Text: H.R.34 — 114th Congress (2015-2016)All Information (Except Text)

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Public Law No: 114-255 (12/13/2016)

 
[114th Congress Public Law 255]
[From the U.S. Government Publishing Office]



[[Page 130 STAT. 1033]]

Public Law 114-255
114th Congress

                                 An Act


 
 To accelerate the discovery, development, and delivery of 21st century 
  cures, and for other purposes. <<NOTE: Dec. 13, 2016 -  [H.R. 34]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: 21st Century 
Cures Act. 42 USC 201 note.>> 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``21st Century Cures 
Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

                     DIVISION A--21ST CENTURY CURES

Sec. 1000. Short title.

    TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE

Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.

                           TITLE II--DISCOVERY

        Subtitle A--National Institutes of Health Reauthorization

Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.

                Subtitle B--Advancing Precision Medicine

Sec. 2011. Precision Medicine Initiative.
Sec. 2012. Privacy protection for human research subjects.
Sec. 2013. Protection of identifiable and sensitive information.
Sec. 2014. Data sharing.

            Subtitle C--Supporting Young Emerging Scientists

Sec. 2021. Investing in the next generation of researchers.
Sec. 2022. Improvement of loan repayment program.

  Subtitle D--National Institutes of Health Planning and Administration

Sec. 2031. National Institutes of Health strategic plan.
Sec. 2032. Triennial reports.
Sec. 2033. Increasing accountability at the National Institutes of 
           Health.
Sec. 2034. Reducing administrative burden for researchers.
Sec. 2035. Exemption for the National Institutes of Health from the 
           Paperwork Reduction Act requirements.
Sec. 2036. High-risk, high-reward research.
Sec. 2037. National Center for Advancing Translational Sciences.
Sec. 2038. Collaboration and coordination to enhance research.
Sec. 2039. Enhancing the rigor and reproducibility of scientific 
           research.
Sec. 2040. Improving medical rehabilitation research at the National 
           Institutes of Health.

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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.

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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.

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          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.

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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.

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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.

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Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly 
           enrolled providers or suppliers within a temporary moratorium 
           area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare 
           Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a 
           Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the 
           Medicare Shared Savings Program.

                      TITLE XVIII--OTHER PROVISIONS

Sec. 18001. Exception from group health plan requirements for qualified 
           small employer health reimbursement arrangements.

DIVISION <<NOTE: 21st Century Cures Act.>>  A--21ST CENTURY CURES
SEC. 1000. <<NOTE: 42 USC 201 note.>>  SHORT TITLE.

    This Division may be cited as the ``21st Century Cures Act''.

    TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE

SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION PROJECTS.

    (a) In General.--The Director of the National Institutes of Health 
(referred to in this section as the ``Director of NIH'') shall use any 
funds appropriated pursuant to the authorization of appropriations in 
subsection (b)(3) to carry out the National Institutes of Health 
innovation projects described in subsection (b)(4) (referred to in this 
section as the ``NIH Innovation Projects'').
    (b) National Institutes of Health Innovation Account.--
            (1) Establishment of nih innovation account.--There is 
        established in the Treasury an account, to be known as the ``NIH 
        Innovation Account'' (referred to in this subsection as the 
        ``Account''), for purposes of carrying out the NIH Innovation 
        Projects described in paragraph (4).
            (2) Transfer of direct spending savings.--
                    (A) In general.--The following amounts shall be 
                transferred to the Account from the general fund of the 
                Treasury:
                          (i) For fiscal year 2017, $352,000,000.
                          (ii) For fiscal year 2018, $496,000,000.
                          (iii) For fiscal year 2019, $711,000,000.
                          (iv) For fiscal year 2020, $492,000,000.
                          (v) For fiscal year 2021, $404,000,000.
                          (vi) For fiscal year 2022, $496,000,000.
                          (vii) For fiscal year 2023, $1,085,000,000.
                          (viii) For fiscal year 2024, $407,000,000.
                          (ix) For fiscal year 2025, $127,000,000.
                          (x) For fiscal year 2026, $226,000,000.
                    (B) Amounts deposited.--Any amounts transferred 
                under subparagraph (A) shall remain unavailable in the 
                Account until such amounts are appropriated pursuant to 
                paragraph (3).
            (3) Appropriations.--
                    (A) Authorization of appropriations.--For each of 
                the fiscal years 2017 through 2026, there is authorized

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                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

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                diagnostic tests for cancer, immunotherapy and the 
                development of combination therapies, and research that 
                has the potential to transform the scientific field, 
                that has inherently higher risk, and that seeks to 
                address major challenges related to cancer, not to 
                exceed a total of $1,800,000,000, as follows:
                          (i) For fiscal year 2017, $300,000,000.
                          (ii) For fiscal year 2018, $300,000,000.
                          (iii) For fiscal year 2019, $400,000,000.
                          (iv) For fiscal year 2020, $195,000,000.
                          (v) For fiscal year 2021, $195,000,000.
                          (vi) For fiscal year 2022, $194,000,000.
                          (vii) For fiscal year 2023, $216,000,000.
                    (D) For the National Institutes of Health, in 
                coordination with the Food and Drug Administration, to 
                award grants and contracts for clinical research to 
                further the field of regenerative medicine using adult 
                stem cells, including autologous stem cells, for which 
                grants and contracts shall be contingent upon the 
                recipient making available non-Federal contributions 
                toward the costs of such research in an amount not less 
                than $1 for each $1 of Federal funds provided in the 
                award, not to exceed a total of $30,000,000, as follows:
                          (i) For fiscal year 2017, $2,000,000.
                          (ii) For each of fiscal years 2018 and 2019, 
                      $10,000,000.
                          (iii) For fiscal year 2020, $8,000,000.
                          (iv) For each of fiscal years 2021 through 
                      2026, $0.

    (c) Accountability and Oversight.--
            (1) Work plan.--
                    (A) In general.--Not later than 180 days after the 
                date of enactment of this Act, the Director of NIH shall 
                submit to the Committee on Health, Education, Labor, and 
                Pensions and the Committee on Appropriations of the 
                Senate and the Committee on Energy and Commerce and the 
                Committee on Appropriations of the House of 
                Representatives, a work plan including the proposed 
                allocation of funds authorized to be appropriated 
                pursuant to subsection (b)(3) for each of fiscal years 
                2017 through 2026 for the NIH Innovation Projects and 
                the contents described in subparagraph (B).
                    (B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                          (i) recommendations from the Advisory 
                      Committee described in subparagraph (C);
                          (ii) the amount of money to be obligated or 
                      expended in each fiscal year for each NIH 
                      Innovation Project;
                          (iii) a description and justification of each 
                      such project; and
                          (iv) a description of how each such project 
                      supports the strategic research priorities 
                      identified in the NIH Strategic Plan under 
                      subsection (m) of section 402 of the Public Health 
                      Service Act (42 U.S.C. 282), as added by section 
                      2031.

[[Page 130 STAT. 1042]]

                    (C) Recommendations.--Prior to submitting the work 
                plan under this paragraph, the Director of NIH shall 
                seek recommendations from the Advisory Committee to the 
                Director of NIH appointed under section 222 of the 
                Public Health Service Act (42 U.S.C. 217a) on--
                          (i) the allocations of funds appropriated 
                      pursuant to the authorization of appropriations 
                      under subsection (b)(3) for each of fiscal years 
                      2017 through 2026; and
                          (ii) on the contents of the proposed work 
                      plan.
            (2) Reports.--
                    (A) Annual reports.--Not later than October 1 of 
                each of fiscal years 2018 through 2027, the Director of 
                NIH shall submit to the Committee on Health, Education, 
                Labor, and Pensions and the Committee on Appropriations 
                of the Senate and the Committee on Energy and Commerce 
                and the Committee on Appropriations of the House of 
                Representatives, a report including--
                          (i) the amount of money obligated or expended 
                      in the prior fiscal year for each NIH Innovation 
                      Project;
                          (ii) a description of any such project using 
                      funds provided pursuant to the authorization of 
                      appropriations under subsection (b)(3); and
                          (iii) whether such projects are advancing the 
                      strategic research priorities identified in the 
                      NIH Strategic Plan under subsection (m) of section 
                      402 of the Public Health Service Act (42 U.S.C. 
                      282), as added by section 2031.
                    (B) Additional reports.--At the request of the 
                Committee on Health, Education, Labor, and Pensions or 
                the Committee on Appropriations of the Senate, or the 
                Committee on Energy and Commerce or the Committee on 
                Appropriations of the House of Representatives, the 
                Director of NIH shall provide an update in the form of 
                testimony and any additional reports to the respective 
                congressional committee regarding the allocation of 
                funding under this section or the description of the NIH 
                Innovation Projects.

    (d) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available pursuant 
to the authorization of appropriations under subsection (b)(3) may not 
be used for any purpose other than a NIH Innovation Project.
    (e) Sunset.--This section shall expire on September 30, 2026.
SEC. 1002. FDA INNOVATION PROJECTS.

    (a) In General.--The Commissioner of Food and Drugs (referred to in 
this section as the ``Commissioner'') shall use any funds appropriated 
pursuant to the authorization of appropriations under subsection (b)(3) 
to carry out the activities described in subsection (b)(4).
    (b) FDA Innovation Account.--
            (1) Establishment of fda innovation account.--There is 
        established in the Treasury an account, to be known as the ``FDA 
        Innovation Account'' (referred to in this subsection as the 
        ``Account''), for purposes of carrying out the activities 
        described in paragraph (4).
            (2) Transfer of direct spending savings.--

[[Page 130 STAT. 1043]]

                    (A) In general.--For each of fiscal years 2017 
                through 2025, the following amounts shall be transferred 
                to the Account from the general fund of the Treasury:
                          (i) For fiscal year 2017, $20,000,000.
                          (ii) For fiscal year 2018, $60,000,000.
                          (iii) For fiscal year 2019, $70,000,000.
                          (iv) For fiscal year 2020, $75,000,000.
                          (v) For fiscal year 2021, $70,000,000.
                          (vi) For fiscal year 2022, $50,000,000.
                          (vii) For fiscal year 2023, $50,000,000.
                          (viii) For fiscal year 2024, $50,000,000.
                          (ix) For fiscal year 2025, $55,000,000.
                    (B) Amounts deposited.--Any amounts transferred 
                under subparagraph (A) shall remain unavailable in the 
                Account until such amounts are appropriated pursuant to 
                paragraph (3).
            (3) Appropriations.--
                    (A) Authorization of appropriations.--For each of 
                the fiscal years 2017 through 2025, there is authorized 
                to be appropriated from the Account to the Commissioner, 
                for the purpose of carrying out the activities described 
                in paragraph (5), an amount not to exceed the total 
                amount transferred to the Account under paragraph 
                (2)(A), to remain available until expended.
                    (B) Offsetting future appropriations.--For any of 
                fiscal years 2017 through 2025, for any discretionary 
                appropriation under the heading ``FDA Innovation 
                Account'' provided to the Commissioner pursuant to the 
                authorization of appropriations under subparagraph (A) 
                for the purpose of carrying out the projects activities 
                described in paragraph (4), the total amount of such 
                appropriations in the applicable fiscal year (not to 
                exceed the total amount remaining in the Account) shall 
                be subtracted from the estimate of discretionary budget 
                authority and the resulting outlays for any estimate 
                under the Congressional Budget and Impoundment Control 
                Act of 1974 or the Balanced Budget and Emergency Deficit 
                Control Act of 1985, and the amount transferred to the 
                Account shall be reduced by the same amount.
            (4) FDA activities.--The activities authorized to be funded 
        under this section are the activities under subtitles A through 
        F (including the amendments made by such subtitles) of title III 
        of this Act and section 1014 of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3073 of this Act.

    (c) Accountability and Oversight.--
            (1) Work plan.--
                    (A) In general.--Not later than 180 days after the 
                date of enactment of this Act, the Commissioner shall 
                submit to the Committee on Health, Education, Labor, and 
                Pensions and the Committee on Appropriations of the 
                Senate and the Committee on Energy and Commerce and the 
                Committee on Appropriations of the House of 
                Representatives, a work plan including the proposed 
                allocation of funds appropriated pursuant to the 
                authorization of appropriations under subsection (b)(3) 
                for each of fiscal years 2017 through 2025 and the 
                contents described in subparagraph (B).

[[Page 130 STAT. 1044]]

                    (B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                          (i) recommendations from the Advisory 
                      Committee described in subparagraph (C);
                          (ii) the amount of money to be obligated or 
                      expended in each fiscal year for each activity 
                      described in subsection (b)(4); and
                          (iii) a description and justification of each 
                      such project activity.
                    (C) Recommendations.--Prior to submitting the work 
                plan under this paragraph, the Commissioner shall seek 
                recommendations from the Science Board to the Food and 
                Drug Administration, on the proposed allocation of funds 
                appropriated pursuant to the authorization of 
                appropriations under subsection (b)(3) for each of 
                fiscal years 2017 through 2025 and on the contents of 
                the proposed work plan.
            (2) Reports.--
                    (A) Annual reports.--Not later than October 1 of 
                each of fiscal years 2018 through 2026, the Commissioner 
                shall submit to the Committee on Health, Education, 
                Labor, and Pensions and the Committee on Appropriations 
                of the Senate and the Committee on Energy and Commerce 
                and the Committee on Appropriations of the House of 
                Representatives, a report including--
                          (i) the amount of money obligated or expended 
                      in the prior fiscal year for each activity 
                      described in subsection (b)(4);
                          (ii) a description of all such activities 
                      using funds provided pursuant to the authorization 
                      of appropriations under subsection (b)(3); and
                          (iii) how the activities are advancing public 
                      health.
                    (B) Additional reports.--At the request of the 
                Committee on Health, Education, Labor, and Pensions or 
                the Committee on Appropriations of the Senate, or the 
                Committee on Energy and Commerce or the Committee on 
                Appropriations of the House of Representatives, the 
                Commissioner shall provide an update in the form of 
                testimony and any additional reports to the respective 
                congressional committee regarding the allocation of 
                funding under this section or the description of the 
                activities undertaken with such funding.

    (d) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available pursuant 
to the authorization of appropriations in subsection (b)(3) shall not be 
used for any purpose other than an activity described in subsection 
(b)(4).
    (e) Sunset.--This section shall expire on September 30, 2025.
SEC. 1003. <<NOTE: 42 USC 290ee-3 note.>>  ACCOUNT FOR THE STATE 
                          RESPONSE TO THE OPIOID ABUSE CRISIS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall use any funds 
appropriated pursuant to the authorization of appropriations under 
subsection (b) to carry out the grant program described in subsection 
(c) for purposes of addressing the opioid abuse crisis within the 
States.

[[Page 130 STAT. 1045]]

    (b) Account for the State Response to the Opioid Abuse Crisis.--
            (1) Establishment.--There is established in the Treasury an 
        account, to be known as the ``Account For the State Response to 
        the Opioid Abuse Crisis'' (referred to in this subsection as the 
        ``Account''), to carry out the opioid grant program described in 
        subsection (c).
            (2) Transfer of direct spending savings.--
                    (A) In general.--The following amounts shall be 
                transferred to the Account from the general fund of the 
                Treasury:
                          (i) For fiscal year 2017, $500,000,000.
                          (ii) For fiscal year 2018, $500,000,000.
                    (B) Amounts deposited.--Any amounts transferred 
                under subparagraph (A) shall remain unavailable in the 
                Account until such amounts are appropriated pursuant to 
                paragraph (3).
            (3) Appropriations.--
                    (A) Authorization of appropriations.--In each of the 
                fiscal years 2017 and 2018, there is authorized to be 
                appropriated from the Account to the Secretary, for the 
                grant program described in subsection (c), an amount not 
                to exceed the total amount transferred to the Account 
                under paragraph (2)(A), to remain available until 
                expended.
                    (B) Offsetting future appropriations.--In each of 
                fiscal years 2017 and 2018, for any discretionary 
                appropriation under the heading ``Account For the State 
                Response to the Opioid Abuse Crisis'' for the grant 
                program described in subsection (c), the total amount of 
                such appropriations in the applicable fiscal year (not 
                to exceed the total amount remaining in the Account) 
                shall be subtracted from the estimate of discretionary 
                budget authority and the resulting outlays for any 
                estimate under the Congressional Budget and Impoundment 
                Control Act of 1974 or the Balanced Budget and Emergency 
                Deficit Control Act of 1985, and the amount transferred 
                to the Account shall be reduced by the same amount.

    (c) Opioid Grant Program.--
            (1) State response to the opioid abuse crisis.--Subject to 
        the availability of appropriations, the Secretary shall award 
        grants to States for the purpose of addressing the opioid abuse 
        crisis within such States, in accordance with subparagraph (B). 
        In awarding such grants, the Secretary shall give preference to 
        States with an incidence or prevalence of opioid use disorders 
        that is substantially higher relative to other States.
            (2) Opioid grants.--Grants awarded to a State under this 
        subsection shall be used for carrying out activities that 
        supplement activities pertaining to opioids undertaken by the 
        State agency responsible for administering the substance abuse 
        prevention and treatment block grant under subpart II of part B 
        of title XIX of the Public Health Service Act (42 U.S.C. 300x-21 
        et seq.), which may include public health-related activities 
        such as the following:
                    (A) Improving State prescription drug monitoring 
                programs.

[[Page 130 STAT. 1046]]

                    (B) Implementing prevention activities, and 
                evaluating such activities to identify effective 
                strategies to prevent opioid abuse.
                    (C) Training for health care practitioners, such as 
                best practices for prescribing opioids, pain management, 
                recognizing potential cases of substance abuse, referral 
                of patients to treatment programs, and overdose 
                prevention.
                    (D) Supporting access to health care services, 
                including those services provided by Federally certified 
                opioid treatment programs or other appropriate health 
                care providers to treat substance use disorders.
                    (E) Other public health-related activities, as the 
                State determines appropriate, related to addressing the 
                opioid abuse crisis within the State.

    (d) Accountability and Oversight.--A State receiving a grant under 
subsection (c) shall include in a report related to substance abuse 
submitted to the Secretary pursuant to section 1942 of the Public Health 
Service Act (42 U.S.C. 300x-52), a description of--
            (1) the purposes for which the grant funds received by the 
        State under such subsection for the preceding fiscal year were 
        expended and a description of the activities of the State under 
        the program; and
            (2) the ultimate recipients of amounts provided to the State 
        in the grant.

    (e) Limitations.--Any funds made available pursuant to the 
authorization of appropriations under subsection (b)--
            (1) notwithstanding any transfer authority in any 
        appropriations Act, shall not be used for any purpose other than 
        the grant program in subsection (c); and
            (2) shall be subject to the same requirements as substance 
        abuse prevention and treatment programs under titles V and XIX 
        of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w 
        et seq.).

    (f) Sunset.--This section shall expire on September 30, 2026.
SEC. 1004. BUDGETARY TREATMENT.

    (a) Statutory Paygo Scorecards.--The budgetary effects of division A 
of this Act shall not be entered on either PAYGO scorecard maintained 
pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
    (b) Senate Paygo Scorecards.--The budgetary effects of division A of 
this Act shall not be entered on any PAYGO scorecard maintained for 
purposes of section 201 of S. Con. Res. 21 (110th Congress).
    (c) Reservation of Savings.--None of the funds in the NIH Innovation 
Account, the FDA Innovation Account, or the Account For the State 
Response to the Opioid Abuse Crisis established by this title shall be 
made available except to the extent provided in advance in 
appropriations Acts, and legislation or an Act that rescinds or reduces 
amounts in such accounts shall not be estimated as a reduction in direct 
spending under the Congressional Budget and Impoundment Control Act of 
1974 or the Balanced Budget and Emergency Deficit Control Act of 1985.

[[Page 130 STAT. 1047]]

                           TITLE II--DISCOVERY

        Subtitle A--National Institutes of Health Reauthorization

SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.

    Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 
282a(a)(1)) is amended--
            (1) in subparagraph (B), by striking ``and'' at the end;
            (2) in subparagraph (C), by striking the period at the end 
        and inserting a semicolon; and
            (3) by adding at the end the following new subparagraphs:
                    ``(D) $34,851,000,000 for fiscal year 2018;
                    ``(E) $35,585,871,000 for fiscal year 2019; and
                    ``(F) $36,472,442,775 for fiscal year 2020.''.
SEC. 2002. <<NOTE: 42 USC 283q.>>  EUREKA PRIZE COMPETITIONS.

    (a) In General.--Pursuant to the authorities and processes 
established under section 24 of the Stevenson-Wydler Technology 
Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National 
Institutes of Health shall support prize competitions for one or both of 
the following goals:
            (1) Identifying and funding areas of biomedical science that 
        could realize significant advancements through a prize 
        competition.
            (2) Improving health outcomes, particularly with respect to 
        human diseases and conditions--
                    (A) for which public and private investment in 
                research is disproportionately small relative to Federal 
                Government expenditures on prevention and treatment 
                activities with respect to such diseases and conditions, 
                such that Federal expenditures on health programs would 
                be reduced;
                    (B) that are serious and represent a significant 
                disease burden in the United States; or
                    (C) for which there is potential for significant 
                return on investment to the United States.

    (b) Tracking; Reporting.--The Director of the National Institutes of 
Health shall--
            (1) collect information on--
                    (A) the effect of innovations funded through the 
                prize competitions under this section in advancing 
                biomedical science or improving health outcomes pursuant 
                to subsection (a); and
                    (B) the effect of the innovations on Federal 
                expenditures; and
            (2) include the information collected under paragraph (1) in 
        the triennial report under section 403 of the Public Health 
        Service Act (42 U.S.C. 283) (as amended by section 2032).

                Subtitle B--Advancing Precision Medicine

SEC. 2011. <<NOTE: 42 USC 289g-5.>>  PRECISION MEDICINE 
                          INITIATIVE.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by adding at the end the following:

[[Page 130 STAT. 1048]]

``SEC. 498E. PRECISION MEDICINE INITIATIVE.

    ``(a) In General.--The Secretary is encouraged to establish and 
carry out an initiative, to be known as the `Precision Medicine 
Initiative' (in this section referred to as the `Initiative'), to 
augment efforts to address disease prevention, diagnosis, and treatment.
    ``(b) Components.--The Initiative described under subsection (a) may 
include--
            ``(1) developing a network of scientists to assist in 
        carrying out the purposes of the Initiative;
            ``(2) developing new approaches for addressing scientific, 
        medical, public health, and regulatory science issues;
            ``(3) applying genomic technologies, such as whole genomic 
        sequencing, to provide data on the molecular basis of disease;
            ``(4) collecting information voluntarily provided by a 
        diverse cohort of individuals that can be used to better 
        understand health and disease; and
            ``(5) other activities to advance the goals of the 
        Initiative, as the Secretary determines appropriate.

    ``(c) Authority of the Secretary.--In carrying out this section, the 
Secretary may--
            ``(1) coordinate with the Secretary of Energy, private 
        industry, and others, as the Secretary determines appropriate, 
        to identify and address the advanced supercomputing and other 
        advanced technology needs for the Initiative;
            ``(2) develop and utilize public-private partnerships; and
            ``(3) leverage existing data sources.

    ``(d) Requirements.--In the implementation of the Initiative under 
subsection (a), the Secretary shall--
            ``(1) ensure the collaboration of the National Institutes of 
        Health, the Food and Drug Administration, the Office of the 
        National Coordinator for Health Information Technology, and the 
        Office for Civil Rights of the Department of Health and Human 
        Services;
            ``(2) comply with existing laws and regulations for the 
        protection of human subjects involved in research, including the 
        protection of participant privacy;
            ``(3) implement policies and mechanisms for appropriate 
        secure data sharing across systems that include protections for 
        privacy and security of data;
            ``(4) consider the diversity of the cohort to ensure 
        inclusion of a broad range of participants, including 
        consideration of biological, social, and other determinants of 
        health that contribute to health disparities;
            ``(5) ensure that only authorized individuals may access 
        controlled or sensitive, identifiable biological material and 
        associated information collected or stored in connection with 
        the Initiative; and
            ``(6) on the appropriate Internet website of the Department 
        of Health and Human Services, identify any entities with access 
        to such information and provide information with respect to the 
        purpose of such access, a summary of the research project for 
        which such access is granted, as applicable, and a description 
        of the biological material and associated information to which 
        the entity has access.

    ``(e) Report.--Not later than 1 year after the date of enactment of 
the 21st Century Cures Act, the Secretary shall submit a report

[[Page 130 STAT. 1049]]

on the relevant data access policies and procedures to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives. Such report 
shall include steps the Secretary has taken to consult with experts or 
other heads of departments or agencies of the Federal Government in the 
development of such policies.''.
SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.

    (a) In General.--Subsection (d) of section 301 of the Public Health 
Service Act (42 U.S.C. 241) is amended to read as follows:
    ``(d)(1)(A) If a person is engaged in biomedical, behavioral, 
clinical, or other research, in which identifiable, sensitive 
information is collected (including research on mental health and 
research on the use and effect of alcohol and other psychoactive drugs), 
the Secretary, in coordination with other agencies, as applicable--
            ``(i) shall issue to such person a certificate of 
        confidentiality to protect the privacy of individuals who are 
        the subjects of such research if the research is funded wholly 
        or in part by the Federal Government; and
            ``(ii) may, upon application by a person engaged in 
        research, issue to such person a certificate of confidentiality 
        to protect the privacy of such individuals if the research is 
        not so funded.

    ``(B) Except as provided in subparagraph (C), any person to whom a 
certificate is issued under subparagraph (A) to protect the privacy of 
individuals described in such subparagraph shall not disclose or provide 
to any other person not connected with the research the name of such an 
individual or any information, document, or biospecimen that contains 
identifiable, sensitive information about such an individual and that 
was created or compiled for purposes of the research.
    ``(C) The disclosure prohibition in subparagraph (B) shall not apply 
to disclosure or use that is--
            ``(i) required by Federal, State, or local laws, excluding 
        instances described in subparagraph (D);
            ``(ii) necessary for the medical treatment of the individual 
        to whom the information, document, or biospecimen pertains and 
        made with the consent of such individual;
            ``(iii) made with the consent of the individual to whom the 
        information, document, or biospecimen pertains; or
            ``(iv) made for the purposes of other scientific research 
        that is in compliance with applicable Federal regulations 
        governing the protection of human subjects in research.

    ``(D) Any person to whom a certificate is issued under subparagraph 
(A) to protect the privacy of an individual described in such 
subparagraph shall not, in any Federal, State, or local civil, criminal, 
administrative, legislative, or other proceeding, disclose or provide 
the name of such individual or any such information, document, or 
biospecimen that contains identifiable, sensitive information about the 
individual and that was created or compiled for purposes of the 
research, except in the circumstance described in subparagraph (C)(iii).
    ``(E) Identifiable, sensitive information protected under 
subparagraph (A), and all copies thereof, shall be immune from the legal 
process, and shall not, without the consent of the individual to whom 
the information pertains, be admissible as evidence or used

[[Page 130 STAT. 1050]]

for any purpose in any action, suit, or other judicial, legislative, or 
administrative proceeding.
    ``(F) Identifiable, sensitive information collected by a person to 
whom a certificate has been issued under subparagraph (A), and all 
copies thereof, shall be subject to the protections afforded by this 
section for perpetuity.
    ``(G) The Secretary shall take steps to minimize the burden to 
researchers, streamline the process, and reduce the time it takes to 
comply with the requirements of this subsection.
    ``(2) The Secretary shall coordinate with the heads of other 
applicable Federal agencies to ensure that such departments have 
policies in place with respect to the issuance of a certificate of 
confidentiality pursuant to paragraph (1) and other requirements of this 
subsection.
    ``(3) Nothing in this subsection shall be construed to limit the 
access of an individual who is a subject of research to information 
about himself or herself collected during such individual's 
participation in the research.
    ``(4) For purposes of this subsection, the term `identifiable, 
sensitive information' means information that is about an individual and 
that is gathered or used during the course of research described in 
paragraph (1)(A) and--
            ``(A) through which an individual is identified; or
            ``(B) for which there is at least a very small risk, as 
        determined by current scientific practices or statistical 
        methods, that some combination of the information, a request for 
        the information, and other available data sources could be used 
        to deduce the identity of an individual.''.

    (b) <<NOTE: 42 USC 241 note.>>  Applicability.--Beginning 180 days 
after the date of enactment of this Act, all persons engaged in research 
and authorized by the Secretary of Health and Human Services to protect 
information under section 301(d) of the Public Health Service Act (42 
U.S.C. 241(d)) prior to the date of enactment of this Act shall be 
subject to the requirements of such section (as amended by this Act).
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.

    Section 301 of the Public Health Service Act (42 U.S.C. 241) is 
amended by adding at the end the following:
    ``(f)(1) The Secretary may exempt from disclosure under section 
552(b)(3) of title 5, United States Code, biomedical information that is 
about an individual and that is gathered or used during the course of 
biomedical research if--
            ``(A) an individual is identified; or
            ``(B) there is at least a very small risk, as determined by 
        current scientific practices or statistical methods, that some 
        combination of the information, the request, and other available 
        data sources could be used to deduce the identity of an 
        individual.

    ``(2)(A) Each determination of the Secretary under paragraph (1) to 
exempt information from disclosure shall be made in writing and 
accompanied by a statement of the basis for the determination.
    ``(B) Each such determination and statement of basis shall be 
available to the public, upon request, through the Office of the Chief 
FOIA Officer of the Department of Health and Human Services.

[[Page 130 STAT. 1051]]

    ``(3) Nothing in this subsection shall be construed to limit a 
research participant's access to information about such participant 
collected during the participant's participation in the research.''.
SEC. 2014. DATA SHARING.

    (a) In General.--Section 402(b) of the Public Health Service Act (42 
U.S.C. 282(b)) is amended--
            (1) in paragraph (23), by striking ``and'' at the end;
            (2) in paragraph (24), by striking the period and inserting 
        ``; and''; and
            (3) by inserting after paragraph (24) the following:
            ``(25) may require recipients of National Institutes of 
        Health awards to share scientific data, to the extent feasible, 
        generated from such National Institutes of Health awards in a 
        manner that is consistent with all applicable Federal laws and 
        regulations, including such laws and regulations for the 
        protection of--
                    ``(A) human research participants, including with 
                respect to privacy, security, informed consent, and 
                protected health information; and
                    ``(B) proprietary interests, confidential commercial 
                information, and the intellectual property rights of the 
                funding recipient.''.

    (b) <<NOTE: 42 USC 282 note.>>  Confidentiality.--Nothing in the 
amendments made by subsection (a) authorizes the Secretary of Health and 
Human Services to disclose any information that is a trade secret, or 
other privileged or confidential information, described in section 
552(b)(4) of title 5, United States Code, or section 1905 of title 18, 
United States Code, or be construed to require recipients of grants or 
cooperative agreements through the National Institutes of Health to 
share such information.

            Subtitle C--Supporting Young Emerging Scientists

SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.

    (a) In General.--Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.) is amended by adding at the end the following:
``SEC. 404M. <<NOTE: 42 USC 283o.>>  NEXT GENERATION OF 
                          RESEARCHERS.

    ``(a) Next Generation of Researchers Initiative.--There shall be 
established within the Office of the Director of the National Institutes 
of Health, the Next Generation of Researchers Initiative (referred to in 
this section as the `Initiative'), through which the Director shall 
coordinate all policies and programs within the National Institutes of 
Health that are focused on promoting and providing opportunities for new 
researchers and earlier research independence.
    ``(b) Activities.--The Director of the National Institutes of 
Health, through the Initiative shall--
            ``(1) promote policies and programs within the National 
        Institutes of Health that are focused on improving opportunities 
        for new researchers and promoting earlier research independence, 
        including existing policies and programs, as appropriate;

[[Page 130 STAT. 1052]]

            ``(2) develop, modify, or prioritize policies, as needed, 
        within the National Institutes of Health to promote 
        opportunities for new researchers and earlier research 
        independence, such as policies to increase opportunities for new 
        researchers to receive funding, enhance training and mentorship 
        programs for researchers, and enhance workforce diversity;
            ``(3) coordinate, as appropriate, with relevant agencies, 
        professional and academic associations, academic institutions, 
        and others, to improve and update existing information on the 
        biomedical research workforce in order to inform programs 
        related to the training, recruitment, and retention of 
        biomedical researchers; and
            ``(4) carry out other activities, including evaluation and 
        oversight of existing programs, as appropriate, to promote the 
        development of the next generation of researchers and earlier 
        research independence.''.

    (b) Consideration of Recommendations.--In carrying out activities 
under section 404M(b) of the Public Health Service Act, the Director of 
the National Institutes of Health shall take into consideration the 
recommendations made by the National Academies of Sciences, Engineering, 
and Medicine as part of the comprehensive study on policies affecting 
the next generation of researchers under the Department of Health and 
Human Services Appropriations Act, 2016 (Public Law 114-113), and submit 
a report to the Committee on Health, Education, Labor, and Pensions and 
the Committee on Appropriations of the Senate, and the Committee on 
Energy and Commerce and the Committee on Appropriations of the House of 
Representatives, with respect to any actions taken by the National 
Institutes of Health based on the recommendations not later than 2 years 
after the completion of the study required pursuant to the Department of 
Health and Human Services Appropriations Act, 2016.
SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.

    (a) Intramural Loan Repayment Program.--Section 487A of the Public 
Health Service Act (42 U.S.C. 288-1) is amended--
            (1) by amending the section heading to read as follows: 
        ``intramural loan repayment program'';
            (2) in subsection (a)--
                    (A) by striking ``The Secretary shall carry out a 
                program'' and inserting ``The Director of the National 
                Institutes of Health shall, as appropriate and based on 
                workforce and scientific priorities, carry out a program 
                through the subcategories listed in subsection (b)(1) 
                (or modified subcategories as provided for in subsection 
                (b)(2))'';
                    (B) by striking ``conduct'' and inserting ``conduct 
                research'';
                    (C) by striking ``research with respect to acquired 
                immune deficiency syndrome''; and
                    (D) by striking ``$35,000'' and inserting 
                ``$50,000'';
            (3) by redesignating subsection (b) as subsection (d);
            (4) by inserting after subsection (a), the following:

    ``(b) Subcategories of Research.--
            ``(1) In general.--In carrying out the program under 
        subsection (a), the Director of the National Institutes of 
        Health--
                    ``(A) shall continue to focus on--
                          ``(i) general research;

[[Page 130 STAT. 1053]]

                          ``(ii) research on acquired immune deficiency 
                      syndrome; and
                          ``(iii) clinical research conducted by 
                      appropriately qualified health professional who 
                      are from disadvantaged backgrounds; and
                    ``(B) may focus on an area of emerging scientific or 
                workforce need.
            ``(2) Elimination or establishment of subcategories.--The 
        Director of the National Institutes of Health may eliminate one 
        or more subcategories provided for in paragraph (1) due to 
        changes in workforce or scientific needs related to biomedical 
        research. The Director may establish other subcategory areas 
        based on workforce and scientific priorities if the total number 
        of subcategories does not exceed the number of subcategories 
        listed in paragraph (1).

    ``(c) Limitation.--The Director of the National Institutes of Health 
may not enter into a contract with a health professional pursuant to 
subsection (a) unless such professional has a substantial amount of 
education loans relative to income (as determined pursuant to guidelines 
issued by the Director).''; and
            (5) by adding at the end the following:

    ``(e) Availability of Appropriations.--Amounts available for 
carrying out this section shall remain available until the expiration of 
the second fiscal year beginning after the fiscal year for which such 
amounts are made available.''.
    (b) Extramural Loan Repayment Program.--Section 487B of the Public 
Health Service Act (42 U.S.C. 288-2) is amended--
            (1) by amending the section heading to read as follows: 
        ``extramural loan repayment program'';
            (2) in subsection (a)--
                    (A) by striking ``The Secretary, in consultation 
                with the Director of the Eunice Kennedy Shriver National 
                Institute of Child Health and Human Development, shall 
                establish a program'' and inserting ``In General.--The 
                Director of the National Institutes of Health shall, as 
                appropriate and based on workforce and scientific 
                priorities, carry out a program through the 
                subcategories listed in subsection (b)(1) (or modified 
                subcategories as provided for in subsection (b)(2)),'';
                    (B) by striking ``(including graduate students)'';
                    (C) by striking ``with respect to contraception, or 
                with respect to infertility,''; and
                    (D) by striking ``service, not more than $35,000'' 
                and inserting ``research, not more than $50,000'';
            (3) by redesignating subsections (b) and (c) as subsections 
        (d) and (e), respectively;
            (4) by inserting after subsection (a), the following:

    ``(b) Subcategories of Research.--
            ``(1) In general.--In carrying out the program under 
        subsection (a), the Director of the National Institutes of 
        Health--
                    ``(A) shall continue to focus on--
                          ``(i) contraception or infertility research;
                          ``(ii) pediatric research, including pediatric 
                      pharmacological research;
                          ``(iii) minority health disparities research;
                          ``(iv) clinical research; and

[[Page 130 STAT. 1054]]

                          ``(v) clinical research conducted by 
                      appropriately qualified health professional who 
                      are from disadvantaged backgrounds; and
                    ``(B) may focus on an area of emerging scientific or 
                workforce need.
            ``(2) Elimination or establishment of subcategories.--The 
        Director of the National Institutes of Health may eliminate one 
        or more subcategories provided for in paragraph (1) due to 
        changes in workforce or scientific needs related to biomedical 
        research. The Director may establish other subcategory areas 
        based on workforce and scientific priorities if the total number 
        of subcategories does not exceed the number of subcategories 
        listed in paragraph (1).

    ``(c) Limitation.--The Director of the National Institutes of Health 
may not enter into a contract with a health professional pursuant to 
subsection (a) unless such professional has a substantial amount of 
education loans relative to income (as determined pursuant to guidelines 
issued by the Director).'';
            (5) in subsection (d) (as so redesignated), by striking 
        ``The provisions'' and inserting ``Applicability of Certain 
        Provisions Regarding Obligated Service.--The provisions''; and
            (6) in subsection (e) (as so redesignated), by striking 
        ``Amounts'' and inserting ``Availability of Appropriations.--
        Amounts''.

    (c) Technical and Conforming Amendments.--Title IV of the Public 
Health Service Act is amended--
            (1) by striking section 464z-5 (42 U.S.C. 285t-2);
            (2) by striking section 487C (42 U.S.C. 288-3);
            (3) by striking section 487E (42 U.S.C. 288-5);
            (4) by striking section 487F (42 U.S.C. 288-5a), as added by 
        section 205 of Public Law 106-505, relating to loan repayment 
        for clinical researchers; and
            (5) by striking section 487F (42 U.S.C. 288-6), as added by 
        section 1002(b) of Public Law 106-310 relating to pediatric 
        research loan repayment.

    (d) GAO Report.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to Congress a report on the efforts of the National 
Institutes of Health to attract, retain, and develop emerging 
scientists, including underrepresented individuals in the sciences, such 
as women, racial and ethnic minorities, and other groups. Such report 
shall include an analysis of the impact of the additional authority 
provided to the Secretary of Health and Human Services under this Act to 
address workforce shortages and gaps in priority research areas, 
including which centers and research areas offered loan repayment 
program participants the increased award amount.

  Subtitle D--National Institutes of Health Planning and Administration

SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.

    (a) Strategic Plan.--Section 402 of the Public Health Service Act 
(42 U.S.C. 282) is amended--
            (1) in subsection (b)(5), by inserting before the semicolon 
        the following: ``, and through the development, implementation,

[[Page 130 STAT. 1055]]

        and updating of the strategic plan developed under subsection 
        (m)''; and
            (2) by adding at the end the following:

    ``(m) National Institutes of Health Strategic Plan.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the 21st Century Cures Act, and at least every 6 
        years thereafter, the Director of the National Institutes of 
        Health shall develop and submit to the appropriate committees of 
        Congress and post on the Internet website of the National 
        Institutes of Health, a coordinated strategy (to be known as the 
        `National Institutes of Health Strategic Plan') to provide 
        direction to the biomedical research investments made by the 
        National Institutes of Health, to facilitate collaboration 
        across the institutes and centers, to leverage scientific 
        opportunity, and to advance biomedicine.
            ``(2) Requirements.--The strategy under paragraph (1) 
        shall--
                    ``(A) identify strategic research priorities and 
                objectives across biomedical research, including--
                          ``(i) an assessment of the state of biomedical 
                      and behavioral research, including areas of 
                      opportunity with respect to basic, clinical, and 
                      translational research;
                          ``(ii) priorities and objectives to advance 
                      the treatment, cure, and prevention of health 
                      conditions;
                          ``(iii) emerging scientific opportunities, 
                      rising public health challenges, and scientific 
                      knowledge gaps; and
                          ``(iv) the identification of near-, mid-, and 
                      long-term scientific needs;
                    ``(B) consider, in carrying out subparagraph (A)--
                          ``(i) disease burden in the United States and 
                      the potential for return on investment to the 
                      United States;
                          ``(ii) rare diseases and conditions;
                          ``(iii) biological, social, and other 
                      determinants of health that contribute to health 
                      disparities; and
                          ``(iv) other factors the Director of National 
                      Institutes of Health determines appropriate;
                    ``(C) include multi-institute priorities, including 
                coordination of research among institutes and centers;
                    ``(D) include strategic priorities for funding 
                research through the Common Fund, in accordance with 
                section 402A(c)(1)(C);
                    ``(E) address the National Institutes of Health's 
                proposed and ongoing activities related to training and 
                the biomedical workforce; and
                    ``(F) describe opportunities for collaboration with 
                other agencies and departments, as appropriate.
            ``(3) Use of plans.--Strategic plans developed and updated 
        by the national research institutes and national centers of the 
        National Institutes of Health shall be prepared regularly and in 
        such a manner that such plans will be informed by the strategic 
        plans developed and updated under this subsection. Such plans 
        developed by and updated by the national research institutes and 
        national centers shall have a common template.

