practice;
``(3) recruiting students in accordance with subsection
(b)(1);
``(4) developing and implementing interprofessional training
and integration within primary care;
``(5) developing and implementing accredited field
placements and internships; and
``(6) collecting data on the number of students trained in
behavioral health care and the number of available accredited
internships and field placements.
``(f) Authorization of Appropriations.--For each of fiscal years
2018 through 2022, there are authorized to be appropriated to carry out
this section $50,000,000, to be allocated as follows:
``(1) For grants described in subsection (a)(1),
$15,000,000.
``(2) For grants described in subsection (a)(2),
$15,000,000.
``(3) For grants described in subsection (a)(3),
$10,000,000.
``(4) For grants described in subsection (a)(4),
$10,000,000.''.
[[Page 130 STAT. 1250]]
SEC. 9022. <<NOTE: 42 USC 294k.>> STRENGTHENING THE MENTAL AND
SUBSTANCE USE DISORDERS WORKFORCE.
Part D of title VII of the Public Health Service Act (42 U.S.C. 294
et seq.) is amended by adding at the end the following:
``SEC. 760. TRAINING DEMONSTRATION PROGRAM.
``(a) In General.--The Secretary shall establish a training
demonstration program to award grants to eligible entities to support--
``(1) training for medical residents and fellows to practice
psychiatry and addiction medicine in underserved, community-
based settings that integrate primary care with mental and
substance use disorders prevention and treatment services;
``(2) training for nurse practitioners, physician
assistants, health service psychologists, and social workers to
provide mental and substance use disorders services in
underserved community-based settings that integrate primary care
and mental and substance use disorders services; and
``(3) establishing, maintaining, or improving academic units
or programs that--
``(A) provide training for students or faculty,
including through clinical experiences and research, to
improve the ability to be able to recognize, diagnose,
and treat mental and substance use disorders, with a
special focus on addiction; or
``(B) develop evidence-based practices or
recommendations for the design of the units or programs
described in subparagraph (A), including curriculum
content standards.
``(b) Activities.--
``(1) Training for residents and fellows.--A recipient of a
grant under subsection (a)(1)--
``(A) shall use the grant funds--
``(i)(I) to plan, develop, and operate a
training program for medical psychiatry residents
and fellows in addiction medicine practicing in
eligible entities described in subsection (c)(1);
or
``(II) to train new psychiatric residents and
fellows in addiction medicine to provide and
expand access to integrated mental and substance
use disorders services; and
``(ii) to provide at least 1 training track
that is--
``(I) a virtual training track that
includes an in-person rotation at a
teaching health center or in a
community-based setting, followed by a
virtual rotation in which the resident
or fellow continues to support the care
of patients at the teaching health
center or in the community-based setting
through the use of health information
technology and, as appropriate,
telehealth services;
``(II) an in-person training track
that includes a rotation, during which
the resident or fellow practices at a
teaching health center or in a
community-based setting; or
``(III) an in-person training track
that includes a rotation during which
the resident practices in a community-
based setting that specializes in the
[[Page 130 STAT. 1251]]
treatment of infants, children,
adolescents, or pregnant or postpartum
women; and
``(B) may use the grant funds to provide additional
support for the administration of the program or to meet
the costs of projects to establish, maintain, or improve
faculty development, or departments, divisions, or other
units necessary to implement such training.
``(2) Training for other providers.--A recipient of a grant
under subsection (a)(2)--
``(A) shall use the grant funds to plan, develop, or
operate a training program to provide mental and
substance use disorders services in underserved,
community-based settings, as appropriate, that integrate
primary care and mental and substance use disorders
prevention and treatment services; and
``(B) may use the grant funds to provide additional
support for the administration of the program or to meet
the costs of projects to establish, maintain, or improve
faculty development, or departments, divisions, or other
units necessary to implement such program.
``(3) Academic units or programs.--A recipient of a grant
under subsection (a)(3) shall enter into a partnership with
organizations such as an education accrediting organization
(such as the Liaison Committee on Medical Education, the
Accreditation Council for Graduate Medical Education, the
Commission on Osteopathic College Accreditation, the
Accreditation Commission for Education in Nursing, the
Commission on Collegiate Nursing Education, the Accreditation
Council for Pharmacy Education, the Council on Social Work
Education, American Psychological Association Commission on
Accreditation, or the Accreditation Review Commission on
Education for the Physician Assistant) to carry out activities
under subsection (a)(3).
``(c) Eligible Entities.--
``(1) Training for residents and fellows.--To be eligible to
receive a grant under subsection (a)(1), an entity shall--
``(A) be a consortium consisting of--
``(i) at least one teaching health center; and
``(ii) the sponsoring institution (or parent
institution of the sponsoring institution) of--
``(I) a psychiatry residency program
that is accredited by the Accreditation
Council of Graduate Medical Education
(or the parent institution of such a
program); or
``(II) a fellowship in addiction
medicine, as determined appropriate by
the Secretary; or
``(B) be an entity described in subparagraph (A)(ii)
that provides opportunities for residents or fellows to
train in community-based settings that integrate primary
care with mental and substance use disorders prevention
and treatment services.
``(2) Training for other providers.--To be eligible to
receive a grant under subsection (a)(2), an entity shall be--
``(A) a teaching health center (as defined in
section 749A(f));
``(B) a Federally qualified health center (as
defined in section 1905(l)(2)(B) of the Social Security
Act);
[[Page 130 STAT. 1252]]
``(C) a community mental health center (as defined
in section 1861(ff)(3)(B) of the Social Security Act);
``(D) a rural health clinic (as defined in section
1861(aa) of the Social Security Act);
``(E) a health center operated by the Indian Health
Service, an Indian tribe, a tribal organization, or an
urban Indian organization (as defined in section 4 of
the Indian Health Care Improvement Act); or
``(F) an entity with a demonstrated record of
success in providing training for nurse practitioners,
physician assistants, health service psychologists, and
social workers.
``(3) Academic units or programs.--To be eligible to receive
a grant under subsection (a)(3), an entity shall be a school of
medicine or osteopathic medicine, a nursing school, a physician
assistant training program, a school of pharmacy, a school of
social work, an accredited public or nonprofit private hospital,
an accredited medical residency program, or a public or private
nonprofit entity which the Secretary has determined is capable
of carrying out such grant.
``(d) Priority.--
``(1) In general.--In awarding grants under subsection
(a)(1) or (a)(2), the Secretary shall give priority to eligible
entities that--
``(A) demonstrate sufficient size, scope, and
capacity to undertake the requisite training of an
appropriate number of psychiatric residents, fellows,
nurse practitioners, physician assistants, or social
workers in addiction medicine per year to meet the needs
of the area served;
``(B) demonstrate experience in training providers
to practice team-based care that integrates mental and
substance use disorder prevention and treatment services
with primary care in community-based settings;
``(C) demonstrate experience in using health
information technology and, as appropriate, telehealth
to support--
``(i) the delivery of mental and substance use
disorders services at the eligible entities
described in subsections (c)(1) and (c)(2); and
``(ii) community health centers in integrating
primary care and mental and substance use
disorders treatment; or
``(D) have the capacity to expand access to mental
and substance use disorders services in areas with
demonstrated need, as determined by the Secretary, such
as tribal, rural, or other underserved communities.
``(2) Academic units or programs.--In awarding grants under
subsection (a)(3), the Secretary shall give priority to eligible
entities that--
``(A) have a record of training the greatest
percentage of mental and substance use disorders
providers who enter and remain in these fields or who
enter and remain in settings with integrated primary
care and mental and substance use disorder prevention
and treatment services;
``(B) have a record of training individuals who are
from underrepresented minority groups, including native
populations, or from a rural or disadvantaged
background;
``(C) provide training in the care of vulnerable
populations such as infants, children, adolescents,
pregnant and
[[Page 130 STAT. 1253]]
postpartum women, older adults, homeless individuals,
victims of abuse or trauma, individuals with
disabilities, and other groups as defined by the
Secretary;
``(D) teach trainees the skills to provide
interprofessional, integrated care through collaboration
among health professionals; or
``(E) provide training in cultural competency and
health literacy.
``(e) Duration.--Grants awarded under this section shall be for a
minimum of 5 years.
``(f) Study and Report.--
``(1) Study.--
``(A) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall conduct a study on the results of
the demonstration program under this section.
``(B) Data submission.--Not later than 90 days after
the completion of the first year of the training program
and each subsequent year that the program is in effect,
each recipient of a grant under subsection (a) shall
submit to the Secretary such data as the Secretary may
require for analysis for the report described in
paragraph (2).
``(2) Report to congress.--Not later than 1 year after
receipt of the data described in paragraph (1)(B), the Secretary
shall submit to Congress a report that includes--
``(A) an analysis of the effect of the demonstration
program under this section on the quality, quantity, and
distribution of mental and substance use disorders
services;
``(B) an analysis of the effect of the demonstration
program on the prevalence of untreated mental and
substance use disorders in the surrounding communities
of health centers participating in the demonstration;
and
``(C) recommendations on whether the demonstration
program should be expanded.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $10,000,000 for each of fiscal
years 2018 through 2022.''.
SEC. 9023. <<NOTE: 42 USC 294l-1 note.>> CLARIFICATION ON CURRENT
ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.
The Administrator of the Health Resources and Services
Administration shall clarify the eligibility pursuant to section
338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
1(b)(1)(B)) of child and adolescent psychiatrists for the National
Health Service Corps Loan Repayment Program under subpart III of part D
of title III of such Act (42 U.S.C. 254l et seq.).
SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
is amended by adding at the end the following:
``PART K--MINORITY FELLOWSHIP PROGRAM
``SEC. 597. <<NOTE: 42 USC 290ll.>> FELLOWSHIPS.
``(a) In General.--The Secretary shall maintain a program, to be
known as the Minority Fellowship Program, under which the Secretary
shall award fellowships, which may include stipends, for the purposes
of--
[[Page 130 STAT. 1254]]
``(1) increasing the knowledge of mental and substance use
disorders practitioners on issues related to prevention,
treatment, and recovery support for individuals who are from
racial and ethnic minority populations and who have a mental or
substance use disorder;
``(2) improving the quality of mental and substance use
disorder prevention and treatment services delivered to racial
and ethnic minority populations; and
``(3) increasing the number of culturally competent mental
and substance use disorders professionals who teach, administer
services, conduct research, and provide direct mental or
substance use disorder services to racial and ethnic minority
populations.
``(b) Training Covered.--The fellowships awarded under subsection
(a) shall be for postbaccalaureate training (including for master's and
doctoral degrees) for mental and substance use disorder treatment
professionals, including in the fields of psychiatry, nursing, social
work, psychology, marriage and family therapy, mental health counseling,
and substance use disorder and addiction counseling.
``(c) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $12,669,000 for each of fiscal
years 2018 through 2022.''.
SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
Section 224 of the Public Health Service Act (42 U.S.C. 233) is
amended by adding at the end the following:
``(q)(1) For purposes of this section, a health professional
volunteer at a deemed entity described in subsection (g)(4) shall, in
providing a health professional service eligible for funding under
section 330 to an individual, be deemed to be an employee of the Public
Health Service for a calendar year that begins during a fiscal year for
which a transfer was made under paragraph (4)(C). The preceding sentence
is subject to the provisions of this subsection.
``(2) In providing a health service to an individual, a health care
practitioner shall for purposes of this subsection be considered to be a
health professional volunteer at an entity described in subsection
(g)(4) if the following conditions are met:
``(A) The service is provided to the individual at the
facilities of an entity described in subsection (g)(4), or
through offsite programs or events carried out by the entity.
``(B) The entity is sponsoring the health care practitioner
pursuant to paragraph (3)(B).
``(C) The health care practitioner does not receive any
compensation for the service from the individual, the entity
described in subsection (g)(4), or any third-party payer
(including reimbursement under any insurance policy or health
plan, or under any Federal or State health benefits program),
except that the health care practitioner may receive repayment
from the entity described in subsection (g)(4) for reasonable
expenses incurred by the health care practitioner in the
provision of the service to the individual, which may include
travel expenses to or from the site of services.
``(D) Before the service is provided, the health care
practitioner or the entity described in subsection (g)(4) posts
a clear
[[Page 130 STAT. 1255]]
and conspicuous notice at the site where the service is provided
of the extent to which the legal liability of the health care
practitioner is limited pursuant to this subsection.
``(E) At the time the service is provided, the health care
practitioner is licensed or certified in accordance with
applicable Federal and State laws regarding the provision of the
service.
``(F) At the time the service is provided, the entity
described in subsection (g)(4) maintains relevant documentation
certifying that the health care practitioner meets the
requirements of this subsection.
``(3) Subsection (g) (other than paragraphs (3) and (5)) and
subsections (h), (i), and (l) apply to a health care practitioner for
purposes of this subsection to the same extent and in the same manner as
such subsections apply to an officer, governing board member, employee,
or contractor of an entity described in subsection (g)(4), subject to
paragraph (4), and subject to the following:
``(A) The first sentence of paragraph (1) applies in lieu of
the first sentence of subsection (g)(1)(A).
``(B) With respect to an entity described in subsection
(g)(4), a health care practitioner is not a health professional
volunteer at such entity unless the entity sponsors the health
care practitioner. For purposes of this subsection, the entity
shall be considered to be sponsoring the health care
practitioner if--
``(i) with respect to the health care practitioner,
the entity submits to the Secretary an application
meeting the requirements of subsection (g)(1)(D); and
``(ii) the Secretary, pursuant to subsection
(g)(1)(E), determines that the health care practitioner
is deemed to be an employee of the Public Health
Service.
``(C) In the case of a health care practitioner who is
determined by the Secretary pursuant to subsection (g)(1)(E) to
be a health professional volunteer at such entity, this
subsection applies to the health care practitioner (with respect
to services performed on behalf of the entity sponsoring the
health care practitioner pursuant to subparagraph (B)) for any
cause of action arising from an act or omission of the health
care practitioner occurring on or after the date on which the
Secretary makes such determination.
``(D) Subsection (g)(1)(F) applies to a health care
practitioner for purposes of this subsection only to the extent
that, in providing health services to an individual, each of the
conditions specified in paragraph (2) is met.
``(4)(A) Amounts in the fund established under subsection (k)(2)
shall be available for transfer under subparagraph (C) for purposes of
carrying out this subsection.
``(B)(i) Not later than May 1 of each fiscal year, the Attorney
General, in consultation with the Secretary, shall submit to the
Congress a report providing an estimate of the amount of claims
(together with related fees and expenses of witnesses) that, by reason
of the acts or omissions of health professional volunteers, will be paid
pursuant to this section during the calendar year that begins in the
following fiscal year.
``(ii) Subsection (k)(1)(B) applies to the estimate under clause (i)
regarding health professional volunteers to the same extent and in the
same manner as such subsection applies to the estimate
[[Page 130 STAT. 1256]]
under such subsection regarding officers, governing board members,
employees, and contractors of entities described in subsection (g)(4).
``(iii) The report shall include a summary of the data relied upon
for the estimate in clause (i), including the number of claims filed and
paid from the previous calendar year.
``(C) Not later than December 31 of each fiscal year, the Secretary
shall transfer from the fund under subsection (k)(2) to the appropriate
accounts in the Treasury an amount equal to the estimate made under
subparagraph (B) for the calendar year beginning in such fiscal year,
subject to the extent of amounts in the fund.
``(5)(A) This subsection shall take effect on October 1, 2017,
except as provided in subparagraph (B) and paragraph (6).
``(B) Effective on the date of the enactment of this subsection--
``(i) the Secretary may issue regulations for carrying out
this subsection, and the Secretary may accept and consider
applications submitted pursuant to paragraph (3)(B); and
``(ii) reports under paragraph (4)(B) may be submitted to
Congress.
``(6) Beginning on October 1, 2022, this subsection shall cease to
have any force or effect.''.
SEC. 9026. REPORTS.
(a) Workforce Development Report.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Administrator of the Health Resources
and Services Administration, in consultation with the Assistant
Secretary for Mental Health and Substance Use, shall conduct a
study and publicly post on the appropriate Internet website of
the Department of Health and Human Services a report on the
adult and pediatric mental health and substance use disorder
workforce in order to inform Federal, State, and local efforts
related to workforce enhancement.
(2) Contents.--The report under this subsection shall
contain--
(A) national and State-level projections of the
supply and demand of the mental health and substance use
disorder health workforce, disaggregated by profession;
(B) an assessment of the mental health and substance
use disorder workforce capacity, strengths, and
weaknesses as of the date of the report, including the
extent to which primary care providers are preventing,
screening, or referring for mental and substance use
disorder services;
(C) information on trends within the mental health
and substance use disorder provider workforce, including
the number of individuals expected to enter the mental
health workforce over the next 5 years; and
(D) any additional information determined by the
Administrator of the Health Resources and Services
Administration, in consultation with the Assistant
Secretary for Mental Health and Substance Use, to be
relevant to the mental health and substance use disorder
provider workforce.
(b) Peer-Support Specialist Programs.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on peer-support specialist programs
in up to 10 States that receive funding from the Substance Abuse
and Mental Health Services Administration.
[[Page 130 STAT. 1257]]
(2) Contents of study.--In conducting the study under
paragraph (1), the Comptroller General of the United States
shall examine and identify best practices, in the States
selected pursuant to such paragraph, related to training and
credential requirements for peer-support specialist programs,
such as--
(A) hours of formal work or volunteer experience
related to mental and substance use disorders conducted
through such programs;
(B) types of peer-support specialist exams required
for such programs in the selected States;
(C) codes of ethics used by such programs in the
selected States;
(D) required or recommended skill sets for such
programs in the selected States; and
(E) requirements for continuing education.
(3) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
study conducted under paragraph (1).
Subtitle C--Mental Health on Campus Improvement
SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON
CAMPUS.
Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
36b) is amended--
(1) in the section heading, by striking ``and behavioral
health'' and inserting ``health and substance use disorder'';
(2) in subsection (a)--
(A) by striking ``Services,'' and inserting
``Services and'';
(B) by striking ``and behavioral health problems''
and inserting ``health or substance use disorders'';
(C) by striking ``substance abuse'' and inserting
``substance use disorders''; and
(D) by adding after, ``suicide attempts,'' the
following: ``prevent mental and substance use disorders,
reduce stigma, and improve the identification and
treatment for students at risk,'';
(3) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``for--'' and inserting ``for one or more of
the following:''; and
(B) by striking paragraphs (1) through (6) and
inserting the following:
``(1) Educating students, families, faculty, and staff to
increase awareness of mental and substance use disorders.
``(2) The operation of hotlines.
``(3) Preparing informational material.
``(4) Providing outreach services to notify students about
available mental and substance use disorder services.
``(5) Administering voluntary mental and substance use
disorder screenings and assessments.
[[Page 130 STAT. 1258]]
``(6) Supporting the training of students, faculty, and
staff to respond effectively to students with mental and
substance use disorders.
``(7) Creating a network infrastructure to link institutions
of higher education with health care providers who treat mental
and substance use disorders.
``(8) Providing mental and substance use disorders
prevention and treatment services to students, which may include
recovery support services and programming and early
intervention, treatment, and management, including through the
use of telehealth services.
``(9) Conducting research through a counseling or health
center at the institution of higher education involved regarding
improving the behavioral health of students through clinical
services, outreach, prevention, or academic success, in a manner
that is in compliance with all applicable personal privacy laws.
``(10) Supporting student groups on campus, including
athletic teams, that engage in activities to educate students,
including activities to reduce stigma surrounding mental and
behavioral disorders, and promote mental health.
``(11) Employing appropriately trained staff.
``(12) Developing and supporting evidence-based and emerging
best practices, including a focus on culturally and
linguistically appropriate best practices.'';
(4) in subsection (c)(5), by striking ``substance abuse''
and inserting ``substance use disorder'';
(5) in subsection (d)--
(A) in the matter preceding paragraph (1), by
striking ``An institution of higher education desiring a
grant under this section'' and inserting ``To be
eligible to receive a grant under this section, an
institution of higher education'';
(B) by striking paragraph (1) and inserting--
``(1) A description of the population to be targeted by the
program carried out under the grant, including veterans whenever
possible and appropriate, and of identified mental and substance
use disorder needs of students at the institution of higher
education.'';
(C) in paragraph (2), by inserting ``, which may
include, as appropriate and in accordance with
subsection (b)(7), a plan to seek input from relevant
stakeholders in the community, including appropriate
public and private entities, in order to carry out the
program under the grant'' before the period at the end;
and
(D) by adding after paragraph (5) the following new
paragraphs:
``(6) An outline of the objectives of the program carried
out under the grant.
``(7) For an institution of higher education proposing to
use the grant for an activity described in paragraph (8) or (9)
of subsection (b), a description of the policies and procedures
of the institution of higher education that are related to
applicable laws regarding access to, and sharing of, treatment
records of students at any campus-based mental health center or
partner organization, including the policies and State laws
governing when such records can be accessed and shared for non-
treatment purposes and a description of the process used
[[Page 130 STAT. 1259]]
by the institution of higher education to notify students of
these policies and procedures, including the extent to which
written consent is required.
``(8) An assurance that grant funds will be used to
supplement and not supplant any other Federal, State, or local
funds available to carry out activities of the type carried out
under the grant.'';
(6) in subsection (e)(1), by striking ``and behavioral
health problems'' and inserting ``health and substance use
disorders'';
(7) in subsection (f)(2)--
(A) by striking ``and behavioral health'' and
inserting ``health and substance use disorder''; and
(B) by striking ``suicide and substance abuse'' and
inserting ``suicide and substance use disorders'';
(8) by redesignating subsection (h) as subsection (i);
(9) by inserting after subsection (g) the following new
subsection:
``(h) Technical Assistance.--The Secretary may provide technical
assistance to grantees in carrying out this section.''; and
(10) in subsection (i), as redesignated by paragraph (8), by
striking ``$5,000,000 for fiscal year 2005'' and all that
follows through the period at the end and inserting ``$7,000,000
for each of fiscal years 2018 through 2022.''.
SEC. 9032. <<NOTE: 42 USC 290bb-36b note.>> INTERAGENCY WORKING
GROUP ON COLLEGE MENTAL HEALTH.
(a) Purpose.--It is the purpose of this section to provide for the
establishment of a College Campus Task Force to discuss mental and
behavioral health concerns on campuses of institutions of higher
education.
(b) Establishment.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall establish a
College Campus Task Force (referred to in this section as the ``Task
Force'') to discuss mental and behavioral health concerns on campuses of
institutions of higher education.
(c) Membership.--The Task Force shall be composed of a
representative from each Federal agency (as appointed by the head of the
agency) that has jurisdiction over, or is affected by, mental health and
education policies and projects, including--
(1) the Department of Education;
(2) the Department of Health and Human Services;
(3) the Department of Veterans Affairs; and
(4) such other Federal agencies as the Assistant Secretary
for Mental Health and Substance Use, in consultation with the
Secretary, determines to be appropriate.
(d) Duties.--The Task Force shall--
(1) serve as a centralized mechanism to coordinate a
national effort to--
(A) discuss and evaluate evidence and knowledge on
mental and behavioral health services available to, and
the prevalence of mental illness among, the age
population of students attending institutions of higher
education in the United States;
(B) determine the range of effective, feasible, and
comprehensive actions to improve mental and behavioral
health on campuses of institutions of higher education;
[[Page 130 STAT. 1260]]
(C) examine and better address the needs of the age
population of students attending institutions of higher
education dealing with mental illness;
(D) survey Federal agencies to determine which
policies are effective in encouraging, and how best to
facilitate outreach without duplicating, efforts
relating to mental and behavioral health promotion;
(E) establish specific goals within and across
Federal agencies for mental health promotion, including
determinations of accountability for reaching those
goals;
(F) develop a strategy for allocating
responsibilities and ensuring participation in mental
and behavioral health promotion, particularly in the
case of competing agency priorities;
(G) coordinate plans to communicate research results
relating to mental and behavioral health amongst the age
population of students attending institutions of higher
education to enable reporting and outreach activities to
produce more useful and timely information;
(H) provide a description of evidence-based
practices, model programs, effective guidelines, and
other strategies for promoting mental and behavioral
health on campuses of institutions of higher education;
(I) make recommendations to improve Federal efforts
relating to mental and behavioral health promotion on
campuses of institutions of higher education and to
ensure Federal efforts are consistent with available
standards, evidence, and other programs in existence as
of the date of enactment of this Act;
(J) monitor Federal progress in meeting specific
mental and behavioral health promotion goals as they
relate to settings of institutions of higher education;
and
(K) examine and disseminate best practices related
to intracampus sharing of treatment records;
(2) consult with national organizations with expertise in
mental and behavioral health, especially those organizations
working with the age population of students attending
institutions of higher education; and
(3) consult with and seek input from mental health
professionals working on campuses of institutions of higher
education as appropriate.
(e) Meetings.--
(1) In general.--The Task Force shall meet not fewer than
three times each year.
(2) Annual conference.--The Secretary shall sponsor an
annual conference on mental and behavioral health in settings of
institutions of higher education to enhance coordination, build
partnerships, and share best practices in mental and behavioral
health promotion, data collection, analysis, and services.
(f) Definition.--In this section, the term ``institution of higher
education'' has the meaning given such term in section 101 of the Higher
Education Act of 1965 (20 U.S.C. 1001).
(g) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $1,000,000 for the period of
fiscal years 2018 through 2022.
[[Page 130 STAT. 1261]]
SEC. 9033. <<NOTE: 42 USC 290ee-4.>> IMPROVING MENTAL HEALTH ON
COLLEGE CAMPUSES.
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
et seq.) is amended by adding at the end the following:
``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON
COLLEGE CAMPUSES.
``(a) Purpose.--It is the purpose of this section to increase access
to, and reduce the stigma associated with, mental health services to
ensure that students at institutions of higher education have the
support necessary to successfully complete their studies.
``(b) National Public Education Campaign.--The Secretary, acting
through the Assistant Secretary and in collaboration with the Director
of the Centers for Disease Control and Prevention, shall convene an
interagency, public-private sector working group to plan, establish, and
begin coordinating and evaluating a targeted public education campaign
that is designed to focus on mental and behavioral health on the
campuses of institutions of higher education. Such campaign shall be
designed to--
``(1) improve the general understanding of mental health and
mental disorders;
``(2) encourage help-seeking behaviors relating to the
promotion of mental health, prevention of mental disorders, and
treatment of such disorders;
``(3) make the connection between mental and behavioral
health and academic success; and
``(4) assist the general public in identifying the early
warning signs and reducing the stigma of mental illness.
