[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 34 Enrolled Bill (ENR)]
H.R.34
One Hundred Fourteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday,
the fourth day of January, two thousand and sixteen
An Act
To accelerate the discovery, development, and delivery of 21st century
cures, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.
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.
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.
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.
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.
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.
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 A--21ST CENTURY CURES
SEC. 1000. 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 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 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.
(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.--
(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).
(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. 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.
(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.
(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.
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. 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. 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:
``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 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 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) 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.
``(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) 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. 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;
``(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;
``(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
``(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, 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.
``(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 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 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;
(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. 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 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.--
(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.
(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--
``(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
(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;''.
(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. 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) Reporting.--
(1) In general.--The Secretary, in collaboration with the
Director of the National Institutes of Health, shall as
appropriate--
(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) 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 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) 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) 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--
(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. 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 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:
``(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. 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 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).
(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.
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''.
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--
``(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 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:
``SEC. 399S-1. 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.
``(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.
``(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. 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.
(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. 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--
(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.
(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:
(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--
(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. 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.
(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. 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. 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 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. 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
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.--
``(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'--
``(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) Guidance.--
(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).
(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. 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 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.''.
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;
(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:
``(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. 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. 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--
(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. 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;
``(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
``(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. 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 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 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. 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.
``(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));
``(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
``(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) 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. 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. 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 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. 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.
``(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:
``(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 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).
``(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 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
(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) 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.
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.
``(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) 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 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 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. 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. 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
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;
``(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
``(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.
``(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 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 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
``(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) 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. 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--
``(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;
``(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);
``(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--
(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) 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) 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 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
``(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
``(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. 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 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.''.
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) 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, 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) 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) 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;
(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
(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:
``SEC. 714A. 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.
``(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. 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;
``(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. 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.
(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;''.
(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) 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:
``(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 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.
``(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 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:
``SEC. 565A. 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 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
``(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 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
(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. 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 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 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. 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
(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--
(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''.
(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''.
(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 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).
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. 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
``(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
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 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).''.
``(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. 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--
``(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
``(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
``(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
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;
``(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 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) 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 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. 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.
``(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, 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. 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.--
``(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.--
``(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, 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 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) 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. 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.
``(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. 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 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
``(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.--
``(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;
``(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. 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 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 (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 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 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 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) 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 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.''.
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 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;
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.
``(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)--
(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 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--
``(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) 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 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) 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)) 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 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) 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) 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 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) 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) 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) 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.
(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) 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;
``(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 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 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.
``(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) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after January 1, 2021.
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
SEC. 6000. 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.--
``(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) 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) 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.
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
(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 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--
(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:
``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
(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;
``(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);
``(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 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'';
(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.''.
(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--
``(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. 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--
(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 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'').
(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.
(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.
(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. 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
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--
``(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. 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. 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)--
(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)--
(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--
``(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 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.''.
(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)--
(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
(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''.
(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 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'';
(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. 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. 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;
(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
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
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.
``(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) 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 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. 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. 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
``(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
``(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 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)--
(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. 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.
``(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 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. 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.
``(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.--
``(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.''.
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);
(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.''.
SEC. 9022. 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
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);
``(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 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. 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. 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--
``(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 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 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.
(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.
``(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 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. 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;
(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.
SEC. 9033. 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
``(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:
``SEC. 330M 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 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
``(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, 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. 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 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. 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 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 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.
(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. 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.
(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. 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.
(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. 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 & 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. 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 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--
(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. 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
``(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:
``(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) 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) 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 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.--
``(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 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,
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
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 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) 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.
(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
(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).
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. 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 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. 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. 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.''.
(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
``(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. 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.
(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--
(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. 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,
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
``(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 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
``(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 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. 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.
(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. 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.''.
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. 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;
``(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;
``(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.--
``(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, 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--
``(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. 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;
``(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 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 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. 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--
(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. 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) 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) 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).''.
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
``(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,
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. 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--
(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;
``(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
``(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.
``(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.
``(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 C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
AMERICANS
SEC. 15000. 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
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.
``(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--
(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
(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) 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 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) 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).
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) 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)''.
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 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 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 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) 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 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) 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--
(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.
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) 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 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''.
TITLE XVII--OTHER MEDICARE PROVISIONS
SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR MEDICARE
ADVANTAGE PLANS FAILING TO ACHIEVE MINIMUM QUALITY RATINGS.
(a) 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.
``(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. 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
``(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 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;
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) 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)--
(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) 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 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 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) 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 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.--
(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.--
``(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.
``(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.
``(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 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) 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) 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.--
(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) 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) Effective date.--The amendments made by this subsection
shall apply to plan years beginning after December 31, 2016.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.