[[Page 130 STAT. 1056]]

            ``(4) Consultation.--The Director of National Institutes of 
        Health shall develop the strategic plan under paragraph (1) in 
        consultation with the directors of the national research 
        institutes and national centers, researchers, patient advocacy 
        groups, and industry leaders.''.

    (b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public 
Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking 
``Not later than June 1, 2007, and every 2 years thereafter,'' and 
inserting ``As part of the National Institutes of Health Strategic Plan 
required under section 402(m),''.
    (c) Strategic Plan.--Section 492B(a) of the Public Health Service 
Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the following:
            ``(3) Strategic planning.--
                    ``(A) In general.--The directors of the national 
                institutes and national centers shall consult at least 
                once annually with the Director of the National 
                Institute on Minority Health and Health Disparities and 
                the Director of the Office of Research on Women's Health 
                regarding objectives of the national institutes and 
                national centers to ensure that future activities by 
                such institutes and centers take into account women and 
                minorities and are focused on reducing health 
                disparities.
                    ``(B) Strategic plans.--Any strategic plan issued by 
                a national institute or national center shall include 
                details on the objectives described in subparagraph 
                (A).''.
SEC. 2032. TRIENNIAL REPORTS.

    Section 403 of the Public Health Service Act (42 U.S.C. 283) is 
amended--
            (1) in the section heading, by striking ``biennial'' and 
        inserting ``triennial'' ; and
            (2) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``biennial'' and inserting ``triennial'';
                    (B) by amending paragraph (3) to read as follows:
            ``(3) A description of intra-National Institutes of Health 
        activities, including--
                    ``(A) identification of the percentage of funds made 
                available by each national research institute and 
                national center with respect to each applicable fiscal 
                year for conducting or supporting research that involves 
                collaboration between the institute or center and 1 or 
                more other national research institutes or national 
                centers; and
                    ``(B) recommendations for promoting coordination of 
                information among the centers of excellence.'';
                    (C) in paragraph (4)--
                          (i) in subparagraph (B), by striking 
                      ``demographic variables and other variables'' and 
                      inserting ``demographic variables, including 
                      biological and social variables and relevant age 
                      categories (such as pediatric subgroups), and 
                      determinants of health,''; and
                          (ii) in subparagraph (C)(v)--
                                    (I) by striking ``demographic 
                                variables and such'' and inserting 
                                ``demographic variables, including 
                                relevant age categories (such as 
                                pediatric subgroups), information 
                                submitted by each

[[Page 130 STAT. 1057]]

                                national research institute and national 
                                center to the Director of National 
                                Institutes of Health under section 
                                492B(f), and such''; and
                                    (II) by striking ``(regarding 
                                inclusion of women and minorities in 
                                clinical research)'' and inserting ``and 
                                other applicable requirements regarding 
                                inclusion of demographic groups''; and
                    (D) in paragraph (6)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``the following:'' and inserting ``the 
                      following--'';
                          (ii) in subparagraph (A)--
                                    (I) by striking ``An evaluation'' 
                                and inserting ``an evaluation''; and
                                    (II) by striking the period and 
                                inserting ``; and'';
                          (iii) by striking subparagraphs (B) and (D);
                          (iv) by redesignating subparagraph (C) as 
                      subparagraph (B); and
                          (v) in subparagraph (B), as redesignated by 
                      clause (iv), by striking ``Recommendations'' and 
                      inserting ``recommendations''.
SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL INSTITUTES OF 
                          HEALTH.

    (a) Appointment and Terms of Directors of National Research 
Institutes and National Centers.--Subsection (a) of section 405 of the 
Public Health Service Act (42 U.S.C. 284) is amended to read as follows:
    ``(a) Appointment.--
            ``(1) In general.--The Director of the National Cancer 
        Institute shall be appointed by the President, and the Directors 
        of the other national research institutes and national centers 
        shall be appointed by the Secretary, acting through the Director 
        of National Institutes of Health. Each Director of a national 
        research institute or national center shall report directly to 
        the Director of National Institutes of Health.
            ``(2) Appointment.--
                    ``(A) Term.--A Director of a national research 
                institute or national center who is appointed by the 
                Secretary, acting through the Director of National 
                Institutes of Health, shall be appointed for 5 years.
                    ``(B) Reappointment.--At the end of the term of a 
                Director of a national research institute or national 
                center, the Director may be reappointed in accordance 
                with standards applicable to the relevant appointment 
                mechanism. There shall be no limit on the number of 
                terms that a Director may serve.
                    ``(C) Vacancies.--If the office of a Director of a 
                national research institute or national center becomes 
                vacant before the end of such Director's term, the 
                Director appointed to fill the vacancy shall be 
                appointed for a 5-year term starting on the date of such 
                appointment.
                    ``(D) Current directors.--Each Director of a 
                national research institute or national center who is 
                serving on the date of enactment of the 21st Century 
                Cures Act shall

[[Page 130 STAT. 1058]]

                be deemed to be appointed for a 5-year term under this 
                subsection beginning on such date of enactment.
                    ``(E) Rule of construction.--Nothing in this 
                subsection shall be construed to limit the authority of 
                the Secretary or the Director of National Institutes of 
                Health to terminate the appointment of a director 
                referred to in subparagraph (A) before the expiration of 
                such director's 5-year term.
                    ``(F) Nature of appointment.--Appointments and 
                reappointments under this subsection shall be made on 
                the basis of ability and experience as it relates to the 
                mission of the National Institutes of Health and its 
                components, including compliance with any legal 
                requirement that the Secretary or Director of National 
                Institutes of Health determines relevant.
            ``(3) Nonapplication of certain provision.--The restrictions 
        contained in section 202 of the Departments of Labor, Health and 
        Human Services, and Education, and Related Agencies 
        Appropriations Act, 1993 (Public Law 102-394; 42 U.S.C. 238f 
        note) related to consultants and individual scientists appointed 
        for limited periods of time shall not apply to Directors 
        appointed under this subsection.''.

    (b) Review of Certain Awards by Directors.--Section 405(b) of the 
Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at the 
end the following:
    ``(3) Before an award is made by a national research institute or by 
a national center for a grant for a research program or project 
(commonly referred to as an `R-series grant'), other than an award 
constituting a noncompetitive renewal of such a grant, or a 
noncompetitive administrative supplement to such a grant, the Director 
of such national research institute or national center shall, consistent 
with the peer review process--
            ``(A) review and make the final decision with respect to 
        making the award; and
            ``(B) take into consideration, as appropriate--
                    ``(i) the mission of the national research institute 
                or national center and the scientific priorities 
                identified in the strategic plan under section 402(m);
                    ``(ii) programs or projects funded by other agencies 
                on similar research topics; and
                    ``(iii) advice by staff and the advisory council or 
                board of such national research institute or national 
                center.''.

    (c) Report on Duplication in Federal Biomedical Research.--The 
Secretary of Health and Human Services (referred to in this subsection 
as the ``Secretary''), shall, not later than 2 years after the date of 
enactment of this Act, submit a report to Congress on efforts to prevent 
and eliminate duplicative biomedical research that is not necessary for 
scientific purposes. Such report shall--
            (1) describe the procedures in place to identify such 
        duplicative research, including procedures for monitoring 
        research applications and funded research awards to prevent 
        unnecessary duplication;
            (2) describe the steps taken to improve the procedures 
        described in paragraph (1), in response to relevant 
        recommendations made by the Comptroller General of the United 
        States;

[[Page 130 STAT. 1059]]

            (3) describe how the Secretary operationally distinguishes 
        necessary and appropriate scientific replication from 
        unnecessary duplication; and
            (4) provide examples of instances where the Secretary has 
        identified unnecessarily duplicative research and the steps 
        taken to eliminate the unnecessary duplication.
SEC. 2034. <<NOTE: 42 USC 3501 note.>>  REDUCING ADMINISTRATIVE 
                          BURDEN FOR RESEARCHERS.

    (a) Plan Preparation and Implementation of Measures To Reduce 
Administrative Burdens.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary'') 
        shall--
                    (A) lead a review by research funding agencies of 
                all regulations and policies related to the disclosure 
                of financial conflicts of interest, including the 
                minimum threshold for reporting financial conflicts of 
                interest;
                    (B) make revisions, as appropriate, to harmonize 
                existing policies and reduce administrative burden on 
                researchers while maintaining the integrity and 
                credibility of research findings and protections of 
                human participants; and
                    (C) confer with the Office of the Inspector General 
                about the activities of such office related to financial 
                conflicts of interest involving research funding 
                agencies.
            (2) Considerations.--In updating policies under paragraph 
        (1)(B), the Secretary shall consider--
                    (A) modifying the timelines for the reporting of 
                financial conflicts of interest to just-in-time 
                information by institutions receiving grant or 
                cooperative agreement funding from the National 
                Institutes of Health;
                    (B) ensuring that financial interest disclosure 
                reporting requirements are appropriate for, and relevant 
                to, awards that will directly fund research, which may 
                include modification of the definition of the term 
                ``investigator'' for purposes of the regulations and 
                policies described in subparagraphs (A) and (B) of 
                paragraph (1); and
                    (C) updating any applicable training modules of the 
                National Institutes of Health related to Federal 
                financial interest disclosure.

    (b) Monitoring of Subrecipients of Funding From the National 
Institutes of Health.--The Director of the National Institutes of Health 
(referred to in this section as the ``Director of National Institutes of 
Health'') shall implement measures to reduce the administrative burdens 
related to monitoring of subrecipients of grants by primary awardees of 
funding from the National Institutes of Health, which may incorporate 
findings and recommendations from existing and ongoing activities. Such 
measures may include, as appropriate--
            (1) an exemption from subrecipient monitoring requirements, 
        upon request from the primary awardees, provided that--
                    (A) the subrecipient is subject to Federal audit 
                requirements pursuant to the Uniform Guidance of the 
                Office of Management and Budget;
                    (B) the primary awardee conducts, pursuant to 
                guidance of the National Institutes of Health, a pre-
                award

[[Page 130 STAT. 1060]]

                evaluation of each subrecipient's risk of noncompliance 
                with Federal statutes and regulations, the conditions of 
                the subaward, and any recurring audit findings; and
                    (C) such exemption does not absolve the primary 
                awardee of liability for misconduct by subrecipients; 
                and
            (2) the implementation of alternative grant structures that 
        obviate the need for subrecipient monitoring, which may include 
        collaborative grant models allowing for multiple primary 
        awardees.

    (c) Reporting of Financial Expenditures.--The Secretary, in 
consultation with the Director of National Institutes of Health, shall 
evaluate financial expenditure reporting procedures and requirements for 
recipients of funding from the National Institutes of Health and take 
action, as appropriate, to avoid duplication between department and 
agency procedures and requirements and minimize burden to funding 
recipients.
    (d) Animal Care and Use in Research.--Not later than 2 years after 
the date of enactment of this Act, the Director of National Institutes 
of Health, in collaboration with the Secretary of Agriculture and the 
Commissioner of Food and Drugs, shall complete a review of applicable 
regulations and policies for the care and use of laboratory animals and 
make revisions, as appropriate, to reduce administrative burden on 
investigators while maintaining the integrity and credibility of 
research findings and protection of research animals. In carrying out 
this effort, the Director of the National Institutes of Health shall 
seek the input of experts, as appropriate. The Director of the National 
Institutes of Health shall--
            (1) identify ways to ensure such regulations and policies 
        are not inconsistent, overlapping, or unnecessarily duplicative, 
        including with respect to inspection and review requirements by 
        Federal agencies and accrediting associations;
            (2) take steps to eliminate or reduce identified 
        inconsistencies, overlap, or duplication among such regulations 
        and policies; and
            (3) take other actions, as appropriate, to improve the 
        coordination of regulations and policies with respect to 
        research with laboratory animals.

    (e) Documentation of Personnel Expenses.--The Secretary shall 
clarify the applicability of the requirements under the Office of 
Management and Budget Uniform Guidance for management and certification 
systems adopted by entities receiving Federal research grants through 
the Department of Health and Human Services regarding documentation of 
personnel expenses, including clarification of the extent to which any 
flexibility to such requirements specified in such Uniform Guidance 
applies to entities receiving grants through the Department of Health 
and Human Services.
    (f) Research Policy Board.--
            (1) Establishment.--Not later than 1 year after the date of 
        enactment of this Act, the Director of the Office of Management 
        and Budget shall establish an advisory committee, to be known as 
        the ``Research Policy Board'' (referred to in this subsection as 
        the ``Board''), to provide Federal Government officials with 
        information on the effects of regulations related to Federal 
        research requirements.
            (2) Membership.--

[[Page 130 STAT. 1061]]

                    (A) In general.--The Board shall include not more 
                than 10 Federal members, including each of the following 
                Federal members or their designees:
                          (i) The Administrator of the Office of 
                      Information and Regulatory Affairs of the Office 
                      of Management and Budget.
                          (ii) The Director of the Office of Science and 
                      Technology Policy.
                          (iii) The Secretary of Health and Human 
                      Services.
                          (iv) The Director of the National Science 
                      Foundation.
                          (v) The secretaries and directors of other 
                      departments and agencies that support or regulate 
                      scientific research, as determined by the Director 
                      of the Office of Management and Budget.
                    (B) Non-federal members.--The Board shall be 
                comprised of not less than 9 and not more than 12 
                representatives of academic research institutions, other 
                private, nonprofit research institutions, or other 
                nonprofit organizations with relevant expertise. Such 
                members shall be appointed by a formal process, to be 
                established by the Director of the Office of Management 
                and Budget, in consultation with the Federal membership, 
                and that incorporates--
                          (i) nomination by members of the nonprofit 
                      scientific research community, including academic 
                      research institutions; and
                          (ii) procedures to fill membership positions 
                      vacated before the end of a member's term.
            (3) Purpose and responsibilities.--The Board shall make 
        recommendations regarding the modification and harmonization of 
        regulations and policies having similar purposes across research 
        funding agencies to ensure that the administrative burden of 
        such research policy and regulation is minimized to the greatest 
        extent possible and consistent with maintaining responsible 
        oversight of federally funded research. Activities of the Board 
        may include--
                    (A) providing thorough and informed analysis of 
                regulations and policies;
                    (B) identifying negative or adverse consequences of 
                existing policies and making actionable recommendations 
                regarding possible improvement of such policies;
                    (C) making recommendations with respect to efforts 
                within the Federal Government to improve coordination of 
                regulation and policy related to research;
                    (D) creating a forum for the discussion of research 
                policy or regulatory gaps, challenges, clarification, or 
                harmonization of such policies or regulation, and best 
                practices; and
                    (E) conducting ongoing assessment and evaluation of 
                regulatory burden, including development of metrics, 
                periodic measurement, and identification of process 
                improvements and policy changes.
            (4) Expert subcommittees.--The Board may form temporary 
        expert subcommittees, as appropriate, to develop timely analysis 
        on pressing issues and assist the Board in anticipating future 
        regulatory challenges, including challenges emerging from new 
        scientific advances.

[[Page 130 STAT. 1062]]

            (5) Reporting requirements.--Not later than 2 years after 
        the date of enactment of this Act, and once thereafter, the 
        Board shall submit a report to the Director of the Office of 
        Management and Budget, the Administrator of the Office of 
        Information and Regulatory Affairs of the Office of Management 
        and Budget, the Director of the Office of Science and Technology 
        Policy, the heads of relevant Federal departments and agencies, 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate, and the Committee on Energy and Commerce of the House of 
        Representatives containing formal recommendations on the 
        conceptualization, development, harmonization, and 
        reconsideration of scientific research policy, including the 
        regulatory benefits and burdens.
            (6) Sunset.--The Board shall terminate on September 30, 
        2021.
            (7) GAO report.--Not later than 4 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall conduct an independent evaluation of the activities 
        carried out by the Board pursuant to this subsection and submit 
        to the appropriate committees of Congress a report regarding the 
        results of the independent evaluation. Such report shall review 
        and assess the Board's activities with respect to the 
        responsibilities described in paragraph (3).
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM 
                          THE PAPERWORK REDUCTION ACT 
                          REQUIREMENTS.

    Section 301 of the Public Health Service Act (42 U.S.C. 241), as 
amended by section 2013, is further amended by adding at the end the 
following:
    ``(g) Subchapter I of chapter 35 of title 44, United States Code, 
shall not apply to the voluntary collection of information during the 
conduct of research by the National Institutes of Health.''.
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282), as amended by section 2031, is further amended by adding at 
the end the following:
    ``(n) Unique Research Initiatives.--
            ``(1) In general.--The Director of NIH may approve, after 
        consideration of a proposal under paragraph (2)(A), requests by 
        the national research institutes and centers, or program 
        officers within the Office of the Director to engage in 
        transactions other than a contract, grant, or cooperative 
        agreement with respect to projects that carry out--
                    ``(A) the Precision Medicine Initiative under 
                section 498E; or
                    ``(B) section 402(b)(7), except that not more than 
                50 percent of the funds available for a fiscal year 
                through the Common Fund under section 402A(c)(1) for 
                purposes of carrying out such section 402(b)(7) may be 
                used to engage in such other transactions.
            ``(2) Requirements.--The authority provided under this 
        subsection may be used to conduct or support high impact 
        cutting-edge research described in paragraph (1) using the other 
        transactions authority described in such paragraph if the 
        institute, center, or office--

[[Page 130 STAT. 1063]]

                    ``(A) submits a proposal to the Director of NIH for 
                the use of such authority before conducting or 
                supporting the research, including why the use of such 
                authority is essential to promoting the success of the 
                project;
                    ``(B) receives approval for the use of such 
                authority from the Director of NIH; and
                    ``(C) for each year in which the institute, center, 
                or office has used such authority in accordance with 
                this subsection, submits a report to the Director of NIH 
                on the activities of the institute, center, or office 
                relating to such research.''.

    (b) Report to Congress.--Not later than September 30, 2020, the 
Secretary of Health and Human Services, acting through the Director of 
the National Institutes of Health, shall conduct an evaluation of the 
activities under subsection (n) of section 402 of the Public Health 
Service Act (42 U.S.C. 282), as added by subsection (a), and submit a 
report to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives on the results of such evaluation.
    (c) Duties of Directors of Institutes.--Section 405(b)(1) of the 
Public Health Service Act (42 U.S.C. 284(b)(1)) is amended--
            (1) by redesignating subparagraphs (C) through (L) as 
        subparagraphs (D) through (M), respectively; and
            (2) by inserting after subparagraph (B), the following:
            ``(C) shall, as appropriate, conduct and support research 
        that has the potential to transform the scientific field, has 
        inherently higher risk, and that seeks to address major current 
        challenges;''.
SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.

    (a) In General.--Section 479(b) of the Public Health Service Act (42 
U.S.C. 287(b)) is amended--
            (1) in paragraph (1), by striking ``phase IIA'' and 
        inserting ``phase IIB''; and
            (2) in paragraph (2)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``phase IIB'' and inserting ``phase III'';
                    (B) in subparagraph (A), by striking ``phase IIB'' 
                and inserting ``phase III'';
                    (C) in subparagraph (B), by striking ``phase IIA'' 
                and inserting ``phase IIB''; and
                    (D) in subparagraph (C), by striking ``phase IIB'' 
                and inserting ``phase III''.

    (b) Increased Transparency.--Section 479 of the Public Health 
Service Act (42 U.S.C. 287) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (4)(D), by striking ``and'' at the 
                end;
                    (B) in paragraph (5), by striking the period and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
            ``(6) the methods and tools, if any, that have been 
        developed since the last biennial report was prepared; and
            ``(7) the methods and tools, if any, that have been 
        developed and are being utilized by the Food and Drug 
        Administration to support medical product reviews.''; and

[[Page 130 STAT. 1064]]

            (2) by adding at the end the following:

    ``(d) Inclusion of List.--The first biennial report submitted under 
this section after the date of enactment of the 21st Century Cures Act 
shall include a complete list of all of the methods and tools, if any, 
which have been developed by research supported by the Center.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed as authorizing the Secretary to disclose any information that 
is a trade secret, or other privileged or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code.''.
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.

    (a) Research Priorities; Collaborative Research Projects.--Section 
402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
            (1) by amending paragraph (4) to read as follows:
            ``(4) shall assemble accurate data to be used to assess 
        research priorities, including--
                    ``(A) information to better evaluate scientific 
                opportunity, public health burdens, and progress in 
                reducing health disparities; and
                    ``(B) data on study populations of clinical 
                research, funded by or conducted at each national 
                research institute and national center, which--
                          ``(i) specifies the inclusion of--
                                    ``(I) women;
                                    ``(II) members of minority groups;
                                    ``(III) relevant age categories, 
                                including pediatric subgroups; and
                                    ``(IV) other demographic variables 
                                as the Director of the National 
                                Institutes of Health determines 
                                appropriate;
                          ``(ii) is disaggregated by research area, 
                      condition, and disease categories; and
                          ``(iii) is to be made publicly available on 
                      the Internet website of the National Institutes of 
                      Health;''; and
            (2) in paragraph (8)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end; and
                    (B) by adding at the end the following:
                    ``(C) foster collaboration between clinical research 
                projects funded by the respective national research 
                institutes and national centers that--
                          ``(i) conduct research involving human 
                      subjects; and
                          ``(ii) collect similar data; and
                    ``(D) encourage the collaboration described in 
                subparagraph (C) to--
                          ``(i) allow for an increase in the number of 
                      subjects studied; and
                          ``(ii) utilize diverse study populations, with 
                      special consideration to biological, social, and 
                      other determinants of health that contribute to 
                      health disparities;''.

[[Page 130 STAT. 1065]]

    (b) Reporting.--Section 492B(f) of the Public Health Service Act (42 
U.S.C. 289a-2(f)) is amended--
            (1) by striking ``biennial'' each place such term appears 
        and inserting ``triennial'';
            (2) by striking ``The advisory council'' and inserting the 
        following:
            ``(1) In general.--The advisory council''; and
            (3) by adding at the end the following:
            ``(2) Contents.--Each triennial report prepared by an 
        advisory council of each national research institute as 
        described in paragraph (1) shall include each of the following:
                    ``(A) The number of women included as subjects, and 
                the proportion of subjects that are women, in any 
                project of clinical research conducted during the 
                applicable reporting period, disaggregated by categories 
                of research area, condition, or disease, and accounting 
                for single-sex studies.
                    ``(B) The number of members of minority groups 
                included as subjects, and the proportion of subjects 
                that are members of minority groups, in any project of 
                clinical research conducted during the applicable 
                reporting period, disaggregated by categories of 
                research area, condition, or disease and accounting for 
                single-race and single-ethnicity studies.
                    ``(C) For the applicable reporting period, the 
                number of projects of clinical research that include 
                women and members of minority groups and that--
                          ``(i) have been completed during such 
                      reporting period; and
                          ``(ii) are being carried out during such 
                      reporting period and have not been completed.
                    ``(D) The number of studies completed during the 
                applicable reporting period for which reporting has been 
                submitted in accordance with subsection (c)(2)(A).''.

    (c) Coordination.--Section 486(c)(2) of the Public Health Service 
Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and 
inserting ``senior-level staff designees''.
    (d) In General.--Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.), as amended by section 2021, is further amended 
by adding at the end the following:
``SEC. 404N. <<NOTE: 42 USC 283p.>>  POPULATION FOCUSED RESEARCH.

    ``The Director of the National Institutes of Health shall, as 
appropriate, encourage efforts to improve research related to the health 
of sexual and gender minority populations, including by--
            ``(1) facilitating increased participation of sexual and 
        gender minority populations in clinical research supported by 
        the National Institutes of Health, and reporting on such 
        participation, as applicable;
            ``(2) facilitating the development of valid and reliable 
        methods for research relevant to sexual and gender minority 
        populations; and
            ``(3) addressing methodological challenges.''.

    (e) <<NOTE: 42 USC 283p note.>>  Reporting.--
            (1) In general.--The Secretary, in collaboration with the 
        Director of the National Institutes of Health, shall as 
        appropriate--

[[Page 130 STAT. 1066]]

                    (A) continue to support research for the development 
                of appropriate measures related to reporting health 
                information about sexual and gender minority 
                populations; and
                    (B) not later than 2 years after the date of 
                enactment of this Act, disseminate and make public such 
                measures.
            (2) National academy of medicine recommendations.--In 
        developing the measures described in paragraph (1)(A), the 
        Secretary shall take into account recommendations made by the 
        National Academy of Medicine.

    (f) Improving Coordination Related to Minority Health and Health 
Disparities.--Section 464z-3 of the Public Health Service Act (42 U.S.C. 
285t) is amended--
            (1) by redesignating subsection (h), relating to interagency 
        coordination, that follows subsection (j) as subsection (k); and
            (2) in subsection (k) (as so redesignated)--
                    (A) in the subsection heading, by striking 
                ``Interagency'' and inserting ``Intra-National 
                Institutes of Health'';
                    (B) by striking ``as the primary Federal officials'' 
                and inserting ``as the primary Federal official'';
                    (C) by inserting a comma after ``review'';
                    (D) by striking ``Institutes and Centers of the 
                National Institutes of Health'' and inserting ``national 
                research institutes and national centers''; and
                    (E) by adding at the end the following: ``The 
                Director of the Institute may foster partnerships 
                between the national research institutes and national 
                centers and may encourage the funding of collaborative 
                research projects to achieve the goals of the National 
                Institutes of Health that are related to minority health 
                and health disparities.''.

    (g) <<NOTE: 42 USC 284r.>>  Basic Research.--
            (1) Developing policies.--Not later than 2 years after the 
        date of enactment of this Act, the Director of the National 
        Institutes of Health (referred to in this section as the 
        ``Director of the National Institutes of Health''), taking into 
        consideration the recommendations developed under section 2039, 
        shall develop policies for projects of basic research funded by 
        National Institutes of Health to assess--
                    (A) relevant biological variables including sex, as 
                appropriate; and
                    (B) how differences between male and female cells, 
                tissues, or animals may be examined and analyzed.
            (2) Revising policies.--The Director of the National 
        Institutes of Health may update or revise the policies developed 
        under paragraph (1) as appropriate.
            (3) Consultation and outreach.--In developing, updating, or 
        revising the policies under this section, the Director of the 
        National Institutes of Health shall--
                    (A) consult with--
                          (i) the Office of Research on Women's Health;
                          (ii) the Office of Laboratory Animal Welfare; 
                      and
                          (iii) appropriate members of the scientific 
                      and academic communities; and
                    (B) conduct outreach to solicit feedback from 
                members of the scientific and academic communities on 
                the influence of sex as a variable in basic research, 
                including feedback

[[Page 130 STAT. 1067]]

                on when it is appropriate for projects of basic research 
                involving cells, tissues, or animals to include both 
                male and female cells, tissues, or animals.
            (4) Additional requirements.--The Director of the National 
        Institutes of Health shall--
                    (A) ensure that projects of basic research funded by 
                the National Institutes of Health are conducted in 
                accordance with the policies developed, updated, or 
                revised under this section, as applicable; and
                    (B) encourage that the results of such research, 
                when published or reported, be disaggregated as 
                appropriate with respect to the analysis of any sex 
                differences.

    (h) <<NOTE: 42 USC 289a-2 note.>>  Clinical Research.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Director of the National Institutes 
        of Health, in consultation with the Director of the Office of 
        Research on Women's Health and the Director of the National 
        Institute on Minority Health and Health Disparities, shall 
        update the guidelines established under section 492B(d) of 
        Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance 
        with paragraph (2).
            (2) Requirements.--The updated guidelines described in 
        paragraph (1) shall--
                    (A) reflect the science regarding sex differences;
                    (B) improve adherence to the requirements under 
                section 492B of the Public Health Service Act (42 U.S.C. 
                289a-2), including the reporting requirements under 
                subsection (f) of such section; and
                    (C) clarify the circumstances under which studies 
                should be designed to support the conduct of analyses to 
                detect significant differences in the intervention 
                effect due to demographic factors related to section 
                492B of the Public Health Service Act, including in the 
                absence of prior studies that demonstrate a difference 
                in study outcomes on the basis of such factors and 
                considering the effects of the absence of such analyses 
                on the availability of data related to demographic 
                differences.

    (i) <<NOTE: 42 USC 282 note.>>  Appropriate Age Groupings in 
Clinical Research.--
            (1) Input from experts.--Not later than 180 days after the 
        date of enactment of this Act, the Director of the National 
        Institutes of Health shall convene a workshop of experts on 
        pediatric and older populations to provide input on--
                    (A) appropriate age groups to be included in 
                research studies involving human subjects; and
                    (B) acceptable justifications for excluding 
                participants from a range of age groups from human 
                subjects research studies.
            (2) Policy updates.--Not later than 180 days after the 
        conclusion of the workshop under paragraph (1), the Director of 
        the National Institutes of Health shall make a determination 
        with respect to whether the policies of the National Institutes 
        of Health on the inclusion of relevant age groups in clinical 
        studies need to be updated, and shall update such policies as 
        appropriate. In making the determination, the Director of the 
        National Institutes of Health shall take into consideration 
        whether such policies--

[[Page 130 STAT. 1068]]

                    (A) address the consideration of age as an inclusion 
                variable in research involving human subjects; and
                    (B) identify the criteria for justification for any 
                age-related exclusions in such research.
            (3) Public availability of findings and conclusions.--The 
        Director of the National Institutes of Health shall--
                    (A) make the findings and conclusions resulting from 
                the workshop under paragraph (1) and updates to policies 
                in accordance with paragraph (2), as applicable, 
                available to the public on the Internet website of the 
                National Institutes of Health; and
                    (B) ensure that age-related data reported in the 
                triennial report under section 403 of the Public Health 
                Service Act (42 U.S.C. 283) (as amended by section 2032) 
                are made available to the public on the Internet website 
                of the National Institutes of Health.
SEC. 2039. <<NOTE: 42 USC 282 note.>>  ENHANCING THE RIGOR AND 
                          REPRODUCIBILITY OF SCIENTIFIC RESEARCH.

    (a) Establishment.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Director of the National Institutes of Health, shall 
convene a working group under the Advisory Committee to the Director of 
the National Institutes of Health (referred to in this section as the 
``Advisory Committee''), appointed under section 222 of the Public 
Health Service Act (42 U.S.C. 217a), to develop and issue 
recommendations through the Advisory Committee for a formal policy, 
which may incorporate or be informed by relevant existing and ongoing 
activities, to enhance rigor and reproducibility of scientific research 
funded by the National Institutes of Health.
    (b) Considerations.--In developing and issuing recommendations 
through the Advisory Committee under subsection (a), the working group 
established under such subsection shall consider, as appropriate--
            (1) preclinical experiment design, including analysis of sex 
        as a biological variable;
            (2) clinical experiment design, including--
                    (A) the diversity of populations studied for 
                clinical research, with respect to biological, social, 
                and other determinants of health that contribute to 
                health disparities;
                    (B) the circumstances under which summary 
                information regarding biological, social, and other 
                factors that contribute to health disparities should be 
                reported; and
                    (C) the circumstances under which clinical studies, 
                including clinical trials, should conduct an analysis of 
                the data collected during the study on the basis of 
                biological, social, and other factors that contribute to 
                health disparities;
            (3) applicable levels of rigor in statistical methods, 
        methodology, and analysis;
            (4) data and information sharing in accordance with 
        applicable privacy laws and regulations; and
            (5) any other matter the working group determines relevant.

    (c) Policies.--Not later than 18 months after the date of enactment 
of this Act, the Director of the National Institutes of Health shall 
consider the recommendations developed by the working group

[[Page 130 STAT. 1069]]

and issued by the Advisory Committee under subsection (a) and develop or 
update policies as appropriate.
    (d) Report.--Not later than 2 years after the date of enactment of 
this Act, the Director of the National Institutes of Health shall issue 
a report to the Secretary of Health and Human Services, the Committee on 
Health, Education, Labor, and Pensions of the Senate, and the Committee 
on Energy and Commerce of the House of Representatives regarding 
recommendations developed under subsection (a) and any subsequent policy 
changes implemented, to enhance rigor and reproducibility in scientific 
research funded by the National Institutes of Health.
    (e) Confidentiality.--Nothing in this section authorizes the 
Secretary of Health and Human Services to disclose any information that 
is a trade secret, or other privileged or confidential information, 
described in section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.
SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE 
                          NATIONAL INSTITUTES OF HEALTH.

    (a) In General.--Section 452 of the Public Health Service Act (42 
U.S.C. 285g-4) is amended--
            (1) in subsection (b), by striking ``conduct and support'' 
        and inserting ``conduct, support, and coordination'';
            (2) in subsection (c)(1)(C), by striking ``of the Center'' 
        and inserting ``within the Center'';
            (3) in subsection (d)--
                    (A) by striking ``(d)(1) In consultation'' and all 
                that follows through the end of paragraph (1) and 
                inserting the following:

    ``(d)(1) The Director of the Center, in consultation with the 
Director of the Institute, the coordinating committee established under 
subsection (e), and the advisory board established under subsection (f), 
shall develop a comprehensive plan (referred to in this section as the 
`Research Plan') for the conduct, support, and coordination of medical 
rehabilitation research.'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (A), by striking ``; and'' 
                      and inserting a semicolon;
                          (ii) in subparagraph (B), by striking the 
                      period and inserting ``; and''; and
                          (iii) by adding at the end the following:
            ``(C) include goals and objectives for conducting, 
        supporting, and coordinating medical rehabilitation research, 
        consistent with the purpose described in subsection (b).'';
                    (C) by striking paragraph (4) and inserting the 
                following:

    ``(4) The Director of the Center, in consultation with the Director 
of the Institute, the coordinating committee established under 
subsection (e), and the advisory board established under subsection (f), 
shall revise and update the Research Plan periodically, as appropriate, 
or not less than every 5 years. Not later than 30 days after the 
Research Plan is so revised and updated, the Director of the Center 
shall transmit the revised and updated Research Plan to the President, 
the Committee on Health, Education, Labor, and Pensions of the Senate, 
and the Committee on Energy and Commerce of the House of 
Representatives.''; and
                    (D) by adding at the end the following:

[[Page 130 STAT. 1070]]

    ``(5) The Director of the Center, in consultation with the Director 
of the Institute, shall, prior to revising and updating the Research 
Plan, prepare a report for the coordinating committee established under 
subsection (e) and the advisory board established under subsection (f) 
that describes and analyzes the progress during the preceding fiscal 
year in achieving the goals and objectives described in paragraph (2)(C) 
and includes expenditures for rehabilitation research at the National 
Institutes of Health. The report shall include recommendations for 
revising and updating the Research Plan, and such initiatives as the 
Director of the Center and the Director of the Institute determine 
appropriate. In preparing the report, the Director of the Center and the 
Director of the Institute shall consult with the Director of the 
National Institutes of Health.'';
            (4) in subsection (e)--
                    (A) in paragraph (2), by inserting ``periodically 
                host a scientific conference or workshop on medical 
                rehabilitation research and'' after ``The Coordinating 
                Committee shall''; and
                    (B) in paragraph (3), by inserting ``the Director of 
                the Division of Program Coordination, Planning, and 
                Strategic Initiatives within the Office of the Director 
                of the National Institutes of Health,'' after ``shall be 
                composed of'';
            (5) in subsection (f)(3)(B)--
                    (A) by redesignating clauses (ix) through (xi) as 
                clauses (x) through (xii), respectively; and
                    (B) by inserting after clause (viii) the following:
            ``(ix) The Director of the Division of Program Coordination, 
        Planning, and Strategic Initiatives.''; and
            (6) by adding at the end the following:

    ``(g)(1) The Secretary and the heads of other Federal agencies shall 
jointly review the programs carried out (or proposed to be carried out) 
by each such official with respect to medical rehabilitation research 
and, as appropriate, enter into agreements preventing duplication among 
such programs.
    ``(2) The Secretary shall, as appropriate, enter into interagency 
agreements relating to the coordination of medical rehabilitation 
research conducted by agencies of the National Institutes of Health and 
other agencies of the Federal Government.
    ``(h) For purposes of this section, the term `medical rehabilitation 
research' means the science of mechanisms and interventions that 
prevent, improve, restore, or replace lost, underdeveloped, or 
deteriorating function.''.
    (b) Conforming Amendment.--Section 3 of the National Institutes of 
Health Amendments of 1990 (42 U.S.C. 285g-4 note) is amended--
            (1) in subsection (a), by striking ``In General.--''; and
            (2) by striking subsection (b).
SEC. 2041. <<NOTE: 42 USC 289a-2 note.>>  TASK FORCE ON RESEARCH 
                          SPECIFIC TO PREGNANT WOMEN AND LACTATING 
                          WOMEN.

    (a) Task Force on Research Specific to Pregnant Women and Lactating 
Women.--
            (1) Establishment.--Not later than 90 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary'') 
        shall establish a task force, in accordance with the Federal 
        Advisory Committee Act (5 U.S.C. App.), to be known as the 
        ``Task

[[Page 130 STAT. 1071]]

        Force on Research Specific to Pregnant Women and Lactating 
        Women'' (in this section referred to as the ``Task Force'').
            (2) Duties.--The Task Force shall provide advice and 
        guidance to the Secretary regarding Federal activities related 
        to identifying and addressing gaps in knowledge and research 
        regarding safe and effective therapies for pregnant women and 
        lactating women, including the development of such therapies and 
        the collaboration on and coordination of such activities.
            (3) Membership.--
                    (A) Federal members.--The Task Force shall be 
                composed of each of the following Federal members, or 
                the designees of such members:
                          (i) The Director of the Centers for Disease 
                      Control and Prevention.
                          (ii) The Director of the National Institutes 
                      of Health, the Director of the Eunice Kennedy 
                      Shriver National Institute of Child Health and 
                      Human Development, and the directors of such other 
                      appropriate national research institutes.
                          (iii) The Commissioner of Food and Drugs.
                          (iv) The Director of the Office on Women's 
                      Health.
                          (v) The Director of the National Vaccine 
                      Program Office.
                          (vi) The head of any other research-related 
                      agency or department not described in clauses (i) 
                      through (v) that the Secretary determines 
                      appropriate, which may include the Department of 
                      Veterans Affairs and the Department of Defense.
                    (B) Non-federal members.--The Task Force shall be 
                composed of each of the following non-Federal members, 
                including--
                          (i) representatives from relevant medical 
                      societies with subject matter expertise on 
                      pregnant women, lactating women, or children;
                          (ii) nonprofit organizations with expertise 
                      related to the health of women and children;
                          (iii) relevant industry representatives; and
                          (iv) other representatives, as appropriate.
                    (C) Limitations.--The non-Federal members described 
                in subparagraph (B) shall--
                          (i) compose not more than one-half, and not 
                      less than one-third, of the total membership of 
                      the Task Force; and
                          (ii) be appointed by the Secretary.
            (4) Termination.--
                    (A) In general.--Subject to subparagraph (B), the 
                Task Force shall terminate on the date that is 2 years 
                after the date on which the Task Force is established 
                under paragraph (1).
                    (B) Extension.--The Secretary may extend the 
                operation of the Task Force for one additional 2-year 
                period following the 2-year period described in 
                subparagraph (A), if the Secretary determines that the 
                extension is appropriate for carrying out the purpose of 
                this section.
            (5) Meetings.--The Task Force shall meet not less than 2 
        times each year and shall convene public meetings, as 
        appropriate, to fulfill its duties under paragraph (2).

[[Page 130 STAT. 1072]]

            (6) Task force report to congress.--Not later than 18 months 
        after the date on which the Task Force is established under 
        paragraph (1), the Task Force shall prepare and submit to the 
        Secretary, the Committee on Health, Education, Labor, and 
        Pensions of the Senate, and the Committee on Energy and Commerce 
        of the House of Representatives a report that includes each of 
        the following:
                    (A) A plan to identify and address gaps in knowledge 
                and research regarding safe and effective therapies for 
                pregnant women and lactating women, including the 
                development of such therapies.
                    (B) Ethical issues surrounding the inclusion of 
                pregnant women and lactating women in clinical research.
                    (C) Effective communication strategies with health 
                care providers and the public on information relevant to 
                pregnant women and lactating women.
                    (D) Identification of Federal activities, 
                including--
                          (i) the state of research on pregnancy and 
                      lactation;
                          (ii) recommendations for the coordination of, 
                      and collaboration on research related to pregnant 
                      women and lactating women;
                          (iii) dissemination of research findings and 
                      information relevant to pregnant women and 
                      lactating women to providers and the public; and
                          (iv) existing Federal efforts and programs to 
                      improve the scientific understanding of the health 
                      impacts on pregnant women, lactating women, and 
                      related birth and pediatric outcomes, including 
                      with respect to pharmacokinetics, 
                      pharmacodynamics, and toxicities.
                    (E) Recommendations to improve the development of 
                safe and effective therapies for pregnant women and 
                lactating women.

    (b) Confidentiality.--Nothing in this section shall authorize the 
Secretary of Health and Human Services to disclose any information that 
is a trade secret, or other privileged or confidential information, 
described in section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.
    (c) Updating Protections for Pregnant Women and Lactating Women in 
Research.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary, considering any 
        recommendations of the Task Force available at such time and in 
        consultation with the heads of relevant agencies of the 
        Department of Health and Human Services, shall, as appropriate, 
        update regulations and guidance, as applicable, regarding the 
        inclusion of pregnant women and lactating women in clinical 
        research.
            (2) Criteria for excluding pregnant or lactating women.--In 
        updating any regulations or guidance described in paragraph (1), 
        the Secretary shall consider any appropriate criteria to be used 
        by institutional review boards and individuals reviewing grant 
        proposals for excluding pregnant women or lactating women as a 
        study population requiring additional protections from 
        participating in human subject research.

[[Page 130 STAT. 1073]]

SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH REPORTING 
                          REQUIREMENTS.