``(c) Composition.--The working group convened under subsection (b)
shall include--
``(1) mental health consumers, including students and family
members;
``(2) representatives of institutions of higher education;
``(3) representatives of national mental and behavioral
health associations and associations of institutions of higher
education;
``(4) representatives of health promotion and prevention
organizations at institutions of higher education;
``(5) representatives of mental health providers, including
community mental health centers; and
``(6) representatives of private-sector and public-sector
groups with experience in the development of effective public
health education campaigns.
``(d) Plan.--The working group under subsection (b) shall develop a
plan that--
``(1) targets promotional and educational efforts to the age
population of students at institutions of higher education and
individuals who are employed in settings of institutions of
higher education, including through the use of roundtables;
``(2) develops and proposes the implementation of research-
based public health messages and activities;
``(3) provides support for local efforts to reduce stigma by
using the National Health Information Center as a primary point
of contact for information, publications, and service program
referrals; and
[[Page 130 STAT. 1262]]
``(4) develops and proposes the implementation of a social
marketing campaign that is targeted at the population of
students attending institutions of higher education and
individuals who are employed in settings of institutions of
higher education.
``(e) Definition.--In this section, the term `institution of higher
education' has the meaning given such term in section 101 of the Higher
Education Act of 1965 (20 U.S.C. 1001).
``(f) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $1,000,000 for the period of
fiscal years 2018 through 2022.''.
TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
CHILDREN AND ADOLESCENTS
SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
DISTURBANCE.
(a) Comprehensive Community Mental Health Services for Children With
a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health
Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which
may include efforts to identify and serve children at risk'' before the
period.
(b) Requirements With Respect to Carrying Out Purpose of Grants.--
Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b))
is amended by striking ``will not provide an individual with access to
the system if the individual is more than 21 years of age'' and
inserting ``will provide an individual with access to the system through
the age of 21 years''.
(c) Additional Provisions.--Section 564(f) of the Public Health
Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and
provide a copy to the State involved)'' after ``to the Secretary''.
(d) General Provisions.--Section 565 of the Public Health Service
Act (42 U.S.C. 290ff-4) is amended--
(1) in subsection (b)(1)--
(A) in the matter preceding subparagraph (A), by
striking ``receiving a grant under section 561(a)'' and
inserting ``, regardless of whether such public entity
is receiving a grant under section 561(a)''; and
(B) in subparagraph (B), by striking ``pursuant to''
and inserting ``described in'';
(2) in subsection (d)(1), by striking ``not more than 21
years of age'' and inserting ``through the age of 21 years'';
and
(3) in subsection (f)(1), by striking ``$100,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003'' and inserting ``$119,026,000
for each of fiscal years 2018 through 2022''.
SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.
Title III of the Public Health Service Act is amended by inserting
after section 330L of such Act (42 U.S.C. 254c-18) the following new
section:
[[Page 130 STAT. 1263]]
``SEC. 330M <<NOTE: 42 USC 254c-19.>> PEDIATRIC MENTAL HEALTH
CARE ACCESS GRANTS.
``(a) In General.--The Secretary, acting through the Administrator
of the Health Resources and Services Administration and in coordination
with other relevant Federal agencies, shall award grants to States,
political subdivisions of States, and Indian tribes and tribal
organizations (for purposes of this section, as such terms are defined
in section 4 of the Indian Self-Determination and Education Assistance
Act (25 U.S.C. 450b)) to promote behavioral health integration in
pediatric primary care by--
``(1) supporting the development of statewide or regional
pediatric mental health care telehealth access programs; and
``(2) supporting the improvement of existing statewide or
regional pediatric mental health care telehealth access
programs.
``(b) Program Requirements.--
``(1) In general.--A pediatric mental health care telehealth
access program referred to in subsection (a), with respect to
which a grant under such subsection may be used, shall--
``(A) be a statewide or regional network of
pediatric mental health teams that provide support to
pediatric primary care sites as an integrated team;
``(B) support and further develop organized State or
regional networks of pediatric mental health teams to
provide consultative support to pediatric primary care
sites;
``(C) conduct an assessment of critical behavioral
consultation needs among pediatric providers and such
providers' preferred mechanisms for receiving
consultation, training, and technical assistance;
``(D) develop an online database and communication
mechanisms, including telehealth, to facilitate
consultation support to pediatric practices;
``(E) provide rapid statewide or regional clinical
telephone or telehealth consultations when requested
between the pediatric mental health teams and pediatric
primary care providers;
``(F) conduct training and provide technical
assistance to pediatric primary care providers to
support the early identification, diagnosis, treatment,
and referral of children with behavioral health
conditions;
``(G) provide information to pediatric providers
about, and assist pediatric providers in accessing,
pediatric mental health care providers, including child
and adolescent psychiatrists, and licensed mental health
professionals, such as psychologists, social workers, or
mental health counselors and in scheduling and
conducting technical assistance;
``(H) assist with referrals to specialty care and
community or behavioral health resources; and
``(I) establish mechanisms for measuring and
monitoring increased access to pediatric mental health
care services by pediatric primary care providers and
expanded capacity of pediatric primary care providers to
identify, treat, and refer children with mental health
problems.
``(2) Pediatric mental health teams.--In this subsection,
the term `pediatric mental health team' means a team consisting
of at least one case coordinator, at least one child and
adolescent psychiatrist, and at least one licensed clinical
[[Page 130 STAT. 1264]]
mental health professional, such as a psychologist, social
worker, or mental health counselor. Such a team may be
regionally based.
``(c) Application.--A State, political subdivision of a State,
Indian tribe, or tribal organization seeking a grant under this section
shall submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may require,
including a plan for the comprehensive evaluation of activities that are
carried out with funds received under such grant.
``(d) Evaluation.--A State, political subdivision of a State, Indian
tribe, or tribal organization that receives a grant under this section
shall prepare and submit an evaluation of activities that are carried
out with funds received under such grant to the Secretary at such time,
in such manner, and containing such information as the Secretary may
reasonably require, including a process and outcome evaluation.
``(e) Access to Broadband.--In administering grants under this
section, the Secretary may coordinate with other agencies to ensure that
funding opportunities are available to support access to reliable, high-
speed Internet for providers.
``(f) Matching Requirement.--The Secretary may not award a grant
under this section unless the State, political subdivision of a State,
Indian tribe, or tribal organization involved agrees, with respect to
the costs to be incurred by the State, political subdivision of a State,
Indian tribe, or tribal organization in carrying out the purpose
described in this section, to make available non-Federal contributions
(in cash or in kind) toward such costs in an amount that is not less
than 20 percent of Federal funds provided in the grant.
``(g) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated, $9,000,000 for the period of
fiscal years 2018 through 2022.''.
SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
INTERVENTION SERVICES FOR CHILDREN AND
ADOLESCENTS.
The first section 514 of the Public Health Service Act (42 U.S.C.
290bb-7), relating to substance abuse treatment services for children
and adolescents, is amended--
(1) in the section heading, by striking ``abuse treatment''
and inserting ``use disorder treatment and early intervention'';
(2) by striking subsection (a) and inserting the following:
``(a) In General.--The Secretary shall award grants, contracts, or
cooperative agreements to public and private nonprofit entities,
including Indian tribes or tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination and Education
Assistance Act), or health facilities or programs operated by or in
accordance with a contract or grant with the Indian Health Service, for
the purpose of--
``(1) providing early identification and services to meet
the needs of children and adolescents who are at risk of
substance use disorders;
``(2) providing substance use disorder treatment services
for children, including children and adolescents with co-
occurring mental illness and substance use disorders; and
[[Page 130 STAT. 1265]]
``(3) providing assistance to pregnant women, and parenting
women, with substance use disorders, in obtaining treatment
services, linking mothers to community resources to support
independent family lives, and staying in recovery so that
children are in safe, stable home environments and receive
appropriate health care services.'';
(3) in subsection (b)--
(A) by striking paragraph (1) and inserting the
following:
``(1) apply evidence-based and cost-effective methods;'';
(B) in paragraph (2)--
(i) by striking ``treatment''; and
(ii) by inserting ``substance abuse,'' after
``child welfare,'';
(C) in paragraph (3), by striking ``substance abuse
disorders'' and inserting ``substance use disorders,
including children and adolescents with co-occurring
mental illness and substance use disorders,'';
(D) in paragraph (5), by striking ``treatment;'' and
inserting ``services; and'';
(E) in paragraph (6), by striking ``substance abuse
treatment; and'' and inserting ``treatment.''; and
(F) by striking paragraph (7); and
(4) in subsection (f), by striking ``$40,000,000'' and all
that follows through the period and inserting ``$29,605,000 for
each of fiscal years 2018 through 2022.''.
SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
The first section 582 of the Public Health Service Act (42 U.S.C.
290hh-1; relating to grants to address the problems of persons who
experience violence related stress) is amended--
(1) in subsection (a), by striking ``developing programs''
and all that follows through the period at the end and inserting
the following: ``developing and maintaining programs that
provide for--
``(1) the continued operation of the National Child
Traumatic Stress Initiative (referred to in this section as the
`NCTSI'), which includes a cooperative agreement with a
coordinating center, that focuses on the mental, behavioral, and
biological aspects of psychological trauma response, prevention
of the long-term consequences of child trauma, and early
intervention services and treatment to address the long-term
consequences of child trauma; and
``(2) the development of knowledge with regard to evidence-
based practices for identifying and treating mental, behavioral,
and biological disorders of children and youth resulting from
witnessing or experiencing a traumatic event.'';
(2) in subsection (b)--
(A) by striking ``subsection (a) related'' and
inserting ``subsection (a)(2) (related'';
(B) by striking ``treating disorders associated with
psychological trauma'' and inserting ``treating mental,
behavioral, and biological disorders associated with
psychological trauma)''; and
(C) by striking ``mental health agencies and
programs that have established clinical and basic
research'' and inserting ``universities, hospitals,
mental health agencies,
[[Page 130 STAT. 1266]]
and other programs that have established clinical
expertise and research'';
(3) by redesignating subsections (c) through (g) as
subsections (g) through (k), respectively;
(4) by inserting after subsection (b), the following:
``(c) Child Outcome Data.--The NCTSI coordinating center described
in subsection (a)(1) shall collect, analyze, report, and make publicly
available, as appropriate, NCTSI-wide child treatment process and
outcome data regarding the early identification and delivery of
evidence-based treatment and services for children and families served
by the NCTSI grantees.
``(d) Training.--The NCTSI coordinating center shall facilitate the
coordination of training initiatives in evidence-based and trauma-
informed treatments, interventions, and practices offered to NCTSI
grantees, providers, and partners.
``(e) Dissemination and Collaboration.--The NCTSI coordinating
center shall, as appropriate, collaborate with--
``(1) the Secretary, in the dissemination of evidence-based
and trauma-informed interventions, treatments, products, and
other resources to appropriate stakeholders; and
``(2) appropriate agencies that conduct or fund research
within the Department of Health and Human Services, for purposes
of sharing NCTSI expertise, evaluation data, and other
activities, as appropriate.
``(f) Review.--The Secretary shall, consistent with the peer-review
process, ensure that NCTSI applications are reviewed by appropriate
experts in the field as part of a consensus-review process. The
Secretary shall include review criteria related to expertise and
experience in child trauma and evidence-based practices.'';
(5) in subsection (g) (as so redesignated), by striking
``with respect to centers of excellence are distributed
equitably among the regions of the country'' and inserting ``are
distributed equitably among the regions of the United States'';
(6) in subsection (i) (as so redesignated), by striking
``recipient may not exceed 5 years'' and inserting ``recipient
shall not be less than 4 years, but shall not exceed 5 years'';
and
(7) in subsection (j) (as so redesignated), by striking
``$50,000,000'' and all that follows through ``2006'' and
inserting ``$46,887,000 for each of fiscal years 2018 through
2022''.
SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13)
the following:
``SEC. 317L-1. <<NOTE: 42 USC 247b-13a.>> SCREENING AND TREATMENT
FOR MATERNAL DEPRESSION.
``(a) Grants.--The Secretary shall make grants to States to
establish, improve, or maintain programs for screening, assessment, and
treatment services, including culturally and linguistically appropriate
services, as appropriate, for women who are pregnant, or who have given
birth within the preceding 12 months, for maternal depression.
``(b) Application.--To seek a grant under this section, a State
shall submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
[[Page 130 STAT. 1267]]
require. At a minimum, any such application shall include explanations
of--
``(1) how a program, or programs, will increase the
percentage of women screened and treated, as appropriate, for
maternal depression in 1 or more communities; and
``(2) how a program, or programs, if expanded, would
increase access to screening and treatment services for maternal
depression.
``(c) Priority.--In awarding grants under this section, the
Secretary may give priority to States proposing to improve or enhance
access to screening services for maternal depression in primary care
settings.
``(d) Use of Funds.--The activities eligible for funding through a
grant under subsection (a)--
``(1) shall include--
``(A) providing appropriate training to health care
providers; and
``(B) providing information to health care
providers, including information on maternal depression
screening, treatment, and followup support services, and
linkages to community-based resources; and
``(2) may include--
``(A) enabling health care providers (including
obstetrician-gynecologists, pediatricians,
psychiatrists, mental health care providers, and adult
primary care clinicians) to provide or receive real-time
psychiatric consultation (in-person or remotely) to aid
in the treatment of pregnant and parenting women;
``(B) establishing linkages with and among
community-based resources, including mental health
resources, primary care resources, and support groups;
and
``(C) utilizing telehealth services for rural areas
and medically underserved areas (as defined in section
330I(a)).
``(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $5,000,000 for each of fiscal
years 2018 through 2022.''.
SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
INTERVENTION, AND TREATMENT.
Part Q of title III of the Public Health Service Act (42 U.S.C. 280h
et seq.) is amended by adding at the end the following:
``SEC. 399Z-2. <<NOTE: 42 USC 280h-6.>> INFANT AND EARLY
CHILDHOOD MENTAL HEALTH PROMOTION,
INTERVENTION, AND TREATMENT.
``(a) Grants.--The Secretary shall--
``(1) award grants to eligible entities to develop,
maintain, or enhance infant and early childhood mental health
promotion, intervention, and treatment programs, including--
``(A) programs for infants and children at
significant risk of developing, showing early signs of,
or having been diagnosed with mental illness, including
a serious emotional disturbance; and
``(B) multigenerational therapy and other services
that support the caregiving relationship; and
``(2) ensure that programs funded through grants under this
section are evidence-informed or evidence-based models,
practices, and methods that are, as appropriate, culturally and
[[Page 130 STAT. 1268]]
linguistically appropriate, and can be replicated in other
appropriate settings.
``(b) Eligible Children and Entities.--In this section:
``(1) Eligible child.--The term `eligible child' means a
child from birth to not more than 12 years of age who--
``(A) is at risk for, shows early signs of, or has
been diagnosed with a mental illness, including a
serious emotional disturbance; and
``(B) may benefit from infant and early childhood
intervention or treatment programs or specialized
preschool or elementary school programs that are
evidence-based or that have been scientifically
demonstrated to show promise but would benefit from
further applied development.
``(2) Eligible entity.--The term `eligible entity' means a
human services agency or nonprofit institution that--
``(A) employs licensed mental health professionals
who have specialized training and experience in infant
and early childhood mental health assessment, diagnosis,
and treatment, or is accredited or approved by the
appropriate State agency, as applicable, to provide for
children from infancy to 12 years of age mental health
promotion, intervention, or treatment services; and
``(B) provides services or programs described in
subsection (a) that are evidence-based or that have been
scientifically demonstrated to show promise but would
benefit from further applied development.
``(c) Application.--An eligible entity seeking a grant under
subsection (a) shall submit to the Secretary an application at such
time, in such manner, and containing such information as the Secretary
may require.
``(d) Use of Funds for Early Intervention and Treatment Programs.--
An eligible entity may use amounts awarded under a grant under
subsection (a)(1) to carry out the following:
``(1) Provide age-appropriate mental health promotion and
early intervention services or mental illness treatment
services, which may include specialized programs, for eligible
children at significant risk of developing, showing early signs
of, or having been diagnosed with a mental illness, including a
serious emotional disturbance. Such services may include social
and behavioral services as well as multigenerational therapy and
other services that support the caregiving relationship.
``(2) Provide training for health care professionals with
expertise in infant and early childhood mental health care with
respect to appropriate and relevant integration with other
disciplines such as primary care clinicians, early intervention
specialists, child welfare staff, home visitors, early care and
education providers, and others who work with young children and
families.
``(3) Provide mental health consultation to personnel of
early care and education programs (including licensed or
regulated center-based and home-based child care, home visiting,
preschool special education, and early intervention programs)
who work with children and families.
``(4) Provide training for mental health clinicians in
infant and early childhood in promising and evidence-based
practices and models for infant and early childhood mental
health treatment and early intervention, including with regard
to practices
[[Page 130 STAT. 1269]]
for identifying and treating mental illness and behavioral
disorders of infants and children resulting from exposure or
repeated exposure to adverse childhood experiences or childhood
trauma.
``(5) Provide age-appropriate assessment, diagnostic, and
intervention services for eligible children, including early
mental health promotion, intervention, and treatment services.
``(e) Matching Funds.--The Secretary may not award a grant under
this section to an eligible entity unless the eligible entity agrees,
with respect to the costs to be incurred by the eligible entity in
carrying out the activities described in subsection (d), to make
available non-Federal contributions (in cash or in kind) toward such
costs in an amount that is not less than 10 percent of the total amount
of Federal funds provided in the grant.
``(f) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $20,000,000 for the period of
fiscal years 2018 through 2022.''.
TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
SEC. 11001. SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) According to the National Survey on Drug Use and Health,
in 2015, there were approximately 9,800,000 adults in the United
States with serious mental illness.
(2) The Substance Abuse and Mental Health Services
Administration defines the term ``serious mental illness'' as an
illness affecting individuals 18 years of age or older as
having, at any time in the past year, a diagnosable mental,
behavioral, or emotional disorder that results in serious
functional impairment and substantially interferes with or
limits one or more major life activities.
(3) In reporting on the incidence of serious mental illness,
the Substance Abuse and Mental Health Services Administration
includes major depression, schizophrenia, bipolar disorder, and
other mental disorders that cause serious impairment.
(4) Adults with a serious mental illness are at a higher
risk for chronic physical illnesses and premature death.
(5) According to the World Health Organization, adults with
a serious mental illness have lifespans that are 10 to 25 years
shorter than those without serious mental illness. The vast
majority of these deaths are due to chronic physical medical
conditions, such as cardiovascular, respiratory, and infectious
diseases, as well as diabetes and hypertension.
(6) According to the World Health Organization, the majority
of deaths of adults with a serious mental illness that are due
to physical medical conditions are preventable.
(7) Supported decision making can facilitate care decisions
in areas where serious mental illness may impact the capacity of
an individual to determine a course of treatment while still
allowing the individual to make decisions independently.
(8) Help should be provided to adults with a serious mental
illness to address their acute or chronic physical illnesses,
make informed choices about treatment, and understand and follow
through with appropriate treatment.
[[Page 130 STAT. 1270]]
(9) There is confusion in the health care community
regarding permissible practices under the regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996 (commonly known as ``HIPAA''). This
confusion may hinder appropriate communication of health care
information or treatment preferences with appropriate
caregivers.
(b) Sense of Congress.--It is the sense of Congress that
clarification is needed regarding the privacy rule promulgated under
section 264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses
and disclosures of health information by health care professionals to
communicate with caregivers of adults with a serious mental illness to
facilitate treatment.
SEC. 11002. CONFIDENTIALITY OF RECORDS.
Not later than 1 year after the date on which the Secretary of
Health and Human Services (in this title referred to as the
``Secretary'') first finalizes regulations updating part 2 of title 42,
Code of Federal Regulations, relating to confidentiality of alcohol and
drug abuse patient records, after the date of enactment of this Act, the
Secretary shall convene relevant stakeholders to determine the effect of
such regulations on patient care, health outcomes, and patient privacy.
SEC. 11003. <<NOTE: 42 USC 1320d-2 note.>> CLARIFICATION ON
PERMITTED USES AND DISCLOSURES OF
PROTECTED HEALTH INFORMATION.
(a) In General.--The Secretary, acting through the Director of the
Office for Civil Rights, shall ensure that health care providers,
professionals, patients and their families, and others involved in
mental or substance use disorder treatment have adequate, accessible,
and easily comprehensible resources relating to appropriate uses and
disclosures of protected health information under the regulations
promulgated under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
(b) Guidance.--
(1) Issuance.--In carrying out subsection (a), not later
than 1 year after the date of enactment of this section, the
Secretary shall issue guidance clarifying the circumstances
under which, consistent with regulations promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, a health care provider or covered
entity may use or disclose protected health information.
(2) Circumstances addressed.--The guidance issued under this
section shall address circumstances including those that--
(A) require the consent of the patient;
(B) require providing the patient with an
opportunity to object;
(C) are based on the exercise of professional
judgment regarding whether the patient would object when
the opportunity to object cannot practicably be provided
because of the incapacity of the patient or an emergency
treatment circumstance; and
(D) are determined, based on the exercise of
professional judgment, to be in the best interest of the
patient when the patient is not present or otherwise
incapacitated.
[[Page 130 STAT. 1271]]
(3) Communication with family members and caregivers.--In
addressing the circumstances described in paragraph (2), the
guidance issued under this section shall clarify permitted uses
or disclosures of protected health information for purposes of--
(A) communicating with a family member of the
patient, caregiver of the patient, or other individual,
to the extent that such family member, caregiver, or
individual is involved in the care of the patient;
(B) in the case that the patient is an adult,
communicating with a family member of the patient,
caregiver of the patient, or other individual involved
in the care of the patient;
(C) in the case that the patient is a minor,
communicating with the parent or caregiver of the
patient;
(D) involving the family members or caregivers of
the patient, or others involved in the patient's care or
care plan, including facilitating treatment and
medication adherence;
(E) listening to the patient, or receiving
information with respect to the patient from the family
or caregiver of the patient;
(F) communicating with family members of the
patient, caregivers of the patient, law enforcement, or
others when the patient presents a serious and imminent
threat of harm to self or others; and
(G) communicating to law enforcement and family
members or caregivers of the patient about the admission
of the patient to receive care at, or the release of a
patient from, a facility for an emergency psychiatric
hold or involuntary treatment.
SEC. 11004. <<NOTE: 42 USC 1320d-2 note.>> DEVELOPMENT AND
DISSEMINATION OF MODEL TRAINING
PROGRAMS.
(a) Initial Programs and Materials.--Not later than 1 year after the
date of the enactment of this Act, the Secretary, in consultation with
appropriate experts, shall identify the following model programs and
materials, or (in the case that no such programs or materials exist)
recognize private or public entities to develop and disseminate each of
the following:
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, including child and adolescent psychiatrists,
psychologists, counselors, therapists, nurse practitioners,
physician assistants, behavioral health facilities and clinics,
care managers, and hospitals, including individuals such as
general counsels or regulatory compliance staff who are
responsible for establishing provider privacy policies)
regarding the permitted uses and disclosures, consistent with
the standards governing the privacy and security of individually
identifiable health information promulgated by the Secretary
under part C of title XI of the Social Security Act (42 U.S.C.
1320d et seq.) and regulations promulgated under section 264(c)
of the Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note) and such part C, of the protected
health information of patients seeking or undergoing mental or
substance use disorder treatment.
[[Page 130 STAT. 1272]]
(2) A model program and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations specified in
paragraph (1).
(b) Periodic Updates.--The Secretary shall--
(1) periodically review and update the model programs and
materials identified or developed under subsection (a); and
(2) disseminate the updated model programs and materials to
the individuals described in subsection (a).
(c) Coordination.--The Secretary shall carry out this section in
coordination with the Director of the Office for Civil Rights within the
Department of Health and Human Services, the Assistant Secretary for
Mental Health and Substance Use, the Administrator of the Health
Resources and Services Administration, and the heads of other relevant
agencies within the Department of Health and Human Services.
(d) Input of Certain Entities.--In identifying, reviewing, or
updating the model programs and materials under subsections (a) and (b),
the Secretary shall solicit the input of relevant national, State, and
local associations; medical societies; licensing boards; providers of
mental and substance use disorder treatment; organizations with
expertise on domestic violence, sexual assault, elder abuse, and child
abuse; and organizations representing patients and consumers and the
families of patients and consumers.
(e) Funding.--There are authorized to be appropriated to carry out
this section--
(1) $4,000,000 for fiscal year 2018;
(2) $2,000,000 for each of fiscal years 2019 and 2020; and
(3) $1,000,000 for each of fiscal years 2021 and 2022.
TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
SEC. 12001. <<NOTE: 42 USC 1396 note.>> RULE OF CONSTRUCTION
RELATED TO MEDICAID COVERAGE OF MENTAL
HEALTH SERVICES AND PRIMARY CARE
SERVICES FURNISHED ON THE SAME DAY.
Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et
seq.) shall be construed as prohibiting separate payment under the State
plan under such title (or under a waiver of the plan) for the provision
of a mental health service or primary care service under such plan, with
respect to an individual, because such service is--
(1) a primary care service furnished to the individual by a
provider at a facility on the same day a mental health service
is furnished to such individual by such provider (or another
provider) at the facility; or
(2) a mental health service furnished to the individual by a
provider at a facility on the same day a primary care service is
furnished to such individual by such provider (or another
provider) at the facility.
SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE
REGULATION.
(a) Study.--The Secretary of Health and Human Services, acting
through the Administrator of the Centers for Medicare &
[[Page 130 STAT. 1273]]
Medicaid Services, shall conduct a study on coverage under the Medicaid
program under title XIX of the Social Security Act (42 U.S.C. 1396 et
seq.) of services provided through a medicaid managed care organization
(as defined in section 1903(m) of such Act (42 U.S.C. 1396b(m)) or a
prepaid inpatient health plan (as defined in section 438.2 of title 42,
Code of Federal Regulations (or any successor regulation)) with respect
to individuals over the age of 21 and under the age of 65 for the
treatment of a mental health disorder in institutions for mental
diseases (as defined in section 1905(i) of such Act (42 U.S.C.
1396d(i))). Such study shall include information on the following:
(1) The extent to which States, including the District of
Columbia and each territory or possession of the United States,
are providing capitated payments to such organizations or plans
for enrollees who are receiving services in institutions for
mental diseases.
(2) The number of individuals receiving medical assistance
under a State plan under such title XIX, or a waiver of such
plan, who receive services in institutions for mental diseases
through such organizations and plans.
(3) The range of and average number of months, and the
length of stay during such months, that such individuals are
receiving such services in such institutions.
(4) How such organizations or plans determine when to
provide for the furnishing of such services through an
institution for mental diseases in lieu of other benefits
(including the full range of community-based services) under
their contract with the State agency administering the State
plan under such title XIX, or a waiver of such plan, to address
psychiatric or substance use disorder treatment.
(5) The extent to which the provision of services within
such institutions has affected the capitated payments for such
organizations or plans.
(b) Report.--Not later than 3 years after the date of the enactment
of this Act, the Secretary shall submit to Congress a report on the
study conducted under subsection (a).
SEC. 12003. <<NOTE: 42 USC 1315 note.>> GUIDANCE ON OPPORTUNITIES
FOR INNOVATION.
Not later than 1 year after the date of the enactment of this Act,
the Administrator of the Centers for Medicare & Medicaid Services shall
issue a State Medicaid Director letter regarding opportunities to design
innovative service delivery systems, including systems for providing
community-based services, for adults with a serious mental illness or
children with a serious emotional disturbance who are receiving medical
assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et
seq.). The letter shall include opportunities for demonstration projects
under section 1115 of such Act (42 U.S.C. 1315) to improve care for such
adults and children.
SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC
DEMONSTRATION PROJECT.
(a) Collection of Information.--The Secretary of Health and Human
Services, acting through the Administrator of the Centers for Medicare &
Medicaid Services, shall, to the extent practical and data is available,
with respect to each State that has participated in the demonstration
project established under section 2707
[[Page 130 STAT. 1274]]
of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a
note), collect from each such State information on the following:
(1) The number of institutions for mental diseases (as
defined in section 1905(i) of the Social Security Act (42 U.S.C.
1396d(i))) and beds in such institutions that received payment
for the provision of services to individuals who receive medical
assistance under a State plan under the Medicaid program under
title XIX of the Social Security Act (42 U.S.C. 1396 et seq.)
(or under a waiver of such plan) through the demonstration
project in each such State as compared to the total number of
institutions for mental diseases and beds in the State.
(2) The extent to which there is a reduction in expenditures
under the Medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) or other spending on the
full continuum of physical or mental health care for individuals
who receive treatment in an institution for mental diseases
under the demonstration project, including outpatient,
inpatient, emergency, and ambulatory care, that is attributable
to such individuals receiving treatment in institutions for
mental diseases under the demonstration project.
(3) The number of forensic psychiatric hospitals, the number
of beds in such hospitals, and the number of forensic
psychiatric beds in other hospitals in such State, based on the
most recent data available, to the extent practical, as
determined by such Administrator.
(4) The amount of any disproportionate share hospital
payments under section 1923 of the Social Security Act (42
U.S.C. 1396r-4) that institutions for mental diseases in the
State received during the period beginning on July 1, 2012, and
ending on June 30, 2015, and the extent to which the
demonstration project reduced the amount of such payments.
(5) The most recent data regarding all facilities or sites
in the State in which any adults with a serious mental illness
who are receiving medical assistance under a State plan under
the Medicaid program under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.) (or under a waiver of such plan) are
treated during the period referred to in paragraph (4), to the
extent practical, as determined by the Administrator,
including--
(A) the types of such facilities or sites (such as
an institution for mental diseases, a hospital emergency
department, or other inpatient hospital);
(B) the average length of stay in such a facility or
site by such an individual, disaggregated by facility
type; and
(C) the payment rate under the State plan (or a
waivers of such plan) for services furnished to such an
individual for that treatment, disaggregated by facility
type, during the period in which the demonstration
project is in operation.
(6) The extent to which the utilization of hospital
emergency departments during the period in which the
demonstration project was is in operation differed, with respect
to individuals who are receiving medical assistance under a
State plan under the Medicaid program under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.) (or under a waiver
of such plan), between--
[[Page 130 STAT. 1275]]
(A) those individuals who received treatment in an
institution for mental diseases under the demonstration
project;
(B) those individuals who met the eligibility
requirements for the demonstration project but who did
not receive treatment in an institution for mental
diseases under the demonstration project; and
(C) those adults with a serious mental illness who
did not meet such eligibility requirements and did not
receive treatment for such illness in an institution for
mental diseases.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit to
Congress a report that summarizes and analyzes the information collected
under subsection (a). Such report may be submitted as part of the report
required under section 2707(f) of the Patient Protection and Affordable
Care Act (42 U.S.C. 1396a note) or separately.
SEC. 12005. <<NOTE: 42 USC 1396d note.>> PROVIDING EPSDT SERVICES
TO CHILDREN IN IMDS.
(a) In General.--Section 1905(a)(16) of the Social Security Act (42
U.S.C. 1396d(a)(16)) is amended--
(1) by striking ``effective January 1, 1973'' and inserting
``(A) effective January 1, 1973''; and
(2) by inserting before the semicolon at the end the
following: ``, and, (B) for individuals receiving services
described in subparagraph (A), early and periodic screening,
diagnostic, and treatment services (as defined in subsection
(r)), whether or not such screening, diagnostic, and treatment
services are furnished by the provider of the services described
in such subparagraph''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply with respect to items and services furnished in calendar quarters
beginning on or after January 1, 2019.
SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
PERSONAL CARE SERVICES AND HOME HEALTH
CARE SERVICES UNDER MEDICAID.
(a) In General.--Section 1903 of the Social Security Act (42 U.S.C.
1396b) is amended by inserting after subsection (k) the following new
subsection:
``(l)(1) Subject to paragraphs (3) and (4), with respect to any
amount expended for personal care services or home health care services
requiring an in-home visit by a provider that are provided under a State
plan under this title (or under a waiver of the plan) and furnished in a
calendar quarter beginning on or after January 1, 2019 (or, in the case
of home health care services, on or after January 1, 2023), unless a
State requires the use of an electronic visit verification system for
such services furnished in such quarter under the plan or such waiver,
the Federal medical assistance percentage shall be reduced--
``(A) in the case of personal care services--
``(i) for calendar quarters in 2019 and 2020, by .25
percentage points;
``(ii) for calendar quarters in 2021, by .5
percentage points;
``(iii) for calendar quarters in 2022, by .75
percentage points; and
[[Page 130 STAT. 1276]]
``(iv) for calendar quarters in 2023 and each year
thereafter, by 1 percentage point; and
``(B) in the case of home health care services--
``(i) for calendar quarters in 2023 and 2024, by .25
percentage points;
``(ii) for calendar quarters in 2025, by .5
percentage points;
``(iii) for calendar quarters in 2026, by .75
percentage points; and
``(iv) for calendar quarters in 2027 and each year
thereafter, by 1 percentage point.
``(2) Subject to paragraphs (3) and (4), in implementing the
requirement for the use of an electronic visit verification system under
paragraph (1), a State shall--
``(A) consult with agencies and entities that provide
personal care services, home health care services, or both under
the State plan (or under a waiver of the plan) to ensure that
such system--
``(i) is minimally burdensome;
``(ii) takes into account existing best practices
and electronic visit verification systems in use in the
State; and
``(iii) is conducted in accordance with the
requirements of HIPAA privacy and security law (as
defined in section 3009 of the Public Health Service
Act);
``(B) take into account a stakeholder process that includes
input from beneficiaries, family caregivers, individuals who
furnish personal care services or home health care services, and
other stakeholders, as determined by the State in accordance
with guidance from the Secretary; and
``(C) ensure that individuals who furnish personal care
services, home health care services, or both under the State
plan (or under a waiver of the plan) are provided the
opportunity for training on the use of such system.
``(3) Paragraphs (1) and (2) shall not apply in the case of a State
that, as of the date of the enactment of this subsection, requires the
use of any system for the electronic verification of visits conducted as
part of both personal care services and home health care services, so
long as the State continues to require the use of such system with
respect to the electronic verification of such visits.
``(4)(A) In the case of a State described in subparagraph (B), the
reduction under paragraph (1) shall not apply--
``(i) in the case of personal care services, for calendar
quarters in 2019; and
``(ii) in the case of home health care services, for
calendar quarters in 2023.
``(B) For purposes of subparagraph (A), a State described in this
subparagraph is a State that demonstrates to the Secretary that the
State--
``(i) has made a good faith effort to comply with the
requirements of paragraphs (1) and (2) (including by taking
steps to adopt the technology used for an electronic visit
verification system); and
``(ii) in implementing such a system, has encountered
unavoidable system delays.
``(5) In this subsection:
[[Page 130 STAT. 1277]]
``(A) The term `electronic visit verification system' means,
with respect to personal care services or home health care
services, a system under which visits conducted as part of such
services are electronically verified with respect to--
``(i) the type of service performed;
``(ii) the individual receiving the service;
``(iii) the date of the service;
``(iv) the location of service delivery;
``(v) the individual providing the service; and
``(vi) the time the service begins and ends.
``(B) The term `home health care services' means services
described in section 1905(a)(7) provided under a State plan
under this title (or under a waiver of the plan).
``(C) The term `personal care services' means personal care
services provided under a State plan under this title (or under
a waiver of the plan), including services provided under section
1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a
wavier under section 1115.
``(6)(A) In the case in which a State requires personal care service
and home health care service providers to utilize an electronic visit
verification system operated by the State or a contractor on behalf of
the State, the Secretary shall pay to the State, for each quarter, an
amount equal to 90 per centum of so much of the sums expended during
such quarter as are attributable to the design, development, or
installation of such system, and 75 per centum of so much of the sums
for the operation and maintenance of such system.
``(B) Subparagraph (A) shall not apply in the case in which a State
requires personal care service and home health care service providers to
utilize an electronic visit verification system that is not operated by
the State or a contractor on behalf of the State.''.
(b) <<NOTE: 42 USC 1396b note.>> Collection and Dissemination of
Best Practices.--Not later than January 1, 2018, the Secretary of Health
and Human Services shall, with respect to electronic visit verification
systems (as defined in subsection (l)(5) of section 1903 of the Social
Security Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect
and disseminate best practices to State Medicaid Directors with respect
to--
(1) training individuals who furnish personal care services,
home health care services, or both under the State plan under
title XIX of such Act (or under a waiver of the plan) on such
systems and the operation of such systems and the prevention of
fraud with respect to the provision of personal care services or
home health care services (as defined in such subsection
(l)(5)); and
(2) the provision of notice and educational materials to
family caregivers and beneficiaries with respect to the use of
such electronic visit verification systems and other means to
prevent such fraud.
(c) <<NOTE: 42 USC 1396b note.>> Rules of Construction.--
(1) No employer-employee relationship established.--Nothing
in the amendment made by this section may be construed as
establishing an employer-employee relationship between the
agency or entity that provides for personal care services or
home health care services and the individuals who, under a
contract with such an agency or entity, furnish such
[[Page 130 STAT. 1278]]
services for purposes of part 552 of title 29, Code of Federal
Regulations (or any successor regulations).
(2) No particular or uniform electronic visit verification
system required.--Nothing in the amendment made by this section
shall be construed to require the use of a particular or uniform
electronic visit verification system (as defined in subsection
(l)(5) of section 1903 of the Social Security Act (42 U.S.C.
1396b), as inserted by subsection (a)) by all agencies or
entities that provide personal care services or home health care
under a State plan under title XIX of the Social Security Act
(or under a waiver of the plan) (42 U.S.C. 1396 et seq.).
(3) No limits on provision of care.--Nothing in the
amendment made by this section may be construed to limit, with
respect to personal care services or home health care services
provided under a State plan under title XIX of the Social
Security Act (or under a waiver of the plan) (42 U.S.C. 1396 et
seq.), provider selection, constrain beneficiaries' selection of
a caregiver, or impede the manner in which care is delivered.
(4) No prohibition on state quality measures requirements.--
Nothing in the amendment made by this section shall be construed
as prohibiting a State, in implementing an electronic visit
verification system (as defined in subsection (l)(5) of section
1903 of the Social Security Act (42 U.S.C. 1396b), as inserted
by subsection (a)), from establishing requirements related to
quality measures for such system.
TITLE XIII--MENTAL HEALTH PARITY
SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE
USE DISORDER COVERAGE REQUIREMENTS.
(a) Compliance Program Guidance Document.--Section 2726(a) of the
Public Health Service Act (42 U.S.C. 300gg-26(a)) is amended by adding
at the end the following:
``(6) Compliance program guidance document.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of the Treasury,
in consultation with the Inspector General of the
Department of Health and Human Services, the Inspector
General of the Department of Labor, and the Inspector
General of the Department of the Treasury, shall issue a
compliance program guidance document to help improve
compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, and
section 9812 of the Internal Revenue Code of 1986, as
applicable. In carrying out this paragraph, the
Secretaries may take into consideration the 2016
publication of the Department of Health and Human
Services and the Department of Labor, entitled `Warning
Signs - Plan or Policy Non-Quantitative Treatment
Limitations (NQTLs) that Require Additional Analysis to
Determine Mental Health Parity Compliance'.
``(B) Examples illustrating compliance and
noncompliance.--
[[Page 130 STAT. 1279]]
``(i) In general.--The compliance program
guidance document required under this paragraph
shall provide illustrative, de-identified examples
(that do not disclose any protected health
information or individually identifiable
information) of previous findings of compliance
and noncompliance with this section, section 712
of the Employee Retirement Income Security Act of
1974, or section 9812 of the Internal Revenue Code
of 1986, as applicable, based on investigations of
violations of such sections, including--
``(I) examples illustrating
requirements for information disclosures
and nonquantitative treatment
limitations; and
``(II) descriptions of the
violations uncovered during the course
of such investigations.
``(ii) Nonquantitative treatment
limitations.--To the extent that any example
described in clause (i) involves a finding of
compliance or noncompliance with regard to any
requirement for nonquantitative treatment
limitations, the example shall provide sufficient
detail to fully explain such finding, including a
full description of the criteria involved for
approving medical and surgical benefits and the
criteria involved for approving mental health and
substance use disorder benefits.
``(iii) Access to additional information
regarding compliance.--In developing and issuing
the compliance program guidance document required
under this paragraph, the Secretaries specified in
subparagraph (A)--
``(I) shall enter into interagency
agreements with the Inspector General of
the Department of Health and Human
Services, the Inspector General of the
Department of Labor, and the Inspector
General of the Department of the
Treasury to share findings of compliance
and noncompliance with this section,
section 712 of the Employee Retirement
Income Security Act of 1974, or section
9812 of the Internal Revenue Code of
1986, as applicable; and
``(II) shall seek to enter into an
agreement with a State to share
information on findings of compliance
and noncompliance with this section,
section 712 of the Employee Retirement
Income Security Act of 1974, or section
9812 of the Internal Revenue Code of
1986, as applicable.
``(C) Recommendations.--The compliance program
guidance document shall include recommendations to
advance compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, or
section 9812 of the Internal Revenue Code of 1986, as
applicable, and encourage the development and use of
internal controls to monitor adherence to applicable
statutes, regulations, and program requirements. Such
internal controls may include illustrative examples of
nonquantitative treatment limitations on mental health
and substance use disorder benefits, which may fail to
comply with this
[[Page 130 STAT. 1280]]
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, in relation to
nonquantitative treatment limitations on medical and
surgical benefits.
``(D) Updating the compliance program guidance
document.--The Secretary, the Secretary of Labor, and
the Secretary of the Treasury, in consultation with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of
Labor, and the Inspector General of the Department of
the Treasury, shall update the compliance program
guidance document every 2 years to include illustrative,
de-identified examples (that do not disclose any
protected health information or individually
identifiable information) of previous findings of
compliance and noncompliance with this section, section
712 of the Employee Retirement Income Security Act of
1974, or section 9812 of the Internal Revenue Code of
1986, as applicable.''.
(b) Additional Guidance.--Section 2726(a) of the Public Health
Service Act (42 U.S.C. 300gg-26(a)), as amended by subsection (a), is
further amended by adding at the end the following:
``(7) Additional guidance.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of the Treasury
shall issue guidance to group health plans and health
insurance issuers offering group or individual health
insurance coverage to assist such plans and issuers in
satisfying the requirements of this section, section 712
of the Employee Retirement Income Security Act of 1974,
or section 9812 of the Internal Revenue Code of 1986, as
applicable.
``(B) Disclosure.--
``(i) Guidance for plans and issuers.--The
guidance issued under this paragraph shall include
clarifying information and illustrative examples
of methods that group health plans and health
insurance issuers offering group or individual
health insurance coverage may use for disclosing
information to ensure compliance with the
requirements under this section, section 712 of
the Employee Retirement Income Security Act of
1974, or section 9812 of the Internal Revenue Code
of 1986, as applicable, (and any regulations
promulgated pursuant to such sections, as
applicable).
``(ii) Documents for participants,
beneficiaries, contracting providers, or
authorized representatives.--The guidance issued
under this paragraph shall include clarifying
information and illustrative examples of methods
that group health plans and health insurance
issuers offering group or individual health
insurance coverage may use to provide any
participant, beneficiary, contracting provider, or
authorized representative, as applicable, with
documents containing information that the health
plans or issuers are required to disclose to
participants, beneficiaries, contracting
providers, or authorized representatives to ensure
compliance with this section,
[[Page 130 STAT. 1281]]
section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the
Internal Revenue Code of 1986, as applicable,
compliance with any regulation issued pursuant to
such respective section, or compliance with any
other applicable law or regulation. Such guidance
shall include information that is comparative in
nature with respect to--
``(I) nonquantitative treatment
limitations for both medical and
surgical benefits and mental health and
substance use disorder benefits;
``(II) the processes, strategies,
evidentiary standards, and other factors
used to apply the limitations described
in subclause (I); and
``(III) the application of the
limitations described in subclause (I)
to ensure that such limitations are
applied in parity with respect to both
medical and surgical benefits and mental
health and substance use disorder
benefits.
``(C) Nonquantitative treatment limitations.--The
guidance issued under this paragraph shall include
clarifying information and illustrative examples of
methods, processes, strategies, evidentiary standards,
and other factors that group health plans and health
insurance issuers offering group or individual health
insurance coverage may use regarding the development and
application of nonquantitative treatment limitations to
ensure compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, or
section 9812 of the Internal Revenue Code of 1986, as
applicable, (and any regulations promulgated pursuant to
such respective section), including--
``(i) examples of methods of determining
appropriate types of nonquantitative treatment
limitations with respect to both medical and
surgical benefits and mental health and substance
use disorder benefits, including nonquantitative
treatment limitations pertaining to--
``(I) medical management standards
based on medical necessity or
appropriateness, or whether a treatment
is experimental or investigative;
``(II) limitations with respect to
prescription drug formulary design; and
``(III) use of fail-first or step
therapy protocols;
``(ii) examples of methods of determining--
``(I) network admission standards
(such as credentialing); and
``(II) factors used in provider
reimbursement methodologies (such as
service type, geographic market, demand
for services, and provider supply,
practice size, training, experience, and
licensure) as such factors apply to
network adequacy;
``(iii) examples of sources of information
that may serve as evidentiary standards for the
purposes of making determinations regarding the
development and application of nonquantitative
treatment limitations;
``(iv) examples of specific factors, and the
evidentiary standards used to evaluate such
factors, used
[[Page 130 STAT. 1282]]
by such plans or issuers in performing a
nonquantitative treatment limitation analysis;
``(v) examples of how specific evidentiary
standards may be used to determine whether
treatments are considered experimental or
investigative;
``(vi) examples of how specific evidentiary
standards may be applied to each service category
or classification of benefits;
``(vii) examples of methods of reaching
appropriate coverage determinations for new mental
health or substance use disorder treatments, such
as evidence-based early intervention programs for
individuals with a serious mental illness and
types of medical management techniques;
``(viii) examples of methods of reaching
appropriate coverage determinations for which
there is an indirect relationship between the
covered mental health or substance use disorder
benefit and a traditional covered medical and
surgical benefit, such as residential treatment or
hospitalizations involving voluntary or
involuntary commitment; and
``(ix) additional illustrative examples of
methods, processes, strategies, evidentiary
standards, and other factors for which the
Secretary determines that additional guidance is
necessary to improve compliance with this section,
section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the
Internal Revenue Code of 1986, as applicable.
``(D) Public comment.--Prior to issuing any final
guidance under this paragraph, the Secretary shall
provide a public comment period of not less than 60 days
during which any member of the public may provide
comments on a draft of the guidance.''.
(c) Availability of Plan Information.--
(1) Solicitation of public feedback.--Not later than 6
months after the date of enactment of this Act, the Secretary of
Health and Human Services, the Secretary of Labor, and the
Secretary of the Treasury shall solicit feedback from the public
on how the disclosure request process for documents containing
information that health plans or health insurance issuers are
required under Federal or State law to disclose to participants,
beneficiaries, contracting providers, or authorized
representatives to ensure compliance with existing mental health
parity and addiction equity requirements can be improved while
continuing to ensure consumers' rights to access all information
required by Federal or State law to be disclosed.
(2) Public availability.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of Health and
Human Services, the Secretary of Labor, and the Secretary of the
Treasury shall make such feedback publicly available.
(3) NAIC.--The Secretary of Health and Human Services, the
Secretary of Labor, and the Secretary of the Treasury shall
share feedback obtained pursuant to paragraph (1) directly with
the National Association of Insurance Commissioners to the
extent such feedback includes recommendations for the
development of simplified information disclosure tools to
provide consistent information for consumers. Such feedback
[[Page 130 STAT. 1283]]
may be taken into consideration by the National Association of
Insurance Commissioners and other appropriate entities for the
voluntary development and voluntary use of common templates and
other sample standardized forms to improve consumer access to
plan information.
(d) Improving Compliance.--
(1) <<NOTE: 42 USC 300gg-26 note.>> In general.--In the
case that the Secretary of Health and Human Services, the
Secretary of Labor, or the Secretary of the Treasury determines
that a group health plan or health insurance issuer offering
group or individual health insurance coverage has violated, at
least 5 times, section 2726 of the Public Health Service Act (42
U.S.C. 300gg-26), section 712 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185a), or section 9812 of the
Internal Revenue Code of 1986, respectively, the appropriate
Secretary shall audit plan documents for such health plan or
issuer in the plan year following the Secretary's determination
in order to help improve compliance with such section.
(2) Rule of construction.--Nothing in this subsection shall
be construed to limit the authority, as in effect on the day
before the date of enactment of this Act, of the Secretary of
Health and Human Services, the Secretary of Labor, or the
Secretary of the Treasury to audit documents of health plans or
health insurance issuers.
SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL HEALTH
AND SUBSTANCE USE DISORDER COVERAGE.
(a) Public Meeting.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall convene a public meeting of stakeholders
described in paragraph (2) to produce an action plan for
improved Federal and State coordination related to the
enforcement of section 2726 of the Public Health Service Act (42
U.S.C. 300gg-26), section 712 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the
Internal Revenue Code of 1986, and any comparable provisions of
State law (in this section such sections and provisions are
collectively referred to as ``mental health parity and addiction
equity requirements'').
(2) Stakeholders.--The stakeholders described in this
paragraph shall include each of the following:
(A) The Federal Government, including
representatives from--
(i) the Department of Health and Human
Services;
(ii) the Department of the Treasury;
(iii) the Department of Labor; and
(iv) the Department of Justice.
(B) State governments, including--
(i) State health insurance commissioners;
(ii) appropriate State agencies, including
agencies on public health or mental health; and
(iii) State attorneys general or other
representatives of State entities involved in the
enforcement of mental health parity and addiction
equity requirements.
[[Page 130 STAT. 1284]]
(C) Representatives from key stakeholder groups,
including--
(i) the National Association of Insurance
Commissioners;
(ii) health insurance issuers;
(iii) providers of mental health and substance
use disorder treatment;
(iv) employers; and
(v) patients or their advocates.
(b) Action Plan.--Not later than 6 months after the conclusion of
the public meeting under subsection (a), the Secretary of Health and
Human Services shall finalize the action plan described in such
subsection and make it plainly available on the Internet website of the
Department of Health and Human Services.
(c) Content.--The action plan under this section shall--
(1) take into consideration the recommendations of the
Mental Health and Substance Use Disorder Parity Task Force in
its final report issued in October of 2016, and any subsequent
Federal and State actions in relation to such recommendations;
(2) reflect the input of the stakeholders participating in
the public meeting under subsection (a);
(3) identify specific strategic objectives regarding how the
various Federal and State agencies charged with enforcement of
mental health parity and addiction equity requirements will
collaborate to improve enforcement of such requirements;
(4) provide a timeline for implementing the action plan; and
(5) provide specific examples of how such objectives may be
met, which may include--
(A) providing common educational information and
documents, such as the Consumer Guide to Disclosure
Rights, to patients about their rights under mental
health parity and addiction equity requirements;
(B) facilitating the centralized collection of,
monitoring of, and response to patient complaints or
inquiries relating to mental health parity and addiction
equity requirements, which may be through the
development and administration of--
(i) a single, toll-free telephone number; and
(ii) a new parity website--
(I) to help consumers find the
appropriate Federal or State agency to
assist with their parity complaints,
appeals, and other actions; and
(II) that takes into consideration,
but is not duplicative of, the parity
beta site being tested, and released for
public comment, by the Department of
Health and Human Services as of the date
of the enactment of this Act;
(C) Federal and State law enforcement agencies
entering into memoranda of understanding to better
coordinate enforcement responsibilities and information
sharing--
(i) including whether such agencies should
make the results of enforcement actions related to
mental health parity and addiction equity
requirements publicly available; and
[[Page 130 STAT. 1285]]
(ii) which may include State Policy Academies
on Parity Implementation for State Officials and
other forums to bring together national experts to
provide technical assistance to teams of State
officials on strategies to advance compliance with
mental health parity and addiction equity
requirements in both the commercial market, and in
the Medicaid program under title XIX of the Social
Security Act and the State Children's Health
Insurance Program under title XXI of such Act; and
(D) recommendations to the Congress regarding the
need for additional legal authority to improve
enforcement of mental health parity and addiction equity
requirements, including the need for additional legal
authority to ensure that nonquantitative treatment
limitations are applied, and the extent and frequency of
the applications of such limitations, both to medical
and surgical benefits and to mental health and substance
use disorder benefits in a comparable manner.
SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL
HEALTH AND SUBSTANCE USE DISORDER
BENEFITS.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, and annually thereafter for the subsequent 5 years, the
Assistant Secretary of Labor of the Employee Benefits Security
Administration, in collaboration with the Administrator of the Centers
for Medicare & Medicaid Services and the Secretary of the Treasury,
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report summarizing the results of all closed
Federal investigations completed during the preceding 12-month period
with findings of any serious violation regarding compliance with mental
health and substance use disorder coverage requirements under section
2726 of the Public Health Service Act (42 U.S.C. 300gg-26), section 712
of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
1185a), and section 9812 of the Internal Revenue Code of 1986.
(b) Contents.--Subject to subsection (c), a report under subsection
(a) shall, with respect to investigations described in such subsection,
include each of the following:
(1) The number of closed Federal investigations conducted
during the covered reporting period.
(2) Each benefit classification examined by any such
investigation conducted during the covered reporting period.
(3) Each subject matter, including compliance with
requirements for quantitative and nonquantitative treatment
limitations, of any such investigation conducted during the
covered reporting period.
(4) A summary of the basis of the final decision rendered
for each closed investigation conducted during the covered
reporting period that resulted in a finding of a serious
violation.
(c) Limitation.--Any individually identifiable information shall be
excluded from reports under subsection (a) consistent with protections
under the health privacy and security rules promulgated under section
264(c) of the Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note).
[[Page 130 STAT. 1286]]
SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE
DISORDER BENEFITS.
Not later than 3 years after the date of enactment of this Act, the
Comptroller General of the United States, in consultation with the
Secretary of Health and Human Services, the Secretary of Labor, and the
Secretary of the Treasury, shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report detailing the
extent to which group health plans or health insurance issuers offering
group or individual health insurance coverage that provides both medical
and surgical benefits and mental health or substance use disorder
benefits, medicaid managed care organizations with a contract under
section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), and
health plans provided under the State Children's Health Insurance
Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et
seq.) comply with section 2726 of the Public Health Service Act (42
U.S.C. 300gg-26), section 712 of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal Revenue
Code of 1986, including--
(1) how nonquantitative treatment limitations, including
medical necessity criteria, of such plans or issuers comply with
such sections;
(2) how the responsible Federal departments and agencies
ensure that such plans or issuers comply with such sections,
including an assessment of how the Secretary of Health and Human
Services has used its authority to conduct audits of such plans
to ensure compliance;
(3) a review of how the various Federal and State agencies
responsible for enforcing mental health parity requirements have
improved enforcement of such requirements in accordance with the
objectives and timeline described in the action plan under
section 13002; and
(4) recommendations for how additional enforcement,
education, and coordination activities by responsible Federal
and State departments and agencies could better ensure
compliance with such sections, including recommendations
regarding the need for additional legal authority.
SEC. 13005. <<NOTE: 42 USC 237a note.>> INFORMATION AND AWARENESS
ON EATING DISORDERS.
(a) Information.--The Secretary of Health and Human Services, acting
through the Director of the Office on Women's Health, may--
(1) update information, related fact sheets, and resource
lists related to eating disorders that are available on the
public Internet website of the National Women's Health
Information Center sponsored by the Office on Women's Health, to
include--
(A) updated findings and current research related to
eating disorders, as appropriate; and
(B) information about eating disorders, including
information related to males and females;
(2) incorporate, as appropriate, and in coordination with
the Secretary of Education, information from publicly available
resources into appropriate obesity prevention programs developed
by the Office on Women's Health; and
(3) make publicly available (through a public Internet
website or other method) information, related fact sheets, and
[[Page 130 STAT. 1287]]
resource lists, as updated under paragraph (1), and the
information incorporated into appropriate obesity prevention
programs under paragraph (2).
(b) Awareness.--The Secretary of Health and Human Services may
advance public awareness on--
(1) the types of eating disorders;
(2) the seriousness of eating disorders, including
prevalence, comorbidities, and physical and mental health
consequences;
(3) methods to identify, intervene, refer for treatment, and
prevent behaviors that may lead to the development of eating
disorders;
(4) discrimination and bullying based on body size;
(5) the effects of media on self-esteem and body image; and
(6) the signs and symptoms of eating disorders.
SEC. 13006. <<NOTE: 42 USC 237a note.>> EDUCATION AND TRAINING ON
EATING DISORDERS.
The Secretary of Health and Human Services may facilitate the
identification of model programs and materials for educating and
training health professionals in effective strategies to--
(1) identify individuals with eating disorders;
(2) provide early intervention services for individuals with
eating disorders;
(3) refer patients with eating disorders for appropriate
treatment;
(4) prevent the development of eating disorders; and
(5) provide appropriate treatment services for individuals
with eating disorders.
SEC. 13007. <<NOTE: 42 USC 300gg-26 note.>> CLARIFICATION OF
EXISTING PARITY RULES.
If a group health plan or a health insurance issuer offering group
or individual health insurance coverage provides coverage for eating
disorder benefits, including residential treatment, such group health
plan or health insurance issuer shall provide such benefits consistent
with the requirements of section 2726 of the Public Health Service Act
(42 U.S.C. 300gg-26), section 712 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal
Revenue Code of 1986.
TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A--Mental Health and Safe Communities
SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS,
MENTAL HEALTH PURPOSES.
(a) Edward Byrne Memorial Justice Assistance Grant Program.--Section
501(a)(1) of title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the end the
following:
``(H) Mental health programs and related law
enforcement and corrections programs, including
behavioral programs and crisis intervention teams.''.
[[Page 130 STAT. 1288]]
(b) Community Oriented Policing Services Program.--Section 1701(b)
of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42
U.S.C. 3796dd(b)) is amended--
(1) in paragraph (17), by striking ``and'' at the end;
(2) by redesignating paragraph (18) as paragraph (22);
(3) by inserting after paragraph (17) the following:
``(18) to provide specialized training to law enforcement
officers to--
``(A) recognize individuals who have a mental
illness; and
``(B) properly interact with individuals who have a
mental illness, including strategies for verbal de-
escalation of crises;
``(19) to establish collaborative programs that enhance the
ability of law enforcement agencies to address the mental
health, behavioral, and substance abuse problems of individuals
encountered by law enforcement officers in the line of duty;
``(20) to provide specialized training to corrections
officers to recognize individuals who have a mental illness;
``(21) to enhance the ability of corrections officers to
address the mental health of individuals under the care and
custody of jails and prisons, including specialized training and
strategies for verbal de-escalation of crises; and''; and
(4) in paragraph (22), as redesignated, by striking
``through (17)'' and inserting ``through (21)''.
(c) Modifications to the Staffing for Adequate Fire and Emergency
Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention and
Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting
before the period at the end the following: ``and to provide specialized
training to paramedics, emergency medical services workers, and other
first responders to recognize individuals who have mental illness and
how to properly intervene with individuals with mental illness,
including strategies for verbal de-escalation of crises''.
SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
(a) In General.--Section 2201 of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in
paragraph (2)(B), by inserting before the semicolon the following: ``,
or court-ordered assisted outpatient treatment when the court has
determined such treatment to be necessary''.
(b) Definitions.--Section 2202 of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting a semicolon; and
(3) by adding at the end the following:
``(3) the term `court-ordered assisted outpatient treatment'
means a program through which a court may order a treatment plan
for an eligible patient that--
``(A) requires such patient to obtain outpatient
mental health treatment while the patient is not
currently residing in a correctional facility or
inpatient treatment facility; and
[[Page 130 STAT. 1289]]
``(B) is designed to improve access and adherence by
such patient to intensive behavioral health services in
order to--
``(i) avert relapse, repeated
hospitalizations, arrest, incarceration, suicide,
property destruction, and violent behavior; and
``(ii) provide such patient with the
opportunity to live in a less restrictive
alternative to incarceration or involuntary
hospitalization; and
``(4) the term `eligible patient' means an adult, mentally
ill person who, as determined by a court--
``(A) has a history of violence, incarceration, or
medically unnecessary hospitalizations;
``(B) without supervision and treatment, may be a
danger to self or others in the community;
``(C) is substantially unlikely to voluntarily
participate in treatment;
``(D) may be unable, for reasons other than
indigence, to provide for any of his or her basic needs,
such as food, clothing, shelter, health, or safety;
``(E) has a history of mental illness or a condition
that is likely to substantially deteriorate if the
person is not provided with timely treatment; or
``(F) due to mental illness, lacks capacity to fully
understand or lacks judgment to make informed decisions
regarding his or her need for treatment, care, or
supervision.''.
SEC. 14003. <<NOTE: 42 USC 3796ii note.>> FEDERAL DRUG AND MENTAL
HEALTH COURTS.
(a) Definitions.--In this section--
(1) the term ``eligible offender'' means a person who--
(A)(i) previously or currently has been diagnosed by
a qualified mental health professional as having a
mental illness, mental retardation, or co-occurring
mental illness and substance abuse disorders; or
(ii) manifests obvious signs of mental illness,
mental retardation, or co-occurring mental illness and
substance abuse disorders during arrest or confinement
or before any court;
(B) comes into contact with the criminal justice
system or is arrested or charged with an offense that is
not--
(i) a crime of violence, as defined under
applicable State law or in section 3156 of title
18, United States Code; or
(ii) a serious drug offense, as defined in
section 924(e)(2)(A) of title 18, United States
Code; and
(C) is determined by a judge to be eligible; and
(2) the term ``mental illness'' means a diagnosable mental,
behavioral, or emotional disorder--
(A) of sufficient duration to meet diagnostic
criteria within the most recent edition of the
Diagnostic and Statistical Manual of Mental Disorders
published by the American Psychiatric Association; and
(B) that has resulted in functional impairment that
substantially interferes with or limits 1 or more major
life activities.
[[Page 130 STAT. 1290]]
(b) Establishment of Program.--Not later than 1 year after the date
of enactment of this Act, the Attorney General shall establish a pilot
program to determine the effectiveness of diverting eligible offenders
from Federal prosecution, Federal probation, or a Bureau of Prisons
facility, and placing such eligible offenders in drug or mental health
courts.
(c) Program Specifications.--The pilot program established under
subsection (b) shall involve--
(1) continuing judicial supervision, including periodic
review, of program participants who have a substance abuse
problem or mental illness; and
(2) the integrated administration of services and sanctions,
which shall include--
(A) mandatory periodic testing, as appropriate, for
the use of controlled substances or other addictive
substances during any period of supervised release or
probation for each program participant;
(B) substance abuse treatment for each program
participant who requires such services;
(C) diversion, probation, or other supervised
release with the possibility of prosecution,
confinement, or incarceration based on noncompliance
with program requirements or failure to show
satisfactory progress toward completing program
requirements;
(D) programmatic offender management, including case
management, and aftercare services, such as relapse
prevention, health care, education, vocational training,
job placement, housing placement, and child care or
other family support services for each program
participant who requires such services;
(E) outpatient or inpatient mental health treatment,
as ordered by the court, that carries with it the
possibility of dismissal of charges or reduced
sentencing upon successful completion of such treatment;
(F) centralized case management, including--
(i) the consolidation of all cases, including
violations of probations, of the program
participant; and
(ii) coordination of all mental health
treatment plans and social services, including
life skills and vocational training, housing and
job placement, education, health care, and relapse
prevention for each program participant who
requires such services; and
(G) continuing supervision of treatment plan
compliance by the program participant for a term not to
exceed the maximum allowable sentence or probation
period for the charged or relevant offense and, to the
extent practicable, continuity of psychiatric care at
the end of the supervised period.
(d) Implementation; Duration.--The pilot program established under
subsection (b) shall be conducted--
(1) in not less than 1 United States judicial district,
designated by the Attorney General in consultation with the
Director of the Administrative Office of the United States
Courts, as appropriate for the pilot program; and
(2) during fiscal year 2017 through fiscal year 2021.
(e) Criteria for Designation.--Before making a designation under
subsection (d)(1), the Attorney General shall--
[[Page 130 STAT. 1291]]
(1) obtain the approval, in writing, of the United States
Attorney for the United States judicial district being
designated;
(2) obtain the approval, in writing, of the chief judge for
the United States judicial district being designated; and
(3) determine that the United States judicial district being
designated has adequate behavioral health systems for treatment,
including substance abuse and mental health treatment.
(f) Assistance From Other Federal Entities.--The Administrative
Office of the United States Courts and the United States Probation
Offices shall provide such assistance and carry out such functions as
the Attorney General may request in monitoring, supervising, providing
services to, and evaluating eligible offenders placed in a drug or
mental health court under this section.
(g) Reports.--The Attorney General, in consultation with the
Director of the Administrative Office of the United States Courts, shall
monitor the drug and mental health courts under this section, and shall
submit a report to Congress on the outcomes of the program at the end of
the period described in subsection (d)(2).
SEC. 14004. <<NOTE: 42 USC 3796ii-8.>> MENTAL HEALTH IN THE
JUDICIAL SYSTEM.
Part V of title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end
the following:
``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
``(a) Pretrial Screening and Supervision.--
``(1) In general.--The Attorney General may award grants to
States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
implement, or expand pretrial services programs to improve the
identification and outcomes of individuals with mental illness.
``(2) Allowable uses.--Grants awarded under this subsection
may be may be used for--
``(A) behavioral health needs and risk screening of
defendants, including verification of interview
information, mental health evaluation, and criminal
history screening;
``(B) assessment of risk of pretrial misconduct
through objective, statistically validated means, and
presentation to the court of recommendations based on
such assessment, including services that will reduce the
risk of pre-trial misconduct;
``(C) followup review of defendants unable to meet
the conditions of pretrial release;
``(D) evaluation of process and results of pre-trial
service programs;
``(E) supervision of defendants who are on pretrial
release, including reminders to defendants of scheduled
court dates;
``(F) reporting on process and results of pretrial
services programs to relevant public and private mental
health stakeholders; and
``(G) data collection and analysis necessary to make
available information required for assessment of risk.
``(b) Behavioral Health Assessments and Intervention.--
``(1) In general.--The Attorney General may award grants to
States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
[[Page 130 STAT. 1292]]
implement, or expand a behavioral health screening and
assessment program framework for State or local criminal justice
systems.
``(2) Allowable uses.--Grants awarded under this subsection
may be used for--
``(A) promotion of the use of validated assessment
tools to gauge the criminogenic risk, substance abuse
needs, and mental health needs of individuals;
``(B) initiatives to match the risk factors and
needs of individuals to programs and practices
associated with research-based, positive outcomes;
``(C) implementing methods for identifying and
treating individuals who are most likely to benefit from
coordinated supervision and treatment strategies, and
identifying individuals who can do well with fewer
interventions; and
``(D) collaborative decision-making among the heads
of criminal justice agencies, mental health systems,
judicial systems, substance abuse systems, and other
relevant systems or agencies for determining how
treatment and intensive supervision services should be
allocated in order to maximize benefits, and developing
and utilizing capacity accordingly.
``(c) Use of Grant Funds.--A State, unit of local government,
territory, Indian Tribe, or nonprofit agency that receives a grant under
this section shall, in accordance with subsection (b)(2), use grant
funds for the expenses of a treatment program, including--
``(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program,
including costs relating to enforcement;
``(2) payments for treatment providers that are approved by
the State or Indian Tribe and licensed, if necessary, to provide
needed treatment to program participants, including aftercare
supervision, vocational training, education, and job placement;
and
``(3) payments to public and nonprofit private entities that
are approved by the State or Indian Tribe and licensed, if
necessary, to provide alcohol and drug addiction treatment to
offenders participating in the program.
``(d) Supplement of Non-Federal Funds.--
``(1) In general.--Grants awarded under this section shall
be used to supplement, and not supplant, non-Federal funds that
would otherwise be available for programs described in this
section.
``(2) Federal share.--The Federal share of a grant made
under this section may not exceed 50 percent of the total costs
of the program described in an application under subsection (e).
``(e) Applications.--To request a grant under this section, a State,
unit of local government, territory, Indian Tribe, or nonprofit agency
shall submit an application to the Attorney General in such form and
containing such information as the Attorney General may reasonably
require.
``(f) Geographic Distribution.--The Attorney General shall ensure
that, to the extent practicable, the distribution of grants under this
section is equitable and includes--
``(1) each State; and
[[Page 130 STAT. 1293]]
``(2) a unit of local government, territory, Indian Tribe,
or nonprofit agency--
``(A) in each State; and
``(B) in rural, suburban, Tribal, and urban
jurisdictions.
``(g) Reports and Evaluations.--For each fiscal year, each grantee
under this section during that fiscal year shall submit to the Attorney
General a report on the effectiveness of activities carried out using
such grant. Each report shall include an evaluation in such form and
containing such information as the Attorney General may reasonably
require. The Attorney General shall specify the dates on which such
reports shall be submitted.
``(h) Accountability.--Grants awarded under this section shall be
subject to the following accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term
`unresolved audit finding' means a finding in the final
audit report of the Inspector General of the Department
of Justice under subparagraph (C) that the audited
grantee has used grant funds for an unauthorized
expenditure or otherwise unallowable cost that is not
closed or resolved within 1 year after the date on which
final audit report is issued.
``(B) Audits.--Beginning in the first fiscal year
beginning after the date of enactment of this section,
and in each fiscal year thereafter, the Inspector
General of the Department of Justice shall conduct
audits of grantees under this section to prevent waste,
fraud, and abuse of funds by grantees. The Inspector
General shall determine the appropriate number of
grantees to be audited each year.
``(C) Final audit report.--The Inspector General of
the Department of Justice shall submit to the Attorney
General a final report on each audit conducted under
subparagraph (B).
``(D) Mandatory exclusion.--Grantees under this
section about which there is an unresolved audit finding
shall not be eligible to receive a grant under this
section during the 2 fiscal years beginning after the
end of the 1-year period described in subparagraph (A).
``(E) Priority.--In making grants under this
section, the Attorney General shall give priority to
applicants that did not have an unresolved audit finding
during the 3 fiscal years before submitting an
application for a grant under this section.
``(F) Reimbursement.--If an entity receives a grant
under this section during the 2-fiscal-year period
during which the entity is prohibited from receiving
grants under subparagraph (D), the Attorney General
shall--
``(i) deposit an amount equal to the amount of
the grant that was improperly awarded to the
grantee into the General Fund of the Treasury; and
``(ii) seek to recoup the costs of the
repayment under clause (i) from the grantee that
was erroneously awarded grant funds.
``(2) Nonprofit agency requirements.--
``(A) Definition.--For purposes of this paragraph
and the grant program under this section, the term
`nonprofit agency' means an organization that is
described in section
[[Page 130 STAT. 1294]]
501(c)(3) of the Internal Revenue Code of 1986 (26
U.S.C. 501(c)(3)) and is exempt from taxation under
section 501(a) of the Internal Revenue Code of 1986 (26
U.S.C. 501(a)).
``(B) Prohibition.--The Attorney General may not
award a grant under this section to a nonprofit agency
that holds money in an offshore account for the purpose
of avoiding paying the tax described in section 511(a)
of the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
``(C) Disclosure.--Each nonprofit agency that is
awarded a grant under this section and uses the
procedures prescribed in regulations to create a
rebuttable presumption of reasonableness for the
compensation of its officers, directors, trustees, and
key employees, shall disclose to the Attorney General,
in the application for the grant, the process for
determining such compensation, including the independent
persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make
the information disclosed under this subparagraph
available for public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--Not more than $20,000 of the
amounts made available to the Department of Justice to
carry out this section may be used by the Attorney
General, or by any individual or entity awarded a grant
under this section to host, or make any expenditures
relating to, a conference unless the Deputy Attorney
General provides prior written authorization that the
funds may be expended to host the conference or make
such expenditure.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment,
honoraria for speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall
submit an annual report to the Committee on the
Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives on all
conference expenditures approved under this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit to the Committee on the
Judiciary and the Committee on Appropriations of the Senate and
the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives an annual
certification--
``(A) indicating whether--
``(i) all final audit reports issued by the
Office of the Inspector General under paragraph
(1) have been completed and reviewed by the
appropriate Assistant Attorney General or
Director;
``(ii) all mandatory exclusions required under
paragraph (1)(D) have been issued; and
``(iii) any reimbursements required under
paragraph (1)(F) have been made; and
[[Page 130 STAT. 1295]]
``(B) that includes a list of any grantees excluded
under paragraph (1)(D) from the previous year.
``(i) Preventing Duplicative Grants.--
``(1) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney General
shall compare the possible grant with any other grants awarded
to the applicant under this Act to determine whether the grants
are for the same purpose.
``(2) Report.--If the Attorney General awards multiple
grants to the same applicant for the same purpose, the Attorney
General shall submit to the Committee on the Judiciary of the
Senate and the Committee on the Judiciary of the House of
Representatives a report that includes--
``(A) a list of all duplicate grants awarded,
including the total dollar amount of any such grants
awarded; and
``(B) the reason the Attorney General awarded the
duplicate grants.''.
SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
Section 2991 of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3797aa) is amended by--
(1) redesignating subsection (j) as subsection (o); and
(2) inserting after subsection (i) the following:
``(j) Forensic Assertive Community Treatment (FACT) Initiative
Program.--
``(1) In general.--The Attorney General may make grants to
States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
implement, or expand Assertive Community Treatment initiatives
to develop forensic assertive community treatment (referred to
in this subsection as `FACT') programs that provide high
intensity services in the community for individuals with mental
illness with involvement in the criminal justice system to
prevent future incarcerations.
``(2) Allowable uses.--Grant funds awarded under this
subsection may be used for--
``(A) multidisciplinary team initiatives for
individuals with mental illnesses with criminal justice
involvement that address criminal justice involvement as
part of treatment protocols;
``(B) FACT programs that involve mental health
professionals, criminal justice agencies, chemical
dependency specialists, nurses, psychiatrists,
vocational specialists, forensic peer specialists,
forensic specialists, and dedicated administrative
support staff who work together to provide recovery
oriented, 24/7 wraparound services;
``(C) services such as integrated evidence-based
practices for the treatment of co-occurring mental
health and substance-related disorders, assertive
outreach and engagement, community-based service
provision at participants' residence or in the
community, psychiatric rehabilitation, recovery oriented
services, services to address criminogenic risk factors,
and community tenure;
``(D) payments for treatment providers that are
approved by the State or Indian Tribe and licensed, if
necessary, to provide needed treatment to eligible
offenders
[[Page 130 STAT. 1296]]
participating in the program, including behavioral
health services and aftercare supervision; and
``(E) training for all FACT teams to promote high-
fidelity practice principles and technical assistance to
support effective and continuing integration with
criminal justice agency partners.
``(3) Supplement and not supplant.--Grants made under this
subsection shall be used to supplement, and not supplant, non-
Federal funds that would otherwise be available for programs
described in this subsection.
``(4) Applications.--To request a grant under this
subsection, a State, unit of local government, territory, Indian
Tribe, or nonprofit agency shall submit an application to the
Attorney General in such form and containing such information as
the Attorney General may reasonably require.''.
SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
SYSTEMS.
Section 2976(f) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period at the end and
inserting a semicolon; and
(3) by adding at the end the following:
``(7) provide mental health treatment and transitional
services for those with mental illnesses or with co-occurring
disorders, including housing placement or assistance; and''.
SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN DRUG COURTS.
Part EE of title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3797u et seq.) is amended--
(1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
inserting ``, including co-occurring substance abuse and mental
health problems,'' after ``problems''; and
(2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
``, including training for drug court personnel and officials on
identifying and addressing co-occurring substance abuse and
mental health problems'' after ``part''.
SEC. 14008. <<NOTE: 42 USC 3797aa-1 note.>> MENTAL HEALTH
TRAINING FOR FEDERAL UNIFORMED
SERVICES.
(a) In General.--Not later than 180 days after the date of enactment
of this Act, the Secretary of Defense, the Secretary of Homeland
Security, the Secretary of Health and Human Services, and the Secretary
of Commerce shall provide the following to each of the uniformed
services (as that term is defined in section 101 of title 10, United
States Code) under their direction:
(1) Training programs.--Programs that offer specialized and
comprehensive training in procedures to identify and respond
appropriately to incidents in which the unique needs of
individuals with mental illnesses are involved.
(2) Improved technology.--Computerized information systems
or technological improvements to provide timely information to
Federal law enforcement personnel, other branches of the
uniformed services, and criminal justice system personnel to
improve the Federal response to mentally ill individuals.
[[Page 130 STAT. 1297]]
(3) Cooperative programs.--The establishment and expansion
of cooperative efforts to promote public safety through the use
of effective intervention with respect to mentally ill
individuals encountered by members of the uniformed services.
SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
(a) Reentry Demonstration Projects.--Section 2976(f) of title I of
the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
3797w(f)), as amended by section 14006, is amended--
(1) in paragraph (3)(C), by inserting ``mental health
services,'' before ``drug treatment''; and
(2) by adding at the end the following:
``(8) target offenders with histories of homelessness,
substance abuse, or mental illness, including a prerelease
assessment of the housing status of the offender and behavioral
health needs of the offender with clear coordination with mental
health, substance abuse, and homelessness services systems to
achieve stable and permanent housing outcomes with appropriate
support service.''.
(b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of
2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including
mental health care'' after ``community''.
SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
Section 2701(b) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
(1) by redesignating paragraphs (4) and (5) as paragraphs
(5) and (6), respectively; and
(2) by inserting after paragraph (3) the following:
``(4) The development and operation of crisis intervention
teams that may include coordination with law enforcement
agencies and specialized training for school officials in
responding to mental health crises.''.
SEC. 14011. <<NOTE: 42 USC 3752 note.>> ACTIVE-SHOOTER TRAINING
FOR LAW ENFORCEMENT.
The Attorney General, as part of the Preventing Violence Against Law
Enforcement and Ensuring Officer Resilience and Survivability Initiative
(VALOR) of the Department of Justice, may provide safety training and
technical assistance to local law enforcement agencies, including
active-shooter response training.
SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN RESIDENTIAL SUBSTANCE
ABUSE TREATMENT PROGRAMS.
Section 1901(a) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(3) developing and implementing specialized residential
substance abuse treatment programs that identify and provide
appropriate treatment to inmates with co-occurring mental health
and substance abuse disorders or challenges.''.
[[Page 130 STAT. 1298]]
SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
INCARCERATION PROGRAMS.
Title I of the Omnibus Crime Control and Safe Streets Act of 1968
(42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting
the following:
``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
INCARCERATION PROGRAMS
``SEC. 2901. <<NOTE: 42 USC 3797q.>> MENTAL HEALTH AND DRUG
TREATMENT ALTERNATIVES TO INCARCERATION
PROGRAMS.