    (a) Trans-National Institutes of Health Research Reporting.--Section 
402A(c)(2) of the Public Health Service Act (42 U.S.C. 282a(c)(2)) is 
amended--
            (1) by amending subparagraph (B) to read as follows:
                    ``(B) Reporting.--Not later than 2 years after the 
                date of enactment of 21st Century Cures Act, the head of 
                each national research institute or national center 
                shall submit to the Director of the National Institutes 
                of Health a report, to be included in the triennial 
                report under section 403, on the amount made available 
                by the institute or center for conducting or supporting 
                research that involves collaboration between the 
                institute or center and 1 or more other national 
                research institutes or national centers.''; and
            (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' each 
        place it appears and inserting ``(B)''.

    (b) Fraud and Abuse Reporting.--Section 403B of the Public Health 
Service Act (42 U.S.C. 283a-1) is amended--
            (1) by striking subsection (b);
            (2) by redesignating subsection (c) as subsection (b); and
            (3) in subsection (b) (as so redesignated), by striking 
        ``subsections (a) and (b)'' and inserting ``subsection (a)''.

    (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public 
Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking 
``(not including any leaves of absence)''.
    (d) Vaccine Reporting.--Section 404B of the Public Health Service 
Act (42 U.S.C. 283d) is amended--
            (1) by striking subsection (b); and
            (2) by striking ``(a) Development of New Vaccines.--The 
        Secretary'' and inserting ``The Secretary''.

    (e) National Center for Advancing Translational Sciences.--Section 
479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
            (1) in the subsection heading, by striking ``Annual'' and 
        inserting ``Biennial''; and
            (2) in the matter preceding paragraph (1), by striking ``an 
        annual report'' and inserting ``a report on a biennial basis''.

    (f) Review of Centers of Excellence.--
            (1) Repeal.--Section 404H of the Public Health Service Act 
        (42 U.S.C. 283j) is repealed.
            (2) Conforming amendment.--Section 399EE(c) of the Public 
        Health Service Act (42 U.S.C. 280-4(c)) is amended by striking 
        ``399CC, 404H,'' and inserting ``399CC''.

    (g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE 
Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
            (1) by striking paragraph (2); and
            (2) by redesignating paragraph (3) as paragraph (2).

    (h) National Institute of Nursing Research.--
            (1) Repeal.--Section 464Y of the Public Health Service Act 
        (42 U.S.C. 285q-3) is repealed.
            (2) Conforming amendment.--Section 464X(g) of the Public 
        Health Service Act (42 U.S.C. 285q-2(g)) is amended by striking 
        ``biennial report made under section 464Y,'' and inserting 
        ``triennial report made under section 403''.

[[Page 130 STAT. 1074]]

SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING 
                          ORGANISMS.

    Section 301 of the Public Health Service Act (42 U.S.C. 241), as 
amended by section 2035, is further amended--
            (1) in the flush matter at the end of subsection (a)--
                    (A) by redesignating such matter as subsection 
                (h)(1); and
                    (B) by moving such matter so as to appear at the end 
                of such section; and
            (2) in subsection (h) (as so redesignated), by adding at the 
        end the following:

    ``(2) Where research substances and living organisms are made 
available under paragraph (1) through contractors, the Secretary may 
direct such contractors to collect payments on behalf of the Secretary 
for the costs incurred to make available such substances and organisms 
and to forward amounts so collected to the Secretary, in the time and 
manner specified by the Secretary.
    ``(3) Amounts collected under paragraph (2) shall be credited to the 
appropriations accounts that incurred the costs to make available the 
research substances and living organisms involved, and shall remain 
available until expended for carrying out activities under such 
accounts.''.
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF 
                          UNDERREPRESENTED POPULATIONS IN CLINICAL 
                          TRIALS.

    It is the sense of Congress that the National Institute on Minority 
Health and Health Disparities should include within its strategic plan 
under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m)) 
ways to increase representation of underrepresented populations in 
clinical trials.

 Subtitle E--Advancement of the National Institutes of Health Research 
                             and Data Access

SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.

    Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(D)) is amended--
            (1) in clause (ii)(I), by inserting before the semicolon ``, 
        unless the responsible party affirmatively requests that the 
        Director of the National Institutes of Health publicly post such 
        clinical trial information for an applicable device clinical 
        trial prior to such date of clearance or approval''; and
            (2) by adding at the end the following:
                          ``(iii) Option to make certain clinical trial 
                      information available earlier.--The Director of 
                      the National Institutes of Health shall inform 
                      responsible parties of the option to request that 
                      clinical trial information for an applicable 
                      device clinical trial be publicly posted prior to 
                      the date of clearance or approval, in accordance 
                      with clause (ii)(I).
                          ``(iv) Combination products.--An applicable 
                      clinical trial for a product that is a combination 
                      of drug, device, or biological product shall be 
                      considered--

[[Page 130 STAT. 1075]]

                                    ``(I) an applicable drug clinical 
                                trial, if the Secretary determines under 
                                section 503(g) of the Federal Food, 
                                Drug, and Cosmetic Act that the primary 
                                mode of action of such product is that 
                                of a drug or biological product; or
                                    ``(II) an applicable device clinical 
                                trial, if the Secretary determines under 
                                such section that the primary mode of 
                                action of such product is that of a 
                                device.''.
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.

    (a) Definitions.--In this section:
            (1) Applicable clinical trial.--The term ``applicable 
        clinical trial'' has the meaning given the term in section 
        402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

    (b) Report on Activities To Encourage Compliance.--Not later than 2 
years after the date of enactment of this Act, the Secretary, acting 
through the Director of the National Institutes of Health and in 
collaboration with the Commissioner of Food and Drugs, shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report that describes education and outreach, 
guidance, enforcement, and other activities undertaken to encourage 
compliance with section 402(j) of the Public Health Service Act (42 
U.S.C. 282(j)).
    (c) Reports on Clinical Trials.--
            (1) In general.--Not later than 2 years after the final 
        compliance date under the final rule implementing section 402(j) 
        of the Public Health Service Act, and every 2 years thereafter 
        for the next 4 years, the Secretary, acting through the Director 
        of the National Institutes of Health and in collaboration with 
        the Commissioner of Food and Drugs, shall submit to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, a report describing--
                    (A) the total number of applicable clinical trials 
                with complete data bank registration information 
                registered during the period for which the report is 
                being prepared (broken down by each year of such 
                reporting period);
                    (B) the total number of applicable clinical trials 
                registered during the period for which the report is 
                being prepared for which results have been submitted to 
                the data bank (broken down by each year of such 
                reporting period);
                    (C) the activities undertaken by the Secretary to 
                educate responsible persons about data bank registration 
                and results submission requirements, including through 
                issuance of guidance documents, informational meetings, 
                and training sessions; and
                    (D) the activities described in the report submitted 
                under subsection (b).
            (2) Actions to enforce compliance.--After the Secretary has 
        undertaken the educational activities described in paragraph 
        (1)(C), the Secretary shall include in subsequent reports

[[Page 130 STAT. 1076]]

        submitted under paragraph (1) the number of actions taken by the 
        Secretary during the period for which the report is being 
        prepared to enforce compliance with data bank registration and 
        results submission requirements.
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.

    Section 492B(c) of the Public Health Service Act (42 U.S.C. 289a-
2(c)) is amended--
            (1) by striking ``In the case'' and inserting the following:
            ``(1) In general.--In the case''; and
            (2) by adding at the end the following:
            ``(2) Reporting requirements.--For any new and competing 
        project of clinical research subject to the requirements under 
        this section that receives a grant award 1 year after the date 
        of enactment of the 21st Century Cures Act, or any date 
        thereafter, for which a valid analysis is provided under 
        paragraph (1)--
                    ``(A) and which is an applicable clinical trial as 
                defined in section 402(j), the entity conducting such 
                clinical research shall submit the results of such valid 
                analysis to the clinical trial registry data bank 
                expanded under section 402(j)(3), and the Director of 
                the National Institutes of Health shall, as appropriate, 
                consider whether such entity has complied with the 
                reporting requirement described in this subparagraph in 
                awarding any future grant to such entity, including 
                pursuant to section 402(j)(5)(A)(ii) when applicable; 
                and
                    ``(B) the Director of the National Institutes of 
                Health shall encourage the reporting of the results of 
                such valid analysis described in paragraph (1) through 
                any additional means determined appropriate by the 
                Director.''.
SEC. 2054. CONSULTATION.

    Not later than 90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall consult with relevant 
Federal agencies, including the Food and Drug Administration, the Office 
of the National Coordinator for Health Information Technology, and the 
National Institutes of Health, as well as other stakeholders (including 
patients, researchers, physicians, industry representatives, and 
developers of health information technology) to receive recommendations 
with respect to enhancements to the clinical trial registry data bank 
under section 402(j) of the Public Health Service Act (42 U.S.C. 
282(j)), including with respect to usability, functionality, and search 
capability.

             Subtitle F--Facilitating Collaborative Research

SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE SYSTEM.

    Part P of title III of the Public Health Service Act (42 U.S.C. 280g 
et seq.) is amended by inserting after section 399S the following:

[[Page 130 STAT. 1077]]

``SEC. 399S-1. <<NOTE: 42 USC 280g-7a.>>  SURVEILLANCE OF 
                              NEUROLOGICAL DISEASES.

    ``(a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention and in coordination with 
other agencies as the Secretary determines, shall, as appropriate--
            ``(1) enhance and expand infrastructure and activities to 
        track the epidemiology of neurological diseases; and
            ``(2) incorporate information obtained through such 
        activities into an integrated surveillance system, which may 
        consist of or include a registry, to be known as the National 
        Neurological Conditions Surveillance System.

    ``(b) Research.--The Secretary shall ensure that the National 
Neurological Conditions Surveillance System is designed in a manner that 
facilitates further research on neurological diseases.
    ``(c) Content.--In carrying out subsection (a), the Secretary--
            ``(1) shall provide for the collection and storage of 
        information on the incidence and prevalence of neurological 
        diseases in the United States;
            ``(2) to the extent practicable, shall provide for the 
        collection and storage of other available information on 
        neurological diseases, including information related to persons 
        living with neurological diseases who choose to participate, 
        such as--
                    ``(A) demographics, such as age, race, ethnicity, 
                sex, geographic location, family history, and other 
                information, as appropriate;
                    ``(B) risk factors that may be associated with 
                neurological diseases, such as genetic and environmental 
                risk factors and other information, as appropriate; and
                    ``(C) diagnosis and progression markers;
            ``(3) may provide for the collection and storage of 
        information relevant to analysis on neurological diseases, such 
        as information concerning--
                    ``(A) the natural history of the diseases;
                    ``(B) the prevention of the diseases;
                    ``(C) the detection, management, and treatment 
                approaches for the diseases; and
                    ``(D) the development of outcomes measures;
            ``(4) may address issues identified during the consultation 
        process under subsection (d); and
            ``(5) initially may address a limited number of neurological 
        diseases.

    ``(d) Consultation.--In carrying out this section, the Secretary 
shall consult with individuals with appropriate expertise, which may 
include--
            ``(1) epidemiologists with experience in disease 
        surveillance or registries;
            ``(2) representatives of national voluntary health 
        associations that--
                    ``(A) focus on neurological diseases; and
                    ``(B) have demonstrated experience in research, 
                care, or patient services;
            ``(3) health information technology experts or other 
        information management specialists;
            ``(4) clinicians with expertise in neurological diseases; 
        and
            ``(5) research scientists with experience conducting 
        translational research or utilizing surveillance systems for 
        scientific research purposes.

[[Page 130 STAT. 1078]]

    ``(e) Grants.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, public or private nonprofit 
entities to carry out activities under this section.
    ``(f) Coordination With Other Federal, State, and Local Agencies.--
Subject to subsection (h), the Secretary shall--
            ``(1) make information and analysis in the National 
        Neurological Conditions Surveillance System available, as 
        appropriate--
                    ``(A) to Federal departments and agencies, such as 
                the National Institutes of Health and the Department of 
                Veterans Affairs; and
                    ``(B) to State and local agencies; and
            ``(2) identify, build upon, leverage, and coordinate among 
        existing data and surveillance systems, surveys, registries, and 
        other Federal public health infrastructure, wherever 
        practicable.

    ``(g) Public Access.--Subject to subsection (h), the Secretary shall 
ensure that information and analysis in the National Neurological 
Conditions Surveillance System are available, as appropriate, to the 
public, including researchers.
    ``(h) Privacy.--The Secretary shall ensure that information and 
analysis in the National Neurological Conditions Surveillance System are 
made available only to the extent permitted by applicable Federal and 
State law, and in a manner that protects personal privacy, to the extent 
required by applicable Federal and State privacy law, at a minimum.
    ``(i) Reports.--
            ``(1) Report on information and analyses.--Not later than 1 
        year after the date on which any system is established under 
        this section, the Secretary shall submit an interim report to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives regarding aggregate information collected 
        pursuant to this section and epidemiological analyses, as 
        appropriate. Such report shall be posted on the Internet website 
        of the Department of Health and Human Services and shall be 
        updated biennially.
            ``(2) Implementation report.--Not later than 4 years after 
        the date of the enactment of this section, the Secretary shall 
        submit a report to the Congress concerning the implementation of 
        this section. Such report shall include information on--
                    ``(A) the development and maintenance of the 
                National Neurological Conditions Surveillance System;
                    ``(B) the type of information collected and stored 
                in the surveillance system;
                    ``(C) the use and availability of such information, 
                including guidelines for such use; and
                    ``(D) the use and coordination of databases that 
                collect or maintain information on neurological 
                diseases.

    ``(j) Definition.--In this section, the term `national voluntary 
health association' means a national nonprofit organization with 
chapters, other affiliated organizations, or networks in States 
throughout the United States with experience serving the population of 
individuals with neurological disease and have demonstrated experience 
in neurological disease research, care, and patient services.

[[Page 130 STAT. 1079]]

    ``(k) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 2062. <<NOTE: 42 USC 284s.>>  TICK-BORNE DISEASES.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as ``the Secretary'') shall continue to 
conduct or support epidemiological, basic, translational, and clinical 
research related to vector-borne diseases, including tick-borne 
diseases.
    (b) Reports.--The Secretary shall ensure that each triennial report 
under section 403 of the Public Health Service Act (42 U.S.C. 283) (as 
amended by section 2032) includes information on actions undertaken by 
the National Institutes of Health to carry out subsection (a) with 
respect to tick-borne diseases.
    (c) Tick-borne Diseases Working Group.--
            (1) Establishment.--The Secretary shall establish a working 
        group, to be known as the Tick-Borne Disease Working Group 
        (referred to in this section as the ``Working Group''), 
        comprised of representatives of appropriate Federal agencies and 
        other non-Federal entities, to provide expertise and to review 
        all efforts within the Department of Health and Human Services 
        related to all tick-borne diseases, to help ensure interagency 
        coordination and minimize overlap, and to examine research 
        priorities.
            (2) Responsibilities.--The working group shall--
                    (A) not later than 2 years after the date of 
                enactment of this Act, develop or update a summary of--
                          (i) ongoing tick-borne disease research, 
                      including research related to causes, prevention, 
                      treatment, surveillance, diagnosis, diagnostics, 
                      duration of illness, and intervention for 
                      individuals with tick-borne diseases;
                          (ii) advances made pursuant to such research;
                          (iii) Federal activities related to tick-borne 
                      diseases, including--
                                    (I) epidemiological activities 
                                related to tick-borne diseases; and
                                    (II) basic, clinical, and 
                                translational tick-borne disease 
                                research related to the pathogenesis, 
                                prevention, diagnosis, and treatment of 
                                tick-borne diseases;
                          (iv) gaps in tick-borne disease research 
                      described in clause (iii)(II);
                          (v) the Working Group's meetings required 
                      under paragraph (4); and
                          (vi) the comments received by the Working 
                      Group;
                    (B) make recommendations to the Secretary regarding 
                any appropriate changes or improvements to such 
                activities and research; and
                    (C) solicit input from States, localities, and 
                nongovernmental entities, including organizations 
                representing patients, health care providers, 
                researchers, and industry regarding scientific advances, 
                research questions, surveillance activities, and 
                emerging strains in species of pathogenic organisms.

[[Page 130 STAT. 1080]]

            (3) Membership.--The members of the working group shall 
        represent a diversity of scientific disciplines and views and 
        shall be composed of the following members:
                    (A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of each of the 
                following:
                          (i) The Office of the Assistant Secretary for 
                      Health.
                          (ii) The Food and Drug Administration.
                          (iii) The Centers for Disease Control and 
                      Prevention.
                          (iv) The National Institutes of Health.
                          (v) Such other agencies and offices of the 
                      Department of Health and Human Services as the 
                      Secretary determines appropriate.
                    (B) Non-Federal public members.--Seven non-Federal 
                public members, consisting of representatives of the 
                following categories:
                          (i) Physicians and other medical providers 
                      with experience in diagnosing and treating tick-
                      borne diseases.
                          (ii) Scientists or researchers with expertise.
                          (iii) Patients and their family members.
                          (iv) Nonprofit organizations that advocate for 
                      patients with respect to tick-borne diseases.
                          (v) Other individuals whose expertise is 
                      determined by the Secretary to be beneficial to 
                      the functioning of the Working Group.
            (4) Meetings.--The Working Group shall meet not less than 
        twice each year.
            (5) Reporting.--Not later than 2 years after the date of 
        enactment of this Act, and every 2 years thereafter until 
        termination of the Working Group pursuant to paragraph (7), the 
        Working Group shall--
                    (A) submit a report on its activities under 
                paragraph (2)(A) and any recommendations under paragraph 
                (2)(B) to the Secretary, the Committee on Energy and 
                Commerce of the House of Representatives, and the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate; and
                    (B) make such report publicly available on the 
                Internet website of the Department of Health and Human 
                Services.
            (6) Applicability of faca.--The Working Group shall be 
        treated as an advisory committee subject to the Federal Advisory 
        Committee Act (5 U.S.C. App.).
            (7) Sunset.--The Working Group under this section shall 
        terminate 6 years after the date of enactment of this Act.
SEC. 2063. <<NOTE: 42 USC 1320d-2 note.>>  ACCESSING, SHARING, AND 
                          USING HEALTH DATA FOR RESEARCH PURPOSES.

    (a) Guidance Related to Remote Access.--Not later than 1 year after 
the date of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ``Secretary'') shall issue 
guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii) 
of part 164 of the Rule (prohibiting the removal of protected health 
information by a researcher) does not prohibit remote access to health 
information by a researcher for such purposes as described in section 
164.512(i)(1)(ii) of part 164 of the Rule so long as--

[[Page 130 STAT. 1081]]

            (1) at a minimum, security and privacy safeguards, 
        consistent with the requirements of the Rule, are maintained by 
        the covered entity and the researcher; and
            (2) the protected health information is not copied or 
        otherwise retained by the researcher.

    (b) Guidance Related to Streamlining Authorization.--Not later than 
1 year after the date of enactment of this Act, the Secretary shall 
issue guidance on the following:
            (1) Authorization for use and disclosure of health 
        information.--Clarification of the circumstances under which the 
        authorization for the use or disclosure of protected health 
        information, with respect to an individual, for future research 
        purposes contains a sufficient description of the purpose of the 
        use or disclosure, such as if the authorization--
                    (A) sufficiently describes the purposes such that it 
                would be reasonable for the individual to expect that 
                the protected health information could be used or 
                disclosed for such future research;
                    (B) either--
                          (i) states that the authorization will expire 
                      on a particular date or on the occurrence of a 
                      particular event; or
                          (ii) states that the authorization will remain 
                      valid unless and until it is revoked by the 
                      individual; and
                    (C) provides instruction to the individual on how to 
                revoke such authorization at any time.
            (2) Reminder of the right to revoke.--Clarification of the 
        circumstances under which it is appropriate to provide an 
        individual with an annual notice or reminder that the individual 
        has the right to revoke such authorization.
            (3) Revocation of authorization.--Clarification of 
        appropriate mechanisms by which an individual may revoke an 
        authorization for future research purposes, such as described in 
        paragraph (1)(C).

    (c) Working Group on Protected Health Information for Research.--
            (1) Establishment.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall convene a working 
        group to study and report on the uses and disclosures of 
        protected health information for research purposes, under the 
        Health Insurance Portability and Accountability Act of 1996 
        (Public Law 104-191).
            (2) Members.--The working group shall include 
        representatives of--
                    (A) relevant Federal agencies, including the 
                National Institutes of Health, the Centers for Disease 
                Control and Prevention, the Food and Drug 
                Administration, and the Office for Civil Rights;
                    (B) the research community;
                    (C) patients;
                    (D) experts in civil rights, such as privacy rights;
                    (E) developers of health information technology;
                    (F) experts in data privacy and security;
                    (G) health care providers;
                    (H) bioethicists; and
                    (I) other experts and entities, as the Secretary 
                determines appropriate.

[[Page 130 STAT. 1082]]

            (3) Report.--Not later than 1 year after the date on which 
        the working group is convened under paragraph (1), the working 
        group shall conduct a review and submit a report to the 
        Secretary containing recommendations on whether the uses and 
        disclosures of protected health information for research 
        purposes should be modified to allow protected health 
        information to be available, as appropriate, for research 
        purposes, including studies to obtain generalizable knowledge, 
        while protecting individuals' privacy rights. In conducting the 
        review and making recommendations, the working group shall--
                    (A) address, at a minimum--
                          (i) the appropriate manner and timing of 
                      authorization, including whether additional 
                      notification to the individual should be required 
                      when the individual's protected health information 
                      will be used or disclosed for such research;
                          (ii) opportunities for individuals to set 
                      preferences on the manner in which their protected 
                      health information is used in research;
                          (iii) opportunities for patients to revoke 
                      authorization;
                          (iv) notification to individuals of a breach 
                      in privacy;
                          (v) existing gaps in statute, regulation, or 
                      policy related to protecting the privacy of 
                      individuals, and
                          (vi) existing barriers to research related to 
                      the current restrictions on the uses and 
                      disclosures of protected health information; and
                    (B) consider, at a minimum--
                          (i) expectations and preferences on how an 
                      individual's protected health information is 
                      shared and used;
                          (ii) issues related to specific subgroups of 
                      people, such as children, incarcerated 
                      individuals, and individuals with a cognitive or 
                      intellectual disability impacting capacity to 
                      consent;
                          (iii) relevant Federal and State laws;
                          (iv) models of facilitating data access and 
                      levels of data access, including data 
                      segmentation, where applicable;
                          (v) potential impacts of disclosure and non-
                      disclosure of protected health information on 
                      access to health care services; and
                          (vi) the potential uses of such data.
            (4) Report submission.--The Secretary shall submit the 
        report under paragraph (3) to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives, and 
        shall post such report on the appropriate Internet website of 
        the Department of Health and Human Services.
            (5) Termination.--The working group convened under paragraph 
        (1) shall terminate the day after the report under paragraph (3) 
        is submitted to Congress and made public in accordance with 
        paragraph (4).

    (d) Definitions.--In this section:

[[Page 130 STAT. 1083]]

            (1) The rule.--References to ``the Rule'' refer to part 160 
        or part 164, as appropriate, of title 45, Code of Federal 
        Regulations (or any successor regulation).
            (2) Part 164.--References to a specified section of ``part 
        164'', refer to such specified section of part 164 of title 45, 
        Code of Federal Regulations (or any successor section).

                Subtitle G--Promoting Pediatric Research

SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.

    Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d)) 
is amended--
            (1) in paragraph (1), by striking ``in consultation with the 
        Director of the Eunice Kennedy Shriver National Institute of 
        Child Health and Human Development and in collaboration with 
        other appropriate national research institutes and national 
        centers that carry out activities involving pediatric research, 
        may provide for the establishment of'' and inserting ``in 
        collaboration with the national research institutes and national 
        centers that carry out activities involving pediatric research, 
        shall support''; and
            (2) in paragraph (2)(A) and the first sentence of paragraph 
        (2)(E), by striking ``may'' each place such term appears and 
        inserting ``shall''.
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.

    It is the sense of Congress that--
            (1) the National Institutes of Health should encourage a 
        global pediatric clinical study network by providing grants, 
        contracts, or cooperative agreements to support new and early 
        stage investigators who participate in the global pediatric 
        clinical study network;
            (2) the Secretary of Health and Human Services (referred to 
        in this section as the ``Secretary'') should engage with 
        clinical investigators and appropriate authorities outside of 
        the United States, including authorities in the European Union, 
        during the formation of the global pediatric clinical study 
        network to encourage the participation of such investigator and 
        authorities; and
            (3) once a global pediatric clinical study network is 
        established and becomes operational, the Secretary should 
        continue to encourage and facilitate the participation of 
        clinical investigators and appropriate authorities outside of 
        the United States, including in the European Union, to 
        participate in the network with the goal of enhancing the global 
        reach of the network.

                         TITLE III--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

SEC. 3001. PATIENT EXPERIENCE DATA.

    Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-8c) is amended--

[[Page 130 STAT. 1084]]

            (1) in subsection (a)--
                    (A) in the subsection heading, by striking ``In 
                General'' and inserting ``Patient Engagement in Drugs 
                and Devices'';
                    (B) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively, and moving such 
                subparagraphs 2 ems to the right; and
                    (C) by striking ``The Secretary'' and inserting the 
                following:
            ``(1) In general.--The Secretary'';
            (2) by redesignating subsections (b) through (e) as 
        paragraphs (2) through (5), respectively, and moving such 
        paragraphs 2 ems to the right; and
            (3) by adding at the end the following:

    ``(b) Statement of Patient Experience.--
            ``(1) In general.--Following the approval of an application 
        that was submitted under section 505(b) of this Act or section 
        351(a) of the Public Health Service Act at least 180 days after 
        the date of enactment of the 21st Century Cures Act, the 
        Secretary shall make public a brief statement regarding the 
        patient experience data and related information, if any, 
        submitted and reviewed as part of such application.
            ``(2) Data and information.--The data and information 
        referred to in paragraph (1) are--
                    ``(A) patient experience data;
                    ``(B) information on patient-focused drug 
                development tools; and
                    ``(C) other relevant information, as determined by 
                the Secretary.

    ``(c) Patient Experience Data.--For purposes of this section, the 
term `patient experience data' includes data that--
            ``(1) are collected by any persons (including patients, 
        family members and caregivers of patients, patient advocacy 
        organizations, disease research foundations, researchers, and 
        drug manufacturers); and
            ``(2) are intended to provide information about patients' 
        experiences with a disease or condition, including--
                    ``(A) the impact of such disease or condition, or a 
                related therapy, on patients' lives; and
                    ``(B) patient preferences with respect to treatment 
                of such disease or condition.''.
SEC. 3002. <<NOTE: 21 USC 360bbb-8c note.>>  PATIENT-FOCUSED DRUG 
                          DEVELOPMENT GUIDANCE.

    (a) Publication of Guidance Documents.--Not later than 180 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ``Secretary''), 
acting through the Commissioner of Food and Drugs, shall develop a plan 
to issue draft and final versions of one or more guidance documents, 
over a period of 5 years, regarding the collection of patient experience 
data, and the use of such data and related information in drug 
development. Not later than 18 months after the date of enactment of 
this Act, the Secretary shall issue a draft version of at least one such 
guidance document. Not later than 18 months after the public comment 
period on the draft guidance ends, the Secretary shall issue a revised 
draft guidance or final guidance.

[[Page 130 STAT. 1085]]

    (b) Patient Experience Data.--For purposes of this section, the term 
``patient experience data'' has the meaning given such term in section 
569C of the Federal Food, Drug, and Cosmetic Act (as added by section 
3001).
    (c) Contents.--The guidance documents described in subsection (a) 
shall address--
            (1) methodological approaches that a person seeking to 
        collect patient experience data for submission to, and proposed 
        use by, the Secretary in regulatory decisionmaking may use, that 
        are relevant and objective and ensure that such data are 
        accurate and representative of the intended population, 
        including methods to collect meaningful patient input throughout 
        the drug development process and methodological considerations 
        for data collection, reporting, management, and analysis;
            (2) methodological approaches that may be used to develop 
        and identify what is most important to patients with respect to 
        burden of disease, burden of treatment, and the benefits and 
        risks in the management of the patient's disease;
            (3) approaches to identifying and developing methods to 
        measure impacts to patients that will help facilitate collection 
        of patient experience data in clinical trials;
            (4) methodologies, standards, and technologies to collect 
        and analyze clinical outcome assessments for purposes of 
        regulatory decisionmaking;
            (5) how a person seeking to develop and submit proposed 
        draft guidance relating to patient experience data for 
        consideration by the Secretary may submit such proposed draft 
        guidance to the Secretary;
            (6) the format and content required for submissions under 
        this section to the Secretary, including with respect to the 
        information described in paragraph (1);
            (7) how the Secretary intends to respond to submissions of 
        information described in paragraph (1), if applicable, including 
        any timeframe for response when such submission is not part of a 
        regulatory application or other submission that has an 
        associated timeframe for response; and
            (8) how the Secretary, if appropriate, anticipates using 
        relevant patient experience data and related information, 
        including with respect to the structured risk-benefit assessment 
        framework described in section 505(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory 
        decisionmaking.
SEC. 3003. <<NOTE: 21 USC 360bbb-8c note.>>  STREAMLINING PATIENT 
                          INPUT.

    Chapter 35 of title 44, United States Code, shall not apply to the 
collection of information to which a response is voluntary, that is 
initiated by the Secretary under section 569C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-8c) (as amended by section 3001) or 
section 3002.
SEC. 3004. <<NOTE: 21 USC 355 note.>>  REPORT ON PATIENT 
                          EXPERIENCE DRUG DEVELOPMENT.

    Not later than June 1 of 2021, 2026, and 2031, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall prepare and publish on the Internet website of the Food and 
Drug Administration a report assessing the use of patient experience 
data in regulatory decisionmaking, in particular with respect to the 
review of patient experience data and information on patient-focused 
drug development tools as part

[[Page 130 STAT. 1086]]

of applications approved under section 505(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public 
Health Service Act (42 U.S.C. 262(a)).

                Subtitle B--Advancing New Drug Therapies

SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following new section:
``SEC. 507. <<NOTE: 21 USC 357.>>  QUALIFICATION OF DRUG 
                        DEVELOPMENT TOOLS.

    ``(a) Process for Qualification.--
            ``(1) In general.--The Secretary shall establish a process 
        for the qualification of drug development tools for a proposed 
        context of use under which--
                    ``(A)(i) a requestor initiates such process by 
                submitting a letter of intent to the Secretary; and
                    ``(ii) the Secretary accepts or declines to accept 
                such letter of intent;
                    ``(B)(i) if the Secretary accepts the letter of 
                intent, a requestor submits a qualification plan to the 
                Secretary; and
                    ``(ii) the Secretary accepts or declines to accept 
                the qualification plan; and
                    ``(C)(i) if the Secretary accepts the qualification 
                plan, the requestor submits to the Secretary a full 
                qualification package;
                    ``(ii) the Secretary determines whether to accept 
                such qualification package for review; and
                    ``(iii) if the Secretary accepts such qualification 
                package for review, the Secretary conducts such review 
                in accordance with this section.
            ``(2) Acceptance and review of submissions.--
                    ``(A) In general.--Subparagraphs (B), (C), and (D) 
                shall apply with respect to the treatment of a letter of 
                intent, a qualification plan, or a full qualification 
                package submitted under paragraph (1) (referred to in 
                this paragraph as `qualification submissions').
                    ``(B) Acceptance factors; nonacceptance.--The 
                Secretary shall determine whether to accept a 
                qualification submission based on factors which may 
                include the scientific merit of the qualification 
                submission. A determination not to accept a submission 
                under paragraph (1) shall not be construed as a final 
                determination by the Secretary under this section 
                regarding the qualification of a drug development tool 
                for its proposed context of use.
                    ``(C) Prioritization of qualification review.--The 
                Secretary may prioritize the review of a full 
                qualification package submitted under paragraph (1) with 
                respect to a drug development tool, based on factors 
                determined appropriate by the Secretary, including--
                          ``(i) as applicable, the severity, rarity, or 
                      prevalence of the disease or condition targeted by 
                      the drug

[[Page 130 STAT. 1087]]

                      development tool and the availability or lack of 
                      alternative treatments for such disease or 
                      condition; and
                          ``(ii) the identification, by the Secretary or 
                      by biomedical research consortia and other expert 
                      stakeholders, of such a drug development tool and 
                      its proposed context of use as a public health 
                      priority.
                    ``(D) Engagement of external experts.--The Secretary 
                may, for purposes of the review of qualification 
                submissions, through the use of cooperative agreements, 
                grants, or other appropriate mechanisms, consult with 
                biomedical research consortia and may consider the 
                recommendations of such consortia with respect to the 
                review of any qualification plan submitted under 
                paragraph (1) or the review of any full qualification 
                package under paragraph (3).
            ``(3) Review of full qualification package.--The Secretary 
        shall--
                    ``(A) conduct a comprehensive review of a full 
                qualification package accepted under paragraph (1)(C); 
                and
                    ``(B) determine whether the drug development tool at 
                issue is qualified for its proposed context of use.
            ``(4) Qualification.--The Secretary shall determine whether 
        a drug development tool is qualified for a proposed context of 
        use based on the scientific merit of a full qualification 
        package reviewed under paragraph (3).

    ``(b) Effect of Qualification.--
            ``(1) In general.--A drug development tool determined to be 
        qualified under subsection (a)(4) for a proposed context of use 
        specified by the requestor may be used by any person in such 
        context of use for the purposes described in paragraph (2).
            ``(2) Use of a drug development tool.--Subject to paragraph 
        (3), a drug development tool qualified under this section may be 
        used for--
                    ``(A) supporting or obtaining approval or licensure 
                (as applicable) of a drug or biological product 
                (including in accordance with section 506(c)) under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act; or
                    ``(B) supporting the investigational use of a drug 
                or biological product under section 505(i) of this Act 
                or section 351(a)(3) of the Public Health Service Act.
            ``(3) Rescission or modification.--
                    ``(A) In general.--The Secretary may rescind or 
                modify a determination under this section to qualify a 
                drug development tool if the Secretary determines that 
                the drug development tool is not appropriate for the 
                proposed context of use specified by the requestor. Such 
                a determination may be based on new information that 
                calls into question the basis for such qualification.
                    ``(B) Meeting for review.--If the Secretary rescinds 
                or modifies under subparagraph (A) a determination to 
                qualify a drug development tool, the requestor involved 
                shall, on request, be granted a meeting with the 
                Secretary to discuss the basis of the Secretary's 
                decision to rescind or modify the determination before 
                the effective date of the rescission or modification.

    ``(c) Transparency.--

[[Page 130 STAT. 1088]]

            ``(1) In general.--Subject to paragraph (3), the Secretary 
        shall make publicly available, and update on at least a biannual 
        basis, on the Internet website of the Food and Drug 
        Administration the following:
                    ``(A) Information with respect to each qualification 
                submission under the qualification process under 
                subsection (a), including--
                          ``(i) the stage of the review process 
                      applicable to the submission;
                          ``(ii) the date of the most recent change in 
                      stage status;
                          ``(iii) whether external scientific experts 
                      were utilized in the development of a 
                      qualification plan or the review of a full 
                      qualification package; and
                          ``(iv) submissions from requestors under the 
                      qualification process under subsection (a), 
                      including any data and evidence contained in such 
                      submissions, and any updates to such submissions.
                    ``(B) The Secretary's formal written determinations 
                in response to such qualification submissions.
                    ``(C) Any rescissions or modifications under 
                subsection (b)(3) of a determination to qualify a drug 
                development tool.
                    ``(D) Summary reviews that document conclusions and 
                recommendations for determinations to qualify drug 
                development tools under subsection (a).
                    ``(E) A comprehensive list of--
                          ``(i) all drug development tools qualified 
                      under subsection (a); and
                          ``(ii) all surrogate endpoints which were the 
                      basis of approval or licensure (as applicable) of 
                      a drug or biological product (including in 
                      accordance with section 506(c)) under section 505 
                      of this Act or section 351 of the Public Health 
                      Service Act.
            ``(2) Relation to trade secrets act.--Information made 
        publicly available by the Secretary under paragraph (1) shall be 
        considered a disclosure authorized by law for purposes of 
        section 1905 of title 18, United States Code.
            ``(3) Applicability.--Nothing in this section shall be 
        construed as authorizing the Secretary to disclose any 
        information contained in an application submitted under section 
        505 of this Act or section 351 of the Public Health Service Act 
        that is confidential commercial or trade secret information 
        subject to section 552(b)(4) of title 5, United States Code, or 
        section 1905 of title 18, United States Code.

    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) to alter the standards of evidence under subsection 
        (c) or (d) of section 505, including the substantial evidence 
        standard in such subsection (d), or under section 351 of the 
        Public Health Service Act (as applicable); or
            ``(2) to limit the authority of the Secretary to approve or 
        license products under this Act or the Public Health Service 
        Act, as applicable (as in effect before the date of the 
        enactment of the 21st Century Cures Act).

    ``(e) Definitions.--In this section:
            ``(1) Biomarker.--The term `biomarker'--

[[Page 130 STAT. 1089]]

                    ``(A) means a characteristic (such as a physiologic, 
                pathologic, or anatomic characteristic or measurement) 
                that is objectively measured and evaluated as an 
                indicator of normal biologic processes, pathologic 
                processes, or biological responses to a therapeutic 
                intervention; and
                    ``(B) includes a surrogate endpoint.
            ``(2) Biomedical research consortia.--The term `biomedical 
        research consortia' means collaborative groups that may take the 
        form of public-private partnerships and may include government 
        agencies, institutions of higher education (as defined in 
        section 101(a) of the Higher Education Act of 1965), patient 
        advocacy groups, industry representatives, clinical and 
        scientific experts, and other relevant entities and individuals.
            ``(3) Clinical outcome assessment.--The term `clinical 
        outcome assessment' means--
                    ``(A) a measurement of a patient's symptoms, overall 
                mental state, or the effects of a disease or condition 
                on how the patient functions; and
                    ``(B) includes a patient-reported outcome.
            ``(4) Context of use.--The term `context of use' means, with 
        respect to a drug development tool, the circumstances under 
        which the drug development tool is to be used in drug 
        development and regulatory review.
            ``(5) Drug development tool.--The term `drug development 
        tool' includes--
                    ``(A) a biomarker;
                    ``(B) a clinical outcome assessment; and
                    ``(C) any other method, material, or measure that 
                the Secretary determines aids drug development and 
                regulatory review for purposes of this section.
            ``(6) Patient-reported outcome.--The term `patient-reported 
        outcome' means a measurement based on a report from a patient 
        regarding the status of the patient's health condition without 
        amendment or interpretation of the patient's report by a 
        clinician or any other person.
            ``(7) Qualification.--The terms `qualification' and 
        `qualified' mean a determination by the Secretary that a drug 
        development tool and its proposed context of use can be relied 
        upon to have a specific interpretation and application in drug 
        development and regulatory review under this Act.
            ``(8) Requestor.--The term `requestor' means an entity or 
        entities, including a drug sponsor or a biomedical research 
        consortia, seeking to qualify a drug development tool for a 
        proposed context of use under this section.
            ``(9) Surrogate endpoint.--The term `surrogate endpoint' 
        means a marker, such as a laboratory measurement, radiographic 
        image, physical sign, or other measure, that is not itself a 
        direct measurement of clinical benefit, and--
                    ``(A) is known to predict clinical benefit and could 
                be used to support traditional approval of a drug or 
                biological product; or
                    ``(B) is reasonably likely to predict clinical 
                benefit and could be used to support the accelerated 
                approval of a drug or biological product in accordance 
                with section 506(c).''.

    (b) <<NOTE: 21 USC 357 note.>>  Guidance.--

[[Page 130 STAT. 1090]]

            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') shall, in 
        consultation with biomedical research consortia (as defined in 
        subsection (e) of section 507 of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsection (a)) and other interested 
        parties through a collaborative public process, issue guidance 
        to implement such section 507 that--
                    (A) provides a conceptual framework describing 
                appropriate standards and scientific approaches to 
                support the development of biomarkers delineated under 
                the taxonomy established under paragraph (3);
                    (B) with respect to the qualification process under 
                such section 507--
                          (i) describes the requirements that entities 
                      seeking to qualify a drug development tool under 
                      such section shall observe when engaging in such 
                      process;
                          (ii) outlines reasonable timeframes for the 
                      Secretary's review of letters, qualification 
                      plans, or full qualification packages submitted 
                      under such process; and
                          (iii) establishes a process by which such 
                      entities or the Secretary may consult with 
                      biomedical research consortia and other 
                      individuals and entities with expert knowledge and 
                      insights that may assist the Secretary in the 
                      review of qualification plans and full 
                      qualification submissions under such section; and
                    (C) includes such other information as the Secretary 
                determines appropriate.
            (2) Timing.--Not later than 3 years after the date of the 
        enactment of this Act, the Secretary shall issue draft guidance 
        under paragraph (1) on the implementation of section 507 of the 
        Federal Food, Drug, and Cosmetic Act (as added by subsection 
        (a)). The Secretary shall issue final guidance on the 
        implementation of such section not later than 6 months after the 
        date on which the comment period for the draft guidance closes.
            (3) Taxonomy.--
                    (A) In general.--For purposes of informing guidance 
                under this subsection, the Secretary shall, in 
                consultation with biomedical research consortia and 
                other interested parties through a collaborative public 
                process, establish a taxonomy for the classification of 
                biomarkers (and related scientific concepts) for use in 
                drug development.
                    (B) Public availability.--Not later than 2 years 
                after the date of the enactment of this Act, the 
                Secretary shall make such taxonomy publicly available in 
                draft form for public comment. The Secretary shall 
                finalize the taxonomy not later than 1 year after the 
                close of the public comment period.

    (c) Meeting and Report.--
            (1) Meeting.--Not later than 2 years after the date of the 
        enactment of this Act, the Secretary shall convene a public 
        meeting to describe and solicit public input regarding the 
        qualification process under section 507 of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (a).

[[Page 130 STAT. 1091]]

            (2) Report.--Not later than 5 years after the date of the 
        enactment of this Act, the Secretary shall make publicly 
        available on the Internet website of the Food and Drug 
        Administration a report. Such report shall include, with respect 
        to the qualification process under section 507 of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a), 
        information on--
                    (A) the number of requests submitted, as a letter of 
                intent, for qualification of a drug development tool (as 
                defined in subsection (e) of such section 507);
                    (B) the number of such requests accepted and 
                determined to be eligible for submission of a 
                qualification plan or full qualification package (as 
                such terms are defined in subsection (e) of such section 
                507), respectively;
                    (C) the number of such requests for which external 
                scientific experts were utilized in the development of a 
                qualification plan or review of a full qualification 
                package;
                    (D) the number of qualification plans and full 
                qualification packages, respectively, submitted to the 
                Secretary; and
                    (E) the drug development tools qualified through 
                such qualification process, specified by type of tool, 
                such as a biomarker or clinical outcome assessment (as 
                such terms are defined in subsection (e) of such section 
                507).
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.

    Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529 
the following:
``SEC. 529A. <<NOTE: 21 USC 360ff-1.>>  TARGETED DRUGS FOR RARE 
                          DISEASES.

    ``(a) Purpose.--The purpose of this section, through the approach 
provided for in subsection (b), is to--
            ``(1) facilitate the development, review, and approval of 
        genetically targeted drugs and variant protein targeted drugs to 
        address an unmet medical need in one or more patient subgroups, 
        including subgroups of patients with different mutations of a 
        gene, with respect to rare diseases or conditions that are 
        serious or life-threatening; and
            ``(2) maximize the use of scientific tools or methods, 
        including surrogate endpoints and other biomarkers, for such 
        purposes.

    ``(b) Leveraging of Data From Previously Approved Drug Application 
or Applications.--The Secretary may, consistent with applicable 
standards for approval under this Act or section 351(a) of the Public 
Health Service Act, allow the sponsor of an application under section 
505(b)(1) of this Act or section 351(a) of the Public Health Service Act 
for a genetically targeted drug or a variant protein targeted drug to 
rely upon data and information--
            ``(1) previously developed by the same sponsor (or another 
        sponsor that has provided the sponsor with a contractual right 
        of reference to such data and information); and
            ``(2) submitted by a sponsor described in paragraph (1) in 
        support of one or more previously approved applications that 
        were submitted under section 505(b)(1) of this Act or section 
        351(a) of the Public Health Service Act,

for a drug that incorporates or utilizes the same or similar genetically 
targeted technology as the drug or drugs that are the subject

[[Page 130 STAT. 1092]]

of an application or applications described in paragraph (2) or for a 
variant protein targeted drug that is the same or incorporates or 
utilizes the same variant protein targeted drug, as the drug or drugs 
that are the subject of an application or applications described in 
paragraph (2).
    ``(c) Definitions.--For purposes of this section--
            ``(1) the term `genetically targeted drug' means a drug 
        that--
                    ``(A) is the subject of an application under section 
                505(b)(1) of this Act or section 351(a) of the Public 
                Health Service Act for the treatment of a rare disease 
                or condition (as such term is defined in section 526) 
                that is serious or life-threatening;
                    ``(B) may result in the modulation (including 
                suppression, up-regulation, or activation) of the 
                function of a gene or its associated gene product; and
                    ``(C) incorporates or utilizes a genetically 
                targeted technology;
            ``(2) the term `genetically targeted technology' means a 
        technology comprising non-replicating nucleic acid or analogous 
        compounds with a common or similar chemistry that is intended to 
        treat one or more patient subgroups, including subgroups of 
        patients with different mutations of a gene, with the same 
        disease or condition, including a disease or condition due to 
        other variants in the same gene; and
            ``(3) the term `variant protein targeted drug' means a drug 
        that--
                    ``(A) is the subject of an application under section 
                505(b)(1) of this Act or section 351(a) of the Public 
                Health Service Act for the treatment of a rare disease 
                or condition (as such term is defined in section 526) 
                that is serious or life-threatening;
                    ``(B) modulates the function of a product of a 
                mutated gene where such mutation is responsible in whole 
                or in part for a given disease or condition; and
                    ``(C) is intended to treat one or more patient 
                subgroups, including subgroups of patients with 
                different mutations of a gene, with the same disease or 
                condition.

    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to--
            ``(1) alter the authority of the Secretary to approve drugs 
        pursuant to this Act or section 351 of the Public Health Service 
        Act (as authorized prior to the date of enactment of the 21st 
        Century Cures Act), including the standards of evidence, and 
        applicable conditions, for approval under such applicable Act; 
        or
            ``(2) confer any new rights, beyond those authorized under 
        this Act or the Public Health Service Act prior to enactment of 
        this section, with respect to the permissibility of a sponsor 
        referencing information contained in another application 
        submitted under section 505(b)(1) of this Act or section 351(a) 
        of the Public Health Service Act.''.

[[Page 130 STAT. 1093]]

SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR 
                          RARE PEDIATRIC DISEASES.

    (a) In General.--Section 529(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) 
and inserting the following:
            ``(5) Termination of authority.--The Secretary may not award 
        any priority review vouchers under paragraph (1) after September 
        30, 2020, unless the rare pediatric disease product 
        application--
                    ``(A) is for a drug that, not later than September 
                30, 2020, is designated under subsection (d) as a drug 
                for a rare pediatric disease; and
                    ``(B) is, not later than September 30, 2022, 
                approved under section 505(b)(1) of this Act or section 
                351(a) of the Public Health Service Act.''.

    (b) Report.--The Advancing Hope Act of 2016 (Public Law 114-229) is 
amended by striking section 3.
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.

    (a) Study.--The Comptroller General of the United States (referred 
to in this section as the ``Comptroller General'') shall conduct a study 
addressing the effectiveness and overall impact of the following 
priority review voucher programs, including any such programs amended or 
established by this Act:
            (1) The neglected tropical disease priority review voucher 
        program under section 524 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360n).
            (2) The rare pediatric disease priority review voucher 
        program under section 529 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360ff).
            (3) The medical countermeasure priority review voucher 
        program under section 565A of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3086.

    (b) Issuance of Report.--Not later than January 31, 2020, the 
Comptroller General shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report containing the results 
of the study under subsection (a).
    (c) Contents of Reports.--The report submitted under subsection (b) 
shall address--
            (1) for each drug for which a priority review voucher has 
        been awarded as of initiation of the study--
                    (A) the indications for which the drug is approved 
                under section 505(c) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(c)), pursuant to an 
                application under section 505(b)(1) of such Act, or 
                licensed under section 351(a) of the Public Health 
                Service Act (42 U.S.C. 262(a));
                    (B) whether, and to what extent, the voucher 
                impacted the sponsor's decision to develop the drug; and
                    (C) whether, and to what extent, the approval or 
                licensure of the drug, as applicable and appropriate--
                          (i) addressed a global unmet need related to 
                      the treatment or prevention of a neglected 
                      tropical disease, including whether the sponsor of 
                      a drug coordinated with international development 
                      organizations;

[[Page 130 STAT. 1094]]

                          (ii) addressed an unmet need related to the 
                      treatment of a rare pediatric disease; or
                          (iii) affected the Nation's preparedness 
                      against a chemical, biological, radiological, or 
                      nuclear threat, including naturally occurring 
                      threats;
            (2) for each drug for which a priority review voucher has 
        been used--
                    (A) the indications for which such drug is approved 
                under section 505(c) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(c)), pursuant to an 
                application under section 505(b)(1) of such Act, or 
                licensed under section 351(a) of the Public Health 
                Service Act (42 U.S.C. 262);
                    (B) the value of the voucher, if transferred; and
                    (C) the length of time between the date on which the 
                voucher was awarded and the date on which the voucher 
                was used; and
            (3) an analysis of the priority review voucher programs 
        described in subsection (a), including--
                    (A) the resources used by the Food and Drug 
                Administration in reviewing drugs for which vouchers 
                were used, including the effect of the programs on the 
                Food and Drug Administration's review of drugs for which 
                priority review vouchers were not awarded or used;
                    (B) whether any improvements to such programs are 
                necessary to appropriately target incentives for the 
                development of drugs that would likely not otherwise be 
                developed, or developed in as timely a manner, and, as 
                applicable and appropriate--
                          (i) address global unmet needs related to the 
                      treatment or prevention of neglected tropical 
                      diseases, including in countries in which 
                      neglected tropical diseases are endemic; or
                          (ii) address unmet needs related to the 
                      treatment of rare pediatric diseases; and
                    (C) whether the sunset of the rare pediatric disease 
                program and medical countermeasure program has had an 
                impact on the program, including any potential 
                unintended consequences.

    (d) Protection of National Security.--The Comptroller General shall 
conduct the study and issue reports under this section in a manner that 
does not compromise national security.
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.

    Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
            (1) in subsection (a), by striking paragraph (1) and 
        inserting the following: ``(1) defraying the costs of developing 
        drugs for rare diseases or conditions, including qualified 
        testing expenses,''; and
            (2) in subsection (b)(1)--
                    (A) in subparagraph (A)(ii), by striking ``and'' 
                after the semicolon;
                    (B) in subparagraph (B), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:

[[Page 130 STAT. 1095]]

                    ``(C) prospectively planned and designed 
                observational studies and other analyses conducted to 
                assist in the understanding of the natural history of a 
                rare disease or condition and in the development of a 
                therapy, including studies and analyses to--
                          ``(i) develop or validate a drug development 
                      tool related to a rare disease or condition; or
                          ``(ii) understand the full spectrum of the 
                      disease manifestations, including describing 
                      genotypic and phenotypic variability and 
                      identifying and defining distinct subpopulations 
                      affected by a rare disease or condition.''.
SEC. 3016. <<NOTE: 21 USC 399h.>>  GRANTS FOR STUDYING CONTINUOUS 
                          DRUG MANUFACTURING.

    (a) In General.--The Secretary of Health and Human Services may 
award grants to institutions of higher education and nonprofit 
organizations for the purpose of studying and recommending improvements 
to the process of continuous manufacturing of drugs and biological 
products and similar innovative monitoring and control techniques.
    (b) Definitions.--In this section--
            (1) the term ``drug'' has the meaning given such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321);
            (2) the term ``biological product'' has the meaning given 
        such term in section 351(i) of the Public Health Service Act (42 
        U.S.C. 262(i)); and
            (3) the term ``institution of higher education'' has the 
        meaning given such term in section 101(a) of the Higher 
        Education Act of 1965 (20 U.S.C. 1001(a)).

        Subtitle C--Modern Trial Design and Evidence Development

SEC. 3021. <<NOTE: 21 USC 355 note.>>  NOVEL CLINICAL TRIAL 
                          DESIGNS.

    (a) Proposals for Use of Novel Clinical Trial Designs for Drugs and 
Biological Products.--For purposes of assisting sponsors in 
incorporating complex adaptive and other novel trial designs into 
proposed clinical protocols and applications for new drugs under section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 
biological products under section 351 of the Public Health Service Act 
(42 U.S.C. 262), the Secretary of Health and Human Services (referred to 
in this section as the ``Secretary'') shall conduct a public meeting and 
issue guidance in accordance with subsection (b).
    (b) Guidance Addressing Use of Novel Clinical Trial Designs.--
            (1) In general.--The Secretary, acting through the 
        Commissioner of Food and Drugs, shall update or issue guidance 
        addressing the use of complex adaptive and other novel trial 
        design in the development and regulatory review and approval or 
        licensure for drugs and biological products.
            (2) Contents.--The guidance under paragraph (1) shall 
        address--

[[Page 130 STAT. 1096]]

                    (A) the use of complex adaptive and other novel 
                trial designs, including how such clinical trials 
                proposed or submitted help to satisfy the substantial 
                evidence standard under section 505(d) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
                    (B) how sponsors may obtain feedback from the 
                Secretary on technical issues related to modeling and 
                simulations prior to--
                          (i) completion of such modeling or 
                      simulations; or
                          (ii) the submission of resulting information 
                      to the Secretary;
                    (C) the types of quantitative and qualitative 
                information that should be submitted for review; and
                    (D) recommended analysis methodologies.
            (3) Public meeting.--Prior to updating or issuing the 
        guidance required by paragraph (1), the Secretary shall consult 
        with stakeholders, including representatives of regulated 
        industry, academia, patient advocacy organizations, consumer 
        groups, and disease research foundations, through a public 
        meeting to be held not later than 18 months after the date of 
        enactment of this Act.
            (4) Timing.--The Secretary shall update or issue a draft 
        version of the guidance required by paragraph (1) not later than 
        18 months after the date of the public meeting required by 
        paragraph (3) and finalize such guidance not later than 1 year 
        after the date on which the public comment period for the draft 
        guidance closes.
SEC. 3022. REAL WORLD EVIDENCE.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505E (21 U.S.C. 355f) the following:
``SEC. 505F. <<NOTE: 21 USC 355g.>>  UTILIZING REAL WORLD 
                          EVIDENCE.

    ``(a) In General.--The Secretary shall establish a program to 
evaluate the potential use of real world evidence--
            ``(1) to help to support the approval of a new indication 
        for a drug approved under section 505(c); and
            ``(2) to help to support or satisfy postapproval study 
        requirements.

    ``(b) Real World Evidence Defined.--In this section, the term `real 
world evidence' means data regarding the usage, or the potential 
benefits or risks, of a drug derived from sources other than randomized 
clinical trials.
    ``(c) Program Framework.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the 21st Century Cures Act, the Secretary shall 
        establish a draft framework for implementation of the program 
        under this section.
            ``(2) Contents of framework.--The framework shall include 
        information describing--
                    ``(A) the sources of real world evidence, including 
                ongoing safety surveillance, observational studies, 
                registries, claims, and patient-centered outcomes 
                research activities;
                    ``(B) the gaps in data collection activities;

[[Page 130 STAT. 1097]]

                    ``(C) the standards and methodologies for collection 
                and analysis of real world evidence; and
                    ``(D) the priority areas, remaining challenges, and 
                potential pilot opportunities that the program 
                established under this section will address.
            ``(3) Consultation.--
                    ``(A) In general.--In developing the program 
                framework under this subsection, the Secretary shall 
                consult with regulated industry, academia, medical 
                professional organizations, representatives of patient 
                advocacy organizations, consumer organizations, disease 
                research foundations, and other interested parties.
                    ``(B) Process.--The consultation under subparagraph 
                (A) may be carried out through approaches such as--
                          ``(i) a public-private partnership with the 
                      entities described in such subparagraph in which 
                      the Secretary may participate;
                          ``(ii) a contract, grant, or other 
                      arrangement, as the Secretary determines 
                      appropriate, with such a partnership or an 
                      independent research organization; or
                          ``(iii) public workshops with the entities 
                      described in such subparagraph.

    ``(d) Program Implementation.--The Secretary shall, not later than 2 
years after the date of enactment of the 21st Century Cures Act and in 
accordance with the framework established under subsection (c), 
implement the program to evaluate the potential use of real world 
evidence.
    ``(e) Guidance for Industry.--The Secretary shall--
            ``(1) utilize the program established under subsection (a), 
        its activities, and any subsequent pilots or written reports, to 
        inform a guidance for industry on--
                    ``(A) the circumstances under which sponsors of 
                drugs and the Secretary may rely on real world evidence 
                for the purposes described in paragraphs (1) and (2) of 
                subsection (a); and
                    ``(B) the appropriate standards and methodologies 
                for collection and analysis of real world evidence 
                submitted for such purposes;
            ``(2) not later than 5 years after the date of enactment of 
        the 21st Century Cures Act, issue draft guidance for industry as 
        described in paragraph (1); and
            ``(3) not later than 18 months after the close of the public 
        comment period for the draft guidance described in paragraph 
        (2), issue revised draft guidance or final guidance.

    ``(f) Rule of Construction.--
            ``(1) In general.--Subject to paragraph (2), nothing in this 
        section prohibits the Secretary from using real world evidence 
        for purposes not specified in this section, provided the 
        Secretary determines that sufficient basis exists for any such 
        nonspecified use.
            ``(2) Standards of evidence and secretary's authority.--This 
        section shall not be construed to alter--
                    ``(A) the standards of evidence under--
                          ``(i) subsection (c) or (d) of section 505, 
                      including the substantial evidence standard in 
                      such subsection (d); or

[[Page 130 STAT. 1098]]

                          ``(ii) section 351(a) of the Public Health 
                      Service Act; or
                    ``(B) the Secretary's authority to require 
                postapproval studies or clinical trials, or the 
                standards of evidence under which studies or trials are 
                evaluated.''.
SEC. 3023. <<NOTE: 42 USC 289 note.>>  PROTECTION OF HUMAN 
                          RESEARCH SUBJECTS.

    (a) In General.--In order to simplify and facilitate compliance by 
researchers with applicable regulations for the protection of human 
subjects in research, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, to the extent 
practicable and consistent with other statutory provisions, harmonize 
differences between the HHS Human Subject Regulations and the FDA Human 
Subject Regulations in accordance with subsection (b).
    (b) Avoiding Regulatory Duplication and Unnecessary Delays.--The 
Secretary shall, as appropriate--
            (1) make such modifications to the provisions of the HHS 
        Human Subject Regulations, the FDA Human Subject Regulations, 
        and the vulnerable populations rules as may be necessary--
                    (A) to reduce regulatory duplication and unnecessary 
                delays;
                    (B) to modernize such provisions in the context of 
                multisite and cooperative research projects; and
                    (C) to protect vulnerable populations, incorporate 
                local considerations, and support community engagement 
                through mechanisms such as consultation with local 
                researchers and human research protection programs, in a 
                manner consistent with subparagraph (B); and
            (2) ensure that human subject research that is subject to 
        the HHS Human Subject Regulations and to the FDA Human Subject 
        Regulations may--
                    (A) use joint or shared review;
                    (B) rely upon the review of--
                          (i) an independent institutional review board; 
                      or
                          (ii) an institutional review board of an 
                      entity other than the sponsor of the research; or
                    (C) use similar arrangements to avoid duplication of 
                effort.

    (c) Consultation.--In harmonizing or modifying regulations or 
guidance under this section, the Secretary shall consult with 
stakeholders (including researchers, academic organizations, hospitals, 
institutional research boards, pharmaceutical, biotechnology, and 
medical device developers, clinical research organizations, patient 
groups, and others).
    (d) Timing.--The Secretary shall complete the harmonization 
described in subsection (a) not later than 3 years after the date of 
enactment of this Act.
    (e) Progress Report.--Not later than 2 years after the date of 
enactment of this Act, the Secretary shall submit to Congress a report 
on the progress made toward completing such harmonization.
    (f) Definitions.--
            (1) Human subject regulations.--In this section:
                    (A) FDA human subject regulations.--The term ``FDA 
                Human Subject Regulations'' means the provisions

[[Page 130 STAT. 1099]]

                of parts 50, 56, 312, and 812 of title 21, Code of 
                Federal Regulations (or any successor regulations).
                    (B) HHS human subject regulations.--The term ``HHS 
                Human Subject Regulations'' means the provisions of 
                subpart A of part 46 of title 45, Code of Federal 
                Regulations (or any successor regulations).
                    (C) Vulnerable population rules.--The term 
                ``vulnerable population rules'' means--
                          (i) except in the case of research described 
                      in clause (ii), the provisions of subparts B 
                      through D of part 46, Code of Federal Regulations 
                      (or any successor regulations); and
                          (ii) in the case of research that is subject 
                      to FDA Human Subject Regulations, the provisions 
                      applicable to vulnerable populations under part 56 
                      of title 21, Code of Federal Regulations (or any 
                      successor regulations) and subpart D of part 50 of 
                      such title 21 (or any successor regulations).
            (2) Institutional review board defined.--In this section, 
        the term ``institutional review board'' has the meaning that 
        applies to the term ``institutional review board'' under the HHS 
        Human Subject Regulations.
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL 
                          INVESTIGATIONS.

    (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
            (1) in subparagraph (D), by striking ``except where subject 
        to such conditions as the Secretary may prescribe, the 
        investigator'' and inserting the following: ``except where, 
        subject to such conditions as the Secretary may prescribe--
                    ``(i) the proposed clinical testing poses no more 
                than minimal risk to the human subject and includes 
                appropriate safeguards to protect the rights, safety, 
                and welfare of the human subject; or
                    ``(ii) the investigator''; and
            (2) in the matter following subparagraph (D), by striking 
        ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.

    (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where 
it is not feasible or it is contrary to the best interests of such human 
beings'' and inserting ``except where it is not feasible, it is contrary 
to the best interests of such human beings, or the proposed clinical 
testing poses no more than minimal risk to such human beings and 
includes appropriate safeguards as prescribed to protect the rights, 
safety, and welfare of such human beings''.

         Subtitle D--Patient Access to Therapies and Information

SEC. 3031. SUMMARY LEVEL REVIEW.

    (a) FFDCA.--Section 505(c) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(c)) is amended by adding at the end the following:
    ``(5)(A) The Secretary may rely upon qualified data summaries to 
support the approval of a supplemental application, with respect

[[Page 130 STAT. 1100]]

to a qualified indication for a drug, submitted under subsection (b), if 
such supplemental application complies with subparagraph (B).
    ``(B) A supplemental application is eligible for review as described 
in subparagraph (A) only if--
            ``(i) there is existing data available and acceptable to the 
        Secretary demonstrating the safety of the drug; and
            ``(ii) all data used to develop the qualified data summaries 
        are submitted to the Secretary as part of the supplemental 
        application.

    ``(C) The Secretary shall post on the Internet website of the Food 
and Drug Administration and update annually--
            ``(i) the number of applications reviewed solely under 
        subparagraph (A) or section 351(a)(2)(E) of the Public Health 
        Service Act;
            ``(ii) the average time for completion of review under 
        subparagraph (A) or section 351(a)(2)(E) of the Public Health 
        Service Act;
            ``(iii) the average time for review of supplemental 
        applications where the Secretary did not use review flexibility 
        under subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act; and
            ``(iv) the number of applications reviewed under 
        subparagraph (A) or section 351(a)(2)(E) of the Public Health 
        Service Act for which the Secretary made use of full data sets 
        in addition to the qualified data summary.

    ``(D) In this paragraph--
            ``(i) the term `qualified indication' means an indication 
        for a drug that the Secretary determines to be appropriate for 
        summary level review under this paragraph; and
            ``(ii) the term `qualified data summary' means a summary of 
        clinical data that demonstrates the safety and effectiveness of 
        a drug with respect to a qualified indication.''.

    (b) PHSA.--Section 351(a)(2) of the Public Health Service Act (42 
U.S.C. 262(a)(2)) is amended by adding at the end the following:
    ``(E)(i) The Secretary may rely upon qualified data summaries to 
support the approval of a supplemental application, with respect to a 
qualified indication for a drug, submitted under this subsection, if 
such supplemental application complies with the requirements of 
subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and 
Cosmetic Act.
    ``(ii) In this subparagraph, the terms `qualified indication' and 
`qualified data summary' have the meanings given such terms in section 
505(c)(5) of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 3032. EXPANDED ACCESS POLICY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 561 (21 U.S.C. 360bbb) the following:
``SEC. 561A. <<NOTE: 21 USC 360bbb-0.>>  EXPANDED ACCESS POLICY 
                          REQUIRED FOR INVESTIGATIONAL DRUGS.

    ``(a) In General.--The manufacturer or distributor of one or more 
investigational drugs for the diagnosis, monitoring, or treatment of one 
or more serious diseases or conditions shall make available the policy 
of the manufacturer or distributor on evaluating and responding to 
requests submitted under section 561(b) for provision of such a drug.

[[Page 130 STAT. 1101]]

    ``(b) Public Availability of Expanded Access Policy.--The policies 
under subsection (a) shall be made public and readily available, such as 
by posting such policies on a publicly available Internet website. Such 
policies may be generally applicable to all investigational drugs of 
such manufacturer or distributor.
    ``(c) Content of Policy.--A policy described in subsection (a) shall 
include--
            ``(1) contact information for the manufacturer or 
        distributor to facilitate communication about requests described 
        in subsection (a);
            ``(2) procedures for making such requests;
            ``(3) the general criteria the manufacturer or distributor 
        will use to evaluate such requests for individual patients, and 
        for responses to such requests;
            ``(4) the length of time the manufacturer or distributor 
        anticipates will be necessary to acknowledge receipt of such 
        requests; and
            ``(5) a hyperlink or other reference to the clinical trial 
        record containing information about the expanded access for such 
        drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of 
        the Public Health Service Act.

    ``(d) No Guarantee of Access.--The posting of policies by 
manufacturers and distributors under subsection (a) shall not serve as a 
guarantee of access to any specific investigational drug by any 
individual patient.
    ``(e) Revised Policy.--Nothing in this section shall prevent a 
manufacturer or distributor from revising a policy required under this 
section at any time.
    ``(f) Application.--This section shall apply to a manufacturer or 
distributor with respect to an investigational drug beginning on the 
later of--
            ``(1) the date that is 60 calendar days after the date of 
        enactment of the 21st Century Cures Act; or
            ``(2) the first initiation of a phase 2 or phase 3 study (as 
        such terms are defined in section 312.21(b) and (c) of title 21, 
        Code of Federal Regulations (or any successor regulations)) with 
        respect to such investigational drug.''.
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED 
                          THERAPIES.

    (a) In General.--Section 506 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356) is amended--
            (1) by transferring subsection (e) (relating to 
        construction) so that it appears before subsection (f) (relating 
        to awareness efforts); and
            (2) by adding at the end the following:

    ``(g) Regenerative Advanced Therapy.--
            ``(1) In general.--The Secretary, at the request of the 
        sponsor of a drug, shall facilitate an efficient development 
        program for, and expedite review of, such drug if the drug 
        qualifies as a regenerative advanced therapy under the criteria 
        described in paragraph (2).
            ``(2) Criteria.--A drug is eligible for designation as a 
        regenerative advanced therapy under this subsection if--
                    ``(A) the drug is a regenerative medicine therapy 
                (as defined in paragraph (8));

[[Page 130 STAT. 1102]]

                    ``(B) the drug is intended to treat, modify, 
                reverse, or cure a serious or life-threatening disease 
                or condition; and
                    ``(C) preliminary clinical evidence indicates that 
                the drug has the potential to address unmet medical 
                needs for such a disease or condition.
            ``(3) Request for designation.--The sponsor of a drug may 
        request the Secretary to designate the drug as a regenerative 
        advanced therapy concurrently with, or at any time after, 
        submission of an application for the investigation of the drug 
        under section 505(i) of this Act or section 351(a)(3) of the 
        Public Health Service Act.
            ``(4) Designation.--Not later than 60 calendar days after 
        the receipt of a request under paragraph (3), the Secretary 
        shall determine whether the drug that is the subject of the 
        request meets the criteria described in paragraph (2). If the 
        Secretary determines that the drug meets the criteria, the 
        Secretary shall designate the drug as a regenerative advanced 
        therapy and shall take such actions as are appropriate under 
        paragraph (1). If the Secretary determines that a drug does not 
        meet the criteria for such designation, the Secretary shall 
        include with the determination a written description of the 
        rationale for such determination.
            ``(5) Actions.--The sponsor of a regenerative advanced 
        therapy shall be eligible for the actions to expedite 
        development and review of such therapy under subsection 
        (a)(3)(B), including early interactions to discuss any potential 
        surrogate or intermediate endpoint to be used to support the 
        accelerated approval of an application for the product under 
        subsection (c).
            ``(6) Access to expedited approval pathways.--An application 
        for a regenerative advanced therapy under section 505(b)(1) of 
        this Act or section 351(a) of the Public Health Service Act may 
        be--
                    ``(A) eligible for priority review, as described in 
                the Manual of Policies and Procedures of the Food and 
                Drug Administration and goals identified in the letters 
                described in section 101(b) of the Prescription Drug 
                User Fee Amendments of 2012; and
                    ``(B) eligible for accelerated approval under 
                subsection (c), as agreed upon pursuant to subsection 
                (a)(3)(B), through, as appropriate--
                          ``(i) surrogate or intermediate endpoints 
                      reasonably likely to predict long-term clinical 
                      benefit; or
                          ``(ii) reliance upon data obtained from a 
                      meaningful number of sites, including through 
                      expansion to additional sites, as appropriate.
            ``(7) Postapproval requirements.--The sponsor of a 
        regenerative advanced therapy that is granted accelerated 
        approval and is subject to the postapproval requirements under 
        subsection (c) may, as appropriate, fulfill such requirements, 
        as the Secretary may require, through--
                    ``(A) the submission of clinical evidence, clinical 
                studies, patient registries, or other sources of real 
                world evidence, such as electronic health records;
                    ``(B) the collection of larger confirmatory data 
                sets, as agreed upon pursuant to subsection (a)(3)(B); 
                or

[[Page 130 STAT. 1103]]

                    ``(C) postapproval monitoring of all patients 
                treated with such therapy prior to approval of the 
                therapy.
            ``(8) Definition.--For purposes of this section, the term 
        `regenerative medicine therapy' includes cell therapy, 
        therapeutic tissue engineering products, human cell and tissue 
        products, and combination products using any such therapies or 
        products, except for those regulated solely under section 361 of 
        the Public Health Service Act and part 1271 of title 21, Code of 
        Federal Regulations.''.

    (b) <<NOTE: 21 USC 356 note.>>  Rule of Construction.--Nothing in 
this section and the amendments made by this section shall be construed 
to alter the authority of the Secretary of Health and Human Services--
            (1) to approve drugs pursuant to the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the 
        Public Health Service Act (42 U.S.C. 262) as authorized prior to 
        the date of enactment of the 21st Century Cures Act, including 
        the standards of evidence, and applicable conditions, for 
        approval under such Acts; or
            (2) to alter the authority of the Secretary to require 
        postapproval studies pursuant to such Acts, as authorized prior 
        to the date of enactment of the 21st Century Cures Act.

    (c) Conforming Amendment.--Section 506(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting 
``and the 21st Century Cures Act'' after ``Food and Drug Administration 
Safety and Innovation Act''.
SEC. 3034. <<NOTE: 21 USC 356g note.>>  GUIDANCE REGARDING DEVICES 
                          USED IN THE RECOVERY, ISOLATION, OR 
                          DELIVERY OF REGENERATIVE ADVANCED 
                          THERAPIES.

    (a) Draft Guidance.--Not later than 1 year after the date of 
enactment of the 21st Century Cures Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and Drugs, shall 
issue draft guidance clarifying how, in the context of regenerative 
advanced therapies, the Secretary will evaluate devices used in the 
recovery, isolation, or delivery of regenerative advanced therapies. In 
doing so, the Secretary shall specifically address--
            (1) how the Food and Drug Administration intends to simplify 
        and streamline regulatory requirements for combination device 
        and cell or tissue products;
            (2) what, if any, intended uses or specific attributes would 
        result in a device used with a regenerative therapy product to 
        be classified as a class III device;
            (3) when the Food and Drug Administration considers it is 
        necessary, if ever, for the intended use of a device to be 
        limited to a specific intended use with only one particular type 
        of cell; and
            (4) application of the least burdensome approach to 
        demonstrate how a device may be used with more than one cell 
        type.

    (b) Final Guidance.--Not later than 12 months after the close of the 
period for public comment on the draft guidance under subsection (a), 
the Secretary of Health and Human Services shall finalize such guidance.
SEC. 3035. <<NOTE: 21 USC 356 note.>>  REPORT ON REGENERATIVE 
                          ADVANCED THERAPIES.

    (a) Report to Congress.--Before March 1 of each calendar year, the 
Secretary of Health and Human Services shall, with

[[Page 130 STAT. 1104]]

respect to the previous calendar year, submit a report to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives on--
            (1) the number and type of applications for approval of 
        regenerative advanced therapies filed, approved or licensed as 
        applicable, withdrawn, or denied; and
            (2) how many of such applications or therapies, as 
        applicable, were granted accelerated approval or priority 
        review.

    (b) Regenerative Advanced Therapy.--In this section, the term 
``regenerative advanced therapy'' has the meaning given such term in 
section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by 
section 3033 of this Act.
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE 
                          ADVANCED THERAPIES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following:
``SEC. 506G. <<NOTE: 21 USC 356g.>>  STANDARDS FOR REGENERATIVE 
                          MEDICINE AND REGENERATIVE ADVANCED 
                          THERAPIES.

    ``(a) In General.--Not later than 2 years after the date of 
enactment of the 21st Century Cures Act, the Secretary, in consultation 
with the National Institute of Standards and Technology and stakeholders 
(including regenerative medicine and advanced therapies manufacturers 
and clinical trial sponsors, contract manufacturers, academic 
institutions, practicing clinicians, regenerative medicine and advanced 
therapies industry organizations, and standard setting organizations), 
shall facilitate an effort to coordinate and prioritize the development 
of standards and consensus definition of terms, through a public 
process, to support, through regulatory predictability, the development, 
evaluation, and review of regenerative medicine therapies and 
regenerative advanced therapies, including with respect to the 
manufacturing processes and controls of such products.
    ``(b) Activities.--
            ``(1) In general.--In carrying out this section, the 
        Secretary shall continue to--
                    ``(A) identity opportunities to help advance the 
                development of regenerative medicine therapies and 
                regenerative advanced therapies;
                    ``(B) identify opportunities for the development of 
                laboratory regulatory science research and documentary 
                standards that the Secretary determines would help 
                support the development, evaluation, and review of 
                regenerative medicine therapies and regenerative 
                advanced therapies through regulatory predictability; 
                and
                    ``(C) work with stakeholders, such as those 
                described in subsection (a), as appropriate, in the 
                development of such standards.
            ``(2) Regulations and guidance.--Not later than 1 year after 
        the development of standards as described in subsection (a), the 
        Secretary shall review relevant regulations and guidance and, 
        through a public process, update such regulations and guidance 
        as the Secretary determines appropriate.

[[Page 130 STAT. 1105]]

    ``(c) Definitions.--For purposes of this section, the terms 
`regenerative medicine therapy' and `regenerative advanced therapy' have 
the meanings given such terms in section 506(g).''.
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.

    Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(a)) is amended--
            (1) by striking ``(a) If its'' and inserting ``(a)(1) If 
        its'';
            (2) by striking ``a formulary committee, or other similar 
        entity, in the course of the committee or the entity carrying 
        out its responsibilities for the selection of drugs for managed 
        care or other similar organizations'' and inserting ``a payor, 
        formulary committee, or other similar entity with knowledge and 
        expertise in the area of health care economic analysis, carrying 
        out its responsibilities for the selection of drugs for coverage 
        or reimbursement'';
            (3) by striking ``directly relates'' and inserting 
        ``relates'';
            (4) by striking ``and is based on competent and reliable 
        scientific evidence. The requirements set forth in section 
        505(a) or in section 351(a) of the Public Health Service Act 
        shall not apply to health care economic information provided to 
        such a committee or entity in accordance with this paragraph'' 
        and inserting ``, is based on competent and reliable scientific 
        evidence, and includes, where applicable, a conspicuous and 
        prominent statement describing any material differences between 
        the health care economic information and the labeling approved 
        for the drug under section 505 or under section 351 of the 
        Public Health Service Act. The requirements set forth in section 
        505(a) or in subsections (a) and (k) of section 351 of the 
        Public Health Service Act shall not apply to health care 
        economic information provided to such a payor, committee, or 
        entity in accordance with this paragraph''; and
            (5) by striking ``In this paragraph, the term'' and all that 
        follows and inserting the following:

    ``(2)(A) For purposes of this paragraph, the term `health care 
economic information' means any analysis (including the clinical data, 
inputs, clinical or other assumptions, methods, results, and other 
components underlying or comprising the analysis) that identifies, 
measures, or describes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the represented 
health outcomes, of the use of a drug. Such analysis may be comparative 
to the use of another drug, to another health care intervention, or to 
no intervention.
    ``(B) Such term does not include any analysis that relates only to 
an indication that is not approved under section 505 or under section 
351 of the Public Health Service Act for such drug.''.
SEC. 3038. COMBINATION PRODUCT INNOVATION.

    (a) In General.--Section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) is amended--
            (1) by striking paragraph (3);
            (2) by redesignating paragraph (2) as paragraph (7);
            (3) by redesignating paragraphs (4) and (5) as paragraphs 
        (8) and (9), respectively;
            (4) by striking ``(g)(1)'' and all that follows through the 
        end of paragraph (1) and inserting the following:

[[Page 130 STAT. 1106]]

    ``(g)(1)(A) The Secretary shall, in accordance with this subsection, 
assign a primary agency center to regulate products that constitute a 
combination of a drug, device, or biological product.
    ``(B) The Secretary shall conduct the premarket review of any 
combination product under a single application, whenever appropriate.
    ``(C) For purposes of this subsection, the term `primary mode of 
action' means the single mode of action of a combination product 
expected to make the greatest contribution to the overall intended 
therapeutic effects of the combination product.
    ``(D) The Secretary shall determine the primary mode of action of 
the combination product. If the Secretary determines that the primary 
mode of action is that of--
            ``(i) a drug (other than a biological product), the agency 
        center charged with premarket review of drugs shall have primary 
        jurisdiction;
            ``(ii) a device, the agency center charged with premarket 
        review of devices shall have primary jurisdiction; or
            ``(iii) a biological product, the agency center charged with 
        premarket review of biological products shall have primary 
        jurisdiction.

    ``(E) In determining the primary mode of action of a combination 
product, the Secretary shall not determine that the primary mode of 
action is that of a drug or biological product solely because the 
combination product has any chemical action within or on the human body.
    ``(F) If a sponsor of a combination product disagrees with the 
determination under subparagraph (D)--
            ``(i) such sponsor may request, and the Secretary shall 
        provide, a substantive rationale to such sponsor that references 
        scientific evidence provided by the sponsor and any other 
        scientific evidence relied upon by the Secretary to support such 
        determination; and
            ``(ii)(I) the sponsor of the combination product may propose 
        one or more studies (which may be nonclinical, clinical, or 
        both) to establish the relevance, if any, of the chemical action 
        in achieving the primary mode of action of such product;
            ``(II) if the sponsor proposes any such studies, the 
        Secretary and the sponsor of such product shall collaborate and 
        seek to reach agreement, within a reasonable time of such 
        proposal, not to exceed 90 calendar days, on the design of such 
        studies; and
            ``(III) if an agreement is reached under subclause (II) and 
        the sponsor conducts one or more of such studies, the Secretary 
        shall consider the data resulting from any such study when 
        reevaluating the determination of the primary mode of action of 
        such product, and unless and until such reevaluation has 
        occurred and the Secretary issues a new determination, the 
        determination of the Secretary under subparagraph (D) shall 
        remain in effect.

    ``(2)(A)(i) To establish clarity and certainty for the sponsor, the 
sponsor of a combination product may request a meeting on such 
combination product. If the Secretary concludes that a determination of 
the primary mode of action pursuant to paragraph (1)(D) is necessary, 
the sponsor may request such meeting only after the Secretary makes such 
determination. If the sponsor submits a written meeting request, the 
Secretary shall, not later than

[[Page 130 STAT. 1107]]

75 calendar days after receiving such request, meet with the sponsor of 
such combination product.
    ``(ii) A meeting under clause (i) may--
            ``(I) address the standards and requirements for market 
        approval or clearance of the combination product;
            ``(II) address other issues relevant to such combination 
        product, such as requirements related to postmarket modification 
        of such combination product and good manufacturing practices 
        applicable to such combination product; and
            ``(III) identify elements under subclauses (I) and (II) that 
        may be more appropriate for discussion and agreement with the 
        Secretary at a later date given that scientific or other 
        information is not available, or agreement is otherwise not 
        feasible regarding such elements, at the time a request for such 
        meeting is made.

    ``(iii) Any agreement under this subparagraph shall be in writing 
and made part of the administrative record by the Secretary.
    ``(iv) Any such agreement shall remain in effect, except--
            ``(I) upon the written agreement of the Secretary and the 
        sponsor or applicant; or
            ``(II) pursuant to a decision by the director of the 
        reviewing division of the primary agency center, or a person 
        more senior than such director, in consultation with consulting 
        centers and the Office, as appropriate, that an issue essential 
        to determining whether the standard for market clearance or 
        other applicable standard under this Act or the Public Health 
        Service Act applicable to the combination product has been 
        identified since the agreement was reached, or that deviating 
        from the agreement is otherwise justifiable based on scientific 
        evidence, for public health reasons.

    ``(3) For purposes of conducting the premarket review of a 
combination product that contains an approved constituent part described 
in paragraph (4), the Secretary may require that the sponsor of such 
combination product submit to the Secretary only data or information 
that the Secretary determines is necessary to meet the standard for 
clearance or approval, as applicable, under this Act or the Public 
Health Service Act, including any incremental risks and benefits posed 
by such combination product, using a risk-based approach and taking into 
account any prior finding of safety and effectiveness or substantial 
equivalence for the approved constituent part relied upon by the 
applicant in accordance with paragraph (5).
    ``(4) For purposes of paragraph (3), an approved constituent part 
is--
            ``(A) a drug constituent part of a combination product being 
        reviewed in a single application or request under section 515, 
        510(k), or 513(f)(2) (submitted in accordance with paragraph 
        (5)), that is an approved drug, provided such application or 
        request complies with paragraph (5);
            ``(B) a device constituent part approved under section 515 
        that is referenced by the sponsor and that is available for use 
        by the Secretary under section 520(h)(4); or
            ``(C) any constituent part that was previously approved, 
        cleared, or classified under section 505, 510(k), 513(f)(2), or 
        515 of this Act for which the sponsor has a right of reference 
        or any constituent part that is a nonprescription drug, as 
        defined in section 760(a)(2).