``(a) Definitions.--In this section--
``(1) the term `eligible entity' means a State, unit of
local government, Indian tribe, or nonprofit organization; and
``(2) the term `eligible participant' means an individual
who--
``(A) comes into contact with the criminal justice
system or is arrested or charged with an offense that is
not--
``(i) a crime of violence, as defined under
applicable State law or in section 3156 of title
18, United States Code; or
``(ii) a serious drug offense, as defined in
section 924(e)(2)(A) of title 18, United States
Code;
``(B) has a history of, or a current--
``(i) substance use disorder;
``(ii) mental illness; or
``(iii) co-occurring mental illness and
substance use disorder; and
``(C) has been approved for participation in a
program funded under this section by the relevant law
enforcement agency, prosecuting attorney, defense
attorney, probation official, corrections official,
judge, representative of a mental health agency, or
representative of a substance abuse agency, as required
by law.
``(b) Program Authorized.--The Attorney General may make grants to
eligible entities to develop, implement, or expand a treatment
alternative to incarceration program for eligible participants,
including--
``(1) pre-booking treatment alternative to incarceration
programs, including--
``(A) law enforcement training on substance use
disorders, mental illness, and co-occurring mental
illness and substance use disorders;
``(B) receiving centers as alternatives to
incarceration of eligible participants;
``(C) specialized response units for calls related
to substance use disorders, mental illness, or co-
occurring mental illness and substance use disorders;
and
``(D) other arrest and pre-booking treatment
alternatives to incarceration models; or
``(2) post-booking treatment alternative to incarceration
programs, including--
``(A) specialized clinical case management;
[[Page 130 STAT. 1299]]
``(B) pre-trial services related to substances use
disorders, mental illness, and co-occurring mental
illness and substance use disorders;
``(C) prosecutor and defender based programs;
``(D) specialized probation;
``(E) treatment and rehabilitation programs; and
``(F) problem-solving courts, including mental
health courts, drug courts, co-occurring mental health
and substance abuse courts, DWI courts, and veterans
treatment courts.
``(c) Application.--
``(1) In general.--An eligible entity desiring a grant under
this section shall submit an application to the Attorney
General--
``(A) that meets the criteria under paragraph (2);
and
``(B) at such time, in such manner, and accompanied
by such information as the Attorney General may require.
``(2) Criteria.--An eligible entity, in submitting an
application under paragraph (1), shall--
``(A) provide extensive evidence of collaboration
with State and local government agencies overseeing
health, community corrections, courts, prosecution,
substance abuse, mental health, victims services, and
employment services, and with local law enforcement
agencies;
``(B) demonstrate consultation with the Single State
Authority for Substance Abuse of the State (as that term
is defined in section 201(e) of the Second Chance Act of
2007);
``(C) demonstrate that evidence-based treatment
practices will be utilized; and
``(D) demonstrate that evidence-based screening and
assessment tools will be used to place participants in
the treatment alternative to incarceration program.
``(d) Requirements.--Each eligible entity awarded a grant for a
treatment alternative to incarceration program under this section
shall--
``(1) determine the terms and conditions of participation in
the program by eligible participants, taking into consideration
the collateral consequences of an arrest, prosecution or
criminal conviction;
``(2) ensure that each substance abuse and mental health
treatment component is licensed and qualified by the relevant
jurisdiction;
``(3) for programs described in subsection (b)(2), organize
an enforcement unit comprised of appropriately trained law
enforcement professionals under the supervision of the State,
Tribal, or local criminal justice agency involved, the duties of
which shall include--
``(A) the verification of addresses and other
contact information of each eligible participant who
participates or desires to participate in the program;
and
``(B) if necessary, the location, apprehension,
arrest, and return to custody of an eligible participant
in the program who has absconded from the facility of a
treatment provider or has otherwise significantly
violated the terms and conditions of the program,
consistent with Federal and State confidentiality
requirements;
[[Page 130 STAT. 1300]]
``(4) notify the relevant criminal justice entity if any
eligible participant in the program absconds from the facility
of the treatment provider or otherwise violates the terms and
conditions of the program, consistent with Federal and State
confidentiality requirements;
``(5) submit periodic reports on the progress of treatment
or other measured outcomes from participation in the program of
each eligible participant in the program to the relevant State,
Tribal, or local criminal justice agency, including mental
health courts, drug courts, co-occurring mental health and
substance abuse courts, DWI courts, and veterans treatment
courts;
``(6) describe the evidence-based methodology and outcome
measurements that will be used to evaluate the program, and
specifically explain how such measurements will provide valid
measures of the impact of the program; and
``(7) describe how the program could be broadly replicated
if demonstrated to be effective.
``(e) Use of Funds.--An eligible entity shall use a grant received
under this section for expenses of a treatment alternative to
incarceration program, including--
``(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program,
including the enforcement unit;
``(2) payments for treatment providers that are approved by
the relevant State or Tribal jurisdiction and licensed, if
necessary, to provide needed treatment to eligible offenders
participating in the program, including aftercare supervision,
vocational training, education, and job placement; and
``(3) payments to public and nonprofit private entities that
are approved by the State or Tribal jurisdiction and licensed,
if necessary, to provide alcohol and drug addiction treatment to
eligible offenders participating in the program.
``(f) Supplement Not Supplant.--An eligible entity shall use Federal
funds received under this section only to supplement the funds that
would, in the absence of those Federal funds, be made available from
other Federal and non-Federal sources for the activities described in
this section, and not to supplant those funds. The Federal share of a
grant made under this section may not exceed 50 percent of the total
costs of the program described in an application under subsection (d).
``(g) Geographic Distribution.--The Attorney General shall ensure
that, to the extent practicable, the geographical distribution of grants
under this section is equitable and includes a grant to an eligible
entity in--
``(1) each State;
``(2) rural, suburban, and urban areas; and
``(3) Tribal jurisdictions.
``(h) Reports and Evaluations.--Each fiscal year, each recipient of
a grant under this section during that fiscal year shall submit to the
Attorney General a report on the outcomes of activities carried out
using that grant in such form, containing such information, and on such
dates as the Attorney General shall specify.
``(i) Accountability.--All grants awarded by the Attorney General
under this section shall be subject to the following accountability
provisions:
``(1) Audit requirement.--
[[Page 130 STAT. 1301]]
``(A) Definition.--In this paragraph, the term
`unresolved audit finding' means a finding in the final
audit report of the Inspector General of the Department
of Justice that the audited grantee has utilized grant
funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within
12 months from the date on which the final audit report
is issued.
``(B) Audits.--Beginning in the first fiscal year
beginning after the date of enactment of this
subsection, and in each fiscal year thereafter, the
Inspector General of the Department of Justice shall
conduct audits of recipients of grants under this
section to prevent waste, fraud, and abuse of funds by
grantees. The Inspector General shall determine the
appropriate number of grantees to be audited each year.
``(C) Mandatory exclusion.--A recipient of grant
funds under this section that is found to have an
unresolved audit finding shall not be eligible to
receive grant funds under this section during the first
2 fiscal years beginning after the end of the 12-month
period described in subparagraph (A).
``(D) Priority.--In awarding grants under this
section, the Attorney General shall give priority to
eligible applicants that did not have an unresolved
audit finding during the 3 fiscal years before
submitting an application for a grant under this
section.
``(E) Reimbursement.--If an entity is awarded grant
funds under this section during the 2-fiscal-year period
during which the entity is barred from receiving grants
under subparagraph (C), the Attorney General shall--
``(i) deposit an amount equal to the amount of
the grant funds that were improperly awarded to
the grantee into the General Fund of the Treasury;
and
``(ii) seek to recoup the costs of the
repayment to the fund from the grant recipient
that was erroneously awarded grant funds.
``(2) Nonprofit organization requirements.--
``(A) Definition.--For purposes of this paragraph
and the grant programs under this part, the term
`nonprofit organization' means an organization that is
described in section 501(c)(3) of the Internal Revenue
Code of 1986 and is exempt from taxation under section
501(a) of such Code.
``(B) Prohibition.--The Attorney General may not
award a grant under this part to a nonprofit
organization that holds money in offshore accounts for
the purpose of avoiding paying the tax described in
section 511(a) of the Internal Revenue Code of 1986.
``(C) Disclosure.--Each nonprofit organization that
is awarded a grant under this section and uses the
procedures prescribed in regulations to create a
rebuttable presumption of reasonableness for the
compensation of its officers, directors, trustees, and
key employees, shall disclose to the Attorney General,
in the application for the grant, the process for
determining such compensation, including the independent
persons involved in reviewing and approving such
compensation, the comparability data used,
[[Page 130 STAT. 1302]]
and contemporaneous substantiation of the deliberation
and decision. Upon request, the Attorney General shall
make the information disclosed under this subparagraph
available for public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by
the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative
agreement under this section, to host or support any
expenditure for conferences that uses more than $20,000
in funds made available by the Department of Justice,
unless the head of the relevant agency or department,
provides prior written authorization that the funds may
be expended to host the conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment,
honoraria for speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall
submit an annual report to the Committee on the
Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives on all
conference expenditures approved under this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit, to the Committee on the
Judiciary and the Committee on Appropriations of the Senate and
the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives, an annual
certification--
``(A) indicating whether--
``(i) all audits issued by the Office of the
Inspector General under paragraph (1) have been
completed and reviewed by the appropriate
Assistant Attorney General or Director;
``(ii) all mandatory exclusions required under
paragraph (1)(C) have been issued; and
``(iii) all reimbursements required under
paragraph (1)(E) have been made; and
``(B) that includes a list of any grant recipients
excluded under paragraph (1) from the previous year.
``(5) Preventing duplicative grants.--
``(A) In general.--Before the Attorney General
awards a grant to an applicant under this section, the
Attorney General shall compare potential grant awards
with other grants awarded under this Act to determine if
duplicate grant awards are awarded for the same purpose.
``(B) Report.--If the Attorney General awards
duplicate grants to the same applicant for the same
purpose the Attorney General shall submit to the
Committee on the Judiciary of the Senate and the
Committee on the Judiciary of the House of
Representatives a report that includes--
[[Page 130 STAT. 1303]]
``(i) a list of all duplicate grants awarded,
including the total dollar amount of any duplicate
grants awarded; and
``(ii) the reason the Attorney General awarded
the duplicate grants.''.
SEC. 14014. <<NOTE: 42 USC 3797aa-1.>> NATIONAL CRIMINAL JUSTICE
AND MENTAL HEALTH TRAINING AND
TECHNICAL ASSISTANCE.
Part HH of title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end the
following:
``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING
AND TECHNICAL ASSISTANCE.
``(a) Authority.--The Attorney General may make grants to eligible
organizations to provide for the establishment of a National Criminal
Justice and Mental Health Training and Technical Assistance Center.
``(b) Eligible Organization.--For purposes of subsection (a), the
term `eligible organization' means a national nonprofit organization
that provides technical assistance and training to, and has special
expertise and broad, national-level experience in, mental health, crisis
intervention, criminal justice systems, law enforcement, translating
evidence into practice, training, and research, and education and
support of people with mental illness and the families of such
individuals.
``(c) Use of Funds.--Any organization that receives a grant under
subsection (a) shall collaborate with other grant recipients to
establish and operate a National Criminal Justice and Mental Health
Training and Technical Assistance Center to--
``(1) provide law enforcement officer training regarding
mental health and working with individuals with mental
illnesses, with an emphasis on de-escalation of encounters
between law enforcement officers and those with mental disorders
or in crisis, which shall include support the development of in-
person and technical information exchanges between systems and
the individuals working in those systems in support of the
concepts identified in the training;
``(2) provide education, training, and technical assistance
for States, Indian tribes, territories, units of local
government, service providers, nonprofit organizations,
probation or parole officers, prosecutors, defense attorneys,
emergency response providers, and corrections institutions to
advance practice and knowledge relating to mental health crisis
and approaches to mental health and criminal justice across
systems;
``(3) provide training and best practices to mental health
providers and criminal justice agencies relating to diversion
initiatives, jail and prison strategies, reentry of individuals
with mental illnesses into the community, and dispatch protocols
and triage capabilities, including the establishment of learning
sites;
``(4) develop suicide prevention and crisis intervention
training and technical assistance for criminal justice agencies;
``(5) develop a receiving center system and pilot strategy
that provides, for a jurisdiction, a single point of entry into
the mental health and substance abuse system for assessments and
appropriate placement of individuals experiencing a crisis;
[[Page 130 STAT. 1304]]
``(6) collect data and best practices in mental health and
criminal health and criminal justice initiatives and policies
from grantees under this part, other recipients of grants under
this section, Federal, State, and local agencies involved in the
provision of mental health services, and nongovernmental
organizations involved in the provision of mental health
services;
``(7) develop and disseminate to mental health providers and
criminal justice agencies evaluation tools, mechanisms, and
measures to better assess and document performance measures and
outcomes relating to the provision of mental health services;
``(8) disseminate information to States, units of local
government, criminal justice agencies, law enforcement agencies,
and other relevant entities about best practices, policy
standards, and research findings relating to the provision of
mental health services; and
``(9) provide education and support to individuals with
mental illness involved with, or at risk of involvement with,
the criminal justice system, including the families of such
individuals.
``(d) Accountability.--Grants awarded under this section shall be
subject to the following accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term
`unresolved audit finding' means a finding in the final
audit report of the Inspector General of the Department
of Justice under subparagraph (C) that the audited
grantee has used grant funds for an unauthorized
expenditure or otherwise unallowable cost that is not
closed or resolved within 1 year after the date on which
the final audit report is issued.
``(B) Audits.--Beginning in the first fiscal year
beginning after the date of enactment of this section,
and in each fiscal year thereafter, the Inspector
General of the Department of Justice shall conduct
audits of grantees under this section to prevent waste,
fraud, and abuse of funds by grantees. The Inspector
General shall determine the appropriate number of
grantees to be audited each year.
``(C) Final audit report.--The Inspector General of
the Department of Justice shall submit to the Attorney
General a final report on each audit conducted under
subparagraph (B).
``(D) Mandatory exclusion.--Grantees under this
section about which there is an unresolved audit finding
shall not be eligible to receive a grant under this
section during the 2 fiscal years beginning after the
end of the 1-year period described in subparagraph (A).
``(E) Priority.--In making grants under this
section, the Attorney General shall give priority to
applicants that did not have an unresolved audit finding
during the 3 fiscal years before submitting an
application for a grant under this section.
``(F) Reimbursement.--If an entity receives a grant
under this section during the 2-fiscal-year period
during
[[Page 130 STAT. 1305]]
which the entity is prohibited from receiving grants
under subparagraph (D), the Attorney General shall--
``(i) deposit an amount equal to the amount of
the grant that was improperly awarded to the
grantee into the General Fund of the Treasury; and
``(ii) seek to recoup the costs of the
repayment under clause (i) from the grantee that
was erroneously awarded grant funds.
``(2) Nonprofit agency requirements.--
``(A) Definition.--For purposes of this paragraph
and the grant program under this section, the term
`nonprofit agency' means an organization that is
described in section 501(c)(3) of the Internal Revenue
Code of 1986 (26 U.S.C. 501(c)(3)) and is exempt from
taxation under section 501(a) of the Internal Revenue
Code of 1986 (26 U.S.C. 501(a)).
``(B) Prohibition.--The Attorney General may not
award a grant under this section to a nonprofit agency
that holds money in an offshore account for the purpose
of avoiding paying the tax described in section 511(a)
of the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
``(C) Disclosure.--Each nonprofit agency that is
awarded a grant under this section and uses the
procedures prescribed in regulations to create a
rebuttable presumption of reasonableness for the
compensation of its officers, directors, trustees, and
key employees, shall disclose to the Attorney General,
in the application for the grant, the process for
determining such compensation, including the independent
persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make
the information disclosed under this subparagraph
available for public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by
the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative
agreement under this section, to host or support any
expenditure for conferences that uses more than $20,000
in funds made available by the Department of Justice,
unless the head of the relevant agency or department,
provides prior written authorization that the funds may
be expended to host the conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment,
honoraria for speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall
submit an annual report to the Committee on the
Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives on all
conference expenditures approved under this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit to the Committee on the
[[Page 130 STAT. 1306]]
Judiciary and the Committee on Appropriations of the Senate and
the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives an annual
certification--
``(A) indicating whether--
``(i) all final audit reports issued by the
Office of the Inspector General under paragraph
(1) have been completed and reviewed by the
appropriate Assistant Attorney General or
Director;
``(ii) all mandatory exclusions required under
paragraph (1)(D) have been issued; and
``(iii) any reimbursements required under
paragraph (1)(F) have been made; and
``(B) that includes a list of any grantees excluded
under paragraph (1)(D) from the previous year.
``(5) Preventing duplicative grants.--
``(A) In general.--Before the Attorney General
awards a grant to an applicant under this section, the
Attorney General shall compare potential grant awards
with other grants awarded under this Act to determine if
duplicate grant awards are awarded for the same purpose.
``(B) Report.--If the Attorney General awards
duplicate grants to the same applicant for the same
purpose the Attorney General shall submit to the
Committee on the Judiciary of the Senate and the
Committee on the Judiciary of the House of
Representatives a report that includes--
``(i) a list of all duplicate grants awarded,
including the total dollar amount of any duplicate
grants awarded; and
``(ii) the reason the Attorney General awarded
the duplicate grants.''.
SEC. 14015. <<NOTE: 28 USC 534 note.>> IMPROVING DEPARTMENT OF
JUSTICE DATA COLLECTION ON MENTAL
ILLNESS INVOLVED IN CRIME.
(a) In General.--Notwithstanding any other provision of law, on or
after the date that is 90 days after the date on which the Attorney
General promulgates regulations under subsection (b), any data prepared
by, or submitted to, the Attorney General or the Director of the Federal
Bureau of Investigation with respect to the incidences of homicides, law
enforcement officers killed, seriously injured, and assaulted, or
individuals killed or seriously injured by law enforcement officers
shall include data with respect to the involvement of mental illness in
such incidences, if any.
(b) Regulations.--Not later than 90 days after the date of the
enactment of this Act, the Attorney General shall promulgate or revise
regulations as necessary to carry out subsection (a).
SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN
PRISON.
(a) Report on the Cost of Treating the Mentally Ill in the Criminal
Justice System.--Not later than 12 months after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
Congress a report detailing the cost of imprisonment for individuals who
have serious mental illness by the Federal Government or a State or unit
of local government, which shall include--
[[Page 130 STAT. 1307]]
(1) the number and type of crimes committed by individuals
with serious mental illness each year; and
(2) detail strategies or ideas for preventing crimes by
those individuals with serious mental illness from occurring.
(b) Definition.--For purposes of this section, the Attorney General,
in consultation with the Assistant Secretary of Mental Health and
Substance Use Disorders, shall define ``serious mental illness'' based
on the ``Health Care Reform for Americans with Severe Mental Illnesses:
Report'' of the National Advisory Mental Health Council, American
Journal of Psychiatry 1993; 150:1447-1465.
SEC. 14017. <<NOTE: 38 USC 5501A.>> CODIFICATION OF DUE PROCESS
FOR DETERMINATIONS BY SECRETARY OF
VETERANS AFFAIRS OF MENTAL CAPACITY OF
BENEFICIARIES.
(a) In General.--Chapter 55 of title 38, United States Code, is
amended by inserting after section 5501 the following new section:
``Sec. 5501A. Beneficiaries' rights in mental competence
determinations
``The Secretary may not make an adverse determination concerning the
mental capacity of a beneficiary to manage monetary benefits paid to or
for the beneficiary by the Secretary under this title unless such
beneficiary has been provided all of the following, subject to the
procedures and timelines prescribed by the Secretary for determinations
of incompetency:
``(1) Notice of the proposed adverse determination and the
supporting evidence.
``(2) An opportunity to request a hearing.
``(3) An opportunity to present evidence, including an
opinion from a medical professional or other person, on the
capacity of the beneficiary to manage monetary benefits paid to
or for the beneficiary by the Secretary under this title.
``(4) An opportunity to be represented at no expense to the
Government (including by counsel) at any such hearing and to
bring a medical professional or other person to provide relevant
testimony at any such hearing.''.
(b) <<NOTE: 38 USC 5501 prec.>> Clerical Amendment.--The table of
sections at the beginning of such chapter 55 is amended by inserting
after the item relating to section 5501 the following new item:
``5501A. Beneficiaries' rights in mental competence determinations''.
(c) <<NOTE: 38 USC 5501A note.>> Effective Date.--Section 5501A of
title 38, United States Code, as added by subsection (a), shall apply to
determinations made by the Secretary of Veterans Affairs on or after the
date of the enactment of this Act.
SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.
Subsection (o) of section 2991 of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated by section
14006, is amended--
(1) in paragraph (1)(C), by striking ``2009 through 2014''
and inserting ``2017 through 2021''; and
(2) by adding at the end the following:
``(3) Limitation.--Not more than 20 percent of the funds authorized
to be appropriated under this section may be used for purposes described
in subsection (i) (relating to veterans).''.
[[Page 130 STAT. 1308]]
Subtitle B--Comprehensive Justice and Mental Health
SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
Section 2991 of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section 14005, is
amended by inserting after subsection (j), the following:
``(k) Sequential Intercept Grants.--
``(1) Definition.--In this subsection, the term `eligible
entity' means a State, unit of local government, Indian tribe,
or tribal organization.
``(2) Authorization.--The Attorney General may make grants
under this subsection to an eligible entity for sequential
intercept mapping and implementation in accordance with
paragraph (3).
``(3) Sequential intercept mapping; implementation.--An
eligible entity that receives a grant under this subsection may
use funds for--
``(A) sequential intercept mapping, which--
``(i) shall consist of--
``(I) convening mental health and
criminal justice stakeholders to--
``(aa) develop a shared
understanding of the flow of
justice-involved individuals
with mental illnesses through
the criminal justice system; and
``(bb) identify
opportunities for improved
collaborative responses to the
risks and needs of individuals
described in item (aa); and
``(II) developing strategies to
address gaps in services and bring
innovative and effective programs to
scale along multiple intercepts,
including--
``(aa) emergency and crisis
services;
``(bb) specialized police-
based responses;
``(cc) court hearings and
disposition alternatives;
``(dd) reentry from jails
and prisons; and
``(ee) community
supervision, treatment and
support services; and
``(ii) may serve as a starting point for the
development of strategic plans to achieve positive
public health and safety outcomes; and
``(B) implementation, which shall--
``(i) be derived from the strategic plans
described in subparagraph (A)(ii); and
``(ii) consist of--
``(I) hiring and training personnel;
``(II) identifying the eligible
entity's target population;
``(III) providing services and
supports to reduce unnecessary
penetration into the criminal justice
system;
``(IV) reducing recidivism;
``(V) evaluating the impact of the
eligible entity's approach; and
[[Page 130 STAT. 1309]]
``(VI) planning for the
sustainability of effective
interventions.''.
SEC. 14022. PRISON AND JAILS.
Section 2991 of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
subsection (k), as added by section 14021, the following:
``(l) Correctional Facilities.--
``(1) Definitions.--
``(A) Correctional facility.--The term `correctional
facility' means a jail, prison, or other detention
facility used to house people who have been arrested,
detained, held, or convicted by a criminal justice
agency or a court.
``(B) Eligible inmate.--The term `eligible inmate'
means an individual who--
``(i) is being held, detained, or incarcerated
in a correctional facility; and
``(ii) manifests obvious signs of a mental
illness or has been diagnosed by a qualified
mental health professional as having a mental
illness.
``(2) Correctional facility grants.--The Attorney General
may award grants to applicants to enhance the capabilities of a
correctional facility--
``(A) to identify and screen for eligible inmates;
``(B) to plan and provide--
``(i) initial and periodic assessments of the
clinical, medical, and social needs of inmates;
and
``(ii) appropriate treatment and services that
address the mental health and substance abuse
needs of inmates;
``(C) to develop, implement, and enhance--
``(i) post-release transition plans for
eligible inmates that, in a comprehensive manner,
coordinate health, housing, medical, employment,
and other appropriate services and public
benefits;
``(ii) the availability of mental health care
services and substance abuse treatment services;
and
``(iii) alternatives to solitary confinement
and segregated housing and mental health screening
and treatment for inmates placed in solitary
confinement or segregated housing; and
``(D) to train each employee of the correctional
facility to identify and appropriately respond to
incidents involving inmates with mental health or co-
occurring mental health and substance abuse
disorders.''.
SEC. 14023. ALLOWABLE USES.
Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by
adding at the end the following:
``(v) Teams addressing frequent users of
crisis services.--Multidisciplinary teams that--
``(I) coordinate, implement, and
administer community-based crisis
responses and long-term plans for
frequent users of crisis services;
``(II) provide training on how to
respond appropriately to the unique
issues involving frequent users of
crisis services for public service
personnel,
[[Page 130 STAT. 1310]]
including criminal justice, mental
health, substance abuse, emergency room,
healthcare, law enforcement,
corrections, and housing personnel;
``(III) develop or support
alternatives to hospital and jail
admissions for frequent users of crisis
services that provide treatment,
stabilization, and other appropriate
supports in the least restrictive, yet
appropriate, environment; and
``(IV) develop protocols and systems
among law enforcement, mental health,
substance abuse, housing, corrections,
and emergency medical service operations
to provide coordinated assistance to
frequent users of crisis services.''.
SEC. 14024. LAW ENFORCEMENT TRAINING.
Section 2991(h) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
(1) in paragraph (1), by adding at the end the following:
``(F) Academy training.--To provide support for
academy curricula, law enforcement officer orientation
programs, continuing education training, and other
programs that teach law enforcement personnel how to
identify and respond to incidents involving persons with
mental health disorders or co-occurring mental health
and substance abuse disorders.''; and
(2) by adding at the end the following:
``(4) Priority consideration.--The Attorney General, in
awarding grants under this subsection, shall give priority to
programs that law enforcement personnel and members of the
mental health and substance abuse professions develop and
administer cooperatively.''.
SEC. 14025. <<NOTE: 42 USC 3797aa-1 note.>> FEDERAL LAW
ENFORCEMENT TRAINING.
Not later than 1 year after the date of enactment of this Act, the
Attorney General shall provide direction and guidance for the following:
(1) Training programs.--Programs that offer specialized and
comprehensive training, in procedures to identify and
appropriately respond to incidents in which the unique needs of
individuals who have a mental illness are involved, to first
responders and tactical units of--
(A) Federal law enforcement agencies; and
(B) other Federal criminal justice agencies such as
the Bureau of Prisons, the Administrative Office of the
United States Courts, and other agencies that the
Attorney General determines appropriate.