[[Page 130 STAT. 1108]]

    ``(5)(A) If an application is submitted under section 515 or 510(k) 
or a request is submitted under section 513(f)(2), consistent with any 
determination made under paragraph (1)(D), for a combination product 
containing as a constituent part an approved drug--
            ``(i) the application or request shall include the 
        certification or statement described in section 505(b)(2); and
            ``(ii) the applicant or requester shall provide notice as 
        described in section 505(b)(3).

    ``(B) For purposes of this paragraph and paragraph (4), the term 
`approved drug' means an active ingredient--
            ``(i) that was in an application previously approved under 
        section 505(c);
            ``(ii) where such application is relied upon by the 
        applicant submitting the application or request described in 
        subparagraph (A);
            ``(iii) for which full reports of investigations that have 
        been made to show whether such drug is safe for use and whether 
        such drug is effective in use were not conducted by or for the 
        applicant submitting the application or request described in 
        subparagraph (A); and
            ``(iv) for which the applicant submitting the application or 
        request described in subparagraph (A) has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations described in clause (iii) were conducted.

    ``(C) The following provisions shall apply with respect to an 
application or request described in subparagraph (A) to the same extent 
and in the same manner as if such application or request were an 
application described in section 505(b)(2) that referenced the approved 
drug:
            ``(i) Subparagraphs (A), (B), (C), and (D) of section 
        505(c)(3).
            ``(ii) Clauses (ii), (iii), and (iv) of section 
        505(c)(3)(E).
            ``(iii) Subsections (b) and (c) of section 505A.
            ``(iv) Section 505E(a).
            ``(v) Section 527(a).

    ``(D) Notwithstanding any other provision of this subsection, an 
application or request for classification for a combination product 
described in subparagraph (A) shall be considered an application 
submitted under section 505(b)(2) for purposes of section 271(e)(2)(A) 
of title 35, United States Code.
    ``(6) Nothing in this subsection shall be construed as prohibiting a 
sponsor from submitting separate applications for the constituent parts 
of a combination product, unless the Secretary determines that a single 
application is necessary.'';
            (5) in paragraph (8) (as redesignated by paragraph (3))--
                    (A) in subparagraph (C)--
                          (i) by amending clause (i) to read as follows:

    ``(i) In carrying out this subsection, the Office shall help to 
ensure timely and effective premarket review that involves more than one 
agency center by coordinating such reviews, overseeing the timeliness of 
such reviews, and overseeing the alignment of feedback regarding such 
reviews.'';
                          (ii) in clause (ii), by inserting ``and 
                      alignment'' after ``the timeliness'' each place it 
                      appears; and
                          (iii) by adding at the end the following new 
                      clauses:

    ``(iii) The Office shall ensure that, with respect to a combination 
product, a designated person or persons in the primary agency

[[Page 130 STAT. 1109]]

center is the primary point or points of contact for the sponsor of such 
combination product. The Office shall also coordinate communications to 
and from any consulting center involved in such premarket review, if 
requested by such primary agency center or any such consulting center. 
Agency communications and commitments, to the extent consistent with 
other provisions of law and the requirements of all affected agency 
centers, from the primary agency center shall be considered as 
communication from the Secretary on behalf of all agency centers 
involved in the review.
    ``(iv) The Office shall, with respect to the premarket review of a 
combination product--
            ``(I) ensure that any meeting between the Secretary and the 
        sponsor of such product is attended by each agency center 
        involved in the review, as appropriate;
            ``(II) ensure that each consulting agency center has 
        completed its premarket review and provided the results of such 
        review to the primary agency center in a timely manner; and
            ``(III) ensure that each consulting center follows the 
        guidance described in clause (vi) and advises, as appropriate, 
        on other relevant regulations, guidances, and policies.

    ``(v) In seeking agency action with respect to a combination 
product, the sponsor of such product--
            ``(I) shall identify the product as a combination product; 
        and
            ``(II) may request in writing the participation of 
        representatives of the Office in meetings related to such 
        combination product, or to have the Office otherwise engage on 
        such regulatory matters concerning the combination product.

    ``(vi) Not later than 4 years after the date of enactment of the 
21st Century Cures Act, and after a public comment period of not less 
than 60 calendar days, the Secretary shall issue a final guidance that 
describes--
            ``(I) the structured process for managing pre-submission 
        interactions with sponsors developing combination products;
            ``(II) the best practices for ensuring that the feedback in 
        such pre-submission interactions represents the Agency's best 
        advice based on the information provided during such pre-
        submission interactions;
            ``(III) the information that is required to be submitted 
        with a meeting request under paragraph (2), how such meetings 
        relate to other types of meetings in the Food and Drug 
        Administration, and the form and content of any agreement 
        reached through a meeting under such paragraph (2);''; and
                    (B) in subparagraph (G)--
                          (i) in the matter preceding clause (i), by 
                      inserting ``(except with respect to clause (iv), 
                      beginning not later than one year after the date 
                      of the enactment of the 21st Century Cures Act)'' 
                      after ``enactment of this paragraph'';
                          (ii) in clause (ii), by striking ``and'' at 
                      the end;
                          (iii) in clause (iii), by striking the period 
                      at the end and inserting ``; and''; and
                          (iv) by adding at the end the following new 
                      clause:
            ``(iv) identifying the percentage of combination products 
        for which a dispute resolution, with respect to premarket 
        review, was requested by the combination product's sponsor.''; 
        and

[[Page 130 STAT. 1110]]

            (6) in paragraph (9) (as redesignated by paragraph (3))--
                    (A) in subparagraph (C)--
                          (i) in clause (i), by striking the comma at 
                      the end and inserting a semicolon;
                          (ii) in clause (ii), by striking ``, and'' at 
                      the end and inserting a semicolon;
                          (iii) in clause (iii), by striking the period 
                      at the end and inserting ``; and''; and
                          (iv) by adding at the end the following:
                          ``(iv) de novo classification under section 
                      513(a)(1).''; and
                    (B) by adding at the end the following:
            ``(D) The terms `premarket review' and `reviews' include all 
        activities of the Food and Drug Administration conducted prior 
        to approval or clearance of an application, notification, or 
        request for classification submitted under section 505, 510(k), 
        513(f)(2), 515, or 520 of this Act or under section 351 of the 
        Public Health Service Act, including with respect to 
        investigational use of the product.''.

    (b) Information for Approval of Combination Products.--Section 
520(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(h)(4)) is amended--
            (1) in subparagraph (A), by striking ``Any information'' and 
        inserting ``Subject to subparagraph (C), any information''; and
            (2) by adding at the end the following new subparagraph:

    ``(C) No information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) may be used 
to approve or clear any application submitted under section 515 or 
510(k) or to classify a product under section 513(f)(2) for a 
combination product containing as a constituent part an approved drug 
(as defined in section 503(g)(5)(B)) unless--
            ``(i) the application includes the certification or 
        statement referenced in section 503(g)(5)(A);
            ``(ii) the applicant provides notice as described in section 
        503(g)(5)(A); and
            ``(iii) the Secretary's approval of such application is 
        subject to the provisions in section 503(g)(5)(C).''.

    (c) <<NOTE: 21 USC 355 note.>>  Variations From CGMP Streamlined 
Approach.--Not later than 18 months after the date of enactment of this 
Act, the Secretary of Health and Human Services (referred to in this 
subsection as the ``Secretary'') shall identify types of combination 
products and manufacturing processes with respect to which the Secretary 
proposes that good manufacturing processes may be adopted that vary from 
the requirements set forth in section 4.4 of title 21, Code of Federal 
Regulations (or any successor regulations) or that the Secretary 
proposes can satisfy the requirements in section 4.4 through alternative 
or streamlined mechanisms. The Secretary shall identify such types, 
variations from such requirements, and such mechanisms, in a proposed 
list published in the Federal Register. After a public comment period 
regarding the appropriate good manufacturing practices for such types, 
the Secretary shall publish a final list in the Federal Register, 
notwithstanding section 553 of title 5, United States Code. The 
Secretary shall evaluate such types, variations, and mechanisms using a 
risk-based approach. The Secretary shall periodically review such final 
list.

[[Page 130 STAT. 1111]]

          Subtitle E--Antimicrobial Innovation and Stewardship

SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.

    (a) In General.--Section 319E of the Public Health Service Act (42 
U.S.C. 247d-5) is amended--
            (1) by redesignating subsections (f) and (g) as subsections 
        (l) and (m), respectively; and
            (2) by inserting after subsection (e), the following:

    ``(f) Monitoring at Federal Health Care Facilities.--The Secretary 
shall encourage reporting on aggregate antimicrobial drug use and 
antimicrobial resistance to antimicrobial drugs and the implementation 
of antimicrobial stewardship programs by health care facilities of the 
Department of Defense, the Department of Veterans Affairs, and the 
Indian Health Service and shall provide technical assistance to the 
Secretary of Defense and the Secretary of Veterans Affairs, as 
appropriate and upon request.
    ``(g) Report on Antimicrobial Resistance in Humans and Use of 
Antimicrobial Drugs.--Not later than 1 year after the date of enactment 
of the 21st Century Cures Act, and annually thereafter, the Secretary 
shall prepare and make publicly available data and information 
concerning--
            ``(1) aggregate national and regional trends of 
        antimicrobial resistance in humans to antimicrobial drugs, 
        including such drugs approved under section 506(h) of the 
        Federal Food, Drug, and Cosmetic Act;
            ``(2) antimicrobial stewardship, which may include summaries 
        of State efforts to address antimicrobial resistance in humans 
        to antimicrobial drugs and antimicrobial stewardship; and
            ``(3) coordination between the Director of the Centers for 
        Disease Control and Prevention and the Commissioner of Food and 
        Drugs with respect to the monitoring of--
                    ``(A) any applicable resistance under paragraph (1); 
                and
                    ``(B) drugs approved under section 506(h) of the 
                Federal Food, Drug, and Cosmetic Act.

    ``(h) Information Related to Antimicrobial Stewardship Programs.--
The Secretary shall, as appropriate, disseminate guidance, educational 
materials, or other appropriate materials related to the development and 
implementation of evidence-based antimicrobial stewardship programs or 
practices at health care facilities, such as nursing homes and other 
long-term care facilities, ambulatory surgical centers, dialysis 
centers, outpatient clinics, and hospitals, including community and 
rural hospitals.
    ``(i) Supporting State-Based Activities To Combat Antimicrobial 
Resistance.--The Secretary shall continue to work with State and local 
public health departments on statewide or regional programs related to 
antimicrobial resistance. Such efforts may include activities to related 
to--
            ``(1) identifying patterns of bacterial and fungal 
        resistance in humans to antimicrobial drugs;
            ``(2) preventing the spread of bacterial and fungal 
        infections that are resistant to antimicrobial drugs; and
            ``(3) promoting antimicrobial stewardship.

[[Page 130 STAT. 1112]]

    ``(j) Antimicrobial Resistance and Stewardship Activities.--
            ``(1) In general.--For the purposes of supporting 
        stewardship activities, examining changes in antimicrobial 
        resistance, and evaluating the effectiveness of section 506(h) 
        of the Federal Food, Drug, and Cosmetic Act, the Secretary 
        shall--
                    ``(A) provide a mechanism for facilities to report 
                data related to their antimicrobial stewardship 
                activities (including analyzing the outcomes of such 
                activities); and
                    ``(B) evaluate--
                          ``(i) antimicrobial resistance data using a 
                      standardized approach; and
                          ``(ii) trends in the utilization of drugs 
                      approved under such section 506(h) with respect to 
                      patient populations.
            ``(2) Use of systems.--The Secretary shall use available 
        systems, including the National Healthcare Safety Network or 
        other systems identified by the Secretary, to fulfill the 
        requirements or conduct activities under this section.

    ``(k) Antimicrobial.--For purposes of subsections (f) through (j), 
the term `antimicrobial' includes any antibacterial or antifungal drugs, 
and may include drugs that eliminate or inhibit the growth of other 
microorganisms, as appropriate.''.
    (b) <<NOTE: 42 USC 247d-5 note.>>  Availability of Data.--The 
Secretary shall make the data collected pursuant to this subsection 
public. Nothing in this subsection shall be construed as authorizing the 
Secretary to disclose any information that is a trade secret or 
confidential information subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States Code.
SEC. 3042. LIMITED POPULATION PATHWAY.

    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356), as amended by section 3033, is further amended by adding at the 
end the following:
    ``(h) Limited Population Pathway for Antibacterial and Antifungal 
Drugs.--
            ``(1) In general.--The Secretary may approve an 
        antibacterial or antifungal drug, alone or in combination with 
        one or more other drugs, as a limited population drug pursuant 
        to this subsection only if--
                    ``(A) the drug is intended to treat a serious or 
                life-threatening infection in a limited population of 
                patients with unmet needs;
                    ``(B) the standards for approval under section 
                505(c) and (d), or the standards for licensure under 
                section 351 of the Public Health Service Act, as 
                applicable, are met; and
                    ``(C) the Secretary receives a written request from 
                the sponsor to approve the drug as a limited population 
                drug pursuant to this subsection.
            ``(2) Benefit-risk consideration.--The Secretary's 
        determination of safety and effectiveness of an antibacterial or 
        antifungal drug shall reflect the benefit-risk profile of such 
        drug in the intended limited population, taking into account the 
        severity, rarity, or prevalence of the infection the drug is 
        intended to treat and the availability or lack of alternative 
        treatment in such limited population. Such drug may be

[[Page 130 STAT. 1113]]

        approved under this subsection notwithstanding a lack of 
        evidence to fully establish a favorable benefit-risk profile in 
        a population that is broader than the intended limited 
        population.
            ``(3) Additional requirements.--A drug approved under this 
        subsection shall be subject to the following requirements, in 
        addition to any other applicable requirements of this Act:
                    ``(A) Labeling.--To indicate that the safety and 
                effectiveness of a drug approved under this subsection 
                has been demonstrated only with respect to a limited 
                population--
                          ``(i) all labeling and advertising of an 
                      antibacterial or antifungal drug approved under 
                      this subsection shall contain the statement 
                      `Limited Population' in a prominent manner and 
                      adjacent to, and not more prominent than--
                                    ``(I) the proprietary name of such 
                                drug, if any; or
                                    ``(II) if there is no proprietary 
                                name, the established name of the drug, 
                                if any, as defined in section 503(e)(3), 
                                or, in the case of a drug that is a 
                                biological product, the proper name, as 
                                defined by regulation; and
                          ``(ii) the prescribing information for the 
                      drug required by section 201.57 of title 21, Code 
                      of Federal Regulations (or any successor 
                      regulation) shall also include the following 
                      statement: `This drug is indicated for use in a 
                      limited and specific population of patients.'.
                    ``(B) Promotional material.--The sponsor of an 
                antibacterial or antifungal drug subject to this 
                subsection shall submit to the Secretary copies of all 
                promotional materials related to such drug at least 30 
                calendar days prior to dissemination of the materials.
            ``(4) Other programs.--A sponsor of a drug that seeks 
        approval of a drug under this subsection may also seek 
        designation or approval, as applicable, of such drug under other 
        applicable sections or subsections of this Act or the Public 
        Health Service Act.
            ``(5) Guidance.--Not later than 18 months after the date of 
        enactment of the 21st Century Cures Act, the Secretary shall 
        issue draft guidance describing criteria, processes, and other 
        general considerations for demonstrating the safety and 
        effectiveness of limited population antibacterial and antifungal 
        drugs. The Secretary shall publish final guidance within 18 
        months of the close of the public comment period on such draft 
        guidance. The Secretary may approve antibacterial and antifungal 
        drugs under this subsection prior to issuing guidance under this 
        paragraph.
            ``(6) Advice.--The Secretary shall provide prompt advice to 
        the sponsor of a drug for which the sponsor seeks approval under 
        this subsection to enable the sponsor to plan a development 
        program to obtain the necessary data for such approval, and to 
        conduct any additional studies that would be required to gain 
        approval of such drug for use in a broader population.
            ``(7) Termination of limitations.--If, after approval of a 
        drug under this subsection, the Secretary approves a broader 
        indication for such drug under section 505(b) or section 351(a) 
        of the Public Health Service Act, the Secretary may remove

[[Page 130 STAT. 1114]]

        any postmarketing conditions, including requirements with 
        respect to labeling and review of promotional materials under 
        paragraph (3), applicable to the approval of the drug under this 
        subsection.
            ``(8) Rules of construction.--Nothing in this subsection 
        shall be construed to alter the authority of the Secretary to 
        approve drugs pursuant to this Act or section 351 of the Public 
        Health Service Act, including the standards of evidence and 
        applicable conditions for approval under such Acts, the 
        standards of approval of a drug under such Acts, or to alter the 
        authority of the Secretary to monitor drugs pursuant to such 
        Acts.
            ``(9) Reporting and accountability.--
                    ``(A) Biennial reporting.--The Secretary shall 
                report to Congress not less often than once every 2 
                years on the number of requests for approval, and the 
                number of approvals, of an antibacterial or antifungal 
                drug under this subsection.
                    ``(B) GAO report.--Not later than December 2021, the 
                Comptroller General of the United States shall submit to 
                the Committee on Energy and Commerce of the House of 
                Representatives and the Committee on Health, Education, 
                Labor and Pensions of the Senate a report on the 
                coordination of activities required under section 319E 
                of the Public Health Service Act. Such report shall 
                include a review of such activities, and the extent to 
                which the use of the pathway established under this 
                subsection has streamlined premarket approval for 
                antibacterial or antifungal drugs for limited 
                populations, if such pathway has functioned as intended, 
                if such pathway has helped provide for safe and 
                effective treatment for patients, if such premarket 
                approval would be appropriate for other categories of 
                drugs, and if the authorities under this subsection have 
                affected antibacterial or antifungal resistance.''.
SEC. 3043. <<NOTE: 21 USC 356 note.>>  PRESCRIBING AUTHORITY.

    Nothing in this subtitle, or an amendment made by this subtitle, 
shall be construed to restrict the prescribing of antimicrobial drugs or 
other products, including drugs approved under subsection (h) of section 
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as 
added by section 3042), by health care professionals, or to limit the 
practice of health care.
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
                          MICROORGANISMS; ANTIMICROBIAL 
                          SUSCEPTIBILITY TESTING DEVICES.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 511 the following:
``SEC. 511A. <<NOTE: 21 USC 360a-2.>>  SUSCEPTIBILITY TEST 
                          INTERPRETIVE CRITERIA FOR 
                          MICROORGANISMS.

    ``(a) Purpose; Identification of Criteria.--
            ``(1) Purpose.--The purpose of this section is to clarify 
        the Secretary's authority to--
                    ``(A) efficiently update susceptibility test 
                interpretive criteria for antimicrobial drugs when 
                necessary for public

[[Page 130 STAT. 1115]]

                health, due to, among other things, the constant 
                evolution of microorganisms that leads to the 
                development of resistance to drugs that have been 
                effective in decreasing morbidity and mortality for 
                patients, which warrants unique management of 
                antimicrobial drugs that is inappropriate for most other 
                drugs in order to delay or prevent the development of 
                further resistance to existing therapies;
                    ``(B) provide for public notice of the availability 
                of recognized interpretive criteria and interpretive 
                criteria standards; and
                    ``(C) clear under section 510(k), classify under 
                section 513(f)(2), or approve under section 515, 
                antimicrobial susceptibility testing devices utilizing 
                updated, recognized susceptibility test interpretive 
                criteria to characterize the in vitro susceptibility of 
                particular bacteria, fungi, or other microorganisms, as 
                applicable, to antimicrobial drugs.
            ``(2) Identification of criteria.--The Secretary shall 
        identify appropriate susceptibility test interpretive criteria 
        with respect to antimicrobial drugs--
                    ``(A) if such criteria are available on the date of 
                approval of the drug under section 505 of this Act or 
                licensure of the drug under section 351 of the Public 
                Health Service Act (as applicable), upon such approval 
                or licensure; or
                    ``(B) if such criteria are unavailable on such date, 
                on the date on which such criteria are available for 
                such drug.
            ``(3) Bases for initial identification.--The Secretary shall 
        identify appropriate susceptibility test interpretive criteria 
        under paragraph (2), based on the Secretary's review of, to the 
        extent available and relevant--
                    ``(A) preclinical and clinical data, including 
                pharmacokinetic, pharmacodynamic, and epidemiological 
                data;
                    ``(B) the relationship of susceptibility test 
                interpretive criteria to morbidity and mortality 
                associated with the disease or condition for which such 
                drug is used; and
                    ``(C) such other evidence and information as the 
                Secretary considers appropriate.

    ``(b) Susceptibility Test Interpretive Criteria Website.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of the 21st Century Cures Act, the Secretary shall 
        establish, and maintain thereafter, on the website of the Food 
        and Drug Administration, a dedicated website that contains a 
        list of any appropriate new or updated susceptibility test 
        interpretive criteria standards and interpretive criteria in 
        accordance with paragraph (2) (referred to in this section as 
        the `Interpretive Criteria Website').
            ``(2) Listing of susceptibility test interpretive criteria 
        standards and interpretive criteria.--
                    ``(A) In general.--The list described in paragraph 
                (1) shall consist of any new or updated susceptibility 
                test interpretive criteria standards that are--
                          ``(i) established by a nationally or 
                      internationally recognized standard development 
                      organization that--
                                    ``(I) establishes and maintains 
                                procedures to address potential 
                                conflicts of interest and ensure 
                                transparent decisionmaking;

[[Page 130 STAT. 1116]]

                                    ``(II) holds open meetings to ensure 
                                that there is an opportunity for public 
                                input by interested parties, and 
                                establishes and maintains processes to 
                                ensure that such input is considered in 
                                decisionmaking; and
                                    ``(III) permits its standards to be 
                                made publicly available, through the 
                                National Library of Medicine or another 
                                similar source acceptable to the 
                                Secretary; and
                          ``(ii) recognized in whole, or in part, by the 
                      Secretary under subsection (c).
                    ``(B) Other list.--The Interpretive Criteria Website 
                shall, in addition to the list described in subparagraph 
                (A), include a list of interpretive criteria, if any, 
                that the Secretary has determined to be appropriate with 
                respect to legally marketed antimicrobial drugs, where--
                          ``(i) the Secretary does not recognize, in 
                      whole or in part, an interpretive criteria 
                      standard described under subparagraph (A) 
                      otherwise applicable to such a drug;
                          ``(ii) the Secretary withdraws under 
                      subsection (c)(1)(A) recognition of a standard, in 
                      whole or in part, otherwise applicable to such a 
                      drug;
                          ``(iii) the Secretary approves an application 
                      under section 505 of this Act or section 351 of 
                      the Public Health Service Act, as applicable, with 
                      respect to marketing of such a drug for which 
                      there are no relevant interpretive criteria 
                      included in a standard recognized by the Secretary 
                      under subsection (c); or
                          ``(iv) because the characteristics of such a 
                      drug differ from other drugs with the same active 
                      ingredient, the interpretive criteria with respect 
                      to such drug--
                                    ``(I) differ from otherwise 
                                applicable interpretive criteria 
                                included in a standard listed under 
                                subparagraph (A) or interpretive 
                                criteria otherwise listed under this 
                                subparagraph; and
                                    ``(II) are determined by the 
                                Secretary to be appropriate for the 
                                drug.
                    ``(C) Required statements.--The Interpretive 
                Criteria Website shall include statements conveying--
                          ``(i) that the website provides information 
                      about the in vitro susceptibility of bacteria, 
                      fungi, or other microorganisms, as applicable to a 
                      certain drug (or drugs);
                          ``(ii) that--
                                    ``(I) the safety and efficacy of 
                                such drugs in treating clinical 
                                infections due to such bacteria, fungi, 
                                or other microorganisms, as applicable, 
                                may or may not have been established in 
                                adequate and well-controlled clinical 
                                trials in order for the susceptibility 
                                information described in clause (i) to 
                                be included on the website; and
                                    ``(II) the clinical significance of 
                                such susceptibility information in such 
                                instances is unknown;
                          ``(iii) that the approved product labeling for 
                      specific drugs provides the uses for which the 
                      Secretary has approved the product; and

[[Page 130 STAT. 1117]]

                          ``(iv) any other information that the 
                      Secretary determines appropriate to adequately 
                      convey the meaning of the data supporting the 
                      recognition or listing of susceptibility test 
                      interpretive criteria standards or susceptibility 
                      test interpretive criteria included on the 
                      website.
            ``(3) Notice.--Not later than the date on which the 
        Interpretive Criteria Website is established, the Secretary 
        shall publish a notice of that establishment in the Federal 
        Register.
            ``(4) Inapplicability of misbranding provision.--The 
        inclusion in the approved labeling of an antimicrobial drug of a 
        reference or hyperlink to the Interpretive Criteria Website, in 
        and of itself, shall not cause the drug to be misbranded in 
        violation of section 502.
            ``(5) Trade secrets and confidential information.--Nothing 
        in this section shall be construed as authorizing the Secretary 
        to disclose any information that is a trade secret or 
        confidential information subject to section 552(b)(4) of title 
        5, United States Code.

    ``(c) Recognition of Susceptibility Test Interpretive Criteria.--
            ``(1) Evaluation and publication.--
                    ``(A) In general.--Beginning on the date of the 
                establishment of the Interpretive Criteria Website, and 
                at least every 6 months thereafter, the Secretary 
                shall--
                          ``(i) evaluate any appropriate new or updated 
                      susceptibility test interpretive criteria 
                      standards established by a nationally or 
                      internationally recognized standard development 
                      organization described in subsection (b)(2)(A)(i); 
                      and
                          ``(ii) publish on the public website of the 
                      Food and Drug Administration a notice--
                                    ``(I) withdrawing recognition of any 
                                different susceptibility test 
                                interpretive criteria standard, in whole 
                                or in part;
                                    ``(II) recognizing the new or 
                                updated standards;
                                    ``(III) recognizing one or more 
                                parts of the new or updated interpretive 
                                criteria specified in such a standard 
                                and declining to recognize the remainder 
                                of such standard; and
                                    ``(IV) making any necessary updates 
                                to the lists under subsection (b)(2).
                    ``(B) Upon approval of a drug.--Upon the approval of 
                an initial or supplemental application for an 
                antimicrobial drug under section 505 of this Act or 
                section 351 of the Public Health Service Act, as 
                applicable, where such approval is based on 
                susceptibility test interpretive criteria which differ 
                from those contained in a standard recognized, or from 
                those otherwise listed, by the Secretary pursuant to 
                this subsection, or for which there are no relevant 
                interpretive criteria standards recognized, or 
                interpretive criteria otherwise listed, by the Secretary 
                pursuant to this subsection, the Secretary shall update 
                the lists under subparagraphs (A) and (B) of subsection 
                (b)(2) to include the susceptibility test interpretive 
                criteria upon which such approval was based.

[[Page 130 STAT. 1118]]

            ``(2) Bases for updating interpretive criteria standards.--
        In evaluating new or updated susceptibility test interpretive 
        criteria standards under paragraph (1)(A), the Secretary may 
        consider--
                    ``(A) the Secretary's determination that such a 
                standard is not applicable to a particular drug because 
                the characteristics of the drug differ from other drugs 
                with the same active ingredient;
                    ``(B) information provided by interested third 
                parties, including public comment on the annual 
                compilation of notices published under paragraph (3);
                    ``(C) any bases used to identify susceptibility test 
                interpretive criteria under subsection (a)(2); and
                    ``(D) such other information or factors as the 
                Secretary determines appropriate.
            ``(3) Annual compilation of notices.--Each year, the 
        Secretary shall compile the notices published under paragraph 
        (1)(A) and publish such compilation in the Federal Register and 
        provide for public comment. If the Secretary receives comments, 
        the Secretary shall review such comments and, if the Secretary 
        determines appropriate, update pursuant to this subsection 
        susceptibility test interpretive criteria standards or 
        criteria--
                    ``(A) recognized by the Secretary under this 
                subsection; or
                    ``(B) otherwise listed on the Interpretive Criteria 
                Website under subsection (b)(2).
            ``(4) Relation to section 514(c).--Any susceptibility test 
        interpretive standard recognized under this subsection or any 
        criteria otherwise listed under subsection (b)(2)(B) shall be 
        deemed to be recognized as a standard by the Secretary under 
        section 514(c)(1).
            ``(5) Voluntary use of interpretive criteria.--Nothing in 
        this section prohibits a person from seeking approval or 
        clearance of a drug or device, or changes to the drug or the 
        device, on the basis of susceptibility test interpretive 
        criteria which differ from those contained in a standard 
        recognized, or from those otherwise listed, by the Secretary 
        pursuant to subsection (b)(2).

    ``(d) Antimicrobial Drug Labeling.--
            ``(1) Drugs marketed prior to establishment of interpretive 
        criteria website.--
                    ``(A) In general.--With respect to an antimicrobial 
                drug lawfully introduced or delivered for introduction 
                into interstate commerce for commercial distribution 
                before the establishment of the Interpretive Criteria 
                Website, a holder of an approved application under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act, as applicable, for each such drug, 
                not later than 1 year after establishment of the 
                Interpretive Criteria Website described in subsection 
                (b)(1), shall remove susceptibility test interpretive 
                criteria, if any, and related information from the 
                approved drug labeling and replace it with a reference 
                to the Interpretive Criteria Website.
                    ``(B) Labeling changes.--The labeling changes 
                required by this section shall be considered a minor 
                change

[[Page 130 STAT. 1119]]

                under section 314.70 of title 21, Code of Federal 
                Regulations (or any successor regulations) that may be 
                implemented through documentation in the next applicable 
                annual report.
            ``(2) Drugs marketed subsequent to establishment of 
        interpretive criteria website.--With respect to antimicrobial 
        drugs approved on or after the date of the establishment of the 
        Interpretive Criteria Website described in subsection (b)(1), 
        the labeling for such a drug shall include, in lieu of 
        susceptibility test interpretive criteria and related 
        information, a reference to such Website.

    ``(e) Special Condition for Marketing of Antimicrobial 
Susceptibility Testing Devices.--
            ``(1) In general.--Notwithstanding sections 501, 502, 505, 
        510, 513, and 515, if the conditions specified in paragraph (2) 
        are met (in addition to other applicable provisions under this 
        chapter) with respect to an antimicrobial susceptibility testing 
        device described in subsection (f)(1), the Secretary may 
        authorize the marketing of such device for a use described in 
        such subsection.
            ``(2) Conditions applicable to antimicrobial susceptibility 
        testing devices.--The conditions specified in this paragraph are 
        the following:
                    ``(A) The device is used to make a determination of 
                susceptibility using susceptibility test interpretive 
                criteria that are--
                          ``(i) included in a standard recognized by the 
                      Secretary under subsection (c); or
                          ``(ii) otherwise listed on the Interpretive 
                      Criteria Website under subsection (b)(2).
                    ``(B) The labeling of such device includes 
                statements conveying--
                          ``(i) that the device provides information 
                      about the in vitro susceptibility of bacteria, 
                      fungi, or other microorganisms, as applicable to 
                      antimicrobial drugs;
                          ``(ii) that--
                                    ``(I) the safety and efficacy of 
                                such drugs in treating clinical 
                                infections due to such bacteria, fungi, 
                                or other microorganisms, as applicable, 
                                may or may not have been established in 
                                adequate and well-controlled clinical 
                                trials in order for the device to report 
                                the susceptibility of such bacteria, 
                                fungi, or other microorganisms, as 
                                applicable, to such drugs; and
                                    ``(II) the clinical significance of 
                                such susceptibility information in those 
                                instances is unknown;
                          ``(iii) that the approved labeling for drugs 
                      tested using such a device provides the uses for 
                      which the Secretary has approved such drugs; and
                          ``(iv) any other information the Secretary 
                      determines appropriate to adequately convey the 
                      meaning of the data supporting the recognition or 
                      listing of susceptibility test interpretive 
                      criteria standards or susceptibility test 
                      interpretive criteria described in subparagraph 
                      (A).
                    ``(C) The antimicrobial susceptibility testing 
                device meets all other requirements to be cleared under 
                section

[[Page 130 STAT. 1120]]

                510(k), classified under section 513(f)(2), or approved 
                under section 515.

    ``(f) Definitions.--In this section:
            ``(1) The term `antimicrobial susceptibility testing device' 
        means a device that utilizes susceptibility test interpretive 
        criteria to determine and report the in vitro susceptibility of 
        certain microorganisms to a drug (or drugs).
            ``(2) The term `qualified infectious disease product' means 
        a qualified infectious disease product designated under section 
        505E(d).
            ``(3) The term `susceptibility test interpretive criteria' 
        means--
                    ``(A) one or more specific numerical values which 
                characterize the susceptibility of bacteria or other 
                microorganisms to the drug tested; and
                    ``(B) related categorizations of such 
                susceptibility, including categorization of the drug as 
                susceptible, intermediate, resistant, or such other term 
                as the Secretary determines appropriate.
            ``(4)(A) The term `antimicrobial drug' means, subject to 
        subparagraph (B), a systemic antibacterial or antifungal drug 
        that--
                    ``(i) is intended for human use in the treatment of 
                a disease or condition caused by a bacterium or fungus;
                    ``(ii) may include a qualified infectious disease 
                product designated under section 505E(d); and
                    ``(iii) is subject to section 503(b)(1).
            ``(B) If provided by the Secretary through regulations, such 
        term may include--
                    ``(i) drugs other than systemic antibacterial and 
                antifungal drugs; and
                    ``(ii) biological products (as such term is defined 
                in section 351 of the Public Health Service Act) to the 
                extent such products exhibit antimicrobial activity. 
            ``(5) The term `interpretive criteria standard' means a 
        compilation of susceptibility test interpretive criteria 
        developed by a standard development organization that meets the 
        criteria set forth in subsection (b)(2)(A)(i).

    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to--
            ``(1) alter the standards of evidence under subsection (c) 
        or (d) of section 505 (including the substantial evidence 
        standard under section 505(d)) or under section 351 of the 
        Public Health Service Act (as applicable); or
            ``(2) with respect to clearing devices under section 510(k), 
        classifying devices under section 513(f)(2), or approving 
        devices under section 515--
                    ``(A) apply with respect to any drug, device, or 
                biological product, in any context other than an 
                antimicrobial drug and an antimicrobial susceptibility 
                testing device that uses susceptibility test 
                interpretive criteria to characterize and report the 
                susceptibility of certain bacteria, fungi, or other 
                microorganisms, as applicable, to such drug to reflect 
                patient morbidity and mortality in accordance with this 
                section; or

[[Page 130 STAT. 1121]]

                    ``(B) unless specifically stated, have any effect on 
                authorities provided under other sections of this Act, 
                including any regulations issued under such sections.''.

    (b) Conforming Amendments.--
            (1) Repeal of prior related authority.--Section 1111 of the 
        Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 
        247d-5a), relating to identification of clinically susceptible 
        concentrations of antimicrobials, is repealed.
            (2) Addition to categories of misbranded drugs.--Section 502 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 
        amended by adding at the end the following:

    ``(dd) If it is an antimicrobial drug, as defined in section 
511A(f), and its labeling fails to conform with the requirements under 
section 511A(d).''.
            (3) Recognition of interpretive criteria standard as device 
        standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting 
        after ``the Secretary shall, by publication in the Federal 
        Register'' the following: ``(or, with respect to a 
        susceptibility test interpretive criteria standard under section 
        511A, by posting on the Interpretive Criteria Website in 
        accordance with such section)''.

    (c) Report to Congress.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the progress made in implementing section 
511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 
added by subsection (a).
    (d) <<NOTE: 21 USC 360a-2 note.>>  Requests for Updates to 
Interpretive Criteria Website.--Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information from interested 
parties regarding updating the lists established under section 511A(b) 
of the Federal Food, Drug, and Cosmetic Act and posted on the 
Interpretive Criteria Website established under section 511A(c) of such 
Act.

                 Subtitle F--Medical Device Innovations

SEC. 3051. BREAKTHROUGH DEVICES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B, 
as added by section 3034(b), the following:
``SEC. 515C. <<NOTE: 21 USC 360e-3.>>  BREAKTHROUGH DEVICES.

    ``(a) Purpose.--The purpose of this section is to encourage the 
Secretary, and provide the Secretary with sufficient authority, to apply 
efficient and flexible approaches to expedite the development of, and 
prioritize the Food and Drug Administration's review of, devices that 
represent breakthrough technologies.
    ``(b) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide for the priority 
review for, devices, as determined by the Secretary--

[[Page 130 STAT. 1122]]

            ``(1) that provide for more effective treatment or diagnosis 
        of life-threatening or irreversibly debilitating human disease 
        or conditions; and
            ``(2)(A) that represent breakthrough technologies;
            ``(B) for which no approved or cleared alternatives exist;
            ``(C) that offer significant advantages over existing 
        approved or cleared alternatives, including the potential, 
        compared to existing approved alternatives, to reduce or 
        eliminate the need for hospitalization, improve patient quality 
        of life, facilitate patients' ability to manage their own care 
        (such as through self-directed personal assistance), or 
        establish long-term clinical efficiencies; or
            ``(D) the availability of which is in the best interest of 
        patients.

    ``(c) Request for Designation.--A sponsor of a device may request 
that the Secretary designate such device for expedited development and 
priority review under this section. Any such request for designation may 
be made at any time prior to the submission of an application under 
section 515(c), a notification under section 510(k), or a petition for 
classification under section 513(f)(2).
    ``(d) Designation Process.--
            ``(1) In general.--Not later than 60 calendar days after the 
        receipt of a request under subsection (c), the Secretary shall 
        determine whether the device that is the subject of the request 
        meets the criteria described in subsection (b). If the Secretary 
        determines that the device meets the criteria, the Secretary 
        shall designate the device for expedited development and 
        priority review.
            ``(2) Review.--Review of a request under subsection (c) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(3) Withdrawal.--The Secretary may not withdraw a 
        designation granted under this section on the basis of the 
        criteria under subsection (b) no longer applying because of the 
        subsequent clearance or approval of another device that--
                    ``(A) was designated under this section; or
                    ``(B) was given priority review under section 
                515(d)(5), as in effect prior to the date of enactment 
                of the 21st Century Cures Act.

    ``(e) Expedited Development and Priority Review.--
            ``(1) Actions.--For purposes of expediting the development 
        and review of devices designated under subsection (d) the 
        Secretary shall--
                    ``(A) assign a team of staff, including a team 
                leader with appropriate subject matter expertise and 
                experience, for each device for which a request is 
                submitted under subsection (c);
                    ``(B) provide for oversight of the team by senior 
                agency personnel to facilitate the efficient development 
                of the device and the efficient review of any submission 
                described in subsection (c) for the device;
                    ``(C) adopt an efficient process for timely dispute 
                resolution;
                    ``(D) provide for interactive and timely 
                communication with the sponsor of the device during the 
                development program and review process;

[[Page 130 STAT. 1123]]

                    ``(E) expedite the Secretary's review of 
                manufacturing and quality systems compliance, as 
                applicable;
                    ``(F) disclose to the sponsor, not less than 5 
                business days in advance, the topics of any consultation 
                the Secretary intends to undertake with external experts 
                or an advisory committee concerning the sponsor's device 
                and provide the sponsor the opportunity to recommend 
                such external experts;
                    ``(G) provide for advisory committee input, as the 
                Secretary determines appropriate (including in response 
                to the request of the sponsor) for applications 
                submitted under section 515(c); and
                    ``(H) assign staff to be available within a 
                reasonable time to address questions by institutional 
                review committees concerning the conditions and clinical 
                testing requirements applicable to the investigational 
                use of the device pursuant to an exemption under section 
                520(g).
            ``(2) Additional actions.--In addition to the actions 
        described in paragraph (1), for purposes of expediting the 
        development and review of devices designated under subsection 
        (d), the Secretary, in collaboration with the device sponsor, 
        may, as appropriate--
                    ``(A) coordinate with the sponsor regarding early 
                agreement on a data development plan;
                    ``(B) take steps to ensure that the design of 
                clinical trials is as efficient and flexible as 
                practicable, when scientifically appropriate;
                    ``(C) facilitate, when scientifically appropriate, 
                expedited and efficient development and review of the 
                device through utilization of timely postmarket data 
                collection with regard to application for approval under 
                section 515(c); and
                    ``(D) agree in writing to clinical protocols that 
                the Secretary will consider binding on the Secretary and 
                the sponsor, subject to--
                          ``(i) changes to such protocols agreed to in 
                      writing by the sponsor and the Secretary; or
                          ``(ii) a decision, made by the director of the 
                      office responsible for reviewing the device 
                      submission, that a substantial scientific issue 
                      essential to determining the safety or 
                      effectiveness of such device exists, provided that 
                      such decision is in writing, and is made only 
                      after the Secretary provides to the device sponsor 
                      or applicant an opportunity for a meeting at which 
                      the director and the sponsor or applicant are 
                      present and at which the director documents the 
                      substantial scientific issue.

    ``(f) Priority Review Guidance.--
            ``(1) Content.--Not later than 1 year after the date of 
        enactment of the 21st Century Cures Act, the Secretary shall 
        issue guidance on the implementation of this section. Such 
        guidance shall--
                    ``(A) set forth the process by which a person may 
                seek a designation under subsection (d);
                    ``(B) provide a template for requests under 
                subsection (c);

[[Page 130 STAT. 1124]]

                    ``(C) identify the criteria the Secretary will use 
                in evaluating a request for designation under this 
                section; and
                    ``(D) identify the criteria and processes the 
                Secretary will use to assign a team of staff, including 
                team leaders, to review devices designated for expedited 
                development and priority review, including any training 
                required for such personnel to ensure effective and 
                efficient review.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment on a 
        proposed guidance.

    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to affect--
            ``(1) the criteria and standards for evaluating an 
        application pursuant to section 515(c), a report and request for 
        classification under section 513(f)(2), or a report under 
        section 510(k), including the recognition of valid scientific 
        evidence as described in section 513(a)(3)(B) and consideration 
        and application of the least burdensome means of evaluating 
        device effectiveness or demonstrating substantial equivalence 
        between devices with differing technological characteristics, as 
        applicable;
            ``(2) the authority of the Secretary with respect to 
        clinical holds under section 520(g)(8)(A);
            ``(3) the authority of the Secretary to act on an 
        application pursuant to section 515(d) before completion of an 
        establishment inspection, as the Secretary determines 
        appropriate; or
            ``(4) the authority of the Secretary with respect to 
        postmarket surveillance under sections 519(h) and 522.''.

    (b) Documentation and Review of Significant Decisions.--Section 
517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)(1)) is amended by inserting ``a request for designation under 
section 515C,'' after ``application under section 515,''.
    (c) Termination of Previous Program.--
            (1) In general.--Section 515(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
                    (A) by striking paragraph (5); and
                    (B) by redesignating paragraph (6) as paragraph (5).
            (2) Conforming amendment.--Section 737(5) of the Federal 
        Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by 
        striking ``515(d)(6)'' and inserting ``515(d)(5)''.

    (d) Report.--On January 1, 2019, the Secretary of Health and Human 
Services shall issue a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives--
            (1) on the program under section 515C of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (a), in bringing 
        safe and effective devices included in such program to patients 
        as soon as possible; and
            (2) that includes recommendations, if any, to strengthen the 
        program to better meet patient device needs in a manner as 
        timely as possible.
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended--

[[Page 130 STAT. 1125]]

            (1) in paragraph (1) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000'';
            (2) in paragraph (2)(A) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000''; and
            (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
        inserting ``8,000''.

    (b) <<NOTE: 21 USC 360j note.>>  Guidance Document on Probable 
Benefit.--Not later than 18 months after the date of enactment of this 
Act, the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall publish a draft guidance that 
defines the criteria for establishing ``probable benefit'' as that term 
is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(m)(2)(C)).
SEC. 3053. RECOGNITION OF STANDARDS.

    (a) In General.--Section 514(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
            (1) in paragraph (1), by inserting after subparagraph (B) 
        the following new subparagraphs:

    ``(C)(i) Any person may submit a request for recognition under 
subparagraph (A) of all or part of an appropriate standard established 
by a nationally or internationally recognized standard organization.
    ``(ii) Not later than 60 calendar days after the Secretary receives 
such a request, the Secretary shall--
            ``(I) make a determination to recognize all, part, or none 
        of the standard that is the subject of the request; and
            ``(II) issue to the person who submitted such request a 
        response in writing that states the Secretary's rationale for 
        that determination, including the scientific, technical, 
        regulatory, or other basis for such determination.

    ``(iii) The Secretary shall make a response issued under clause 
(ii)(II) publicly available, in such a manner as the Secretary 
determines appropriate.
    ``(iv) The Secretary shall take such actions as may be necessary to 
implement all or part of a standard recognized under clause (ii)(I), in 
accordance with subparagraph (A).
    ``(D) The Secretary shall make publicly available, in such manner as 
the Secretary determines appropriate, the rationale for recognition 
under subparagraph (A) of all, part, or none of a standard, including 
the scientific, technical, regulatory, or other basis for the decision 
regarding such recognition.''; and
            (2) by adding at the end the following:

    ``(4) The Secretary shall provide to all employees of the Food and 
Drug Administration who review premarket submissions for devices 
periodic training on the concept and use of recognized standards for 
purposes of meeting a premarket submission requirement or other 
applicable requirement under this Act, including standards relevant to 
an employee's area of device review.''.
    (b) <<NOTE: 21 USC 360d note.>>  Guidance.--The Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall review and update, if necessary, previously published guidance and 
standard operating procedures identifying the principles for recognizing 
standards, and for withdrawing the recognition of standards, under 
section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360d(c)), taking into account the experience with and reliance on a 
standard by foreign regulatory authorities and the

[[Page 130 STAT. 1126]]

device industry, and whether recognition of a standard will promote 
harmonization among regulatory authorities in the regulation of devices.
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.

    (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(l)) is amended--
            (1) by striking ``A report under subsection (k)'' and 
        inserting ``(1) A report under subsection (k)''; and
            (2) by adding at the end the following new paragraph:

    ``(2) Not later than 120 calendar days after the date of enactment 
of the 21st Century Cures Act and at least once every 5 years 
thereafter, as the Secretary determines appropriate, the Secretary shall 
identify, through publication in the Federal Register, any type of class 
I device that the Secretary determines no longer requires a report under 
subsection (k) to provide reasonable assurance of safety and 
effectiveness. Upon such publication--
            ``(A) each type of class I device so identified shall be 
        exempt from the requirement for a report under subsection (k); 
        and
            ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.

    (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(m)) is amended--
            (1) by striking ``(m)(1)'' and all that follows through ``by 
        the Secretary.'' and inserting the following:

    ``(m)(1) The Secretary shall--
            ``(A) not later than 90 days after the date of enactment of 
        the 21st Century Cures Act and at least once every 5 years 
        thereafter, as the Secretary determines appropriate--
                    ``(i) publish in the Federal Register a notice that 
                contains a list of each type of class II device that the 
                Secretary determines no longer requires a report under 
                subsection (k) to provide reasonable assurance of safety 
                and effectiveness; and
                    ``(ii) provide for a period of not less than 60 
                calendar days for public comment beginning on the date 
                of the publication of such notice; and
            ``(B) not later than 210 calendar days after the date of 
        enactment of the 21st Century Cures Act, publish in the Federal 
        Register a list representing the Secretary's final determination 
        with respect to the devices contained in the list published 
        under subparagraph (A).''; and
            (2) in paragraph (2)--
                    (A) by striking ``1 day after the date of 
                publication of a list under this subsection,'' and 
                inserting ``1 calendar day after the date of publication 
                of the final list under paragraph (1)(B),''; and
                    (B) by striking ``30-day period'' and inserting 
                ``60-calendar-day period''; and
                    (C) by adding at the end the following new 
                paragraph:

    ``(3) Upon the publication of the final list under paragraph 
(1)(B)--
            ``(A) each type of class II device so listed shall be exempt 
        from the requirement for a report under subsection (k); and

[[Page 130 STAT. 1127]]

            ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.
SEC. 3055. CLASSIFICATION PANELS.

    (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
            (1) by striking ``(5)'' and inserting ``(5)(A)''; and
            (2) by adding at the end the following:

    ``(B) When a device is specifically the subject of review by a 
classification panel, the Secretary shall--
            ``(i) ensure that adequate expertise is represented on the 
        classification panel to assess--
                    ``(I) the disease or condition which the device is 
                intended to cure, treat, mitigate, prevent, or diagnose; 
                and
                    ``(II) the technology of the device; and
            ``(ii) provide an opportunity for the person whose device is 
        specifically the subject of panel review to provide 
        recommendations on the expertise needed among the voting members 
        of the panel.

    ``(C) For purposes of subparagraph (B)(i), the term `adequate 
expertise' means that the membership of the classification panel 
includes--
            ``(i) two or more voting members, with a specialty or other 
        expertise clinically relevant to the device under review; and
            ``(ii) at least one voting member who is knowledgeable about 
        the technology of the device.

    ``(D) The Secretary shall provide an annual opportunity for 
patients, representatives of patients, and sponsors of medical device 
submissions to provide recommendations for individuals with appropriate 
expertise to fill voting member positions on classification panels.''.
    (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
            (1) in subparagraph (A)(iii), by inserting before the period 
        at the end ``, including, subject to the discretion of the panel 
        chairperson, by designating a representative who will be 
        provided a time during the panel meeting to address the panel 
        for the purpose of correcting misstatements of fact or providing 
        clarifying information, and permitting the person or 
        representative to call on experts within the person's 
        organization to address such specific issues in the time 
        provided''; and
            (2) by striking subparagraph (B) and inserting the following 
        new subparagraph:

    ``(B)(i) Any meeting of a classification panel with respect to the 
review of a device shall--
            ``(I) provide adequate time for initial presentations by the 
        person whose device is specifically the subject of such review 
        and by the Secretary; and
            ``(II) encourage free and open participation by all 
        interested persons.

    ``(ii) Following the initial presentations described in clause (i), 
the panel may--
            ``(I) pose questions to a designated representative 
        described in subparagraph (A)(iii); and

[[Page 130 STAT. 1128]]

            ``(II) consider the responses to such questions in the 
        panel's review of the device.''.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended--
            (1) in subsection (g)(3)--
                    (A) in subparagraph (A)(i)--
                          (i) by striking ``local''; and
                          (ii) by striking ``which has been''; and
                    (B) in subparagraph (B), by striking ``a local 
                institutional'' and inserting ``an institutional''; and
            (2) in subsection (m)(4)--
                    (A) by striking subparagraph (A) and inserting the 
                following:
            ``(A) in facilities in which clinical testing of devices is 
        supervised by an institutional review committee established in 
        accordance with the regulations of the Secretary; and'';
                    (B) in subparagraph (B), by striking ``a local 
                institutional'' and inserting ``an institutional''; and
                    (C) in the matter following subparagraph (B), by 
                striking ``local''.
SEC. 3057. <<NOTE: 42 USC 263a note.>>  CLIA WAIVER IMPROVEMENTS.

    (a) Draft Revised Guidance.--Not later than 1 year after the date of 
the enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall publish a draft 
guidance that--
            (1) revises ``Section V. Demonstrating Insignificant Risk of 
        an Erroneous Result - Accuracy'' of the guidance entitled 
        ``Recommendations for Clinical Laboratory Improvement Amendments 
        of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro 
        Diagnostic Devices'' and dated January 30, 2008; and
            (2) includes the appropriate use of comparable performance 
        between a waived user and a moderately complex laboratory user 
        to demonstrate accuracy.

    (b) Final Revised Guidance.--The Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
finalize the draft guidance published under subsection (a) not later 
than 1 year after the comment period for such draft guidance closes.
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.

    (a) In General.--Section 513 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c) is amended by adding at the end the following:
    ``(j) Training and Oversight of Least Burdensome Requirements.--
            ``(1) The Secretary shall--
                    ``(A) ensure that each employee of the Food and Drug 
                Administration who is involved in the review of 
                premarket submissions, including supervisors, receives 
                training regarding the meaning and implementation of the 
                least burdensome requirements under subsections 
                (a)(3)(D) and (i)(1)(D) of this section and section 
                515(c)(5); and
                    ``(B) periodically assess the implementation of the 
                least burdensome requirements, including the employee 
                training

[[Page 130 STAT. 1129]]

                under subparagraph (A), to ensure that the least 
                burdensome requirements are fully and consistently 
                applied.
            ``(2) Not later than 18 months after the date of enactment 
        of the 21st Century Cures Act, the ombudsman for any 
        organizational unit of the Food and Drug Administration 
        responsible for the premarket review of devices shall--
                    ``(A) conduct an audit of the training described in 
                paragraph (1)(A), including the effectiveness of such 
                training in implementing the least burdensome 
                requirements;
                    ``(B) include in such audit interviews of persons 
                who are representatives of the device industry regarding 
                their experiences in the device premarket review 
                process, including with respect to the application of 
                least burdensome concepts to premarket review and 
                decisionmaking;
                    ``(C) include in such audit a list of the 
                measurement tools the Secretary uses to assess the 
                implementation of the least burdensome requirements, 
                including under paragraph (1)(B) and section 517A(a)(3), 
                and may also provide feedback on the effectiveness of 
                such tools in the implementation of the least burdensome 
                requirements;
                    ``(D) summarize the findings of such audit in a 
                final audit report; and
                    ``(E) within 30 calendar days of completion of such 
                final audit report, make such final audit report 
                available--
                          ``(i) to the Committee on Health, Education, 
                      Labor, and Pensions of the Senate and the 
                      Committee on Energy and Commerce of the House of 
                      Representatives; and
                          ``(ii) on the Internet website of the Food and 
                      Drug Administration.''.

    (b) Premarket Applications.--Section 515(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the 
end the following:
    ``(5)(A) In requesting additional information with respect to an 
application under this section, the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate a reasonable 
assurance of device safety and effectiveness.
    ``(B) For purposes of subparagraph (A), the term `necessary' means 
the minimum required information that would support a determination by 
the Secretary that an application provides a reasonable assurance of the 
safety and effectiveness of the device.
    ``(C) For purposes of this paragraph, the Secretary shall consider 
the role of postmarket information in determining the least burdensome 
means of demonstrating a reasonable assurance of device safety and 
effectiveness.
    ``(D) Nothing in this paragraph alters the standards for premarket 
approval of a device.''.
    (c) Rationale for Significant Decisions Regarding Devices.--Section 
517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)) is amended by adding at the end the following:
            ``(3) Application of least burdensome requirements.--The 
        substantive summary required under this subsection shall include 
        a brief statement regarding how the least burdensome 
        requirements were considered and applied consistent with section 
        513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as 
        applicable.''.

[[Page 130 STAT. 1130]]

SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT.

    (a) In General.--Section 510 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360) is amended by adding at the end the following:
    ``(q) Reusable Medical Devices.--
            ``(1) In general.--Not later than 180 days after the date of 
        enactment of the 21st Century Cures Act, the Secretary shall 
        identify and publish a list of reusable device types for which 
        reports under subsection (k) are required to include--
                    ``(A) instructions for use, which have been 
                validated in a manner specified by the Secretary; and
                    ``(B) validation data, the types of which shall be 
                specified by the Secretary;
        regarding cleaning, disinfection, and sterilization, and for 
        which a substantial equivalence determination may be based.
            ``(2) Revision of list.--The Secretary shall revise the list 
        under paragraph (2), as the Secretary determines appropriate, 
        with notice in the Federal Register.
            ``(3) Content of reports.--Reports under subsection (k) that 
        are submitted after the publication of the list described in 
        paragraph (1), for devices or types of devices included on such 
        list, shall include such instructions for use and validation 
        data.''.

    (b) <<NOTE: 21 USC 360 note.>>  Device Modifications.--The Secretary 
of Health and Human Services, acting through the Commissioner of Food 
and Drugs, shall issue final guidance regarding when a premarket 
notification under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a 
modification or change to a legally marketed device. Such final guidance 
shall be issued not later than 1 year after the date on which the 
comment period closes for the draft guidance on such subject.
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.

    (a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j) is amended by adding at the end the following:
    ``(o) Regulation of Medical and Certain Decisions Support 
Software.--
            ``(1) The term device, as defined in section 201(h), shall 
        not include a software function that is intended--
                    ``(A) for administrative support of a health care 
                facility, including the processing and maintenance of 
                financial records, claims or billing information, 
                appointment schedules, business analytics, information 
                about patient populations, admissions, practice and 
                inventory management, analysis of historical claims data 
                to predict future utilization or cost-effectiveness, 
                determination of health benefit eligibility, population 
                health management, and laboratory workflow;
                    ``(B) for maintaining or encouraging a healthy 
                lifestyle and is unrelated to the diagnosis, cure, 
                mitigation, prevention, or treatment of a disease or 
                condition;
                    ``(C) to serve as electronic patient records, 
                including patient-provided information, to the extent 
                that such records are intended to transfer, store, 
                convert formats,

[[Page 130 STAT. 1131]]

                or display the equivalent of a paper medical chart, so 
                long as--
                          ``(i) such records were created, stored, 
                      transferred, or reviewed by health care 
                      professionals, or by individuals working under 
                      supervision of such professionals;
                          ``(ii) such records are part of health 
                      information technology that is certified under 
                      section 3001(c)(5) of the Public Health Service 
                      Act; and
                          ``(iii) such function is not intended to 
                      interpret or analyze patient records, including 
                      medical image data, for the purpose of the 
                      diagnosis, cure, mitigation, prevention, or 
                      treatment of a disease or condition;
                    ``(D) for transferring, storing, converting formats, 
                or displaying clinical laboratory test or other device 
                data and results, findings by a health care professional 
                with respect to such data and results, general 
                information about such findings, and general background 
                information about such laboratory test or other device, 
                unless such function is intended to interpret or analyze 
                clinical laboratory test or other device data, results, 
                and findings; or
                    ``(E) unless the function is intended to acquire, 
                process, or analyze a medical image or a signal from an 
                in vitro diagnostic device or a pattern or signal from a 
                signal acquisition system, for the purpose of--
                          ``(i) displaying, analyzing, or printing 
                      medical information about a patient or other 
                      medical information (such as peer-reviewed 
                      clinical studies and clinical practice 
                      guidelines);
                          ``(ii) supporting or providing recommendations 
                      to a health care professional about prevention, 
                      diagnosis, or treatment of a disease or condition; 
                      and
                          ``(iii) enabling such health care professional 
                      to independently review the basis for such 
                      recommendations that such software presents so 
                      that it is not the intent that such health care 
                      professional rely primarily on any of such 
                      recommendations to make a clinical diagnosis or 
                      treatment decision regarding an individual 
                      patient.
            ``(2) In the case of a product with multiple functions that 
        contains--
                    ``(A) at least one software function that meets the 
                criteria under paragraph (1) or that otherwise does not 
                meet the definition of device under section 201(h); and
                    ``(B) at least one function that does not meet the 
                criteria under paragraph (1) and that otherwise meets 
                the definition of a device under section 201(h),
        the Secretary shall not regulate the software function of such 
        product described in subparagraph (A) as a device. 
        Notwithstanding the preceding sentence, when assessing the 
        safety and effectiveness of the device function or functions of 
        such product described in subparagraph (B), the Secretary may 
        assess the impact that the software function or functions 
        described in subparagraph (A) have on such device function or 
        functions.
            ``(3)(A) Notwithstanding paragraph (1), a software function 
        described in subparagraph (C), (D), or (E) of paragraph (1)

[[Page 130 STAT. 1132]]

        shall not be excluded from the definition of device under 
        section 201(h) if--
                    ``(i) the Secretary makes a finding that use of such 
                software function would be reasonably likely to have 
                serious adverse health consequences; and
                    ``(ii) the software function has been identified in 
                a final order issued by the Secretary under subparagraph 
                (B).
            ``(B) Subparagraph (A) shall apply only if the Secretary--
                    ``(i) publishes a notification and proposed order in 
                the Federal Register;
                    ``(ii) includes in such notification the Secretary's 
                finding, including the rationale and identification of 
                the evidence on which such finding was based, as 
                described in subparagraph (A)(i); and
                    ``(iii) provides for a period of not less than 30 
                calendar days for public comment before issuing a final 
                order or withdrawing such proposed order.
            ``(C) In making a finding under subparagraph (A)(i) with 
        respect to a software function, the Secretary shall consider--
                    ``(i) the likelihood and severity of patient harm if 
                the software function were to not perform as intended;
                    ``(ii) the extent to which the software function is 
                intended to support the clinical judgment of a health 
                care professional;
                    ``(iii) whether there is a reasonable opportunity 
                for a health care professional to review the basis of 
                the information or treatment recommendation provided by 
                the software function; and
                    ``(iv) the intended user and user environment, such 
                as whether a health care professional will use a 
                software function of a type described in subparagraph 
                (E) of paragraph (1).
            ``(4) Nothing in this subsection shall be construed as 
        limiting the authority of the Secretary to--
                    ``(A) exercise enforcement discretion as to any 
                device subject to regulation under this Act;
                    ``(B) regulate software used in the manufacture and 
                transfusion of blood and blood components to assist in 
                the prevention of disease in humans; or
                    ``(C) regulate software as a device under this Act 
                if such software meets the criteria under section 
                513(a)(1)(C).''.

    (b) <<NOTE: 21 USC 360j note.>>  Reports.--The Secretary of Health 
and Human Services (referred to in this subsection as the 
``Secretary''), after consultation with agencies and offices of the 
Department of Health and Human Services involved in health information 
technology, shall publish a report, not later than 2 years after the 
date of enactment of this Act and every 2 years thereafter, that--
            (1) includes input from outside experts, such as 
        representatives of patients, consumers, health care providers, 
        startup companies, health plans or other third-party payers, 
        venture capital investors, information technology vendors, 
        health information technology vendors, small businesses, 
        purchasers, employers, and other stakeholders with relevant 
        expertise, as determined by the Secretary;

[[Page 130 STAT. 1133]]

            (2) examines information available to the Secretary on any 
        risks and benefits to health associated with software functions 
        described in section 520(o)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a)); 
        and
            (3) summarizes findings regarding the impact of such 
        software functions on patient safety, including best practices 
        to promote safety, education, and competency related to such 
        functions.

    (c) Classification of Accessories.--Section 513(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding at 
the end the following:
    ``(9) The Secretary shall classify an accessory under this section 
based on the intended use of the accessory, notwithstanding the 
classification of any other device with which such accessory is intended 
to be used.''.
    (d) Conforming Amendment.--Section 201(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the 
following: ``The term `device' does not include software functions 
excluded pursuant to section 520(o).''.

     Subtitle G--Improving Scientific Expertise and Outreach at FDA

SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND 
                          BIOMEDICAL PRODUCT ASSESSMENT SERVICE.

    (a) Hiring and Retention Authority.--Section 228 of the Public 
Health Service Act (42 U.S.C. 237) is amended--
            (1) in the section heading, by inserting ``and biomedical 
        product assessment'' after ``research'';
            (2) in subsection (a)--
                    (A) in paragraph (1), by striking ``Silvio O. Conte 
                Senior Biomedical Research Service, not to exceed 500 
                members'' and inserting ``Silvio O. Conte Senior 
                Biomedical Research and Biomedical Product Assessment 
                Service (in this section referred to as the `Service'), 
                not to exceed 2,000 members, the purpose of which is to 
                recruit and retain outstanding and qualified scientific 
                and technical experts in the fields of biomedical 
                research, clinical research evaluation, and biomedical 
                product assessment'';
                    (B) by amending paragraph (2) to read as follows:

    ``(2) The authority established in paragraph (1) may not be 
construed to require the Secretary to reduce the number of employees 
serving under any other employment system in order to offset the number 
of members serving in the Service.''; and
                    (C) by adding at the end the following:

    ``(3) The Secretary shall assign experts under this section to 
agencies within the Department of Health and Human Services taking into 
account the need for the expertise of such expert.'';
            (3) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``or clinical research evaluation'' and 
                inserting ``, clinical research evaluation, or 
                biomedical product assessment''; and

[[Page 130 STAT. 1134]]

                    (B) in paragraph (1), by inserting ``or a doctoral 
                or master's level degree in engineering, bioinformatics, 
                or a related or emerging field,'' after the comma;
            (4) in subsection (d)(2), by striking ``and shall not exceed 
        the rate payable for level I of the Executive Schedule unless 
        approved by the President under section 5377(d)(2) of title 5, 
        United States Code'' and inserting ``and shall not exceed the 
        amount of annual compensation (excluding expenses) specified in 
        section 102 of title 3, United States Code'';
            (5) by striking subsection (e); and
            (6) by redesignating subsections (f) and (g) as subsections 
        (e) and (f), respectively.

    (b) GAO Study.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study of the effectiveness of the 
        amendments to section 228 of the Public Health Service Act (42 
        U.S.C. 237) made by subsection (a) and the impact of such 
        amendments, if any, on all agencies or departments of the 
        Department of Health and Human Services, and, not later than 4 
        years after the date of enactment of this Act, shall submit a 
        report based on such study to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives.
            (2) Content of study and report.--The study and report under 
        paragraph (1) shall include an examination of the extent to 
        which recruitment and retention of outstanding and qualified 
        scientific, medical, or technical experts in the fields of 
        biomedical research, clinical research evaluation, and 
        biomedical product assessment have improved or otherwise have 
        been affected by the amendments to section 228 of the Public 
        Health Service Act (42 U.S.C. 237) made by subsection (a), 
        including by determining, during the period between the date of 
        enactment of this Act and the completion of the study--
                    (A) the total number of members recruited and 
                retained under the Senior Biomedical Research and 
                Biomedical Product Assessment Service under such section 
                228, and the effect of increasing the number of members 
                eligible for such Service;
                    (B) the number of members of such Senior Biomedical 
                Research and Biomedical Product Assessment Service hired 
                with a doctoral level degree in biomedicine or a related 
                field, and the number of such members hired with a 
                doctoral or master's level degree in engineering, 
                bioinformatics, or a related or emerging field; and
                    (C) the number of Senior Biomedical Research and 
                Biomedical Product Assessment Service members that have 
                been hired by each agency or department of the 
                Department of Health and Human Services, and how such 
                Department assigns such members to each agency or 
                department.
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
                          PROFESSIONAL PERSONNEL.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 714 (21 U.S.C. 379d-3) the following:

[[Page 130 STAT. 1135]]

``SEC. 714A. <<NOTE: 21 USC 379d-3a.>>  HIRING AUTHORITY FOR 
                          SCIENTIFIC, TECHNICAL, AND PROFESSIONAL 
                          PERSONNEL.

    ``(a) In General.--The Secretary may, notwithstanding title 5, 
United States Code, governing appointments in the competitive service, 
appoint outstanding and qualified candidates to scientific, technical, 
or professional positions that support the development, review, and 
regulation of medical products. Such positions shall be within the 
competitive service.
    ``(b) Compensation.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, including any requirement with respect to General Schedule 
        pay rates under subchapter III of chapter 53 of title 5, United 
        States Code, and consistent with the requirements of paragraph 
        (2), the Commissioner of Food and Drugs may determine and set--
                    ``(A) the annual rate of pay of any individual 
                appointed under subsection (a); and
                    ``(B) for purposes of retaining qualified employees, 
                the annual rate of pay for any qualified scientific, 
                technical, or professional personnel appointed to a 
                position described in subsection (a) before the date of 
                enactment of the 21st Century Cures Act.
            ``(2) Limitation.--The annual rate of pay established 
        pursuant to paragraph (1) may not exceed the amount of annual 
        compensation (excluding expenses) specified in section 102 of 
        title 3, United States Code.
            ``(3) Public availability.--The annual rate of pay provided 
        to an individual in accordance with this section shall be 
        publicly available information.

    ``(c) Rule of Construction.--The authorities under this section 
shall not be construed to affect the authority provided under section 
714.
    ``(d) Report on Workforce Planning.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of the 21st Century Cures Act, the Secretary shall 
        submit a report on workforce planning to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of Representatives 
        that examines the extent to which the Food and Drug 
        Administration has a critical need for qualified individuals for 
        scientific, technical, or professional positions, including--
                    ``(A) an analysis of the workforce needs at the Food 
                and Drug Administration and the Secretary's strategic 
                plan for addressing such needs, including through use of 
                the authority under this section; and
                    ``(B) a recruitment and retention plan for hiring 
                qualified scientific, technical, and professional 
                candidates, which may include the use of--
                          ``(i) recruitment through nongovernmental 
                      recruitment or placement agencies;
                          ``(ii) recruitment through academic 
                      institutions;
                          ``(iii) recruitment or hiring bonuses, if 
                      applicable;
                          ``(iv) recruitment using targeted direct 
                      hiring authorities; and
                          ``(v) retention of qualified scientific, 
                      technical, and professional employees using the 
                      authority under this section, or other applicable 
                      authorities of the Secretary.

[[Page 130 STAT. 1136]]

            ``(2) Recommendations.--The report under paragraph (1) may 
        include the recommendations of the Commissioner of Food and 
        Drugs that would help the Food and Drug Administration to better 
        recruit and retain qualified individuals for scientific, 
        technical, or professional positions at the agency.''.

    (b) GAO Study and Report.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study of the ability of the Food and Drug 
        Administration to hire, train, and retain qualified scientific, 
        technical, and professional staff, not including contractors, 
        necessary to fulfill the mission of the Food and Drug 
        Administration to protect and promote public health. Not later 
        than January 1, 2022, the Comptroller General shall submit a 
        report on such study to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives.
            (2) Contents of study.--The Comptroller General shall 
        include in the study and report under paragraph (1)--
                    (A) information about the progress of the Food and 
                Drug Administration in recruiting and retaining 
                qualified scientific, technical, and professional staff 
                outstanding in the field of biomedical research, 
                clinical research evaluation, and biomedical product 
                assessment;
                    (B) the extent to which critical staffing needs 
                exist at the Food and Drug Administration, and barriers 
                to hiring, training, and retaining qualified staff, if 
                any;
                    (C) an examination of the recruitment and retention 
                strategies of the Food and Drug Administration, 
                including examining any strategic workforce plan, 
                focused on improving scientific, technical, and 
                professional staff recruitment and retention; and
                    (D) recommendations for potential improvements that 
                would address staffing needs of the Food and Drug 
                Administration.
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION 
                          INTERCENTER INSTITUTES.

    (a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the end the 
following:
``SEC. 1014. <<NOTE: 21 USC 399g.>>  FOOD AND DRUG ADMINISTRATION 
                          INTERCENTER INSTITUTES.

    ``(a) In General.--The Secretary shall establish one or more 
Intercenter Institutes within the Food and Drug Administration (referred 
to in this section as an `Institute') for a major disease area or areas. 
With respect to the major disease area of focus of an Institute, such 
Institute shall develop and implement processes for coordination of 
activities, as applicable to such major disease area or areas, among the 
Center for Drug Evaluation and Research, the Center for Biologics 
Evaluation and Research, and the Center for Devices and Radiological 
Health (for the purposes of this section, referred to as the `Centers'). 
Such activities may include--
            ``(1) coordination of staff from the Centers with diverse 
        product expertise in the diagnosis, cure, mitigation, treatment, 
        or prevention of the specific diseases relevant to the major 
        disease area of focus of the Institute;

[[Page 130 STAT. 1137]]

            ``(2) streamlining, where appropriate, the review of medical 
        products to diagnose, cure, mitigate, treat, or prevent the 
        specific diseases relevant to the major disease area of focus of 
        the Institute, applying relevant standards under sections 505, 
        510(k), 513(f)(2), and 515 of this Act and section 351 of the 
        Public Health Service Act, and other applicable authorities;
            ``(3) promotion of scientific programs within the Centers 
        related to the major disease area of focus of the Institute;
            ``(4) development of programs and enhancement of strategies 
        to recruit, train, and provide continuing education 
        opportunities for the personnel of the Centers with expertise 
        related to the major disease area of focus of the Institute;
            ``(5) enhancement of the interactions of the Centers with 
        patients, sponsors, and the external biomedical community 
        regarding the major disease area of focus of the Institute; and
            ``(6) facilitation of the collaborative relationships of the 
        Centers with other agencies within the Department of Health and 
        Human Services regarding the major disease area of focus of the 
        Institute.

    ``(b) Public Process.--The Secretary shall provide a period for 
public comment during the time that each Institute is being implemented.
    ``(c) Timing.--The Secretary shall establish at least one Institute 
under subsection (a) before the date that is 1 year after the date of 
enactment of the 21st Century Cures Act.
    ``(d) Termination of Institutes.--The Secretary may terminate any 
Institute established pursuant to this section if the Secretary 
determines such Institute is no longer benefitting the public health. 
Not less than 60 days prior to so terminating an Institute, the 
Secretary shall provide public notice, including the rationale for such 
termination.''.
    (b) Technical Amendments.--Chapter X of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
            (1) by redesignating section 1012 as section 1013; and
            (2) by redesignating the second section 1011 (with respect 
        to improving the training of State, local, territorial, and 
        tribal food safety officials), as added by section 209(a) of the 
        FDA Food Safety Modernization Act (Public Law 111-353), as 
        section 1012.
SEC. 3074. <<NOTE: 42 USC 3506a.>>  SCIENTIFIC ENGAGEMENT.

    (a) In General.--Scientific meetings that are attended by scientific 
or medical personnel, or other professionals, of the Department of 
Health and Human Services for whom attendance at such meeting is 
directly related to their professional duties and the mission of the 
Department--
            (1) shall not be considered conferences for the purposes of 
        complying with Federal reporting requirements contained in 
        annual appropriations Acts or in this section; and
            (2) shall not be considered conferences for purposes of a 
        restriction contained in an annual appropriations Act, based on 
        Office of Management and Budget Memorandum M-12-12 or any other 
        regulation restricting travel to such meeting.

    (b) Limitation.--Nothing in this section shall be construed to 
exempt travel for scientific meetings from Federal regulations relating 
to travel.

[[Page 130 STAT. 1138]]

    (c) Reports.--Not later than 90 days after the end of the fiscal 
year, each operating division of the Department of Health and Human 
Services shall prepare, and post on an Internet website of the operating 
division, an annual report on scientific meeting attendance and related 
travel spending for each fiscal year. Such report shall include--
            (1) general information concerning the scientific meeting 
        activities involved;
            (2) information concerning the total amount expended for 
        such meetings;
            (3) a description of all such meetings that were attended by 
        scientific or medical personnel, or other professionals, of each 
        such operating division where the total amount expended by the 
        operating division associated with each such meeting were in 
        excess of $30,000, including--
                    (A) the total amount of meeting expenses incurred by 
                the operating division for such meeting;
                    (B) the location of such meeting;
                    (C) the date of such meeting;
                    (D) a brief explanation on how such meeting advanced 
                the mission of the operating division; and
                    (E) the total number of individuals whose travel 
                expenses or other scientific meeting expenses were paid 
                by the operating division; and
            (4) with respect to any such meeting where the total 
        expenses to the operating division exceeded $150,000, a 
        description of the exceptional circumstances that necessitated 
        the expenditure of such amounts.
SEC. 3075. DRUG SURVEILLANCE.

    (a) New Drugs.--Section 505(k)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 2074, is 
further amended--
            (1) in subparagraph (A), by striking ``, bi-weekly 
        screening'' and inserting ``screenings'';
            (2) in subparagraph (B), as redesignated by section 
        2074(1)(C), by striking the period at the end and inserting ``; 
        and''; and
            (3) by adding at the end the following:
            ``(C) make available on the Internet website of the Food and 
        Drug Administration--
                    ``(i) guidelines, developed with input from experts 
                qualified by scientific training and experience to 
                evaluate the safety and effectiveness of drugs, that 
                detail best practices for drug safety surveillance using 
                the Adverse Event Reporting System; and
                    ``(ii) criteria for public posting of adverse event 
                signals.''.

    (b) FAERS Revision.--Section 505(r)(2)(D) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking ``, by 
18 months'' and all that follows through the semicolon at the end of the 
subparagraph and inserting ``and making publicly available on the 
Internet website established under paragraph (1) best practices for drug 
safety surveillance activities for drugs approved under this section or 
section 351 of the Public Health Service Act;''.

[[Page 130 STAT. 1139]]

    (c) Risk Evaluation and Mitigation Strategies.--Section 505-1(f)(5) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is 
amended--
            (1) in the matter preceding subparagraph (A), by inserting 
        ``or other advisory committee'' after ``(or successor 
        committee)''; and
            (2) in subparagraph (B), by striking ``at least annually,'' 
        and inserting ``periodically''.
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                          ADMINISTRATION.

    (a) Board of Directors.--
            (1) Composition and size.--Section 770(d)(1)(C) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) 
        is amended--
                    (A) by redesignating clause (ii) as clause (iii);
                    (B) by inserting after clause (i) the following:
                          ``(ii) Additional members.--The Board, through 
                      amendments to the bylaws of the Foundation, may 
                      provide that the number of voting members of the 
                      Board shall be a number (to be specified in such 
                      amendment) greater than 14. Any Board positions 
                      that are established by any such amendment shall 
                      be appointed (by majority vote) by the individuals 
                      who, as of the date of such amendment, are voting 
                      members of the Board and persons so appointed may 
                      represent any of the categories specified in 
                      subclauses (I) through (V) of clause (i), so long 
                      as no more than 30 percent of the total voting 
                      members of the Board (including members whose 
                      positions are established by such amendment) are 
                      representatives of the general pharmaceutical, 
                      device, food, cosmetic, and biotechnology 
                      industries.''; and
                    (C) in clause (iii)(I), as redesignated by 
                subparagraph (A), by striking ``The ex officio members 
                shall ensure'' and inserting ``The ex officio members, 
                acting pursuant to clause (i), and the Board, acting 
                pursuant to clause (ii), shall ensure''.
            (2) Federal employees allowed to serve on board.--Clause 
        (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by 
        paragraph (1)(A), is amended by adding at the end the following: 
        ``For purposes of this section, the term `employee of the 
        Federal Government' does not include a special Government 
        employee, as that term is defined in section 202(a) of title 18, 
        United States Code.''.
            (3) Staggered terms.--Subparagraph (A) of section 770(d)(3) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379dd(d)(3)) is amended to read as follows:
                    ``(A) Term.--The term of office of each member of 
                the Board appointed under paragraph (1)(C)(i), and the 
                term of office of any member of the Board whose position 
                is established pursuant to paragraph (1)(C)(ii), shall 
                be 4 years, except that--
                          ``(i) the terms of offices for the members of 
                      the Board initially appointed under paragraph 
                      (1)(C)(i)

[[Page 130 STAT. 1140]]

                      shall expire on a staggered basis as determined by 
                      the ex officio members; and
                          ``(ii) the terms of office for the persons 
                      initially appointed to positions established 
                      pursuant to paragraph (1)(C)(ii) may be made to 
                      expire on a staggered basis, as determined by the 
                      individuals who, as of the date of the amendment 
                      establishing such positions, are members of the 
                      Board.''.

    (b) Executive Director Compensation.--Section 770(g)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended 
by striking ``but shall not be greater than the compensation of the 
Commissioner''.
    (c) Separation of Funds.--Section 770(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ``are held 
in separate accounts from funds received from entities under subsection 
(i)'' and inserting ``are managed as individual programmatic funds under 
subsection (i), according to best accounting practices''.

             Subtitle H--Medical Countermeasures Innovation

SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
            (1) in subsection (a), by adding at the end the following:
            ``(3) Utilization guidelines.--The Secretary shall ensure 
        timely and accurate recommended utilization guidelines for 
        qualified countermeasures (as defined in section 319F-1), 
        qualified pandemic and epidemic products (as defined in section 
        319F-3), and security countermeasures (as defined in subsection 
        (c)), including for such products in the stockpile.''; and
            (2) in subsection (g)--
                    (A) by amending paragraph (4) to read as follows:
            ``(4) Report on security countermeasure procurement.--Not 
        later than March 1 of each year in which the Secretary 
        determines that the amount of funds available for procurement of 
        security countermeasures is less than $1,500,000,000, the 
        Secretary shall submit to the Committee on Appropriations and 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Appropriations and the Committee on 
        Energy and Commerce of the House of Representatives a report 
        detailing the amount of such funds available for procurement and 
        the impact such amount of funding will have--
                    ``(A) in meeting the security countermeasure needs 
                identified under this section; and
                    ``(B) on the annual Public Health Emergency Medical 
                Countermeasures Enterprise and Strategy Implementation 
                Plan (pursuant to section 2811(d)).''.
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.

    (a) In General.--Section 319F-2(g) of the Public Health Service Act 
(42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:

[[Page 130 STAT. 1141]]

            ``(5) Clarification on contracting authority.--The 
        Secretary, acting through the Director of the Biomedical 
        Advanced Research and Development Authority, shall carry out the 
        programs funded by the special reserve fund (for the procurement 
        of security countermeasures under subsection (c) and for 
        carrying out section 319L), including the execution of 
        procurement contracts, grants, and cooperative agreements 
        pursuant to this section and section 319L.''.

    (b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public 
Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``, 
including the execution of procurement contracts, grants, and 
cooperative agreements pursuant to this section'' before the period.
SEC. 3083. COUNTERMEASURE BUDGET PLAN.

    Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 
300hh-10(b)(7)) is amended--
            (1) in the matter preceding subparagraph (A), by striking 
        the first sentence and inserting ``Develop, and update not later 
        than March 1 of each year, a coordinated 5-year budget plan 
        based on the medical countermeasure priorities described in 
        subsection (d), including with respect to chemical, biological, 
        radiological, and nuclear agent or agents that may present a 
        threat to the Nation, including such agents that are novel or 
        emerging infectious diseases, and the corresponding efforts to 
        develop qualified countermeasures (as defined in section 319F-
        1), security countermeasures (as defined in section 319F-2), and 
        qualified pandemic or epidemic products (as defined in section 
        319F-3) for each such threat.'';
            (2) in subparagraph (C), by striking ``; and'' and inserting 
        a semicolon;
            (3) in subparagraph (D), by striking ``to the appropriate 
        committees of Congress upon request.'' and inserting ``, not 
        later than March 15 of each year, to the Committee on 
        Appropriations and the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Appropriations 
        and the Committee on Energy and Commerce of the House of 
        Representatives; and''; and
            (4) by adding at the end the following:
                    ``(E) not later than March 15 of each year, be made 
                publicly available in a manner that does not compromise 
                national security.''.
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.

    Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
7e(c)(4)) is amended by adding at the end the following:
                    ``(E) Medical countermeasures innovation partner.--
                          ``(i) In general.--To support the purposes 
                      described in paragraph (2), the Secretary, acting 
                      through the Director of BARDA, may enter into an 
                      agreement (including through the use of grants, 
                      contracts, cooperative agreements, or other 
                      transactions as described in paragraph (5)) with 
                      an independent, nonprofit entity to--
                                    ``(I) foster and accelerate the 
                                development and innovation of medical 
                                countermeasures and technologies that 
                                may assist advanced research and

[[Page 130 STAT. 1142]]

                                the development of qualified 
                                countermeasures and qualified pandemic 
                                or epidemic products, including through 
                                the use of strategic venture capital 
                                practices and methods;
                                    ``(II) promote the development of 
                                new and promising technologies that 
                                address urgent medical countermeasure 
                                needs, as identified by the Secretary;
                                    ``(III) address unmet public health 
                                needs that are directly related to 
                                medical countermeasure requirements, 
                                such as novel antimicrobials for 
                                multidrug resistant organisms and 
                                multiuse platform technologies for 
                                diagnostics, prophylaxis, vaccines, and 
                                therapeutics; and
                                    ``(IV) provide expert consultation 
                                and advice to foster viable medical 
                                countermeasure innovators, including 
                                helping qualified countermeasure 
                                innovators navigate unique industry 
                                challenges with respect to developing 
                                chemical, biological, radiological, and 
                                nuclear countermeasure products.
                          ``(ii) Eligibility.--
                                    ``(I) In general.--To be eligible to 
                                enter into an agreement under clause (i) 
                                an entity shall--
                                            ``(aa) be an independent, 
                                        nonprofit entity;
                                            ``(bb) have a demonstrated 
                                        record of being able to create 
                                        linkages between innovators and 
                                        investors and leverage such 
                                        partnerships and resources for 
                                        the purpose of addressing 
                                        identified strategic needs of 
                                        the Federal Government;
                                            ``(cc) have experience in 
                                        promoting novel technology 
                                        innovation;
                                            ``(dd) be problem-driven and 
                                        solution-focused based on the 
                                        needs, requirements, and 
                                        problems identified by the 
                                        Secretary under clause (iv);
                                            ``(ee) demonstrate the 
                                        ability, or the potential 
                                        ability, to promote the 
                                        development of medical 
                                        countermeasure products;
                                            ``(ff) demonstrate 
                                        expertise, or the capacity to 
                                        develop or acquire expertise, 
                                        related to technical and 
                                        regulatory considerations with 
                                        respect to medical 
                                        countermeasures; and
                                            ``(gg) not be within the 
                                        Department of Health and Human 
                                        Services.
                                    ``(II) Partnering experience.--In 
                                selecting an entity with which to enter 
                                into an agreement under clause (i), the 
                                Secretary shall place a high value on 
                                the demonstrated experience of the 
                                entity in partnering with the Federal 
                                Government to meet identified strategic 
                                needs.
                          ``(iii) Not agency.--An entity that enters 
                      into an agreement under clause (i) shall not be 
                      deemed to be a Federal agency for any purpose, 
                      including for any purpose under title 5, United 
                      States Code.

[[Page 130 STAT. 1143]]

                          ``(iv) Direction.--Pursuant to an agreement 
                      entered into under this subparagraph, the 
                      Secretary, acting through the Director of BARDA, 
                      shall provide direction to the entity that enters 
                      into an agreement under clause (i). As part of 
                      this agreement the Director of BARDA shall--
                                    ``(I) communicate the medical 
                                countermeasure needs, requirements, and 
                                problems to be addressed by the entity 
                                under the agreement;
                                    ``(II) develop a description of work 
                                to be performed by the entity under the 
                                agreement;
                                    ``(III) provide technical feedback 
                                and appropriate oversight over work 
                                carried out by the entity under the 
                                agreement, including subsequent 
                                development and partnerships consistent 
                                with the needs and requirements set 
                                forth in this subparagraph;
                                    ``(IV) ensure fair consideration of 
                                products developed under the agreement 
                                in order to maintain competition to the 
                                maximum practical extent, as applicable 
                                and appropriate under applicable 
                                provisions of this section; and
                                    ``(V) ensure, as a condition of the 
                                agreement that the entity--
                                            ``(aa) has in place a 
                                        comprehensive set of policies 
                                        that demonstrate a commitment to 
                                        transparency and accountability;
                                            ``(bb) protects against 
                                        conflicts of interest through a 
                                        comprehensive set of policies 
                                        that address potential conflicts 
                                        of interest, ethics, disclosure, 
                                        and reporting requirements;
                                            ``(cc) provides monthly 
                                        accounting on the use of funds 
                                        provided under such agreement; 
                                        and
                                            ``(dd) provides on a 
                                        quarterly basis, reports 
                                        regarding the progress made 
                                        toward meeting the identified 
                                        needs set forth in the 
                                        agreement.
                          ``(v) Supplement not supplant.--Activities 
                      carried out under this subparagraph shall 
                      supplement, and not supplant, other activities 
                      carried out under this section.
                          ``(vi) No establishment of entity.--To prevent 
                      unnecessary duplication and target resources 
                      effectively, nothing in this subparagraph shall be 
                      construed to authorize the Secretary to establish 
                      within the Department of Health and Human Services 
                      an entity for the purposes of carrying out this 
                      subparagraph.
                          ``(vii) Transparency and oversight.--Upon 
                      request, the Secretary shall provide to Congress 
                      the information provided to the Secretary under 
                      clause (iv)(V)(dd).
                          ``(viii) Independent evaluation.--Not later 
                      than 4 years after the date of enactment of the 
                      21st Century Cures Act, the Comptroller General of 
                      the United States shall conduct an independent 
                      evaluation, and submit to the Secretary and the 
                      appropriate committees of Congress a report, 
                      concerning the activities

[[Page 130 STAT. 1144]]

                      conducted under this subparagraph. Such report 
                      shall include recommendations with respect to any 
                      agreement or activities carried out pursuant to 
                      this subparagraph.
                          ``(ix) Sunset.--This subparagraph shall have 
                      no force or effect after September 30, 2022.''.
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.

    Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended--
            (1) in paragraph (4)(A)(ii), by striking ``make a 
        recommendation under paragraph (6) that the special reserve fund 
        as defined in subsection (h) be made available for the 
        procurement of such countermeasure'' and inserting ``and subject 
        to the availability of appropriations, make available the 
        special reserve fund as defined in subsection (h) for 
        procurement of such countermeasure, as applicable'';
            (2) in paragraph (6)--
                    (A) by striking subparagraphs (A), (B), and (E);
                    (B) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (A) and (B), respectively;
                    (C) by amending subparagraph (A), as so 
                redesignated, to read as follows:
                    ``(A) Notice to appropriate congressional 
                committees.--The Secretary shall notify the Committee on 
                Appropriations and the Committee on Health, Education, 
                Labor, and Pensions of the Senate and the Committee on 
                Appropriations and the Committee on Energy and Commerce 
                of the House of Representatives of each decision to make 
                available the special reserve fund as defined in 
                subsection (h) for procurement of a security 
                countermeasure, including, where available, the number 
                of, the nature of, and other information concerning 
                potential suppliers of such countermeasure, and whether 
                other potential suppliers of the same or similar 
                countermeasures were considered and rejected for 
                procurement under this section and the reasons for each 
                such rejection.''; and
                    (D) in the heading, by striking ``Recommendation for 
                president's approval'' and inserting ``Recommendations 
                for procurement''; and
            (3) in paragraph (7)--
                    (A) by striking subparagraphs (A) and (B) and 
                inserting the following:
                    ``(A) Payments from special reserve fund.--The 
                special reserve fund as defined in subsection (h) shall 
                be available for payments made by the Secretary to a 
                vendor for procurement of a security countermeasure in 
                accordance with the provisions of this paragraph.''; and
                    (B) by redesignating subparagraph (C) as 
                subparagraph (B).
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A 
                          NATIONAL SECURITY THREAT.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565 
the following:

[[Page 130 STAT. 1145]]

``SEC. 565A. <<NOTE: 21 USC 360bbb-4a.>>  PRIORITY REVIEW TO 
                          ENCOURAGE TREATMENTS FOR AGENTS THAT 
                          PRESENT NATIONAL SECURITY THREATS.

    ``(a) Definitions.--In this section:
            ``(1) Human drug application.--The term `human drug 
        application' has the meaning given such term in section 735(1).
            ``(2) Priority review.--The term `priority review', with 
        respect to a human drug application, means review and action by 
        the Secretary on such application not later than 6 months after 
        receipt by the Secretary of such application, as described in 
        the Manual of Policies and Procedures in the Food and Drug 
        Administration and goals identified in the letters described in 
        section 101(b) of the Food and Drug Administration Safety and 
        Innovation Act.
            ``(3) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of a material threat medical countermeasure application that 
        entitles the holder of such voucher to priority review of a 
        single human drug application submitted under section 505(b)(1) 
        or section 351(a) of the Public Health Service Act after the 
        date of approval of the material threat medical countermeasure 
        application.
            ``(4) Material threat medical countermeasure application.--
        The term `material threat medical countermeasure application' 
        means an application that--
                    ``(A) is a human drug application for a drug 
                intended for use--
                          ``(i) to prevent, or treat harm from a 
                      biological, chemical, radiological, or nuclear 
                      agent identified as a material threat under 
                      section 319F-2(c)(2)(A)(ii) of the Public Health 
                      Service Act; or
                          ``(ii) to mitigate, prevent, or treat harm 
                      from a condition that may result in adverse health 
                      consequences or death and may be caused by 
                      administering a drug, or biological product 
                      against such agent; and
                    ``(B) the Secretary determines eligible for priority 
                review;
                    ``(C) is approved after the date of enactment of the 
                21st Century Cures Act; and
                    ``(D) is for a human drug, no active ingredient 
                (including any ester or salt of the active ingredient) 
                of which has been approved in any other application 
                under section 505(b)(1) or section 351(a) of the Public 
                Health Service Act.

    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a material threat medical 
        countermeasure application upon approval by the Secretary of 
        such material threat medical countermeasure application.
            ``(2) Transferability.--The sponsor of a material threat 
        medical countermeasure application that receives a priority 
        review voucher under this section may transfer (including by 
        sale) the entitlement to such voucher to a sponsor of a human 
        drug for which an application under section 505(b)(1) or section 
        351(a) of the Public Health Service Act will be submitted after 
        the date of the approval of the material threat medical 
        countermeasure application. There is no limit on the number of 
        times

[[Page 130 STAT. 1146]]

        a priority review voucher may be transferred before such voucher 
        is used.
            ``(3) Notification.--
                    ``(A) In general.--The sponsor of a human drug 
                application shall notify the Secretary not later than 90 
                calendar days prior to submission of the human drug 
                application that is the subject of a priority review 
                voucher of an intent to submit the human drug 
                application, including the date on which the sponsor 
                intends to submit the application. Such notification 
                shall be a legally binding commitment to pay for the 
                user fee to be assessed in accordance with this section.
                    ``(B) Transfer after notice.--The sponsor of a human 
                drug application that provides notification of the 
                intent of such sponsor to use the voucher for the human 
                drug application under subparagraph (A) may transfer the 
                voucher after such notification is provided, if such 
                sponsor has not yet submitted the human drug application 
                described in the notification.

    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a human drug application that 
        is the subject of a priority review voucher shall pay to the 
        Secretary a fee determined under paragraph (2). Such fee shall 
        be in addition to any fee required to be submitted by the 
        sponsor under chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary and 
        based on the average cost incurred by the agency in the review 
        of a human drug application subject to priority review in the 
        previous fiscal year.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2016, for that fiscal year, the amount of the 
        priority review user fee.
            ``(4) Payment.--
                    ``(A) In general.--The priority review user fee 
                required by this subsection shall be due upon the 
                submission of a human drug application under section 
                505(b)(1) or section 351(a) of the Public Health Service 
                Act for which the priority review voucher is used.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection and all other applicable user fees are not 
                paid in accordance with the Secretary's procedures for 
                paying such fees.
                    ``(C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due and 
                payable under this section.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and

[[Page 130 STAT. 1147]]

            ``(6) shall not be collected for any fiscal year except to 
        the extent provided in advance in appropriation Acts.

    ``(d) Notice of Issuance of Voucher and Approval of Products Under 
Voucher.--The Secretary shall publish a notice in the Federal Register 
and on the Internet website of the Food and Drug Administration not 
later than 30 calendar days after the occurrence of each of the 
following:
            ``(1) The Secretary issues a priority review voucher under 
        this section.
            ``(2) The Secretary approves a drug pursuant to an 
        application submitted under section 505(b) of this Act or 
        section 351(a) of the Public Health Service Act for which the 
        sponsor of the application used a priority review voucher issued 
        under this section.

    ``(e) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act, except that no sponsor of a material threat medical 
countermeasure application may receive more than one priority review 
voucher issued under any section of this Act with respect to such drug.
    ``(f) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of medical 
countermeasures.
    ``(g) Sunset.--The Secretary may not award any priority review 
vouchers under subsection (b) after October 1, 2023.''.
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH 
                          EMERGENCY.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(f) Determination With Respect to Paperwork Reduction Act Waiver 
During a Public Health Emergency.--
            ``(1) Determination.--If the Secretary determines, after 
        consultation with such public health officials as may be 
        necessary, that--
                    ``(A)(i) the criteria set forth for a public health 
                emergency under paragraph (1) or (2) of subsection (a) 
                has been met; or
                    ``(ii) a disease or disorder, including a novel and 
                emerging public health threat, is significantly likely 
                to become a public health emergency; and
                    ``(B) the circumstances of such public health 
                emergency, or potential for such significantly likely 
                public health emergency, including the specific 
                preparation for and response to such public health 
                emergency or threat, necessitate a waiver from the 
                requirements of subchapter I of chapter 35 of title 44, 
                United States Code (commonly referred to as the 
                Paperwork Reduction Act),
        then the requirements of such subchapter I with respect to 
        voluntary collection of information shall not be applicable 
        during the immediate investigation of, and response to, such 
        public health emergency during the period of such public health 
        emergency or the period of time necessary to determine if a 
        disease or disorder, including a novel and emerging public

[[Page 130 STAT. 1148]]

        health threat, will become a public health emergency as provided 
        for in this paragraph. The requirements of such subchapter I 
        with respect to voluntary collection of information shall not be 
        applicable during the immediate postresponse review regarding 
        such public health emergency if such immediate postresponse 
        review does not exceed a reasonable length of time.
            ``(2) Transparency.--If the Secretary determines that a 
        waiver is necessary under paragraph (1), the Secretary shall 
        promptly post on the Internet website of the Department of 
        Health and Human Services a brief justification for such waiver, 
        the anticipated period of time such waiver will be in effect, 
        and the agencies and offices within the Department of Health and 
        Human Services to which such waiver shall apply, and update such 
        information posted on the Internet website of the Department of 
        Health and Human Services, as applicable.
            ``(3) Effectiveness of waiver.--Any waiver under this 
        subsection shall take effect on the date on which the Secretary 
        posts information on the Internet website as provided for in 
        this subsection.
            ``(4) Termination of waiver.--Upon determining that the 
        circumstances necessitating a waiver under paragraph (1) no 
        longer exist, the Secretary shall promptly update the Internet 
        website of the Department of Health and Human Services to 
        reflect the termination of such waiver.
            ``(5) Limitations.--
                    ``(A) Period of waiver.--The period of a waiver 
                under paragraph (1) shall not exceed the period of time 
                for the related public health emergency, including a 
                public health emergency declared pursuant to subsection 
                (a), and any immediate postresponse review regarding the 
                public health emergency consistent with the requirements 
                of this subsection.
                    ``(B) Subsequent compliance.--An initiative subject 
                to a waiver under paragraph (1) that is ongoing after 
                the date on which the waiver expires, shall be subject 
                to the requirements of subchapter I of chapter 35 of 
                title 44, United States Code, and the Secretary shall 
                ensure that compliance with such requirements occurs in 
                as timely a manner as possible based on the applicable 
                circumstances, but not to exceed 30 calendar days after 
                the expiration of the applicable waiver.''.
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE 
                          AUTHORIZATION.

    (a) Authorization for Medical Products for Use in Emergencies.--
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3) is amended--
            (1) in subsection (a)(2)--
                    (A) in subparagraph (A)--
                          (i) by striking ``or 515'' and inserting 
                      ``512, or 515''; and
                          (ii) by inserting ``or conditionally approved 
                      under section 571 of this Act'' after ``Public 
                      Health Service Act''; and

[[Page 130 STAT. 1149]]

                    (B) in subparagraph (B), by inserting 
                ``conditionally approved under section 571,'' after 
                ``approved,'' each place the term appears;
            (2) in subsection (b)(4), by striking the second comma after 
        ``determination'';
            (3) in subsection (e)(3)(B), by striking ``section 503(b)'' 
        and inserting ``subsection (b) or (f) of section 503 or under 
        section 504'';
            (4) in subsection (f)(2)--
                    (A) by inserting ``, or an animal to which,'' after 
                ``to a patient to whom''; and
                    (B) by inserting ``or by the veterinarian caring for 
                such animal, as applicable'' after ``attending 
                physician'';
            (5) in subsection (g)(1), by inserting ``conditional 
        approval under section 571,'' after ``approval,'';
            (6) in subsection (h)(1), by striking ``or section 
        520(g)''and inserting ``512(j), or 520(g)''; and
            (7) in subsection (k), by striking ``section 520(g),''and 
        inserting ``512(j), or 520(g)''.

    (b) New Animal Drugs.--Section 512(a)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended--
            (1) in subparagraph (B), by striking ``or'' at the end;
            (2) in subparagraph (C), by striking the period and 
        inserting ``; or''; and
            (3) by inserting after subparagraph (C) the following:
            ``(D) there is in effect an authorization pursuant to 
        section 564 with respect to such use or intended use of such 
        drug, and such drug, its labeling, and such use conform to any 
        conditions of such authorization.''.

    (c) Emergency Use of Medical Products.--Section 564A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
            (1) in subsection (a)(1)(A), by inserting ``, conditionally 
        approved under section 571,'' after ``chapter''; and
            (2) in subsection (d), by striking ``sections 503(b) and 
        520(e)'' and inserting ``subsections (b) and (f) of section 503, 
        section 504, and section 520(e)''.

    (d) Products Held for Emergency Use.--Section 564B(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is amended--
            (1) in subparagraph (A)--
                    (A) by inserting ``or conditionally approved under 
                section 571 of this Act'' after ``Public Health Service 
                Act''; and
                    (B) by striking ``or 515'' and inserting ``512, or 
                515''; and
            (2) in subparagraph (B), by striking ``or 520'' and 
        inserting ``512, or 520''.

          Subtitle I--Vaccine Access, Certainty, and Innovation

SEC. 3091. <<NOTE: 21 USC 360bbb-4 note.>>  PREDICTABLE REVIEW 
                          TIMELINES OF VACCINES BY THE ADVISORY 
                          COMMITTEE ON IMMUNIZATION PRACTICES.

    (a) Consideration of New Vaccines.--Upon the licensure of any 
vaccine or any new indication for a vaccine, the Advisory

[[Page 130 STAT. 1150]]

Committee on Immunization Practices (in this section referred to as the 
``Advisory Committee'') shall, as appropriate, consider the use of the 
vaccine at its next regularly scheduled meeting.
    (b) Additional Information.--If the Advisory Committee does not make 
a recommendation with respect to the use of a vaccine at the Advisory 
Committee's first regularly scheduled meeting after the licensure of the 
vaccine or any new indication for the vaccine, the Advisory Committee 
shall provide an update on the status of such committee's review.
    (c) Consideration for Breakthrough Therapies and for Potential Use 
During Public Health Emergency.--The Advisory Committee shall make 
recommendations with respect to the use of certain vaccines in a timely 
manner, as appropriate, including vaccines that--
            (1) are designated as a breakthrough therapy under section 
        506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 
        and licensed under section 351 of the Public Health Service Act 
        (42 U.S.C. 262); or
            (2) could be used in a public health emergency.

    (d) Definition.--In this section, the terms ``Advisory Committee on 
Immunization Practices'' and ``Advisory Committee'' mean the Advisory 
Committee on Immunization Practices established by the Secretary 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.''.
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY 
                          COMMITTEE ON IMMUNIZATION PRACTICES 
                          RECOMMENDATIONS.

    (a) Review.--The Director of the Centers for Disease Control and 
Prevention shall conduct a review of the processes used by the Advisory 
Committee on Immunization Practices in formulating and issuing 
recommendations pertaining to vaccines, including with respect to 
consistency.
    (b) Considerations.--The review under subsection (a) shall include 
an assessment of--
            (1) the criteria used to evaluate new and existing vaccines, 
        including the identification of any areas for which flexibility 
        in evaluating such criteria is necessary and the reason for such 
        flexibility;
            (2) the Grading of Recommendations, Assessment, Development, 
        and Evaluation (GRADE) approach to the review and analysis of 
        scientific and economic data, including the scientific basis for 
        such approach; and
            (3) the extent to which the processes used by the work 
        groups of the Advisory Committee on Immunization Practices are 
        consistent among such groups, including the identification of 
        reasons for any variation.

    (c) Stakeholders.--In carrying out the review under subsection (a), 
the Director of the Centers for Disease Control and Prevention shall 
solicit input from vaccine stakeholders.
    (d) Report.--Not later than 18 months after the date of enactment of 
this Act, the Director of the Centers for Disease Control and Prevention 
shall submit to the appropriate committees of the Congress, and make 
publicly available, a report on the results of the review under 
subsection (a), including any recommendations

[[Page 130 STAT. 1151]]

on improving the consistency of the processes described in such 
subsection.
    (e) Definition.--In this section, the term ``Advisory Committee on 
Immunization Practices'' means the Advisory Committee on Immunization 
Practices established by the Secretary of Health and Human Services 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.
SEC. 3093. <<NOTE: 42 USC 300aa-2 note.>>  ENCOURAGING VACCINE 
                          INNOVATION.

    (a) Vaccine Meetings.--The Director of the Centers for Disease 
Control and Prevention shall ensure that appropriate staff within the 
relevant centers and divisions of the Office of Infectious Diseases, and 
others, as appropriate, coordinate with respect to the public health 
needs, epidemiology, and program planning and implementation 
considerations related to immunization, including with regard to 
meetings with stakeholders related to such topics.
    (b) Report on Vaccine Innovation.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), in 
        collaboration with appropriate agencies or offices within the 
        Department of Health and Human Services, including the National 
        Institutes of Health, the Centers for Disease Control and 
        Prevention, the Food and Drug Administration, and the Biomedical 
        Advanced Research and Development Authority, shall submit to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, and post publicly on the Internet website of 
        the Department of Health and Human Services, a report on ways to 
        promote innovation in the development of vaccines that minimize 
        the burden of infectious disease.
            (2) Contents.--The report described in paragraph (1) shall 
        review the current status of vaccine development and, as 
        appropriate--
                    (A) consider the optimal process to determine which 
                vaccines would be beneficial to public health and how 
                information on such vaccines is disseminated to key 
                stakeholders;
                    (B) examine and identify whether obstacles exist 
                that inhibit the development of beneficial vaccines; and
                    (C) make recommendations about how best to remove 
                any obstacles identified under subparagraph (B) in order 
                to promote and incentivize vaccine innovation and 
                development.
            (3) Consultation.--In preparing the report under this 
        subsection, the Secretary may consult with--
                    (A) representatives of relevant Federal agencies and 
                departments, including the Department of Defense and the 
                Department of Veterans Affairs;
                    (B) academic researchers;
                    (C) developers and manufacturers of vaccines;
                    (D) medical and public health practitioners;
                    (E) representatives of patient, policy, and advocacy 
                organizations; and

[[Page 130 STAT. 1152]]

                    (F) representatives of other entities, as the 
                Secretary determines appropriate.

    (c) Updates Related to Maternal Immunization.--
            (1) Additional vaccines.--Section 2114(e) of the Public 
        Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding 
        at the end the following:
            ``(3) Vaccines recommended for use in pregnant women.--The 
        Secretary shall revise the Vaccine Injury Table included in 
        subsection (a), through the process described in subsection (c), 
        to include vaccines recommended by the Centers for Disease 
        Control and Prevention for routine administration in pregnant 
        women and the information described in subparagraphs (B) and (C) 
        of paragraph (2) with respect to such vaccines.''.
            (2) Petition content.--Section 2111 of the Public Health 
        Service Act (42 U.S.C. 300aa-11) is amended by adding at the end 
        the following:

    ``(f) Maternal Immunization.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, for purposes of this subtitle, both a woman who received a 
        covered vaccine while pregnant and any child who was in utero at 
        the time such woman received the vaccine shall be considered 
        persons to whom the covered vaccine was administered and persons 
        who received the covered vaccine.
            ``(2) Definition.--As used in this subsection, the term 
        `child' shall have the meaning given that term by subsections 
        (a) and (b) of section 8 of title 1, United States Code, except 
        that, for purposes of this subsection, such section 8 shall be 
        applied as if the term `include' in subsection (a) of such 
        section were replaced with the term `mean'.''.
            (3) Petitioners.--Section 2111(b)(2) of the Public Health 
        Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A 
        covered vaccine administered to a pregnant woman shall 
        constitute more than one administration, one to the mother and 
        one to each child (as such term is defined in subsection (f)(2)) 
        who was in utero at the time such woman was administered the 
        vaccine.'' at the end.

                    Subtitle J--Technical Corrections

SEC. 3101. TECHNICAL CORRECTIONS.

    (a) FFDCA.--
            (1) References.--Except as otherwise expressly provided, 
        whenever in this subsection an amendment is expressed in terms 
        of an amendment to a section or other provision, the reference 
        shall be considered to be made to that section or other 
        provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.).
            (2) Amendments.--
                    (A) Prohibited acts.--Section 301(r) (21 U.S.C. 
                331(r)) is amended by inserting ``, drug,'' after 
                ``device'' each place the term appears.
                    (B) New drugs.--Section 505 (21 U.S.C. 355) is 
                amended--

[[Page 130 STAT. 1153]]

                          (i) in subsection (d), in the last sentence, 
                      by striking ``premarket approval'' and inserting 
                      ``marketing approval''; and
                          (ii) in subsection (q)(5)(A), by striking 
                      ``subsection (b)(2) or (j) of the Act or 351(k)'' 
                      and inserting ``subsection (b)(2) or (j) of this 
                      section or section 351(k)''.
                    (C) Risk evaluation and mitigation strategies.--
                Section 505-1(h)(21 U.S.C. 355-1(h)) is amended--
                          (i) in paragraph (2)(A)(iii)--
                                    (I) in the clause heading, by 
                                striking ``label'' and inserting 
                                ``labeling'';
                                    (II) by striking ``label'' each 
                                place the term appears and inserting 
                                ``labeling''; and
                                    (III) by striking ``sponsor'' and 
                                inserting ``responsible person''; and
                          (ii) in paragraph (8), by striking ``and 
                      (7).'' and inserting ``and (7)''.
                    (D) Pediatric study plans.--Section 505B (21 U.S.C. 
                355c) is amended--
                          (i) in subsection (e)--
                                    (I) in paragraph (2)--
                                            (aa) in subparagraph (A), by 
                                        inserting ``study'' after 
                                        ``initial pediatric'' each place 
                                        the term appears; and
                                            (bb) in subparagraph (B), in 
                                        the subparagraph heading, by 
                                        striking ``initial plan'' and 
                                        inserting ``initial pediatric 
                                        study plan'';
                                    (II) in paragraph (5), in the 
                                paragraph heading, by inserting ``agreed 
                                initial pediatric study'' before 
                                ``plan''; and
                                    (III) in paragraph (6), by striking 
                                ``agreed initial pediatric plan'' and 
                                inserting ``agreed initial pediatric 
                                study plan''; and
                          (ii) in subsection (f)(1), by inserting ``and 
                      any significant amendments to such plans,'' after 
                      ``agreed initial pediatric study plans,''.
                    (E) Discontinuance or interruption in the production 
                of live-saving drugs.--Section 506C (21 U.S.C. 356c) is 
                amended--
                          (i) in subsection (c), by striking 
                      ``discontinuation'' and inserting 
                      ``discontinuance''; and
                          (ii) in subsection (g)(1), by striking 
                      ``section 505(j) that could help'' and inserting 
                      ``section 505(j), that could help''.
                    (F) Annual reporting on drug shortages.--Section 
                506C-1(a) (21 U.S.C. 331(a)) is amended, in the matter 
                before paragraph (1)--
                          (i) by striking ``Not later than the end of 
                      calendar year 2013, and not later than the end of 
                      each calendar year thereafter,'' and inserting 
                      ``Not later than March 31 of each calendar 
                      year,''; and
                          (ii) by inserting ``, with respect to the 
                      preceding calendar year,'' after ``a report''.
                    (G) Drug shortage list.--Section 506E(b)(3)(E) (21 
                U.S.C. 356e(b)(3)(E)) is amended by striking 
                ``discontinuation'' and inserting ``discontinuance''.

[[Page 130 STAT. 1154]]

                    (H) Inspections of establishments.--Section 510(h) 
                (21 U.S.C. 360(h)) is amended--
                          (i) in paragraph (4), in the matter preceding 
                      subparagraph (A), by striking ``establishing the 
                      risk-based scheduled'' and inserting 
                      ``establishing a risk-based schedule''; and
                          (ii) in paragraph (6)--
                                    (I) in subparagraph (A), by striking 
                                ``fiscal'' and inserting ``calendar'' 
                                each place the term appears; and
                                    (II) in subparagraph (B), by 
                                striking ``an active ingredient of a 
                                drug, a finished drug product, or an 
                                excipient of a drug'' and inserting ``an 
                                active ingredient of a drug or a 
                                finished drug product''.
                    (I) Classification of devices intended for human 
                use.--Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is 
                amended--
                          (i) in clause (i), by striking ``within 30 
                      days''; and
                          (ii) in clause (iv), by striking ``low-
                      moderate'' and inserting ``low to moderate''.
                    (J) Premarket approval.--Section 515(a)(1) (21 
                U.S.C. 360e(a)(1)) is amended by striking ``subject to a 
                an order'' and inserting ``subject to an order''.
                    (K) Program to improve the device recall system.--
                Section 518A (21 U.S.C. 360h-1) is amended--
                          (i) by striking subsection (c); and
                          (ii) by redesignating subsection (d) as 
                      subsection (c).
                    (L) Unique device identifier.--Section 519(f) (21 
                U.S.C. 360i(f)) is amended by striking ``and life 
                sustaining'' and inserting ``or life sustaining''.
                    (M) Priority review to encourage treatments for 
                tropical diseases.--Section 524(c)(4)(A) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) 
                is amended by striking ``Services Act'' and inserting 
                ``Service Act''.
                    (N) Priority review for qualified infectious disease 
                products.--Section 524A (21 U.S.C. 360n-1) is amended--
                          (i) by striking ``If the Secretary'' and 
                      inserting the following:

    ``(a) In General.--If the Secretary'';
                          (ii) by striking ``any'' and inserting ``the 
                      first''; and
                          (iii) by adding at the end the following:

    ``(b) Construction.--Nothing in this section shall prohibit the 
Secretary from giving priority review to a human drug application or 
efficacy supplement submitted for approval under section 505(b) that 
otherwise meets the criteria for the Secretary to grant priority 
review.''.
                    (O) Consultation with external experts on rare 
                diseases, targeted therapies, and genetic targeting of 
                treatments.--Section 569(a)(2)(A) (21 U.S.C. 360bbb-
                8(a)(2)(A)) is amended, in the first sentence, by 
                striking ``subsection (c)'' and inserting ``subsection 
                (b)''.
                    (P) Optimizing global clinical trials.--Section 
                569A(c) (21 U.S.C. 360bbb-8a(c)) is amended by inserting 
                ``or under the Public Health Service Act'' after ``this 
                Act''.

[[Page 130 STAT. 1155]]

                    (Q) Use of clinical investigation data from outside 
                the united states.--Section 569B (21 U.S.C. 360bbb-8b) 
                is amended by striking ``drug or device'' and inserting 
                ``drug, biological product, or device'' each place the 
                term appears.
                    (R) Medical gases definitions.--Section 575(1)(H) 
                (21 U.S.C. 360ddd(1)(H)) is amended--
                          (i) by inserting ``for a new drug'' after 
                      ``any period of exclusivity''; and
                          (ii) by inserting ``or any period of 
                      exclusivity for a new animal drug under section 
                      512(c)(2)(F),'' after ``section 505A,''.
                    (S) Regulation of medical gases.--Section 576(a) (21 
                U.S.C. 360ddd-1(a)) is amended--
                          (i) in the matter preceding subparagraph (A) 
                      of paragraph (1), by inserting ``who seeks to 
                      initially introduce or deliver for introduction a 
                      designated medical gas into interstate commerce'' 
                      after ``any person''; and
                          (ii) in paragraph (3)--
                                    (I) in subparagraph (A)--
                                            (aa) in clause (i)(VIII), by 
                                        inserting ``for a new drug'' 
                                        after ``any period of 
                                        exclusivity''; and
                                            (bb) in clause (ii), in the 
                                        matter preceding subclause (I), 
                                        by inserting ``the'' before 
                                        ``final use''; and
                                    (II) in subparagraph (B)--
                                            (aa) in clause (i), by 
                                        inserting ``for a new drug'' 
                                        after ``any period of 
                                        exclusivity''; and
                                            (bb) in clause (ii), by 
                                        inserting a comma after ``drug 
                                        product''.
                    (T) Inapplicability of drug fees to designated 
                medical gases.--Section 577 (21 U.S.C. 360ddd-2) is 
                amended by inserting ``or 740(a)'' after ``section 
                736(a)''.
                    (U) Conflicts of interest.--Section 712(e)(1)(B) (21 
                U.S.C. 379d-1(e)(1)(B)) is amended by striking 
                ``services'' and inserting ``service''.
                    (V) Authority to assess and use biosimilar 
                biological product fees.--Section 744H(a) (21 U.S.C. 
                379j-52(a)) is amended--
                          (i) in paragraph (1)(A)(v), by striking 
                      ``Biosimilars User Fee Act of 2012'' and inserting 
                      ``Biosimilar User Fee Act of 2012''; and
                          (ii) in paragraph (2)(B), by striking 
                      ``Biosimilars User Fee Act of 2012'' and inserting 
                      ``Biosimilar User Fee Act of 2012''.
                    (W) Registration of commercial importers.--
                          (i) Amendment.--Section 801(s)(2) (21 U.S.C. 
                      381(s)(2)) is amended by adding at the end the 
                      following:
                    ``(D) Effective date.--In establishing the effective 
                date of the regulations under subparagraph (A), the 
                Secretary shall, in consultation with the Secretary of 
                Homeland Security acting through U.S. Customs and Border 
                Protection, as determined appropriate by the Secretary 
                of Health and Human Services, provide a reasonable 
                period of time for an importer of a drug to comply with 
                good

[[Page 130 STAT. 1156]]

                importer practices, taking into account differences 
                among importers and types of imports, including based on 
                the level of risk posed by the imported product.''.
                          (ii) Conforming amendment.--Section 714 of the 
                      Food and Drug Administration Safety and Innovation 
                      Act (Public Law 112-144; 126 Stat. 1074) is 
                      amended by striking subsection (d).
                    (X) Recognition of foreign government inspections.--
                Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by 
                striking ``conduction'' and inserting ``conducting''.

    (b) FDASIA.--
            (1) Findings relating to drug approval.--Section 
        901(a)(1)(A) of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is 
        amended by striking ``serious and life-threatening diseases'' 
        and inserting ``serious or life-threatening diseases''.
            (2) Reporting of inclusion of demographic subgroups.--
        Section 907 of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is 
        amended--
                    (A) in the section heading, by striking 
                ``biologics'' in the heading and inserting ``biological 
                products''; and
                    (B) in subsection (a)(2)(B), by striking 
                ``applications for new drug applications'' and inserting 
                ``new drug applications''.
            (3) Combating prescription drug abuse.--Section 1122 of the 
        Food and Drug Administration Safety and Innovation Act (Public 
        Law 112-144; 126 Stat. 1112, 1113) is amended--
                    (A) in subsection (a)(2), by striking ``dependance'' 
                and inserting ``dependence''; and
                    (B) in subsection (c), by striking ``promulgate'' 
                and inserting ``issue''.
SEC. 3102. COMPLETED STUDIES.

    The Federal Food, Drug, and Cosmetic Act is amended--
            (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
                    (A) in subparagraph (A), by inserting ``and'' after 
                the semicolon;
                    (B) by striking subparagraph (B); and
                    (C) by redesignating subparagraph (C) as 
                subparagraph (B);
            (2) in section 505A (21 U.S.C. 355a), by striking subsection 
        (p);
            (3) in section 505B (21 U.S.C. 355c)--
                    (A) by striking subsection (l); and
                    (B) by redesignating subsection (m) as subsection 
                (l); and
            (4) in section 523 (21 U.S.C. 360m), by striking subsection 
        (d).

[[Page 130 STAT. 1157]]

                           TITLE IV--DELIVERY

SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF 
                          CARE FOR PATIENTS.

    (a) In General.--The Health Information Technology for Economic and 
Clinical Health Act (title XIII of division A of Public Law 111-5) is 
amended--
            (1) by adding at the end of part 1 of subtitle A the 
        following:
``SEC. 13103. <<NOTE: 42 USC 300jj-11 note.>>  ASSISTING DOCTORS 
                            AND HOSPITALS IN IMPROVING QUALITY OF 
                            CARE FOR PATIENTS.

    ``(a) Reduction in Burdens Goal.--The Secretary of Health and Human 
Services (referred to in this section as the `Secretary'), in 
consultation with providers of health services, health care suppliers of 
services, health care payers, health professional societies, health 
information technology developers, health care quality organizations, 
health care accreditation organizations, public health entities, States, 
and other appropriate entities, shall, in accordance with subsection 
(b)--
            ``(1) establish a goal with respect to the reduction of 
        regulatory or administrative burdens (such as documentation 
        requirements) relating to the use of electronic health records;
            ``(2) develop a strategy for meeting the goal established 
        under paragraph (1); and
            ``(3) develop recommendations for meeting the goal 
        established under paragraph (1).

    ``(b) Strategy and Recommendations.--
            ``(1) In general.--To achieve the goal established under 
        subsection (a)(1), the Secretary, in consultation with the 
        entities described in such subsection, shall, not later than 1 
        year after the date of enactment of the 21st Century Cures Act, 
        develop a strategy and recommendations to meet the goal in 
        accordance with this subsection.
            ``(2) Strategy.--The strategy developed under paragraph (1) 
        shall address the regulatory and administrative burdens (such as 
        documentation requirements) relating to the use of electronic 
        health records. Such strategy shall include broad public comment 
        and shall prioritize--
                    ``(A)(i) incentives for meaningful use of certified 
                EHR technology for eligible professionals and hospitals 
                under sections 1848(a)(7) and 1886(b)(3)(B)(ix), 
                respectively, of the Social Security Act (42 U.S.C. 
                1395w-4(a)(7), 1395ww(b)(3)(B)(ix));
                    ``(ii) the program for making payments under section 
                1903(a)(3)(F) of the Social Security Act (42 U.S.C. 
                1396b(a)(3)(F)) to encourage the adoption and use of 
                certified EHR technology by Medicaid providers;
                    ``(iii) the Merit-based Incentive Payment System 
                under section 1848(q) of the Social Security Act (42 
                U.S.C. 1395w-4(q));
                    ``(iv) alternative payment models (as defined in 
                section 1833(z)(3)(C) of the Social Security Act (42 
                U.S.C. 1395l(z)(3)(C));
                    ``(v) the Hospital Value-Based Purchasing Program 
                under section 1886(o) of the Social Security Act (42 
                U.S.C. 1395ww(o)); and

[[Page 130 STAT. 1158]]

                    ``(vi) other value-based payment programs, as the 
                Secretary determines appropriate;
                    ``(B) health information technology certification;
                    ``(C) standards and implementation specifications, 
                as appropriate;
                    ``(D) activities that provide individuals access to 
                their electronic health information;
                    ``(E) activities related to protecting the privacy 
                of electronic health information;
                    ``(F) activities related to protecting the security 
                of electronic health information;
                    ``(G) activities related to facilitating health and 
                clinical research;
                    ``(H) activities related to public health;
                    ``(I) activities related to aligning and simplifying 
                quality measures across Federal programs and other 
                payers;
                    ``(J) activities related to reporting clinical data 
                for administrative purposes; and
                    ``(K) other areas, as the Secretary determines 
                appropriate.
            ``(3) Recommendations.--The recommendations developed under 
        paragraph (1) shall address--
                    ``(A) actions that improve the clinical 
                documentation experience;
                    ``(B) actions that improve patient care;
                    ``(C) actions to be taken by the Secretary and by 
                other entities; and
                    ``(D) other areas, as the Secretary determines 
                appropriate, to reduce the reporting burden required of 
                health care providers.
            ``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C. 
        App.) shall not apply to the development of the goal, 
        strategies, or recommendations described in this section.

    ``(c) Application of Certain Regulatory Requirements.--A physician 
(as defined in section 1861(r)(1) of the Social Security Act), to the 
extent consistent with applicable State law, may delegate electronic 
medical record documentation requirements specified in regulations 
promulgated by the Centers for Medicare & Medicaid Services to a person 
performing a scribe function who is not such physician if such physician 
has signed and verified the documentation.''; and
            (2) in the table of contents in section 13001(b), by 
        inserting after the item relating to section 13102 the 
        following:

``13103. Assisting doctors and hospitals in improving the quality and 
           care for patients.''.

    (b) Certification of Health Information Technology for Medical 
Specialties and Sites of Service.--Section 3001(c)(5) of the Public 
Health Service Act (42 U.S.C. 300jj-11(c)(5)) is amended by adding at 
the end the following:
                    ``(C) Health information technology for medical 
                specialties and sites of service.--
                          ``(i) In general.--The National Coordinator 
                      shall encourage, keep, or recognize, through 
                      existing authorities, the voluntary certification 
                      of health information technology under the program 
                      developed under

[[Page 130 STAT. 1159]]

                      subparagraph (A) for use in medical specialties 
                      and sites of service for which no such technology 
                      is available or where more technological 
                      advancement or integration is needed.
                          ``(ii) Specific medical specialties.--The 
                      Secretary shall accept public comment on specific 
                      medical specialties and sites of service, in 
                      addition to those described in clause (i), for the 
                      purpose of selecting additional specialties and 
                      sites of service as necessary.
                          ``(iii) Health information technology for 
                      pediatrics.--Not later than 18 months after the 
                      date of enactment of the 21st Century Cures Act, 
                      the Secretary, in consultation with relevant 
                      stakeholders, shall make recommendations for the 
                      voluntary certification of health information 
                      technology for use by pediatric health providers 
                      to support the health care of children. Not later 
                      than 2 years after the date of enactment of the 
                      21st Century Cures Act, the Secretary shall adopt 
                      certification criteria under section 3004 to 
                      support the voluntary certification of health 
                      information technology for use by pediatric health 
                      providers to support the health care of 
                      children.''.