(2) Improved technology.--The establishment of, or
improvement of existing, computerized information systems to
provide timely information to employees of Federal law
enforcement agencies, and Federal criminal justice agencies to
improve the response of such employees to situations involving
individuals who have a mental illness.
SEC. 14026. GAO REPORT.
No later than 1 year after the date of enactment of this Act, the
Comptroller General of the United States, in coordination with the
Attorney General, shall submit to Congress a report on--
[[Page 130 STAT. 1311]]
(1) the practices that Federal first responders, tactical
units, and corrections officers are trained to use in responding
to individuals with mental illness;
(2) procedures to identify and appropriately respond to
incidents in which the unique needs of individuals who have a
mental illness are involved, to Federal first responders and
tactical units;
(3) the application of evidence-based practices in criminal
justice settings to better address individuals with mental
illnesses; and
(4) recommendations on how the Department of Justice can
expand and improve information sharing and dissemination of best
practices.
SEC. 14027. EVIDENCE BASED PRACTICES.
Section 2991(c) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
(1) in paragraph (3), by striking ``or'' at the end;
(2) by redesignating paragraph (4) as paragraph (6); and
(3) by inserting after paragraph (3), the following:
``(4) propose interventions that have been shown by
empirical evidence to reduce recidivism;
``(5) when appropriate, use validated assessment tools to
target preliminarily qualified offenders with a moderate or high
risk of recidivism and a need for treatment and services; or''.
SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT
OF LOCAL AUTHORITY.
(a) In General.--Section 2991(a) of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
(1) in paragraph (7)--
(A) in the heading, by striking ``Mental illness''
and inserting ``Mental illness; mental health
disorder''; and
(B) by striking ``term `mental illness' means'' and
inserting ``terms `mental illness' and `mental health
disorder' mean''; and
(2) by striking paragraph (9) and inserting the following:
``(9) Preliminarily qualified offender.--
``(A) In general.--The term `preliminarily qualified
offender' means an adult or juvenile accused of an
offense who--
``(i)(I) previously or currently has been
diagnosed by a qualified mental health
professional as having a mental illness or co-
occurring mental illness and substance abuse
disorders;
``(II) manifests obvious signs of mental
illness or co-occurring mental illness and
substance abuse disorders during arrest or
confinement or before any court; or
``(III) in the case of a veterans treatment
court provided under subsection (i), has been
diagnosed with, or manifests obvious signs of,
mental illness or a substance abuse disorder or
co-occurring mental illness and substance abuse
disorder;
[[Page 130 STAT. 1312]]
``(ii) has been unanimously approved for
participation in a program funded under this
section by, when appropriate--
``(I) the relevant--
``(aa) prosecuting attorney;
``(bb) defense attorney;
``(cc) probation or
corrections official; and
``(dd) judge; and
``(II) a representative from the
relevant mental health agency described
in subsection (b)(5)(B)(i);
``(iii) has been determined, by each person
described in clause (ii) who is involved in
approving the adult or juvenile for participation
in a program funded under this section, to not
pose a risk of violence to any person in the
program, or the public, if selected to participate
in the program; and
``(iv) has not been charged with or convicted
of--
``(I) any sex offense (as defined in
section 111 of the Sex Offender
Registration and Notification Act (42
U.S.C. 16911)) or any offense relating
to the sexual exploitation of children;
or
``(II) murder or assault with intent
to commit murder.
``(B) Determination.--In determining whether to
designate a defendant as a preliminarily qualified
offender, the relevant prosecuting attorney, defense
attorney, probation or corrections official, judge, and
mental health or substance abuse agency representative
shall take into account--
``(i) whether the participation of the
defendant in the program would pose a substantial
risk of violence to the community;
``(ii) the criminal history of the defendant
and the nature and severity of the offense for
which the defendant is charged;
``(iii) the views of any relevant victims to
the offense;
``(iv) the extent to which the defendant would
benefit from participation in the program;
``(v) the extent to which the community would
realize cost savings because of the defendant's
participation in the program; and
``(vi) whether the defendant satisfies the
eligibility criteria for program participation
unanimously established by the relevant
prosecuting attorney, defense attorney, probation
or corrections official, judge and mental health
or substance abuse agency representative.''.
(b) Technical and Conforming Amendment.--Section 2927(2) of title I
of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
3797s-6(2)) is amended by striking ``has the meaning given that term in
section 2991(a).'' and inserting ``means an offense that--
``(A) does not have as an element the use, attempted
use, or threatened use of physical force against the
person or property of another; or
[[Page 130 STAT. 1313]]
``(B) is not a felony that by its nature involves a
substantial risk that physical force against the person
or property of another may be used in the course of
committing the offense.''.
SEC. 14029. GRANT ACCOUNTABILITY.
Section 2991 of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after
subsection (l), as added by section 14022, the following:
``(m) Accountability.--All grants awarded by the Attorney General
under this section shall be subject to the following accountability
provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term
`unresolved audit finding' means a finding in the final
audit report of the Inspector General of the Department
of Justice that the audited grantee has utilized grant
funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within
12 months from the date when the final audit report is
issued.
``(B) Audits.--Beginning in the first fiscal year
beginning after the date of enactment of this
subsection, and in each fiscal year thereafter, the
Inspector General of the Department of Justice shall
conduct audits of recipients of grants under this
section to prevent waste, fraud, and abuse of funds by
grantees. The Inspector General shall determine the
appropriate number of grantees to be audited each year.
``(C) Mandatory exclusion.--A recipient of grant
funds under this section that is found to have an
unresolved audit finding shall not be eligible to
receive grant funds under this section during the first
2 fiscal years beginning after the end of the 12-month
period described in subparagraph (A).
``(D) Priority.--In awarding grants under this
section, the Attorney General shall give priority to
eligible applicants that did not have an unresolved
audit finding during the 3 fiscal years before
submitting an application for a grant under this
section.
``(E) Reimbursement.--If an entity is awarded grant
funds under this section during the 2-fiscal-year period
during which the entity is barred from receiving grants
under subparagraph (C), the Attorney General shall--
``(i) deposit an amount equal to the amount of
the grant funds that were improperly awarded to
the grantee into the General Fund of the Treasury;
and
``(ii) seek to recoup the costs of the
repayment to the fund from the grant recipient
that was erroneously awarded grant funds.
``(2) Nonprofit organization requirements.--
``(A) Definition.--For purposes of this paragraph
and the grant programs under this part, the term
`nonprofit organization' means an organization that is
described in section 501(c)(3) of the Internal Revenue
Code of 1986 and is exempt from taxation under section
501(a) of such Code.
[[Page 130 STAT. 1314]]
``(B) Prohibition.--The Attorney General may not
award a grant under this part to a nonprofit
organization that holds money in offshore accounts for
the purpose of avoiding paying the tax described in
section 511(a) of the Internal Revenue Code of 1986.
``(C) Disclosure.--Each nonprofit organization that
is awarded a grant under this section and uses the
procedures prescribed in regulations to create a
rebuttable presumption of reasonableness for the
compensation of its officers, directors, trustees, and
key employees, shall disclose to the Attorney General,
in the application for the grant, the process for
determining such compensation, including the independent
persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make
the information disclosed under this subparagraph
available for public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by
the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative
agreement under this section, to host or support any
expenditure for conferences that uses more than $20,000
in funds made available by the Department of Justice,
unless the head of the relevant agency or department,
provides prior written authorization that the funds may
be expended to host the conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment,
honoraria for speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall
submit an annual report to the Committee on the
Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives on all
conference expenditures approved under this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit, to the Committee on the
Judiciary and the Committee on Appropriations of the Senate and
the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives, an annual
certification--
``(A) indicating whether--
``(i) all audits issued by the Office of the
Inspector General under paragraph (1) have been
completed and reviewed by the appropriate
Assistant Attorney General or Director;
``(ii) all mandatory exclusions required under
paragraph (1)(C) have been issued; and
``(iii) all reimbursements required under
paragraph (1)(E) have been made; and
``(B) that includes a list of any grant recipients
excluded under paragraph (1) from the previous year.
[[Page 130 STAT. 1315]]
``(n) Preventing Duplicative Grants.--
``(1) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney General
shall compare potential grant awards with other grants awarded
under this Act to determine if duplicate grant awards are
awarded for the same purpose.
``(2) Report.--If the Attorney General awards duplicate
grants to the same applicant for the same purpose the Attorney
General shall submit to the Committee on the Judiciary of the
Senate and the Committee on the Judiciary of the House of
Representatives a report that includes--
``(A) a list of all duplicate grants awarded,
including the total dollar amount of any duplicate
grants awarded; and
``(B) the reason the Attorney General awarded the
duplicate grants.''.
DIVISION <<NOTE: Increasing Choice, Access, and Quality in Health Care
for Americans Act.>> C--INCREASING CHOICE, ACCESS, AND QUALITY IN
HEALTH CARE FOR AMERICANS
SEC. 15000. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.
This division may be cited as the ``Increasing Choice, Access, and
Quality in Health Care for Americans Act''.
TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG CODES
FOR SIMILAR HOSPITAL SERVICES.
Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is
amended by adding at the end the following new subsection:
``(t) Relating Similar Inpatient and Outpatient Hospital Services.--
``(1) Development of hcpcs version of ms-drg codes.--Not
later than January 1, 2018, the Secretary shall develop HCPCS
versions for MS-DRGs that are similar to the ICD-10-PCS for such
MS-DRGs such that, to the extent possible, the MS-DRG assignment
shall be similar for a claim coded with the HCPCS version as an
identical claim coded with a ICD-10-PCS code.
``(2) Coverage of surgical ms-drgs.--In carrying out
paragraph (1), the Secretary shall develop HCPCS versions of MS-
DRG codes for not fewer than 10 surgical MS-DRGs.
``(3) Publication and dissemination of the hcpcs versions of
ms-drgs.--
``(A) In general.--The Secretary shall develop a
HCPCS MS-DRG definitions manual and software that is
similar to the definitions manual and software for ICD-
10-PCS codes for such MS-DRGs. The Secretary shall post
the HCPCS MS-DRG definitions manual and software on the
Internet website of the Centers for Medicare & Medicaid
Services. The HCPCS MS-DRG definitions
[[Page 130 STAT. 1316]]
manual and software shall be in the public domain and
available for use and redistribution without charge.
``(B) Use of previous analysis done by medpac.--In
developing the HCPCS MS-DRG definitions manual and
software under subparagraph (A), the Secretary shall
consult with the Medicare Payment Advisory Commission
and shall consider the analysis done by such Commission
in translating outpatient surgical claims into inpatient
surgical MS-DRGs in preparing chapter 7 (relating to
hospital short-stay policy issues) of its `Medicare and
the Health Care Delivery System' report submitted to
Congress in June 2015.
``(4) Definition and reference.--In this subsection:
``(A) HCPCS.--The term `HCPCS' means, with respect
to hospital items and services, the code under the
Healthcare Common Procedure Coding System (HCPCS) (or a
successor code) for such items and services.
``(B) ICD-10-PCS.--The term `ICD-10-PCS' means the
International Classification of Diseases, 10th Revision,
Procedure Coding System, and includes any subsequent
revision of such International Classification of
Diseases, Procedure Coding System.''.
SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE
HOSPITAL READMISSION PROGRAM.
(a) Transitional Adjustment for Dual Eligible Population.--Section
1886(q)(3) of the Social Security Act (42 U.S.C. 1395ww(q)(3)) is
amended--
(1) in subparagraph (A), by inserting ``subject to
subparagraph (D),'' after ``purposes of paragraph (1),''; and
(2) by adding at the end the following new subparagraph:
``(D) Transitional adjustment for dual eligibles.--
``(i) In general.--In determining a hospital's
adjustment factor under this paragraph for
purposes of making payments for discharges
occurring during and after fiscal year 2019, and
before the application of clause (i) of
subparagraph (E), the Secretary shall assign
hospitals to groups (as defined by the Secretary
under clause (ii)) and apply the applicable
provisions of this subsection using a methodology
in a manner that allows for separate comparison of
hospitals within each such group, as determined by
the Secretary.
``(ii) Defining groups.--For purposes of this
subparagraph, the Secretary shall define groups of
hospitals, based on their overall proportion, of
the inpatients who are entitled to, or enrolled
for, benefits under part A, and who are full-
benefit dual eligible individuals (as defined in
section 1935(c)(6)). In defining groups, the
Secretary shall consult the Medicare Payment
Advisory Commission and may consider the analysis
done by such Commission in preparing the portion
of its report submitted to Congress in June 2013
relating to readmissions.
``(iii) Minimizing reporting burden on
hospitals.--In carrying out this subparagraph, the
Secretary shall not impose any additional
reporting requirements on hospitals.
[[Page 130 STAT. 1317]]
``(iv) Budget neutral design methodology.--The
Secretary shall design the methodology to
implement this subparagraph so that the estimated
total amount of reductions in payments under this
subsection equals the estimated total amount of
reductions in payments that would otherwise occur
under this subsection if this subparagraph did not
apply.''.
(b) Changes in Risk Adjustment.--Section 1886(q)(3) of the Social
Security Act (42 U.S.C. 1395ww(q)(3)), as amended by subsection (a), is
further amended by adding at the end the following new subparagraph:
``(E) Changes in risk adjustment.--
``(i) Consideration of recommendations in
impact reports.--The Secretary may take into
account the studies conducted and the
recommendations made by the Secretary under
section 2(d)(1) of the IMPACT Act of 2014 (Public
Law 113-185; 42 U.S.C. 1395lll note) with respect
to the application under this subsection of risk
adjustment methodologies. Nothing in this clause
shall be construed as precluding consideration of
the use of groupings of hospitals.
``(ii) Consideration of exclusion of patient
cases based on v or other appropriate codes.--In
promulgating regulations to carry out this
subsection with respect to discharges occurring
after fiscal year 2018, the Secretary may consider
the use of V or other ICD-related codes for
removal of a readmission. The Secretary may
consider modifying measures under this subsection
to incorporate V or other ICD-related codes at the
same time as other changes are being made under
this subparagraph.
``(iii) Removal of certain readmissions.--In
promulgating regulations to carry out this
subsection, with respect to discharges occurring
after fiscal year 2018, the Secretary may consider
removal as a readmission of an admission that is
classified within one or more of the following:
transplants, end-stage renal disease, burns,
trauma, psychosis, or substance abuse. The
Secretary may consider modifying measures under
this subsection to remove readmissions at the same
time as other changes are being made under this
subparagraph.''.
(c) MedPAC Study on Readmissions Program.--The Medicare Payment
Advisory Commission shall conduct a study to review overall hospital
readmissions described in section 1886(q)(5)(E) of the Social Security
Act (42 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions are
related to any changes in outpatient and emergency services furnished.
The Commission shall submit to Congress a report on such study in its
report to Congress in June 2018.
SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL
DEMONSTRATION PROGRAM.
(a) Extension.--Section 410A of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-173; 42
U.S.C. 1395ww note) is amended--
[[Page 130 STAT. 1318]]
(1) in subsection (a)(5), by striking ``5-year extension
period'' and inserting ``10-year extension period''; and
(2) in subsection (g)--
(A) in the subsection heading, by striking ``Five-
Year'' and inserting ``Ten-Year'';
(B) in paragraph (1), by striking ``additional 5-
year'' and inserting ``additional 10-year'';
(C) by striking ``5-year extension period'' and
inserting ``10-year extension period'' each place it
appears;
(D) in paragraph (4)(B)--
(i) in the matter preceding clause (i), by
inserting ``each 5-year period in'' after
``hospital during''; and
(ii) in clause (i), by inserting ``each
applicable 5-year period in'' after ``the first
day of''; and
(E) by adding at the end the following new
paragraphs:
``(5) Other hospitals in demonstration program.--During the
second 5 years of the 10-year extension period, the Secretary
shall apply the provisions of paragraph (4) to rural community
hospitals that are not described in paragraph (4) but are
participating in the demonstration program under this section as
of December 30, 2014, in a similar manner as such provisions
apply to rural community hospitals described in paragraph (4).
``(6) Expansion of demonstration program to rural areas in
any state.--
``(A) In general.--The Secretary shall,
notwithstanding subsection (a)(2) or paragraph (2) of
this subsection, not later than 120 days after the date
of the enactment of this paragraph, issue a solicitation
for applications to select up to the maximum number of
additional rural community hospitals located in any
State to participate in the demonstration program under
this section for the second 5 years of the 10-year
extension period without exceeding the limitation under
paragraph (3) of this subsection.
``(B) Priority.--In determining which rural
community hospitals that submitted an application
pursuant to the solicitation under subparagraph (A) to
select for participation in the demonstration program,
the Secretary--
``(i) shall give priority to rural community
hospitals located in one of the 20 States with the
lowest population densities (as determined by the
Secretary using the 2015 Statistical Abstract of
the United States); and
``(ii) may consider--
``(I) closures of hospitals located
in rural areas in the State in which the
rural community hospital is located
during the 5-year period immediately
preceding the date of the enactment of
this paragraph; and
``(II) the population density of the
State in which the rural community
hospital is located.''.
(b) Change in Timing for Report.--Subsection (e) of such section
410A is amended--
(1) by striking ``Not later than 6 months after the
completion of the demonstration program under this section'' and
inserting ``Not later than August 1, 2018''; and
[[Page 130 STAT. 1319]]
(2) by striking ``such program'' and inserting ``the
demonstration program under this section''.
SEC. 15004. REGULATORY RELIEF FOR LTCHS.
(a) Technical Change to the Medicare Long-Term Care Hospital
Moratorium Exception.--
(1) In general.--Section 114(d)(7) of the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww
note), as amended by sections 3106(b) and 10312(b) of Public Law
111-148, section 1206(b)(2) of the Pathway for SGR Reform Act of
2013 (division B of Public Law 113-67), and section 112 of the
Protecting Access to Medicare Act of 2014 (Public Law 113-93),
is amended by striking ``The moratorium under paragraph (1)(A)''
and inserting ``Any moratorium under paragraph (1)''.
(2) <<NOTE: 42 USC 1395ww note.>> Effective date.--The
amendment made by paragraph (1) shall take effect as if included
in the enactment of section 112 of the Protecting Access to
Medicare Act of 2014.
(b) Modification to Medicare Long-Term Care Hospital High Cost
Outlier Payments.--Section 1886(m) of the Social Security Act (42 U.S.C.
1395ww(m)) is amended by adding at the end the following new paragraph:
``(7) Treatment of high cost outlier payments.--
``(A) Adjustment to the standard federal payment
rate for estimated high cost outlier payments.--Under
the system described in paragraph (1), for fiscal years
beginning on or after October 1, 2017, the Secretary
shall reduce the standard Federal payment rate as if the
estimated aggregate amount of high cost outlier payments
for standard Federal payment rate discharges for each
such fiscal year would be equal to 8 percent of
estimated aggregate payments for standard Federal
payment rate discharges for each such fiscal year.
``(B) Limitation on high cost outlier payment
amounts.--Notwithstanding subparagraph (A), the
Secretary shall set the fixed loss amount for high cost
outlier payments such that the estimated aggregate
amount of high cost outlier payments made for standard
Federal payment rate discharges for fiscal years
beginning on or after October 1, 2017, shall be equal to
99.6875 percent of 8 percent of estimated aggregate
payments for standard Federal payment rate discharges
for each such fiscal year.
``(C) Waiver of budget neutrality.--Any reduction in
payments resulting from the application of subparagraph
(B) shall not be taken into account in applying any
budget neutrality provision under such system.
``(D) No effect on site neutral high cost outlier
payment rate.--This paragraph shall not apply with
respect to the computation of the applicable site
neutral payment rate under paragraph (6).''.
SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT APPLYING
DOCUMENTATION AND CODING ADJUSTMENTS.
Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI Programs
Extension Act of 2007 (Public Law 110-90), as amended by section 631(b)
of the American Taxpayer Relief Act of 2012 (Public Law 112-240) and
section 414(1)(B)(iii) of the Medicare
[[Page 130 STAT. 1320]]
Access and CHIP Reauthorization Act of 2015 (Public Law 114-10), is
amended in clause (iii) by striking ``an increase of 0.5 percentage
points for discharges occurring during each of fiscal years 2018 through
2023'' and inserting ``an increase of 0.4588 percentage points for
discharges occurring during fiscal year 2018 and 0.5 percentage points
for discharges occurring during each of fiscal years 2019 through
2023''.
SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT RULES.
(a) 25-Percent Patient Threshold Payment Adjustment.--Section
114(c)(1)(A) of the Medicare, Medicaid, and SCHIP Extension Act of 2007
(42 U.S.C. 1395ww note), as amended by section 4302(a) of division B of
the American Recovery and Reinvestment Act (Public Law 111-5), sections
3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(B) of
the Pathway for SGR Reform Act of 2013 (division B of Public Law 113-
67), is amended by striking ``for a 9-year period'' and inserting
``through June 30, 2016, and for discharges occurring on or after
October 1, 2016, and before October 1, 2017''.
(b) Payment for Hospitals-Within-Hospitals.--Section 114(c)(2) of
the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C.
1395ww note), as amended by section 4302(a) of division B of the
American Recovery and Reinvestment Act (Public Law 111-5), sections
3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(A) of
the Pathway for SGR Reform Act of 2013 (division B of Public Law 113-
67), is amended--
(1) in subparagraph (A), by inserting ``or any similar
provision,'' after ``Regulations,'';
(2) in subparagraph (B)--
(A) in clause (i), by inserting ``or any similar
provision,'' after ``Regulations,''; and
(B) in clause (ii), by inserting ``, or any similar
provision,'' after ``Regulations''; and
(3) in subparagraph (C), by striking ``for a 9-year period''
and inserting ``through June 30, 2016, and for discharges
occurring on or after October 1, 2016, and before October 1,
2017''.
SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF HOSPITAL
LENGTH OF STAY TO ALL LTCHS.
(a) In General.--Section 1206(a)(3) of the Pathway for SGR Reform
Act of 2013 (division B of Public Law 113-67; 42 U.S.C. 1395ww note) is
amended--
(1) by striking subparagraph (B);
(2) by striking ``site neutral basis.--'' and all that
follows through ``For discharges occurring'' and inserting
``site neutral basis.--For discharges occurring'';
(3) by striking ``subject to subparagraph (B),''; and
(4) by redesignating clauses (i) and (ii) as subparagraphs
(A) and (B), respectively, and moving each of such subparagraphs
(as so redesignated) 2 ems to the left.
(b) <<NOTE: 42 USC 1395ww note.>> Effective Date.--The amendments
made by subsection (a) shall be effective as if included in the
enactment of section 1206(a)(3) of the Pathway for SGR Reform Act of
2013 (division B of Public Law 113-67; 42 U.S.C. 1395ww note).
[[Page 130 STAT. 1321]]
SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN
HOSPITALS.
(a) In General.--Subsection (d)(1)(B)(iv) of section 1886 of the
Social Security Act (42 U.S.C. 1395ww) is amended--
(1) in subclause (I), by striking ``or'' at the end;
(2) in subclause (II)--
(A) by striking ``, or'' at the end and inserting a
semicolon;
(B) by redesignating such subclause as clause (vi)
and by moving it to immediately follow clause (v); and
(C) in clause (v), by striking the semicolon at the
end and inserting ``, or''; and
(3) by striking ``(iv)(I) a hospital'' and inserting ``(iv)
a hospital''.
(b) Conforming Payment References.--The second sentence of
subsection (d)(1)(B) of such section is amended--
(1) by inserting ``(as in effect as of such date)'' after
``clause (iv)''; and
(2) by inserting ``(or, in the case of a hospital described
in clause (iv)(II), as so in effect, shall be classified under
clause (vi) on and after the effective date of such clause (vi)
and for cost reporting periods beginning on or after January 1,
2015, shall not be subject to subsection (m) as of the date of
such classification)'' after ``so classified''.
(c) <<NOTE: 42 USC 1395ww note.>> Application.--
(1) In general.--For cost reporting periods beginning on or
after January 1, 2015, in the case of an applicable hospital (as
defined in paragraph (3)), the following shall apply:
(A) Payment for inpatient operating costs shall be
made on a reasonable cost basis in the manner provided
in section 412.526(c)(3) of title 42, Code of Federal
Regulations (as in effect on January 1, 2015) and in any
subsequent modifications.
(B) Payment for capital costs shall be made in the
manner provided by section 412.526(c)(4) of title 42,
Code of Federal Regulations (as in effect on such date).
(C) Claims for payment for Medicare beneficiaries
who are discharged on or after January 1, 2017, shall be
processed as claims which are paid on a reasonable cost
basis as described in section 412.526(c) of title 42,
Code of Federal Regulations (as in effect on such date).
(2) Applicable hospital defined.--In this subsection, the
term ``applicable hospital'' means a hospital that is classified
under clause (iv)(II) of section 1886(d)(1)(B) of the Social
Security Act (42 U.S.C. 1395ww(d)(1)(B)) on the day before the
date of the enactment of this Act and which is classified under
clause (vi) of such section, as redesignated and moved by
subsection (a), on or after such date of enactment.
(d) Conforming Technical Amendments.--
(1) Section 1899B(a)(2)(A)(iv) of the Social Security Act
(42 U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking
``1886(d)(1)(B)(iv)(II)'' and inserting ``1886(d)(1)(B)(vi)''.
(2) Section 1886(m)(5)(F) of such Act (42 U.S.C.
1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii) by
striking ``(d)(1)(B)(iv)(II)'' and inserting ``(d)(1)(B)(vi)''.
[[Page 130 STAT. 1322]]
SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE MEDICARE
LTCH SITE NEUTRAL PROVISIONS FOR
CERTAIN SPINAL CORD SPECIALTY
HOSPITALS.
(a) Exception.--Section 1886(m)(6) of the Social Security Act (42
U.S.C. 1395ww(m)(6)) is amended--
(1) in subparagraph (A)(i), by striking ``and (E)'' and
inserting ``, (E), and (F)''; and
(2) by adding at the end the following new subparagraph:
``(F) Temporary exception for certain spinal cord
specialty hospitals.--For discharges in cost reporting
periods beginning during fiscal years 2018 and 2019,
subparagraph (A)(i) shall not apply (and payment shall
be made to a long-term care hospital without regard to
this paragraph) if such discharge is from a long-term
care hospital that meets each of the following
requirements:
``(i) Not-for-profit.--The long-term care
hospital was a not-for-profit long-term care
hospital on June 1, 2014, as determined by cost
report data.
``(ii) Primarily providing treatment for
catastrophic spinal cord or acquired brain
injuries or other paralyzing neuromuscular
conditions.--Of the discharges in calendar year
2013 from the long-term care hospital for which
payment was made under this section, at least 50
percent were classified under MS-LTCH-DRGs 28, 29,
52, 57, 551, 573, and 963.
``(iii) Significant out-of-state admissions.--
``(I) In general.--The long-term
care hospital discharged inpatients
(including both individuals entitled to,
or enrolled for, benefits under this
title and individuals not so entitled or
enrolled) during fiscal year 2014 who
had been admitted from at least 20 of
the 50 States, determined by the States
of residency of such inpatients and
based on such data submitted by the
hospital to the Secretary as the
Secretary may require.
``(II) Implementation.--
Notwithstanding any other provision of
law, the Secretary may implement
subclause (I) by program instruction or
otherwise.
``(III) Non-application of paperwork
reduction act.--Chapter 35 of title 44,
United States Code, shall not apply to
data collected under this clause.''.
(b) Study and Report on the Status and Viability of Certain Spinal
Cord Specialty Long-Term Care Hospitals.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on long-term care hospitals described in
section 1886(m)(6)(F) of the Social Security Act, as added by
subsection (a). Such report shall include an analysis of the
following:
(A) The impact on such hospitals of the
classification and facility licensure by State agencies
of such hospitals.
(B) The Medicare payment rates for such hospitals.
(C) Data on the number and health care needs of
Medicare beneficiaries who have been diagnosed with
catastrophic spinal cord or acquired brain injuries or
other paralyzing neuromuscular conditions (as described
within
[[Page 130 STAT. 1323]]
the discharge classifications specified in clause (ii)
of such section) who are receiving services from such
hospitals.
(2) Report.--Not later than October 1, 2018, the Comptroller
General shall submit to Congress a report on the study conducted
under paragraph (1), including recommendations for such
legislation and administrative action as the Comptroller General
determines appropriate.
SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE MEDICARE
LTCH SITE NEUTRAL PROVISIONS FOR
CERTAIN DISCHARGES WITH SEVERE WOUNDS.
(a) In General.--Section 1886(m)(6) of the Social Security Act (42
U.S.C. 1395ww(m)(6)), as amended by section 15009, is further amended--
(1) in subparagraph (A)(i) by striking ``and (F)'' and
inserting ``(F), and (G)'';
(2) in subparagraph (E)(i)(I)(aa), by striking ``the
amendment made'' and all that follows before the semicolon and
inserting ``the last sentence of subsection (d)(1)(B)''; and
(3) by adding at the end the following new subparagraph:
``(G) Additional temporary exception for certain
severe wound discharges from certain long-term care
hospitals.--
``(i) In general.--For a discharge occurring
in a cost reporting period beginning during fiscal
year 2018, subparagraph (A)(i) shall not apply
(and payment shall be made to a long-term care
hospital without regard to this paragraph) if such
discharge--
``(I) is from a long-term care
hospital identified by the last sentence
of subsection (d)(1)(B);
``(II) is classified under MS-LTCH-
DRG 602, 603, 539, or 540; and
``(III) is with respect to an
individual treated by a long-term care
hospital for a severe wound.
``(ii) Severe wound defined.--In this
subparagraph, the term `severe wound' means a
wound which is a stage 3 wound, stage 4 wound,
unstageable wound, non-healing surgical wound, or
fistula as identified in the claim from the long-
term care hospital.
``(iii) Wound defined.--In this subparagraph,
the term `wound' means an injury involving
division of tissue or rupture of the integument or
mucous membrane with exposure to the external
environment.''.
(c) Study and Report to Congress.--
(1) Study.--The Comptroller General of the United States
shall, in consultation with relevant stakeholders, conduct a
study on the treatment needs of individuals entitled to benefits
under part A of title XVIII of the Social Security Act or
enrolled under part B of such title who require specialized
wound care, and the cost, for such individuals and the Medicare
program under such title, of treating severe wounds in rural and
urban areas. Such study shall include an assessment of--
(A) access of such individuals to appropriate levels
of care for such cases;
(B) the potential impact that section
1886(m)(6)(A)(i) of such Act (42 U.S.C.
1395ww(m)(6)(A)(i)) will have on
[[Page 130 STAT. 1324]]
the access, quality, and cost of care for such
individuals; and
(C) how to appropriately pay for such care under the
Medicare program under such title.
(2) Report.--Not later than October 1, 2020, the Comptroller
General shall submit to Congress a report on the study conducted
under paragraph (1), including recommendations for such
legislation and administrative action as the Comptroller General
determines appropriate.
TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE
PAYMENT SYSTEM FOR SERVICES FURNISHED
BY MID-BUILD OFF-CAMPUS OUTPATIENT
DEPARTMENTS OF PROVIDERS.
(a) In General.--Section 1833(t)(21) of the Social Security Act (42
U.S.C. 1395l(t)(21)) is amended--
(1) in subparagraph (B)--
(A) in clause (i), by striking ``clause (ii)'' and
inserting ``the subsequent provisions of this
subparagraph''; and
(B) by adding at the end the following new clauses:
``(iii) Deemed treatment for 2017.--For
purposes of applying clause (ii) with respect to
applicable items and services furnished during
2017, a department of a provider (as so defined)
not described in such clause is deemed to be
billing under this subsection with respect to
covered OPD services furnished prior to November
2, 2015, if the Secretary received from the
provider prior to December 2, 2015, an attestation
(pursuant to section 413.65(b)(3) of title 42 of
the Code of Federal Regulations) that such
department was a department of a provider (as so
defined).
``(iv) Alternative exception beginning with
2018.--For purposes of paragraph (1)(B)(v) and
this paragraph with respect to applicable items
and services furnished during 2018 or a subsequent
year, the term `off-campus outpatient department
of a provider' also shall not include a department
of a provider (as so defined) that is not
described in clause (ii) if--
``(I) the Secretary receives from
the provider an attestation (pursuant to
such section 413.65(b)(3)) not later
than December 31, 2016 (or, if later, 60
days after the date of the enactment of
this clause), that such department met
the requirements of a department of a
provider specified in section 413.65 of
title 42 of the Code of Federal
Regulations;
``(II) the provider includes such
department as part of the provider on
its enrollment form in accordance with
the enrollment process under section
1866(j); and
``(III) the department met the mid-
build requirement of clause (v) and the
Secretary receives, not later than 60
days after the date
[[Page 130 STAT. 1325]]
of the enactment of this clause, from
the chief executive officer or chief
operating officer of the provider a
written certification that the
department met such requirement.
``(v) Mid-build requirement described.--The
mid-build requirement of this clause is, with
respect to a department of a provider, that before
November 2, 2015, the provider had a binding
written agreement with an outside unrelated party
for the actual construction of such department.
``(vii) Audit.--Not later than December 31,
2018, the Secretary shall audit the compliance
with requirements of clause (iv) with respect to
each department of a provider to which such clause
applies. If the Secretary finds as a result of an
audit under this clause that the applicable
requirements were not met with respect to such
department, the department shall not be excluded
from the term `off-campus outpatient department of
a provider' under such clause.
``(viii) Implementation.--For purposes of
implementing clauses (iii) through (vii):
``(I) Notwithstanding any other
provision of law, the Secretary may
implement such clauses by program
instruction or otherwise.
``(II) Subchapter I of chapter 35 of
title 44, United States Code, shall not
apply.
``(III) For purposes of carrying out
this subparagraph with respect to
clauses (iii) and (iv) (and clause (vii)
insofar as it relates to clause (iv)),
$10,000,000 shall be available from the
Federal Supplementary Medical Insurance
Trust Fund under section 1841, to remain
available until December 31, 2018.'';
and
(2) in subparagraph (E), by adding at the end the following
new clause:
``(iv) The determination of an audit under
subparagraph (B)(vii).''.
(b) <<NOTE: 42 USC 1395l note.>> Effective Date.--The amendments
made by this section shall be effective as if included in the enactment
of section 603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT
DEPARTMENT OF A PROVIDER POLICY.
(a) In General.--Section 1833(t)(21)(B) of the Social Security Act
(42 U.S.C. 1395l(t)(21)(B)), as amended by section 16001(a), is
amended--
(1) by inserting after clause (v) the following new clause:
``(vi) Exclusion for certain cancer
hospitals.--For purposes of paragraph (1)(B)(v)
and this paragraph with respect to applicable
items and services furnished during 2017 or a
subsequent year, the term `off-campus outpatient
department of a provider' also shall not include a
department of a provider (as so defined) that is
not described in clause (ii) if the provider is a
hospital described in section 1886(d)(1)(B)(v)
and--
``(I) in the case of a department
that met the requirements of section
413.65 of title 42 of the
[[Page 130 STAT. 1326]]
Code of Federal Regulations after
November 1, 2015, and before the date of
the enactment of this clause, the
Secretary receives from the provider an
attestation that such department met
such requirements not later than 60 days
after such date of enactment; or
``(II) in the case of a department
that meets such requirements after such
date of enactment, the Secretary
receives from the provider an
attestation that such department meets
such requirements not later than 60 days
after the date such requirements are
first met with respect to such
department.'';
(2) in clause (vii), by inserting after the first sentence
the following: ``Not later than 2 years after the date the
Secretary receives an attestation under clause (vi) relating to
compliance of a department of a provider with requirements
referred to in such clause, the Secretary shall audit the
compliance with such requirements with respect to the
department.''; and
(3) in clause (viii)(III), by adding at the end the
following: ``For purposes of carrying out this subparagraph with
respect to clause (vi) (and clause (vii) insofar as it relates
to such clause), $2,000,000 shall be available from the Federal
Supplementary Medical Insurance Trust Fund under section 1841,
to remain available until expended.''.
(b) Offsetting Savings.--Section 1833(t)(18) of the Social Security
Act (42 U.S.C. 1395l(t)(18)) is amended--
(1) in subparagraph (B), by inserting ``, subject to
subparagraph (C),'' after ``shall''; and
(2) by adding at the end the following new subparagraph:
``(C) Target pcr adjustment.--In applying section
419.43(i) of title 42 of the Code of Federal Regulations
to implement the appropriate adjustment under this
paragraph for services furnished on or after January 1,
2018, the Secretary shall use a target PCR that is 1.0
percentage points less than the target PCR that would
otherwise apply. In addition to the percentage point
reduction under the previous sentence, the Secretary may
consider making an additional percentage point reduction
to such target PCR that takes into account payment rates
for applicable items and services described in paragraph
(21)(C) other than for services furnished by hospitals
described in section 1886(d)(1)(B)(v). In making any
budget neutrality adjustments under this subsection for
2018 or a subsequent year, the Secretary shall not take
into account the reduced expenditures that result from
the application of this subparagraph.''.
(c) <<NOTE: 42 USC 1395l note.>> Effective Date.--The amendments
made by this section shall be effective as if included in the enactment
of section 603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY
SURGICAL CENTERS FOR MEANINGFUL USE
AND MIPS.
Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C. 1395w-
4(a)(7)(D)) is amended--
[[Page 130 STAT. 1327]]
(1) by striking ``hospital-based eligible professionals''
and all that follows through ``No payment'' and inserting the
following: ``hospital-based and ambulatory surgical center-based
eligible professionals.--
``(i) Hospital-based.--No payment''; and
(2) by adding at the end the following new clauses:
``(ii) Ambulatory surgical center-based.--
Subject to clause (iv), no payment adjustment may
be made under subparagraph (A) for 2017 and 2018
in the case of an eligible professional with
respect to whom substantially all of the covered
professional services furnished by such
professional are furnished in an ambulatory
surgical center.
``(iii) Determination.--The determination of
whether an eligible professional is an eligible
professional described in clause (ii) may be made
on the basis of--
``(I) the site of service (as
defined by the Secretary); or
``(II) an attestation submitted by
the eligible professional.
Determinations made under subclauses (I) and (II)
shall be made without regard to any employment or
billing arrangement between the eligible
professional and any other supplier or provider of
services.
``(iv) Sunset.--Clause (ii) shall no longer
apply as of the first year that begins more than 3
years after the date on which the Secretary
determines, through notice and comment rulemaking,
that certified EHR technology applicable to the
ambulatory surgical center setting is
available.''.
SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016.
(a) Extension of Enforcement Instruction on Supervision Requirements
for Outpatient Therapeutic Services in Critical Access and Small Rural
Hospitals Through 2016.--Section 1 of Public Law 113-198, as amended by
section 1 of Public Law 114-112, is amended--
(1) in the heading, by striking ``2014 and 2015'' and
inserting ``2016''; and
(2) by striking ``and 2015'' and inserting ``, 2015, and
2016''.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Medicare Payment Advisory Commission (established under
section 1805 of the Social Security Act (42 U.S.C. 1395b-6)) shall
submit to Congress a report analyzing the effect of the extension of the
enforcement instruction under section 1 of Public Law 113-198, as
amended by section 1 of Public Law 114-112 and subsection (a) of this
section, on the access to health care by Medicare beneficiaries, on the
economic impact and the impact upon hospital staffing needs, and on the
quality of health care furnished to such beneficiaries.
[[Page 130 STAT. 1328]]
SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE SCHEDULE
ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES
AND SEATING SYSTEMS WHEN USED IN
CONJUNCTION WITH COMPLEX
REHABILITATION TECHNOLOGY (CRT)
WHEELCHAIRS.
Section 2(a) of the Patient Access and Medicare Protection Act (42
U.S.C. 1305 note) is amended by striking ``January 1, 2017'' and
inserting ``July 1, 2017''.
SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM TENENS
ARRANGEMENTS UNDER MEDICARE.
(a) In General.--The first sentence of section 1842(b)(6) of the
Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by section 5012,
is further amended--
(1) by striking ``and'' before ``(I)''; and
(2) by inserting before the period at the end the following:
``, and (J) in the case of outpatient physical therapy services
furnished by physical therapists in a health professional
shortage area (as defined in section 332(a)(1)(A) of the Public
Health Service Act), a medically underserved area (as designated
pursuant to section 330(b)(3)(A) of such Act), or a rural area
(as defined in section 1886(d)(2)(D)), subparagraph (D) of this
sentence shall apply to such services and therapists in the same
manner as such subparagraph applies to physicians' services
furnished by physicians''.
(b) <<NOTE: 42 USC 1395u note.>> Effective Date; Implementation.--
(1) Effective date.--The amendments made by subsection (a)
shall apply to services furnished beginning not later than six
months after the date of the enactment of this Act.
(2) Implementation.--The Secretary of Health and Human
Services may implement subparagraph (J) of section 1842(b)(6) of
the Social Security Act (42 U.S.C. 1395u(b)(6)), as added by
subsection (a)(2), by program instruction or otherwise.
SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES FOR
DURABLE MEDICAL EQUIPMENT UNDER THE
MEDICARE PROGRAM.
(a) In General.--The Secretary of Health and Human Services shall
extend the transition period described in clause (i) of section
414.210(g)(9) of title 42, Code of Federal Regulations, from June 30,
2016, to December 31, 2016 (with the full implementation described in
clause (ii) of such section applying to items and services furnished
with dates of service on or after January 1, 2017).
(b) Study and Report.--
(1) Study.--
(A) In general.--The Secretary of Health and Human
Services shall conduct a study that examines the impact
of applicable payment adjustments upon--
(i) the number of suppliers of durable medical
equipment that, on a date that is not before
January 1, 2016, and not later than December 31,
2016, ceased to conduct business as such
suppliers; and
(ii) the availability of durable medical
equipment, during the period beginning on January
1, 2016, and ending on December 31, 2016, to
individuals entitled to benefits under part A of
title XVIII of the Social
[[Page 130 STAT. 1329]]
Security Act (42 U.S.C. 1395 et seq.) or enrolled
under part B of such title.
(B) Definitions.--For purposes of this subsection,
the following definitions apply:
(i) Supplier; durable medical equipment.--The
terms ``supplier'' and ``durable medical
equipment'' have the meanings given such terms by
section 1861 of the Social Security Act (42 U.S.C.
1395x).
(ii) Applicable payment adjustment.--The term
``applicable payment adjustment'' means a payment
adjustment described in section 414.210(g) of
title 42, Code of Federal Regulations, that is
phased in by paragraph (9)(i) of such section. For
purposes of the preceding sentence, a payment
adjustment that is phased in pursuant to the
extension under subsection (a) shall be considered
a payment adjustment that is phased in by such
paragraph (9)(i).
(2) Report.--The Secretary of Health and Human Services
shall, not later than January 12, 2017, submit to the Committees
on Ways and Means and on Energy and Commerce of the House of
Representatives, and to the Committee on Finance of the Senate,
a report on the findings of the study conducted under paragraph
(1).
SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING
INFORMATION FROM COMPETITIVE BIDDING
PROGRAMS.
(a) In General.--Section 1834(a)(1)(G) of the Social Security Act
(42 U.S.C. 1395m(a)(1)(G)) is amended by adding at the end the following
new sentence: ``In the case of items and services furnished on or after
January 1, 2019, in making any adjustments under clause (ii) or (iii) of
subparagraph (F), under subsection (h)(1)(H)(ii), or under section
1842(s)(3)(B), the Secretary shall--
``(i) solicit and take into account
stakeholder input; and
``(ii) take into account the highest amount
bid by a winning supplier in a competitive
acquisition area and a comparison of each of the
following with respect to non-competitive
acquisition areas and competitive acquisition
areas:
``(I) The average travel distance
and cost associated with furnishing
items and services in the area.
``(II) The average volume of items
and services furnished by suppliers in
the area.
``(III) The number of suppliers in
the area.''.
(b) Conforming Amendments.--(1) Section 1834(h)(1)(H)(ii) of the
Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is amended by
striking ``the Secretary'' and inserting ``subject to subsection
(a)(1)(G), the Secretary''.
(2) Section 1842(s)(3)(B) of the Social Security Act (42 U.S.C.
1395m(s)(3)(B)) is amended by striking ``the Secretary'' and inserting
``subject to section 1834(a)(1)(G), the Secretary''.
[[Page 130 STAT. 1330]]
TITLE XVII--OTHER MEDICARE PROVISIONS
SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR MEDICARE
ADVANTAGE PLANS FAILING TO ACHIEVE
MINIMUM QUALITY RATINGS.
(a) <<NOTE: 42 USC 1395w-27 note.>> Findings.--Consistent with the
studies provided under the IMPACT Act of 2014 (Public Law 113-185), it
is the intent of Congress--
(1) to continue to study and request input on the effects of
socioeconomic status and dual-eligible populations on the
Medicare Advantage STARS rating system before reforming such
system with the input of stakeholders; and
(2) pending the results of such studies and input, to
provide for a temporary delay in authority of the Centers for
Medicare & Medicaid Services (CMS) to terminate Medicare
Advantage plan contracts solely on the basis of performance of
plans under the STARS rating system.
(b) Delay in MA Contract Termination Authority for Plans Failing To
Achieve Minimum Quality Ratings.--Section 1857(h) of the Social Security
Act (42 U.S.C. 1395w-27(h)) is amended by adding at the end the
following new paragraph:
``(3) Delay in contract termination authority for plans
failing to achieve minimum quality rating.--During the period
beginning on the date of the enactment of this paragraph and
through the end of plan year 2018, the Secretary may not
terminate a contract under this section with respect to the
offering of an MA plan by a Medicare Advantage organization
solely because the MA plan has failed to achieve a minimum
quality rating under the 5-star rating system under section
1853(o)(4).''.
SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA REPORTING FOR
MEDICARE.
Section 1874 of the Social Security Act (42 U.S.C. 1395kk) is
amended by adding at the end the following new subsection:
``(g) Requirement for Enrollment Data Reporting.--
``(1) In general.--Each year (beginning with 2016), the
Secretary shall submit to the Committees on Ways and Means and
Energy and Commerce of the House of Representatives and the
Committee on Finance of the Senate a report on Medicare
enrollment data (and, in the case of part A, on data on
individuals receiving benefits under such part) as of a date in
such year specified by the Secretary. Such data shall be
presented--
``(A) by Congressional district and State; and
``(B) in a manner that provides for such data based
on--
``(i) fee-for-service enrollment (as defined
in paragraph (2));
``(ii) enrollment under part C (including
separate for aggregate enrollment in MA-PD plans
and aggregate enrollment in MA plans that are not
MA-PD plans); and
``(iii) enrollment under part D.
[[Page 130 STAT. 1331]]
``(2) Fee-for-service enrollment defined.--For purpose of
paragraph (1)(B)(i), the term `fee-for-service enrollment' means
aggregate enrollment (including receipt of benefits other than
through enrollment) under--
``(A) part A only;
``(B) part B only; and
``(C) both part A and part B.''.
SEC. 17003. <<NOTE: 42 USC 1395a note.>> UPDATING THE WELCOME TO
MEDICARE PACKAGE.
(a) In General.--Not later than 12 months after the last day of the
period for the request of information described in subsection (b), the
Secretary of Health and Human Services shall, taking into consideration
information collected pursuant to subsection (b), update the information
included in the Welcome to Medicare package to include information,
presented in a clear and simple manner, about options for receiving
benefits under the Medicare program under title XVIII of the Social
Security Act (42 U.S.C. 1395 et seq.), including through the original
medicare fee-for-service program under parts A and B of such title (42
U.S.C. 1395c et seq., 42 U.S.C. 1395j et seq.), Medicare Advantage plans
under part C of such title (42 U.S.C. 1395w-21 et seq.), and
prescription drug plans under part D of such title (42 U.S.C. 1395w-101
et seq.)). The Secretary shall make subsequent updates to the
information included in the Welcome to Medicare package as appropriate.
(b) Request for Information.--Not later than 6 months after the date
of the enactment of this Act, the Secretary of Health and Human Services
shall request information, including recommendations, from stakeholders
(including patient advocates, issuers, and employers) on information
included in the Welcome to Medicare package, including pertinent data
and information regarding enrollment and coverage for Medicare eligible
individuals.
SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY NEWLY
ENROLLED PROVIDERS OR SUPPLIERS WITHIN
A TEMPORARY MORATORIUM AREA.
(a) Medicare.--Section 1866(j)(7) of the Social Security Act (42
U.S.C. 1395cc(j)(7)) is amended--
(1) in the paragraph heading, by inserting ``; nonpayment''
before the period; and
(2) by adding at the end the following new subparagraph:
``(C) Nonpayment.--
``(i) In general.--No payment may be made
under this title or under a program described in
subparagraph (A) with respect to an item or
service described in clause (ii) furnished on or
after October 1, 2017.
``(ii) Item or service described.--An item or
service described in this clause is an item or
service furnished--
``(I) within a geographic area with
respect to which a temporary moratorium
imposed under subparagraph (A) is in
effect; and
``(II) by a provider of services or
supplier that meets the requirements of
clause (iii).
``(iii) Requirements.--For purposes of clause
(ii), the requirements of this clause are that a
provider of services or supplier--
``(I) enrolls under this title on or
after the effective date of such
temporary moratorium; and
[[Page 130 STAT. 1332]]
``(II) is within a category of
providers of services and suppliers (as
described in subparagraph (A)) subject
to such temporary moratorium.
``(iv) Prohibition on charges for specified
items or services.--In no case shall a provider of
services or supplier described in clause (ii)(II)
charge an individual or other person for an item
or service described in clause (ii) furnished on
or after October 1, 2017, to an individual
entitled to benefits under part A or enrolled
under part B or an individual under a program
specified in subparagraph (A).''.
(b) Conforming Amendments.--
(1) Medicaid.--
(A) In general.--Section 1903(i)(2) of the Social
Security Act (42 U.S.C. 1396b(i)(2)), as amended by
section 5005(a)(4), is further amended--
(i) in subparagraph (C), by striking ``or'' at
the end; and
(ii) by adding at the end the following new
subparagraph:
``(E) with respect to any amount expended for such
an item or service furnished during calendar quarters
beginning on or after October 1, 2017, subject to
section 1902(kk)(4)(A)(ii)(II), within a geographic area
that is subject to a moratorium imposed under section
1866(j)(7) by a provider or supplier that meets the
requirements specified in subparagraph (C)(iii) of such
section, during the period of such moratorium; or''.
(B) Exception with respect to access.--Section
1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C.
1396a(kk)(4)(A)(ii)) is amended to read as follows:
``(ii) Exceptions.--
``(I) Compliance with moratorium.--A
State shall not be required to comply
with a temporary moratorium described in
clause (i) if the State determines that
the imposition of such temporary
moratorium would adversely impact
beneficiaries' access to medical
assistance.
``(II) FFP available.--
Notwithstanding section 1903(i)(2)(E),
payment may be made to a State under
this title with respect to amounts
expended for items and services
described in such section if the
Secretary, in consultation with the
State agency administering the State
plan under this title (or a waiver of
the plan), determines that denying
payment to the State pursuant to such
section would adversely impact
beneficiaries' access to medical
assistance. ''.
(C) State plan requirement with respect to
limitation on charges to beneficiaries.--Section
1902(kk)(4)(A) of the Social Security Act (42 U.S.C.
1396a(kk)(4)(A)) is amended by adding at the end the
following new clause:
``(iii) Limitation on charges to
beneficiaries.--With respect to any amount
expended for items or services furnished during
calendar quarters beginning on or after October 1,
2017, the State prohibits, during
[[Page 130 STAT. 1333]]
the period of a temporary moratorium described in
clause (i), a provider meeting the requirements
specified in subparagraph (C)(iii) of section
1866(j)(7) from charging an individual or other
person eligible to receive medical assistance
under the State plan under this title (or a waiver
of the plan) for an item or service described in
section 1903(i)(2)(E) furnished to such an
individual.''.
(2) Correcting amendments to related provisions.--
(A) Section 1866(j).--Section 1866(j) of the Social
Security Act (42 U.S.C. 1395cc(j)) is amended--
(i) in paragraph (1)(A)--
(I) by striking ``paragraph (4)''
and inserting ``paragraph (5)'';
(II) by striking ``moratoria in
accordance with paragraph (5)'' and
inserting ``moratoria in accordance with
paragraph (7)''; and
(III) by striking ``paragraph (6)''
and inserting ``paragraph (9)''; and
(ii) by redesignating the second paragraph (8)
(redesignated by section 1304(1) of Public Law
111-152) as paragraph (9).
(B) Section 1902(kk).--Section 1902(kk) of such Act
(42 U.S.C. 1396a(kk)) is amended--
(i) in paragraph (1), by striking ``section
1886(j)(2)'' and inserting ``section 1866(j)(2)'';
(ii) in paragraph (2), by striking ``section
1886(j)(3)'' and inserting ``section 1866(j)(3)'';
(iii) in paragraph (3), by striking ``section
1886(j)(4)'' and inserting ``section 1866(j)(5)'';
and
(iv) in paragraph (4)(A), by striking
``section 1886(j)(6)'' and inserting ``section
1866(j)(7)''.
SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE UNDER
MEDICARE ADVANTAGE.
Section 1851(e)(2) of the Social Security Act (42 U.S.C. 1395w-
21(e)(2)) is amended--
(1) in subparagraph (C)--
(A) in the heading, by inserting ``from 2011 through
2018'' after ``45-day period''; and
(B) by inserting ``and ending with 2018'' after
``beginning with 2011''; and
(2) by adding at the end the following new subparagraph:
``(G) Continuous open enrollment and disenrollment
for first 3 months in 2016 and subsequent years.--
``(i) In general.--Subject to clause (ii) and
subparagraph (D)--
``(I) in the case of an MA eligible
individual who is enrolled in an MA
plan, at any time during the first 3
months of a year (beginning with 2019);
or
``(II) in the case of an individual
who first becomes an MA eligible
individual during a year (beginning with
2019) and enrolls in an MA plan, during
the first 3 months during such year in
which the individual is an MA eligible
individual;
[[Page 130 STAT. 1334]]
such MA eligible individual may change the
election under subsection (a)(1).
``(ii) Limitation of one change during open
enrollment period each year.--An individual may
change the election pursuant to clause (i) only
once during the applicable 3-month period
described in such clause in each year. The
limitation under this clause shall not apply to
changes in elections effected during an annual,
coordinated election period under paragraph (3) or
during a special enrollment period under paragraph
(4).
``(iii) Limited application to part d.--
Clauses (i) and (ii) of this subparagraph shall
only apply with respect to changes in enrollment
in a prescription drug plan under part D in the
case of an individual who, previous to such change
in enrollment, is enrolled in a Medicare Advantage
plan.
``(iv) Limitations on marketing.-- Pursuant to
subsection (j), no unsolicited marketing or
marketing materials may be sent to an individual
described in clause (i) during the continuous open
enrollment and disenrollment period established
for the individual under such clause,
notwithstanding marketing guidelines established
by the Centers for Medicare & Medicaid
Services.''.
SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES TO
CHOOSE A MEDICARE ADVANTAGE PLAN.
(a) Removing Prohibition.--
(1) In general.--Section 1851(a)(3) of the Social Security
Act (42 U.S.C. 1395w-21(a)(3)) is amended--
(A) by striking subparagraph (B); and
(B) by striking ``eligible individual'' and all that
follows through ``In this title, subject to subparagraph
(B),'' and inserting ``eligible individual.--In this
title,''.
(2) Conforming amendments.--
(A) Section 1852(b)(1) of the Social Security Act
(42 U.S.C. 1395w-22(b)(1)) is amended--
(i) by striking subparagraph (B); and
(ii) by striking ``Beneficiaries'' and all
that follows through ``A Medicare+Choice
organization'' and inserting ``Beneficiaries.--A
Medicare Advantage organization''.
(B) Section 1859(b)(6) of the Social Security Act
(42 U.S.C. 1395w-28(b)(6)) is amended, in the last
sentence, by striking ``may waive'' and all that follows
through ``subparagraph and''.
(3) <<NOTE: 42 USC 1395w-21 note.>> Effective date.--The
amendments made by this subsection shall apply with respect to
plan years beginning on or after January 1, 2021.
(b) Excluding Costs for Kidney Acquisitions From MA Benchmark.--
Section 1853 of the Social Security Act (42 U.S.C. 1395w-23) is
amended--
(1) in subsection (k)--
(A) in paragraph (1)--
[[Page 130 STAT. 1335]]
(i) in the matter preceding subparagraph (A),
by striking ``paragraphs (2) and (4)'' and
inserting ``paragraphs (2), (4), and (5)''; and
(ii) in subparagraph (B)(i), by striking
``paragraphs (2) and (4)'' and inserting
``paragraphs (2), (4), and (5)''; and
(B) by adding at the end the following new
paragraph:
``(5) Exclusion of costs for kidney acquisitions from
capitation rates.--After determining the applicable amount for
an area for a year under paragraph (1) (beginning with 2021),
the Secretary shall adjust such applicable amount to exclude
from such applicable amount the Secretary's estimate of the
standardized costs for payments for organ acquisitions for
kidney transplants covered under this title (including expenses
covered under section 1881(d)) in the area for the year.''; and
(2) in subsection (n)(2)--
(A) in subparagraph (A)(i), by inserting ``and, for
2021 and subsequent years, the exclusion of payments for
organ acquisitions for kidney transplants from the
capitation rate as described in subsection (k)(5)''
before the semicolon at the end;
(B) in subparagraph (E), in the matter preceding
clause (i), by striking ``subparagraph (F)'' and
inserting ``subparagraphs (F) and (G)''; and
(C) by adding at the end the following new
subparagraph:
``(G) Application of kidney acquisitions
adjustment.--The base payment amount specified in
subparagraph (E) for a year (beginning with 2021) shall
be adjusted in the same manner under paragraph (5) of
subsection (k) as the applicable amount is adjusted
under such subsection.''.
(c) FFS Coverage of Kidney Acquisitions.--
(1) In general.--Section 1852(a)(1)(B)(i) of the Social
Security Act (42 U.S.C. 1395w-22(a)(1)(B)(i)) is amended by
inserting ``or coverage for organ acquisitions for kidney
transplants, including as covered under section 1881(d)'' after
``hospice care''.
(2) Conforming amendment.--Section 1851(i) of the Social
Security Act (42 U.S.C. 1395w-21(i)) is amended by adding at the
end the following new paragraph:
``(3) FFS payment for expenses for kidney acquisitions.--
Paragraphs (1) and (2) shall not apply with respect to expenses
for organ acquisitions for kidney transplants described in
section 1852(a)(1)(B)(i).''.
(3) <<NOTE: 42 USC 1395w-21 note.>> Effective date.--The
amendments made by this subsection shall apply with respect to
plan years beginning on or after January 1, 2021.
(d) Evaluation of Quality.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
conduct an evaluation of whether the 5-star rating system based
on the data collected under section 1852(e) of the Social
Security Act (42 U.S.C. 1395w-22(e)) should include a quality
measure specifically related to care for enrollees in Medicare
[[Page 130 STAT. 1336]]
Advantage plans under part C of title XVIII of such Act
determined to have end-stage renal disease.
(2) Public availability.--Not later than April 1, 2020, the
Secretary shall post on the Internet website of the Centers for
Medicare & Medicaid Services the results of the evaluation under
paragraph (1).
(e) Report.--Not later than December 31, 2023, the Secretary of
Health and Human Services (in this subsection referred to as the
``Secretary'') shall submit to Congress a report on the impact of the
provisions of, and amendments made by, this section with respect to the
following:
(1) Spending under--
(A) the original Medicare fee-for-service program
under parts A and B of title XVIII of the Social
Security Act; and
(B) the Medicare Advantage program under part C of
such title.
(2) The number of enrollees determined to have end-stage
renal disease--
(A) in the original Medicare fee-for-service
program; and
(B) in the Medicare Advantage program.
(3) The sufficiency of the amount of data under the original
Medicare fee-for-service program for individuals determined to
have end-stage renal disease for purposes of determining payment
rates for end-stage renal disease under the Medicare Advantage
program.
(f) Improvements to Risk Adjustment Under Medicare Advantage.--
(1) In general.--Section 1853(a)(1) of the Social Security
Act (42 U.S.C. 1395w-23(a)(1)) is amended--
(A) in subparagraph (C)(i), by striking ``The
Secretary'' and inserting ``Subject to subparagraph (I),
the Secretary''; and
(B) by adding at the end the following new
subparagraph:
``(I) Improvements to risk adjustment for 2019 and
subsequent years.--
``(i) In general.--In order to determine the
appropriate adjustment for health status under
subparagraph (C)(i), the following shall apply:
``(I) Taking into account total
number of diseases or conditions.--The
Secretary shall take into account the
total number of diseases or conditions
of an individual enrolled in an MA plan.
The Secretary shall make an additional
adjustment under such subparagraph as
the number of diseases or conditions of
an individual increases.
``(II) Using at least 2 years of
diagnostic data.--The Secretary may use
at least 2 years of diagnosis data.
``(III) Providing separate
adjustments for dual eligible
individuals.--With respect to
individuals who are dually eligible for
benefits under this title and title XIX,
the Secretary shall
[[Page 130 STAT. 1337]]
make separate adjustments for each of
the following:
``(aa) Full-benefit dual
eligible individuals (as defined
in section 1935(c)(6)).
``(bb) Such individuals not
described in item (aa).
``(IV) Evaluation of mental health
and substance use disorders.--The
Secretary shall evaluate the impact of
including additional diagnosis codes
related to mental health and substance
use disorders in the risk adjustment
model.
``(V) Evaluation of chronic kidney
disease.--The Secretary shall evaluate
the impact of including the severity of
chronic kidney disease in the risk
adjustment model.
``(VI) Evaluation of payment rates
for end-stage renal disease.--The
Secretary shall evaluate whether other
factors (in addition to those described
in subparagraph (H)) should be taken
into consideration when computing
payment rates under such subparagraph.
``(ii) Phased-in implementation.--The
Secretary shall phase-in any changes to risk
adjustment payment amounts under subparagraph
(C)(i) under this subparagraph over a 3-year
period, beginning with 2019, with such changes
being fully implemented for 2022 and subsequent
years.
``(iii) Opportunity for review and public
comment.--The Secretary shall provide an
opportunity for review of the proposed changes to
such risk adjustment payment amounts under this
subparagraph and a public comment period of not
less than 60 days before implementing such
changes.''.
(2) Studies and reports.--
(A) Reports on the risk adjustment system.--
(i) Medpac evaluation and report.--
(I) Evaluation.--The Medicare
Payment Advisory Commission shall
conduct an evaluation of the impact of
the provisions of, and amendments made
by, this section on risk scores for
enrollees in Medicare Advantage plans
under part C of title XVIII of the
Social Security Act and payments to
Medicare Advantage plans under such
part, including the impact of such
provisions and amendments on the overall
accuracy of risk scores under the
Medicare Advantage program.
(II) Report.--Not later than July 1,
2020, the Medicare Payment Advisory
Commission shall submit to Congress a
report on the evaluation under subclause
(I), together with recommendations for
such legislation and administrative
action as the Commission determines
appropriate.
(ii) <<NOTE: 42 USC 1395w-23 note.>> Reports
by secretary of health and human services.--Not
later than December 31, 2018, and every 3 years
thereafter, the Secretary of Health and Human
Services shall submit to Congress a report on the
risk adjustment model and the ESRD risk
[[Page 130 STAT. 1338]]
adjustment model under the Medicare Advantage
program under part C of title XVIII of the Social
Security Act, including any revisions to either
such model since the previous report. Such report
shall include information on how such revisions
impact the predictive ratios under either such
model for groups of enrollees in Medicare
Advantage plans, including very high and very low
cost enrollees, and groups defined by the number
of chronic conditions of enrollees.
(B) Study and report on functional status.--
(i) Study.--The Comptroller General of the
United States (in this subparagraph referred to as
the ``Comptroller General'') shall conduct a study
on how to most accurately measure the functional
status of enrollees in Medicare Advantage plans
and whether the use of such functional status
would improve the accuracy of risk adjustment
payments under the Medicare Advantage program
under part C of title XVIII of the Social Security
Act. Such study shall include an analysis of the
challenges in collecting and reporting functional
status information for Medicare Advantage plans
under such part, providers of services and
suppliers under the Medicare program, and the
Centers for Medicare & Medicaid Services.
(ii) Report.--Not later than June 30, 2018,
the Comptroller General shall submit to Congress a
report containing the results of the study under
clause (i), together with recommendations for such
legislation and administrative action as the
Comptroller General determines appropriate.
SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES UNDER
THE MEDICARE SHARED SAVINGS PROGRAM.
Section 1899(c) of the Social Security Act (42 U.S.C. 1395jjj(c)) is
amended--
(1) by striking ``utilization of primary'' and inserting
``utilization of--
``(1) in the case of performance years beginning on or after
April 1, 2012, primary'';
(2) in paragraph (1), as added by paragraph (1) of this
section, by striking the period at the end and inserting ``;
and'';
(3) by adding at the end the following new paragraph:
``(2) in the case of performance years beginning on or after
January 1, 2019, services provided under this title by a
Federally qualified health center or rural health clinic (as
those terms are defined in section 1861(aa)), as may be
determined by the Secretary.''.
TITLE XVIII--OTHER PROVISIONS
SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN REQUIREMENTS FOR
QUALIFIED SMALL EMPLOYER HEALTH
REIMBURSEMENT ARRANGEMENTS.
(a) Amendments to the Internal Revenue Code of 1986 and the Patient
Protection and Affordable Care Act.--
[[Page 130 STAT. 1339]]
(1) In general.--Section 9831 of the Internal Revenue Code
of 1986 is amended by adding at the end the following new
subsection:
``(d) Exception for Qualified Small Employer Health Reimbursement
Arrangements.--
``(1) In general.--For purposes of this title (except as
provided in section 4980I(f)(4) and notwithstanding any other
provision of this title), the term `group health plan' shall not
include any qualified small employer health reimbursement
arrangement.
``(2) Qualified small employer health reimbursement
arrangement.--For purposes of this subsection--
``(A) In general.--The term `qualified small
employer health reimbursement arrangement' means an
arrangement which--
``(i) is described in subparagraph (B), and
``(ii) is provided on the same terms to all
eligible employees of the eligible employer.
``(B) Arrangement described.--An arrangement is
described in this subparagraph if--
``(i) such arrangement is funded solely by an
eligible employer and no salary reduction
contributions may be made under such arrangement,
``(ii) such arrangement provides, after the
employee provides proof of coverage, for the
payment of, or reimbursement of, an eligible
employee for expenses for medical care (as defined
in section 213(d)) incurred by the eligible
employee or the eligible employee's family members
(as determined under the terms of the
arrangement), and
``(iii) the amount of payments and
reimbursements described in clause (ii) for any
year do not exceed $4,950 ($10,000 in the case of
an arrangement that also provides for payments or
reimbursements for family members of the
employee).
``(C) Certain variation permitted.--For purposes of
subparagraph (A)(ii), an arrangement shall not fail to
be treated as provided on the same terms to each
eligible employee merely because the employee's
permitted benefit under such arrangement varies in
accordance with the variation in the price of an
insurance policy in the relevant individual health
insurance market based on--
``(i) the age of the eligible employee (and,
in the case of an arrangement which covers medical
expenses of the eligible employee's family
members, the age of such family members), or
``(ii) the number of family members of the
eligible employee the medical expenses of which
are covered under such arrangement.
The variation permitted under the preceding sentence
shall be determined by reference to the same insurance
policy with respect to all eligible employees.
``(D) Rules relating to maximum dollar limitation.--
[[Page 130 STAT. 1340]]
``(i) Amount prorated in certain cases.--In
the case of an individual who is not covered by an
arrangement for the entire year, the limitation
under subparagraph (B)(iii) for such year shall be
an amount which bears the same ratio to the amount
which would (but for this clause) be in effect for
such individual for such year under subparagraph
(B)(iii) as the number of months for which such
individual is covered by the arrangement for such
year bears to 12.
``(ii) Inflation adjustment.--In the case of
any year beginning after 2016, each of the dollar
amounts in subparagraph (B)(iii) shall be
increased by an amount equal to--
``(I) such dollar amount, multiplied
by
``(II) the cost-of-living adjustment
determined under section 1(f)(3) for the
calendar year in which the taxable year
begins, determined by substituting
`calendar year 2015' for `calendar year
1992' in subparagraph (B) thereof.
If any dollar amount increased under the preceding
sentence is not a multiple of $50, such dollar
amount shall be rounded to the next lowest
multiple of $50.
``(3) Other definitions.--For purposes of this subsection--
``(A) Eligible employee.--The term `eligible
employee' means any employee of an eligible employer,
except that the terms of the arrangement may exclude
from consideration employees described in any clause of
section 105(h)(3)(B) (applied by substituting `90 days'
for `3 years' in clause (i) thereof).
``(B) Eligible employer.--The term `eligible
employer' means an employer that--
``(i) is not an applicable large employer as
defined in section 4980H(c)(2), and
``(ii) does not offer a group health plan to
any of its employees.
``(C) Permitted benefit.--The term `permitted
benefit' means, with respect to any eligible employee,
the maximum dollar amount of payments and reimbursements
which may be made under the terms of the qualified small
employer health reimbursement arrangement for the year
with respect to such employee.
``(4) Notice.--
``(A) In general.--An employer funding a qualified
small employer health reimbursement arrangement for any
year shall, not later than 90 days before the beginning
of such year (or, in the case of an employee who is not
eligible to participate in the arrangement as of the
beginning of such year, the date on which such employee
is first so eligible), provide a written notice to each
eligible employee which includes the information
described in subparagraph (B).
``(B) Contents of notice.--The notice required under
subparagraph (A) shall include each of the following:
``(i) A statement of the amount which would be
such eligible employee's permitted benefit under
the arrangement for the year.
[[Page 130 STAT. 1341]]
``(ii) A statement that the eligible employee
should provide the information described in clause
(i) to any health insurance exchange to which the
employee applies for advance payment of the
premium assistance tax credit.
``(iii) A statement that if the employee is
not covered under minimum essential coverage for
any month the employee may be subject to tax under
section 5000A for such month and reimbursements
under the arrangement may be includible in gross
income.''.
(2) Limitation on exclusion from gross income.--Section 106
of such Code is amended by adding at the end the following:
``(g) Qualified Small Employer Health Reimbursement Arrangement.--
For purposes of this section and section 105, payments or reimbursements
from a qualified small employer health reimbursement arrangement (as
defined in section 9831(d)) of an individual for medical care (as
defined in section 213(d)) shall not be treated as paid or reimbursed
under employer-provided coverage for medical expenses under an accident
or health plan if for the month in which such medical care is provided
the individual does not have minimum essential coverage (within the
meaning of section 5000A(f)).''.
(3) Coordination with health insurance premium credit.--
Section 36B(c) of such Code is amended by adding at the end the
following new paragraph:
``(4) Special rules for qualified small employer health
reimbursement arrangements.--
``(A) In general.--The term `coverage month' shall
not include any month with respect to an employee (or
any spouse or dependent of such employee) if for such
month the employee is provided a qualified small
employer health reimbursement arrangement which
constitutes affordable coverage.
``(B) Denial of double benefit.--In the case of any
employee who is provided a qualified small employer
health reimbursement arrangement for any coverage month
(determined without regard to subparagraph (A)), the
credit otherwise allowable under subsection (a) to the
taxpayer for such month shall be reduced (but not below
zero) by the amount described in subparagraph (C)(i)(II)
for such month.
``(C) Affordable coverage.--For purposes of
subparagraph (A), a qualified small employer health
reimbursement arrangement shall be treated as
constituting affordable coverage for a month if--
``(i) the excess of--
``(I) the amount that would be paid
by the employee as the premium for such
month for self-only coverage under the
second lowest cost silver plan offered
in the relevant individual health
insurance market, over
``(II) \1/12\ of the employee's
permitted benefit (as defined in section
9831(d)(3)(C)) under such arrangement,
does not exceed--
``(ii) \1/12\ of 9.5 percent of the employee's
household income.
[[Page 130 STAT. 1342]]
``(D) Qualified small employer health reimbursement
arrangement.--For purposes of this paragraph, the term
`qualified small employer health reimbursement
arrangement' has the meaning given such term by section
9831(d)(2).
``(E) Coverage for less than entire year.--In the
case of an employee who is provided a qualified small
employer health reimbursement arrangement for less than
an entire year, subparagraph (C)(i)(II) shall be applied
by substituting `the number of months during the year
for which such arrangement was provided' for `12'.
``(F) Indexing.--In the case of plan years beginning
in any calendar year after 2014, the Secretary shall
adjust the 9.5 percent amount under subparagraph (C)(ii)
in the same manner as the percentages are adjusted under
subsection (b)(3)(A)(ii).''.
(4) Application of excise tax on high cost employer-
sponsored health coverage.--
(A) In general.--Section 4980I(f)(4) of such Code is
amended by adding at the end the following: ``Section
9831(d)(1) shall not apply for purposes of this
section.''.
(B) Determination of cost of coverage.--Section
4980I(d)(2) of such Code is amended by redesignating
subparagraph (D) as subparagraph (E) and by inserting
after subparagraph (C) the following new subparagraph:
``(D) Qualified small employer health reimbursement
arrangements.--In the case of applicable employer-
sponsored coverage consisting of coverage under any
qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2)), the cost
of coverage shall be equal to the amount described in
section 6051(a)(15).''.
(5) Enforcement of notice requirement.--Section 6652 of such
Code is amended by adding at the end the following new
subsection:
``(o) Failure to Provide Notices With Respect to Qualified Small
Employer Health Reimbursement Arrangements.--In the case of each failure
to provide a written notice as required by section 9831(d)(4), unless it
is shown that such failure is due to reasonable cause and not willful
neglect, there shall be paid, on notice and demand of the Secretary and
in the same manner as tax, by the person failing to provide such written
notice, an amount equal to $50 per employee per incident of failure to
provide such notice, but the total amount imposed on such person for all
such failures during any calendar year shall not exceed $2,500.''.
(6) Reporting.--
(A) W-2 reporting.--Section 6051(a) of such Code is
amended by striking ``and'' at the end of paragraph
(13), by striking the period at the end of paragraph
(14) and inserting ``, and'', and by inserting after
paragraph (14) the following new paragraph:
``(15) the total amount of permitted benefit (as defined in
section 9831(d)(3)(C)) for the year under a qualified small
employer health reimbursement arrangement (as defined in section
9831(d)(2)) with respect to the employee.''.
(B) Information required to be provided by exchange
subsidy applicants.--Section 1411(b)(3) of the Patient
Protection and Affordable Care Act is amended
[[Page 130 STAT. 1343]]
by redesignating subparagraph (B) as subparagraph (C)
and by inserting after subparagraph (A) the following
new subparagraph:
``(B) Certain individual health insurance policies
obtained through small employers.--The amount of the
enrollee's permitted benefit (as defined in section
9831(d)(3)(C) of the Internal Revenue Code of 1986)
under a qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2) of such
Code).''.
(7) <<NOTE: 26 USC 36B note.>> Effective dates.--
(A) In general.--Except as otherwise provided in
this paragraph, the amendments made by this subsection
shall apply to years beginning after December 31, 2016.
(B) Transition relief.--The relief under Treasury
Notice 2015-17 shall be treated as applying to any plan
year beginning on or before December 31, 2016.
(C) Coordination with health insurance premium
credit.--The amendments made by paragraph (3) shall
apply to taxable years beginning after December 31,
2016.
(D) Employee notice.--
(i) In general.--The amendments made by
paragraph (5) shall apply to notices with respect
to years beginning after December 31, 2016.
(ii) Transition relief.--For purposes of
section 6652(o) of the Internal Revenue Code of
1986 (as added by this Act), a person shall not be
treated as failing to provide a written notice as
required by section 9831(d)(4) of such Code if
such notice is so provided not later than 90 days
after the date of the enactment of this Act.
(E) W-2 reporting.--The amendments made by paragraph
(6)(A) shall apply to calendar years beginning after
December 31, 2016.
(F) Information provided by exchange subsidy
applicants.--
(i) In general.--The amendments made by
paragraph (6)(B) shall apply to applications for
enrollment made after December 31, 2016.
(ii) Verification.--Verification under section
1411 of the Patient Protection and Affordable Care
Act of information provided under section
1411(b)(3)(B) of such Act shall apply with respect
to months beginning after October 2016.
(iii) Transitional relief.--In the case of an
application for enrollment under section 1411(b)
of the Patient Protection and Affordable Care Act
made before April 1, 2017, the requirement of
section 1411(b)(3)(B) of such Act shall be treated
as met if the information described therein is
provided not later than 30 days after the date on
which the applicant receives the notice described
in section 9831(d)(4) of the Internal Revenue Code
of 1986.
(8) <<NOTE: 26 USC 36B note.>> Substantiation
requirements.--The Secretary of the Treasury (or his designee)
may issue substantiation requirements as necessary to carry out
this subsection.
(b) Amendments to the Employee Retirement Income Security Act of
1974.--
[[Page 130 STAT. 1344]]
(1) In general.--Section 733(a)(1) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1191b(a)(1))
is amended by adding at the end the following: ``Such term shall
not include any qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2) of the Internal
Revenue Code of 1986).''.
(2) Exception from continuation coverage requirements,
etc.--Section 607(1) of such Act (29 U.S.C. 1167(1)) is amended
by adding at the end the following: ``Such term shall not
include any qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2) of the Internal
Revenue Code of 1986).''.
(3) <<NOTE: 29 USC 1167 note.>> Effective date.--The
amendments made by this subsection shall apply to plan years
beginning after December 31, 2016.
(c) Amendments to the Public Health Service Act.--
(1) In general.--Section 2791(a)(1) of the Public Health
Service Act (42 U.S.C. 300gg-91(a)(1)) is amended by adding at
the end the following: ``Except for purposes of part C of title
XI of the Social Security Act (42 U.S.C. 1320d et seq.), such
term shall not include any qualified small employer health
reimbursement arrangement (as defined in section 9831(d)(2) of
the Internal Revenue Code of 1986).''.
(2) Exception from continuation coverage requirements.--
Section 2208(1) of the Public Health Service Act (42 U.S.C.
300bb-8(1)) is amended by adding at the end the following:
``Such term shall not include any qualified small employer
health reimbursement arrangement (as defined in section
9831(d)(2) of the Internal Revenue Code of 1986).''.
(3) <<NOTE: 42 USC 300bb-8 note.>> Effective date.--The
amendments made by this subsection shall apply to plan years
beginning after December 31, 2016.
Approved December 13, 2016.
LEGISLATIVE HISTORY--H.R. 34:
---------------------------------------------------------------------------
SENATE REPORTS: No. 114-146 (Comm. on Commerce, Science, and
Transportation).
CONGRESSIONAL RECORD:
Vol. 161 (2015):
Jan. 7, considered and passed House.
Oct. 6, considered and passed
Senate, amended.
Vol. 162 (2016):
Nov. 30, House concurred in Senate
amendment with an
amendment.
Dec. 1, 5-7, Senate considered and
concurred in House
amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):
Dec. 13, Presidential remarks.
<all>