    (c) Meaningful Use Statistics.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall submit to the HIT Advisory Committee of the 
        Office of the National Coordinator for Health Information 
        Technology, a report concerning attestation statistics for the 
        Medicare and Medicaid EHR Meaningful Use Incentive programs to 
        assist in informing standards adoption and related practices. 
        Such statistics shall include attestation information delineated 
        by State, including, to the extent practicable, the number of 
        providers who did not meet the minimum criteria necessary to 
        attest for the Medicare and Medicaid EHR Meaningful Use 
        Incentive programs for a calendar year, and shall be made 
        publicly available on the Internet website of the Secretary on 
        at least a quarterly basis.
            (2) Authority to alter format.--The Secretary of Health and 
        Human Services may alter the format of the reports on the 
        attestation of eligible health care professionals following the 
        first performance year of the Merit-based Incentive Payment 
        System to account for changes arising from the implementation of 
        such payment system.
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND 
                          FUNCTIONALITY.

    (a) Enhancements to Certification.--Section 3001(c)(5) of the Public 
Health Service Act (42 U.S.C. 300jj-11), as amended by section 4001(b), 
is further amended by adding at the end the following:
                    ``(D) Conditions of certification.--Not later than 1 
                year after the date of enactment of the 21st Century 
                Cures Act, the Secretary, through notice and comment 
                rulemaking, shall require, as a condition of 
                certification and maintenance of certification for 
                programs maintained or recognized under this paragraph, 
                consistent with other

[[Page 130 STAT. 1160]]

                conditions and requirements under this title, that the 
                health information technology developer or entity--
                          ``(i) does not take any action that 
                      constitutes information blocking as defined in 
                      section 3022(a);
                          ``(ii) provides assurances satisfactory to the 
                      Secretary that such developer or entity, unless 
                      for legitimate purposes specified by the 
                      Secretary, will not take any action described in 
                      clause (i) or any other action that may inhibit 
                      the appropriate exchange, access, and use of 
                      electronic health information;
                          ``(iii) does not prohibit or restrict 
                      communication regarding--
                                    ``(I) the usability of the health 
                                information technology;
                                    ``(II) the interoperability of the 
                                health information technology;
                                    ``(III) the security of the health 
                                information technology;
                                    ``(IV) relevant information 
                                regarding users' experiences when using 
                                the health information technology;
                                    ``(V) the business practices of 
                                developers of health information 
                                technology related to exchanging 
                                electronic health information; and
                                    ``(VI) the manner in which a user of 
                                the health information technology has 
                                used such technology;
                          ``(iv) has published application programming 
                      interfaces and allows health information from such 
                      technology to be accessed, exchanged, and used 
                      without special effort through the use of 
                      application programming interfaces or successor 
                      technology or standards, as provided for under 
                      applicable law, including providing access to all 
                      data elements of a patient's electronic health 
                      record to the extent permissible under applicable 
                      privacy laws;
                          ``(v) has successfully tested the real world 
                      use of the technology for interoperability (as 
                      defined in section 3000) in the type of setting in 
                      which such technology would be marketed;
                          ``(vi) provides to the Secretary an 
                      attestation that the developer or entity--
                                    ``(I) has not engaged in any of the 
                                conduct described in clause (i);
                                    ``(II) has provided assurances 
                                satisfactory to the Secretary in 
                                accordance with clause (ii);
                                    ``(III) does not prohibit or 
                                restrict communication as described in 
                                clause (iii);
                                    ``(IV) has published information in 
                                accordance with clause (iv);
                                    ``(V) ensures that its technology 
                                allows for health information to be 
                                exchanged, accessed, and used, in the 
                                manner described in clause (iv); and
                                    ``(VI) has undertaken real world 
                                testing as described in clause (v); and
                          ``(vii) submits reporting criteria in 
                      accordance with section 3009A(b).''.

[[Page 130 STAT. 1161]]

                    ``(E) Compliance with conditions of certification.--
                The Secretary may encourage compliance with the 
                conditions of certification described in subparagraph 
                (D) and take action to discourage noncompliance, as 
                appropriate.''.

    (b) EHR Significant Hardship Exception.--
            (1) Application to eligible professionals.--
                    (A) In case of decertification.--Section 
                1848(a)(7)(B) of the Social Security Act (42 U.S.C. 
                1395w-4(a)(7)(B)) is amended by inserting after the 
                first sentence the following new sentence: ``The 
                Secretary shall exempt an eligible professional from the 
                application of the payment adjustment under subparagraph 
                (A) with respect to a year, subject to annual renewal, 
                if the Secretary determines that compliance with the 
                requirement for being a meaningful EHR user is not 
                possible because the certified EHR technology used by 
                such professional has been decertified under a program 
                kept or recognized pursuant to section 3001(c)(5) of the 
                Public Health Service Act.''.
                    (B) Continued application under mips.--Section 
                1848(o)(2)(D) of the Social Security Act (42 U.S.C. 
                1395w-4(o)(2)(D)) is amended by adding at the end the 
                following new sentence: ``The provisions of 
                subparagraphs (B) and (D) of subsection (a)(7), shall 
                apply to assessments of MIPS eligible professionals 
                under subsection (q) with respect to the performance 
                category described in subsection (q)(2)(A)(iv) in an 
                appropriate manner which may be similar to the manner in 
                which such provisions apply with respect to payment 
                adjustments made under subsection (a)(7)(A).''.
            (2) Application to eligible hospitals.--Section 
        1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 
        1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first 
        sentence the following new sentence: ``The Secretary shall 
        exempt an eligible hospital from the application of the payment 
        adjustment under subclause (I) with respect to a fiscal year, 
        subject to annual renewal, if the Secretary determines that 
        compliance with the requirement for being a meaningful EHR user 
        is not possible because the certified EHR technology used by 
        such hospital is decertified under a program kept or recognized 
        pursuant to section 3001(c)(5) of the Public Health Service 
        Act.''.

    (c) Electronic Health Record Reporting Program.--Subtitle A of title 
XXX of the Public Health Service Act (42 U.S.C. 300jj-11 et seq.) is 
amended by adding at the end the following:
``SEC. 3009A. <<NOTE: 42 USC 300jj-19a.>>  ELECTRONIC HEALTH 
                            RECORD REPORTING PROGRAM.

    ``(a) Reporting Criteria.--
            ``(1) Convening of stakeholders.--Not later than 1 year 
        after the date of enactment of the 21st Century Cures Act, the 
        Secretary shall convene stakeholders, as described in paragraph 
        (2), for the purpose of developing the reporting criteria in 
        accordance with paragraph (3).
            ``(2) Development of reporting criteria.--The reporting 
        criteria under this subsection shall be developed through a 
        public, transparent process that reflects input from relevant 
        stakeholders, including--

[[Page 130 STAT. 1162]]

                    ``(A) health care providers, including primary care 
                and specialty care health care professionals;
                    ``(B) hospitals and hospital systems;
                    ``(C) health information technology developers;
                    ``(D) patients, consumers, and their advocates;
                    ``(E) data sharing networks, such as health 
                information exchanges;
                    ``(F) authorized certification bodies and testing 
                laboratories;
                    ``(G) security experts;
                    ``(H) relevant manufacturers of medical devices;
                    ``(I) experts in health information technology 
                market economics;
                    ``(J) public and private entities engaged in the 
                evaluation of health information technology performance;
                    ``(K) quality organizations, including the consensus 
                based entity described in section 1890 of the Social 
                Security Act;
                    ``(L) experts in human factors engineering and the 
                measurement of user-centered design; and
                    ``(M) other entities or individuals, as the 
                Secretary determines appropriate.
            ``(3) Considerations for reporting criteria.--The reporting 
        criteria developed under this subsection--
                    ``(A) shall include measures that reflect categories 
                including--
                          ``(i) security;
                          ``(ii) usability and user-centered design;
                          ``(iii) interoperability;
                          ``(iv) conformance to certification testing; 
                      and
                          ``(v) other categories, as appropriate to 
                      measure the performance of electronic health 
                      record technology;
                    ``(B) may include categories such as--
                          ``(i) enabling the user to order and view the 
                      results of laboratory tests, imaging tests, and 
                      other diagnostic tests;
                          ``(ii) submitting, editing, and retrieving 
                      data from registries such as clinician-led 
                      clinical data registries;
                          ``(iii) accessing and exchanging information 
                      and data from and through health information 
                      exchanges;
                          ``(iv) accessing and exchanging information 
                      and data from medical devices;
                          ``(v) accessing and exchanging information and 
                      data held by Federal, State, and local agencies 
                      and other applicable entities useful to a health 
                      care provider or other applicable user in the 
                      furtherance of patient care;
                          ``(vi) accessing and exchanging information 
                      from other health care providers or applicable 
                      users;
                          ``(vii) accessing and exchanging patient 
                      generated information;
                          ``(viii) providing the patient or an 
                      authorized designee with a complete copy of their 
                      health information from an electronic record in a 
                      computable format;
                          ``(ix) providing accurate patient information 
                      for the correct patient, including exchanging such 
                      information, and avoiding the duplication of 
                      patients records; and

[[Page 130 STAT. 1163]]

                          ``(x) other categories regarding performance, 
                      accessibility, as the Secretary determines 
                      appropriate; and
                    ``(C) shall be designed to ensure that small and 
                startup health information technology developers are not 
                unduly disadvantaged by the reporting criteria.
            ``(4) Modifications.--After the reporting criteria have been 
        developed under paragraph (3), the Secretary may convene 
        stakeholders and conduct a public comment period for the purpose 
        of modifying the reporting criteria developed under such 
        paragraph.

    ``(b) Participation.--As a condition of maintaining certification 
under section 3001(c)(5)(D), a developer of certified electronic health 
records shall submit to an appropriate recipient of a grant, contract, 
or agreement under subsection (c)(1) responses to the criteria developed 
under subsection (a), with respect to all certified technology offered 
by such developer.
    ``(c) Reporting Program.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the 21st Century Cures Act, the Secretary shall 
        award grants, contracts, or agreements to independent entities 
        on a competitive basis to support the convening of stakeholders 
        as described in subsection (a)(2), collect the information 
        required to be reported in accordance with the criteria 
        established as described subsection (a)(3), and develop and 
        implement a process in accordance with paragraph (5) and report 
        such information to the Secretary.
            ``(2) Applications.--An independent entity that seeks a 
        grant, contract, or agreement under this subsection shall submit 
        an application to the Secretary at such time, in such manner, 
        and containing such information as the Secretary may reasonably 
        require, including a description of--
                    ``(A) the proposed method for reviewing and 
                summarizing information gathered based on reporting 
                criteria established under subsection (a);
                    ``(B) if applicable, the intended focus on a 
                specific subset of certified electronic health record 
                technology users, such as health care providers, 
                including primary care, specialty care, and care 
                provided in rural settings; hospitals and hospital 
                systems; and patients, consumers, and patients and 
                consumer advocates;
                    ``(C) the plan for widely distributing reports 
                described in paragraph (6);
                    ``(D) the period for which the grant, contract, or 
                agreement is requested, which may be up to 2 years; and
                    ``(E) the budget for reporting program 
                participation, and whether the eligible independent 
                entity intends to continue participation after the 
                period of the grant, contract, or agreement.
            ``(3) Considerations for independent entities.--In awarding 
        grants, contracts, and agreements under paragraph (1), the 
        Secretary shall give priority to independent entities with 
        appropriate expertise in health information technology 
        usability, interoperability, and security (especially entities 
        with such expertise in electronic health records) with respect 
        to--
                    ``(A) health care providers, including primary care, 
                specialty care, and care provided in rural settings;
                    ``(B) hospitals and hospital systems; and

[[Page 130 STAT. 1164]]

                    ``(C) patients, consumers, and patient and consumer 
                advocates.
            ``(4) Limitations.--
                    ``(A) Assessment and redetermination.--Not later 
                than 4 years after the date of enactment of the 21st 
                Century Cures Act and every 2 years thereafter, the 
                Secretary, in consultation with stakeholders, shall--
                          ``(i) assess performance of the recipients of 
                      the grants, contracts, and agreements under 
                      paragraph (1) based on quality and usability of 
                      reports described in paragraph (6); and
                          ``(ii) re-determine grants, contracts, and 
                      agreements as necessary.
                    ``(B) Prohibitions on participation.--The Secretary 
                may not award a grant, contract, or cooperative 
                agreement under paragraph (1) to--
                          ``(i) a proprietor of certified health 
                      information technology or a business affiliate of 
                      such a proprietor;
                          ``(ii) a developer of certified health 
                      information technology; or
                          ``(iii) a State or local government agency.
            ``(5) Feedback.--Based on reporting criteria established 
        under subsection (a), the recipients of grants, contracts, and 
        agreements under paragraph (1) shall develop and implement a 
        process to collect and verify confidential feedback on such 
        criteria from--
                    ``(A) health care providers, patients, and other 
                users of certified electronic health record technology; 
                and
                    ``(B) developers of certified electronic health 
                record technology.
            ``(6) Reports.--
                    ``(A) Development of reports.--Each recipient of a 
                grant, contract, or agreement under paragraph (1) shall 
                report on the information reported to such recipient 
                pursuant to subsection (a) and the user feedback 
                collected under paragraph (5) by preparing summary 
                reports and detailed reports of such information.
                    ``(B) Distribution of reports.--Each recipient of a 
                grant, contract, or agreement under paragraph (1) shall 
                submit the reports prepared under subparagraph (A) to 
                the Secretary for public distribution in accordance with 
                subsection (d).

    ``(d) Publication.--The Secretary shall distribute widely, as 
appropriate, and publish, on the Internet website of the Office of the 
National Coordinator--
            ``(1) the reporting criteria developed under subsection (a); 
        and
            ``(2) the summary and detailed reports under subsection 
        (c)(6).

    ``(e) Review.--Each recipient of a grant, contract, or agreement 
under paragraph (1) shall develop and implement a process through which 
participating electronic health record technology developers may review 
and recommend changes to the reports created under subsection (c)(6) for 
products developed by such developer prior to the publication of such 
report under subsection (d).
    ``(f) Additional Resources.--The Secretary may provide additional 
resources on the Internet website of the Office of the National

[[Page 130 STAT. 1165]]

Coordinator to better inform consumers of health information technology. 
Such reports may be carried out through partnerships with private 
organizations with appropriate expertise.''.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated $15,000,000 for purposes of carrying out subparagraph (D) 
of section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-
11) (as added by subsection (a)) and section 3009A of the Public Health 
Service Act (as added by subsection (b)), including for purposes of 
administering any contracts, grants, or agreements, to remain available 
until expended.
SEC. 4003. INTEROPERABILITY.

    (a) Definition.--Section 3000 of the Public Health Service Act (42 
U.S.C. 300jj) is amended--
            (1) by redesignating paragraphs (10) through (14), as 
        paragraphs (11) through (15), respectively; and
            (2) by inserting after paragraph (9) the following:
            ``(10) Interoperability.--The term `interoperability', with 
        respect to health information technology, means such health 
        information technology that--
                    ``(A) enables the secure exchange of electronic 
                health information with, and use of electronic health 
                information from, other health information technology 
                without special effort on the part of the user;
                    ``(B) allows for complete access, exchange, and use 
                of all electronically accessible health information for 
                authorized use under applicable State or Federal law; 
                and
                    ``(C) does not constitute information blocking as 
                defined in section 3022(a).''.

    (b) Support for Interoperable Network Exchange.--Section 3001(c) of 
the Public Health Service Act (42 U.S.C. 300jj-11(c)) is amended by 
adding at the end the following:
            ``(9) Support for interoperable networks exchange.--
                    ``(A) In general.--The National Coordinator shall, 
                in collaboration with the National Institute of 
                Standards and Technology and other relevant agencies 
                within the Department of Health and Human Services, for 
                the purpose of ensuring full network-to-network exchange 
                of health information, convene public-private and 
                public-public partnerships to build consensus and 
                develop or support a trusted exchange framework, 
                including a common agreement among health information 
                networks nationally. Such convention may occur at a 
                frequency determined appropriate by the Secretary.
                    ``(B) Establishing a trusted exchange framework.--
                          ``(i) In general.--Not later than 6 months 
                      after the date of enactment of the 21st Century 
                      Cures Act, the National Coordinator shall convene 
                      appropriate public and private stakeholders to 
                      develop or support a trusted exchange framework 
                      for trust policies and practices and for a common 
                      agreement for exchange between health information 
                      networks. The common agreement may include--
                                    ``(I) a common method for 
                                authenticating trusted health 
                                information network participants;

[[Page 130 STAT. 1166]]

                                    ``(II) a common set of rules for 
                                trusted exchange;
                                    ``(III) organizational and 
                                operational policies to enable the 
                                exchange of health information among 
                                networks, including minimum conditions 
                                for such exchange to occur; and
                                    ``(IV) a process for filing and 
                                adjudicating noncompliance with the 
                                terms of the common agreement.
                          ``(ii) Technical assistance.--The National 
                      Coordinator, in collaboration with the National 
                      Institute of Standards and Technology, shall 
                      provide technical assistance on how to implement 
                      the trusted exchange framework and common 
                      agreement under this paragraph.
                          ``(iii) Pilot testing.--The National 
                      Coordinator, in consultation with the National 
                      Institute of Standards and Technology, shall 
                      provide for the pilot testing of the trusted 
                      exchange framework and common agreement 
                      established or supported under this subsection (as 
                      authorized under section 13201 of the Health 
                      Information Technology for Economic and Clinical 
                      Health Act). The National Coordinator, in 
                      consultation with the National Institute of 
                      Standards and Technology, may delegate pilot 
                      testing activities under this clause to 
                      independent entities with appropriate expertise.
                    ``(C) Publication of a trusted exchange framework 
                and common agreement.--Not later than 1 year after 
                convening stakeholders under subparagraph (A), the 
                National Coordinator shall publish on its public 
                Internet website, and in the Federal register, the 
                trusted exchange framework and common agreement 
                developed or supported under subparagraph (B). Such 
                trusted exchange framework and common agreement shall be 
                published in a manner that protects proprietary and 
                security information, including trade secrets and any 
                other protected intellectual property.
                    ``(D) Directory of participating health information 
                networks.--
                          ``(i) In general.--Not later than 2 years 
                      after convening stakeholders under subparagraph 
                      (A), and annually thereafter, the National 
                      Coordinator shall publish on its public Internet 
                      website a list of the health information networks 
                      that have adopted the common agreement and are 
                      capable of trusted exchange pursuant to the common 
                      agreement developed or supported under paragraph 
                      (B).
                          ``(ii) Process.--The Secretary shall, through 
                      notice and comment rulemaking, establish a process 
                      for health information networks that voluntarily 
                      elect to adopt the trusted exchange framework and 
                      common agreement to attest to such adoption of the 
                      framework and agreement.
                    ``(E) Application of the trusted exchange framework 
                and common agreement.--As appropriate, Federal agencies 
                contracting or entering into agreements with

[[Page 130 STAT. 1167]]

                health information exchange networks may require that as 
                each such network upgrades health information technology 
                or trust and operational practices, such network may 
                adopt, where available, the trusted exchange framework 
                and common agreement published under subparagraph (C).
                    ``(F) Rule of construction.--
                          ``(i) General adoption.--Nothing in this 
                      paragraph shall be construed to require a health 
                      information network to adopt the trusted exchange 
                      framework or common agreement.
                          ``(ii) Adoption when exchange of information 
                      is within network.--Nothing in this paragraph 
                      shall be construed to require a health information 
                      network to adopt the trusted exchange framework or 
                      common agreement for the exchange of electronic 
                      health information between participants of the 
                      same network.
                          ``(iii) Existing frameworks and agreements.--
                      The trusted exchange framework and common 
                      agreement published under subparagraph (C) shall 
                      take into account existing trusted exchange 
                      frameworks and agreements used by health 
                      information networks to avoid the disruption of 
                      existing exchanges between participants of health 
                      information networks.
                          ``(iv) Application by federal agencies.--
                      Notwithstanding clauses (i), (ii), and (iii), 
                      Federal agencies may require the adoption of the 
                      trusted exchange framework and common agreement 
                      published under subparagraph (C) for health 
                      information exchanges contracting with or entering 
                      into agreements pursuant to subparagraph (E).
                          ``(v) Consideration of ongoing work.--In 
                      carrying out this paragraph, the Secretary shall 
                      ensure the consideration of activities carried out 
                      by public and private organizations related to 
                      exchange between health information exchanges to 
                      avoid duplication of efforts.''.

    (c) <<NOTE: 42 USC 300jj-11 note.>>  Provider Digital Contact 
Information Index.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this subsection as the ``Secretary'') 
        shall, directly or through a partnership with a private entity, 
        establish a provider digital contact information index to 
        provide digital contact information for health professionals and 
        health facilities.
            (2) Use of existing index.--In establishing the initial 
        index under paragraph (1), the Secretary may utilize an existing 
        provider directory to make such digital contact information 
        available.
            (3) Contact information.--An index established under this 
        subsection shall ensure that contact information is available at 
        the individual health care provider level and at the health 
        facility or practice level.
            (4) Rule of construction.--
                    (A) In general.--The purpose of this subsection is 
                to encourage the exchange of electronic health 
                information by providing the most useful, reliable, and 
                comprehensive

[[Page 130 STAT. 1168]]

                index of providers possible. In furthering such purpose, 
                the Secretary shall include all health professionals and 
                health facilities applicable to provide a useful, 
                reliable, and comprehensive index for use in the 
                exchange of health information.
                    (B) Limitation.--In no case shall exclusion from the 
                index of providers be used as a measure to achieve 
                objectives other the objectives described in 
                subparagraph (A).

    (d) Standards Development Organizations.--Section 3004 of the Public 
Health Service Act (42 U.S.C. 300jj-14) is amended by adding at the end 
the following:
    ``(c) Deference to Standards Development Organizations.--In adopting 
and implementing standards under this section, the Secretary shall give 
deference to standards published by standards development organizations 
and voluntary consensus-based standards bodies.''.
    (e) Health Information Technology Advisory Committee.--
            (1) In general.--Title XXX of the Public Health Service Act 
        (42 U.S.C. 300jj et seq.) is amended by striking sections 3002 
        (42 U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and inserting 
        the following:
``SEC. 3002. <<NOTE: 42 USC 300jj-12.>>  HEALTH INFORMATION 
                          TECHNOLOGY ADVISORY COMMITTEE.

    ``(a) Establishment.--There is established a Health Information 
Technology Advisory Committee (referred to in this section as the `HIT 
Advisory Committee') to recommend to the National Coordinator, 
consistent with the implementation of the strategic plan described in 
section 3001(c)(3), policies, and, for purposes of adoption under 
section 3004, standards, implementation specifications, and 
certification criteria, relating to the implementation of a health 
information technology infrastructure, nationally and locally, that 
advances the electronic access, exchange, and use of health information. 
Such Committee shall serve to unify the roles of, and replace, the HIT 
Policy Committee and the HIT Standards Committee, as in existence before 
the date of the enactment of the 21st Century Cures Act.
    ``(b) Duties.--
            ``(1) Recommendations on policy framework to advance an 
        interoperable health information technology infrastructure.--
                    ``(A) In general.--The HIT Advisory Committee shall 
                recommend to the National Coordinator a policy framework 
                for adoption by the Secretary consistent with the 
                strategic plan under section 3001(c)(3) for advancing 
                the target areas described in this subsection. Such 
                policy framework shall seek to prioritize achieving 
                advancements in the target areas specified in 
                subparagraph (B) of paragraph (2) and may, to the extent 
                consistent with this section, incorporate policy 
                recommendations made by the HIT Policy Committee, as in 
                existence before the date of the enactment of the 21st 
                Century Cures Act.
                    ``(B) Updates.--The HIT Advisory Committee shall 
                propose updates to such recommendations to the policy 
                framework and make new recommendations, as appropriate.

[[Page 130 STAT. 1169]]

            ``(2) General duties and target areas.--
                    ``(A) In general.--The HIT Advisory Committee shall 
                recommend to the National Coordinator for purposes of 
                adoption under section 3004, standards, implementation 
                specifications, and certification criteria and an order 
                of priority for the development, harmonization, and 
                recognition of such standards, specifications, and 
                certification criteria. Such recommendations shall 
                include recommended standards, architectures, and 
                software schemes for access to electronic individually 
                identifiable health information across disparate systems 
                including user vetting, authentication, privilege 
                management, and access control.
                    ``(B) Priority target areas.--For purposes of this 
                section, the HIT Advisory Committee shall make 
                recommendations under subparagraph (A) with respect to 
                at least each of the following target areas:
                          ``(i) Achieving a health information 
                      technology infrastructure, nationally and locally, 
                      that allows for the electronic access, exchange, 
                      and use of health information, including through 
                      technology that provides accurate patient 
                      information for the correct patient, including 
                      exchanging such information, and avoids the 
                      duplication of patient records.
                          ``(ii) The promotion and protection of privacy 
                      and security of health information in health 
                      information technology, including technologies 
                      that allow for an accounting of disclosures and 
                      protections against disclosures of individually 
                      identifiable health information made by a covered 
                      entity for purposes of treatment, payment, and 
                      health care operations (as such terms are defined 
                      for purposes of the regulation promulgated under 
                      section 264(c) of the Health Insurance Portability 
                      and Accountability Act of 1996), including for the 
                      segmentation and protection from disclosure of 
                      specific and sensitive individually identifiable 
                      health information with the goal of minimizing the 
                      reluctance of patients to seek care.
                          ``(iii) The facilitation of secure access by 
                      an individual to such individual's protected 
                      health information and access to such information 
                      by a family member, caregiver, or guardian acting 
                      on behalf of a patient, including due to age-
                      related and other disability, cognitive 
                      impairment, or dementia.
                          ``(iv) Subject to subparagraph (D), any other 
                      target area that the HIT Advisory Committee 
                      identifies as an appropriate target area to be 
                      considered under this subparagraph.
                    ``(C) Additional target areas.--For purposes of this 
                section, the HIT Advisory Committee may make 
                recommendations under subparagraph (A), in addition to 
                areas described in subparagraph (B), with respect to any 
                of the following areas:
                          ``(i) The use of health information technology 
                      to improve the quality of health care, such as by 
                      promoting the coordination of health care and 
                      improving continuity of health care among health 
                      care providers, reducing medical errors, improving 
                      population health,

[[Page 130 STAT. 1170]]

                      reducing chronic disease, and advancing research 
                      and education.
                          ``(ii) The use of technologies that address 
                      the needs of children and other vulnerable 
                      populations.
                          ``(iii) The use of electronic systems to 
                      ensure the comprehensive collection of patient 
                      demographic data, including at a minimum, race, 
                      ethnicity, primary language, and gender 
                      information.
                          ``(iv) The use of self-service, telemedicine, 
                      home health care, and remote monitoring 
                      technologies.
                          ``(v) The use of technologies that meet the 
                      needs of diverse populations.
                          ``(vi) The use of technologies that support--
                                    ``(I) data for use in quality and 
                                public reporting programs;
                                    ``(II) public health; or
                                    ``(III) drug safety.
                          ``(vii) The use of technologies that allow 
                      individually identifiable health information to be 
                      rendered unusable, unreadable, or indecipherable 
                      to unauthorized individuals when such information 
                      is transmitted in a health information network or 
                      transported outside of the secure facilities or 
                      systems where the disclosing covered entity is 
                      responsible for security conditions.
                          ``(viii) The use of a certified health 
                      information technology for each individual in the 
                      United States.
                    ``(D) Authority for temporary additional priority 
                target areas.--For purposes of subparagraph (B)(iv), the 
                HIT Advisory Committee may identify an area to be 
                considered for purposes of recommendations under this 
                subsection as a target area described in subparagraph 
                (B) if--
                          ``(i) the area is so identified for purposes 
                      of responding to new circumstances that have 
                      arisen in the health information technology 
                      community that affect the interoperability, 
                      privacy, or security of health information, or 
                      affect patient safety; and
                          ``(ii) at least 30 days prior to treating such 
                      area as if it were a target area described in 
                      subparagraph (B), the National Coordinator 
                      provides adequate notice to Congress of the intent 
                      to treat such area as so described.
                    ``(E) Focus of committee work.--It is the sense of 
                Congress that the HIT Advisory Committee shall focus its 
                work on the priority areas described in subparagraph (B) 
                before proceeding to other work under subparagraph (C).
            ``(3) Rules relating to recommendations for standards, 
        implementation specifications, and certification criteria.--
                    ``(A) In general.--The HIT Advisory Committee shall 
                recommend to the National Coordinator standards, 
                implementation specifications, and certification 
                criteria described in subsection (a), which may include 
                standards, implementation specifications, and 
                certification criteria that have been developed, 
                harmonized, or recognized by the HIT Advisory Committee 
                or predecessor committee.

[[Page 130 STAT. 1171]]

                The HIT Advisory Committee shall update such 
                recommendations and make new recommendations as 
                appropriate, including in response to a notification 
                sent under section 3004(a)(2)(B). Such recommendations 
                shall be consistent with the latest recommendations made 
                by the Committee.
                    ``(B) Harmonization.--The HIT Advisory Committee may 
                recognize harmonized or updated standards from an entity 
                or entities for the purpose of harmonizing or updating 
                standards and implementation specifications in order to 
                achieve uniform and consistent implementation of the 
                standards and implementation specification.
                    ``(C) Pilot testing of standards and implementation 
                specifications.--In the development, harmonization, or 
                recognition of standards and implementation 
                specifications, the HIT Advisory Committee for purposes 
                of recommendations under paragraph (2)(B), shall, as 
                appropriate, provide for the testing of such standards 
                and specifications by the National Institute for 
                Standards and Technology under section 13201(a) of the 
                Health Information Technology for Economic and Clinical 
                Health Act.
                    ``(D) Consistency.--The standards, implementation 
                specifications, and certification criteria recommended 
                under paragraph (2)(B) shall be consistent with the 
                standards for information transactions and data elements 
                adopted pursuant to section 1173 of the Social Security 
                Act.
                    ``(E) Special rule related to interoperability.--Any 
                recommendation made by the HIT Advisory Committee after 
                the date of the enactment of this subparagraph with 
                respect to interoperability of health information 
                technology shall be consistent with interoperability as 
                described in section 3000.
            ``(4) Forum.--The HIT Advisory Committee shall serve as a 
        forum for the participation of a broad range of stakeholders 
        with specific expertise in policies, including technical 
        expertise, relating to the matters described in paragraphs (1), 
        (2), and (3) to provide input on the development, harmonization, 
        and recognition of standards, implementation specifications, and 
        certification criteria necessary for the development and 
        adoption of health information technology infrastructure 
        nationally and locally that allows for the electronic access, 
        exchange, and use of health information.
            ``(5) Schedule.--Not later than 30 days after the date on 
        which the HIT Advisory Committee first meets, such HIT Advisory 
        Committee shall develop a schedule for the assessment of policy 
        recommendations developed under paragraph (1). The HIT Advisory 
        Committee shall update such schedule annually. The Secretary 
        shall publish such schedule in the Federal Register.
            ``(6) Public input.--The HIT Advisory Committee shall 
        conduct open public meetings and develop a process to allow for 
        public comment on the schedule described in paragraph (5) and 
        recommendations described in this subsection. Under such process 
        comments shall be submitted in a timely manner after the date of 
        publication of a recommendation under this subsection.

    ``(c) Measured Progress in Advancing Priority Areas.--

[[Page 130 STAT. 1172]]

            ``(1) In general.--For purposes of this section, the 
        National Coordinator, in collaboration with the Secretary, shall 
        establish, and update as appropriate, objectives and benchmarks 
        for advancing and measuring the advancement of the priority 
        target areas described in subsection (b)(2)(B).
            ``(2) Annual progress reports on advancing 
        interoperability.--
                    ``(A) In general.--The HIT Advisory Committee, in 
                consultation with the National Coordinator, shall 
                annually submit to the Secretary and Congress a report 
                on the progress made during the preceding fiscal year 
                in--
                          ``(i) achieving a health information 
                      technology infrastructure, nationally and locally, 
                      that allows for the electronic access, exchange, 
                      and use of health information; and
                          ``(ii) meeting the objectives and benchmarks 
                      described in paragraph (1).
                    ``(B) Content.--Each such report shall include, for 
                a fiscal year--
                          ``(i) a description of the work conducted by 
                      the HIT Advisory Committee during the preceding 
                      fiscal year with respect to the areas described in 
                      subsection (b)(2)(B);
                          ``(ii) an assessment of the status of the 
                      infrastructure described in subparagraph (A), 
                      including the extent to which electronic health 
                      information is appropriately and readily available 
                      to enhance the access, exchange, and the use of 
                      electronic health information between users and 
                      across technology offered by different developers;
                          ``(iii) the extent to which advancements have 
                      been achieved with respect to areas described in 
                      subsection (b)(2)(B);
                          ``(iv) an analysis identifying existing gaps 
                      in policies and resources for--
                                    ``(I) achieving the objectives and 
                                benchmarks established under paragraph 
                                (1); and
                                    ``(II) furthering interoperability 
                                throughout the health information 
                                technology infrastructure;
                          ``(v) recommendations for addressing the gaps 
                      identified in clause (iii); and
                          ``(vi) a description of additional initiatives 
                      as the HIT Advisory Committee and National 
                      Coordinator determine appropriate.
            ``(3) Significant advancement determination.--The Secretary 
        shall periodically, based on the reports submitted under this 
        subsection, review the target areas described in subsection 
        (b)(2)(B), and, based on the objectives and benchmarks 
        established under paragraph (1), the Secretary shall determine 
        if significant advancement has been achieved with respect to 
        such an area. Such determination shall be taken into 
        consideration by the HIT Advisory Committee when determining to 
        what extent the Committee makes recommendations for an area 
        other than an area described in subsection (b)(2)(B).

    ``(d) Membership and Operations.--

[[Page 130 STAT. 1173]]

            ``(1) In general.--The National Coordinator shall take a 
        leading position in the establishment and operations of the HIT 
        Advisory Committee.
            ``(2) Membership.--The membership of the HIT Advisory 
        Committee shall--
                    ``(A) include at least 25 members, of which--
                          ``(i) no fewer than 2 members are advocates 
                      for patients or consumers of health information 
                      technology;
                          ``(ii) 3 members are appointed by the 
                      Secretary, 1 of whom shall be appointed to 
                      represent the Department of Health and Human 
                      Services and 1 of whom shall be a public health 
                      official;
                          ``(iii) 2 members are appointed by the 
                      majority leader of the Senate;
                          ``(iv) 2 members are appointed by the minority 
                      leader of the Senate;
                          ``(v) 2 members are appointed by the Speaker 
                      of the House of Representatives;
                          ``(vi) 2 members are appointed by the minority 
                      leader of the House of Representatives; and
                          ``(vii) such other members are appointed by 
                      the Comptroller General of the United States; and
                    ``(B) at least reflect providers, ancillary health 
                care workers, consumers, purchasers, health plans, 
                health information technology developers, researchers, 
                patients, relevant Federal agencies, and individuals 
                with technical expertise on health care quality, system 
                functions, privacy, security, and on the electronic 
                exchange and use of health information, including the 
                use standards for such activity.
            ``(3) Participation.--The members of the HIT Advisory 
        Committee shall represent a balance among various sectors of the 
        health care system so that no single sector unduly influences 
        the recommendations of the Committee.
            ``(4) Terms.--
                    ``(A) In general.--The terms of the members of the 
                HIT Advisory Committee shall be for 3 years, except that 
                the Secretary shall designate staggered terms of the 
                members first appointed.
                    ``(B) Vacancies.--Any member appointed to fill a 
                vacancy in the membership of the HIT Advisory Committee 
                that occurs prior to the expiration of the term for 
                which the member's predecessor was appointed shall be 
                appointed only for the remainder of that term. A member 
                may serve after the expiration of that member's term 
                until a successor has been appointed. A vacancy in the 
                HIT Advisory Committee shall be filled in the manner in 
                which the original appointment was made.
                    ``(C) Limits.--Members of the HIT Advisory Committee 
                shall be limited to two 3-year terms, for a total of not 
                to exceed 6 years of service on the Committee.
            ``(5) Outside involvement.--The HIT Advisory Committee shall 
        ensure an opportunity for the participation in activities of the 
        Committee of outside advisors, including individuals with 
        expertise in the development of policies and standards for the 
        electronic exchange and use of health information,

[[Page 130 STAT. 1174]]

        including in the areas of health information privacy and 
        security.
            ``(6) Quorum.--A majority of the members of the HIT Advisory 
        Committee shall constitute a quorum for purposes of voting, but 
        a lesser number of members may meet and hold hearings.
            ``(7) Consideration.--The National Coordinator shall ensure 
        that the relevant and available recommendations and comments 
        from the National Committee on Vital and Health Statistics are 
        considered in the development of policies.
            ``(8) Assistance.--For the purposes of carrying out this 
        section, the Secretary may provide or ensure that financial 
        assistance is provided by the HIT Advisory Committee to defray 
        in whole or in part any membership fees or dues charged by such 
        Committee to those consumer advocacy groups and not-for-profit 
        entities that work in the public interest as a party of their 
        mission.

    ``(e) Application of FACA.--The Federal Advisory Committee Act (5 
U.S.C. App.), other than section 14 of such Act, shall apply to the HIT 
Advisory Committee.
    ``(f) Publication.--The Secretary shall provide for publication in 
the Federal Register and the posting on the Internet website of the 
Office of the National Coordinator for Health Information Technology of 
all policy recommendations made by the HIT Advisory Committee under this 
section.''.
            (2) Technical and conforming amendments.--Title XXX of the 
        Public Health Service Act (42 U.S.C. 300jj et seq.) is amended--
                    (A) by striking--
                          (i) ``HIT Policy Committee'' and ``HIT 
                      Standards Committee'' each place that such terms 
                      appear (other than within the term ``HIT Policy 
                      Committee and the HIT Standards Committee'' or 
                      within the term ``HIT Policy Committee or the HIT 
                      Standards Committee'') and inserting ``HIT 
                      Advisory Committee'';
                          (ii) ``HIT Policy Committee and the HIT 
                      Standards Committee'' each place that such term 
                      appears and inserting ``HIT Advisory Committee''; 
                      and
                          (iii) ``HIT Policy Committee or the HIT 
                      Standards Committee'' each place that such term 
                      appears and inserting ``HIT Advisory Committee'';
                    (B) in section 3000 (42 U.S.C. 300jj)--
                          (i) by striking paragraphs (7) and (8) and 
                      redesignating paragraphs (9) through (14) as 
                      paragraphs (8) through (13), respectively; and
                          (ii) by inserting after paragraph (6) the 
                      following paragraph:
            ``(7) Hit advisory committee.--The term `HIT Advisory 
        Committee' means such Committee established under section 
        3002(a).'';
                    (C) in section 3001(c) (42 U.S.C. 300jj-11(c))--
                          (i) in paragraph (1)(A), by striking ``under 
                      section 3003'' and inserting ``under section 
                      3002'';
                          (ii) in paragraph (2), by striking 
                      subparagraph (B) and inserting the following:
                    ``(B) Hit advisory committee.--The National 
                Coordinator shall be a leading member in the 
                establishment

[[Page 130 STAT. 1175]]

                and operations of the HIT Advisory Committee and shall 
                serve as a liaison between that Committee and the 
                Federal Government.'';
                    (D) in section 3004(b)(3) (42 U.S.C. 300jj-
                14(b)(3)), by striking ``3003(b)(2)'' and inserting 
                ``3002(b)(4)'';
                    (E) in section 3007(b) (42 U.S.C. 300jj-17(b)), by 
                striking ``3003(a)'' and inserting ``3002(a)(2)''; and
                    (F) in section 3008 (42 U.S.C. 300jj-18)--
                          (i) in subsection (b), by striking ``or 
                      3003''; and
                          (ii) in subsection (c), by striking 
                      ``3003(b)(1)(A)'' and inserting ``3002(b)(2)''.
            (3) <<NOTE: 42 USC 300jj-12 note.>>  Transition to the hit 
        advisory committee.--The Secretary of Health and Human Services 
        shall provide for an orderly and timely transition to the HIT 
        Advisory Committee established under amendments made by this 
        section.

    (f) Priorities for Adoption of Standards, Implementation 
Specifications, and Certification Criteria.--Title XXX of the Public 
Health Service Act (42 U.S.C. 300jj et seq.), as amended by subsection 
(e), is further amended by inserting after section 3002 the following:
``SEC. 3003. <<NOTE: 42 USC 300jj-13.>>  SETTING PRIORITIES FOR 
                          STANDARDS ADOPTION.

    ``(a) Identifying Priorities.--
            ``(1) In general.--Not later than 6 months after the date on 
        which the HIT Advisory Committee first meets, the National 
        Coordinator shall periodically convene the HIT Advisory 
        Committee to--
                    ``(A) identify priority uses of health information 
                technology, focusing on priorities--
                          ``(i) arising from the implementation of the 
                      incentive programs for the meaningful use of 
                      certified EHR technology, the Merit-based 
                      Incentive Payment System, Alternative Payment 
                      Models, the Hospital Value-Based Purchasing 
                      Program, and any other value-based payment program 
                      determined appropriate by the Secretary;
                          ``(ii) related to the quality of patient care;
                          ``(iii) related to public health;
                          ``(iv) related to clinical research;
                          ``(v) related to the privacy and security of 
                      electronic health information;
                          ``(vi) related to innovation in the field of 
                      health information technology;
                          ``(vii) related to patient safety;
                          ``(viii) related to the usability of health 
                      information technology;
                          ``(ix) related to individuals' access to 
                      electronic health information; and
                          ``(x) other priorities determined appropriate 
                      by the Secretary;
                    ``(B) identify existing standards and implementation 
                specifications that support the use and exchange of 
                electronic health information needed to meet the 
                priorities identified in subparagraph (A); and
                    ``(C) publish a report summarizing the findings of 
                the analysis conducted under subparagraphs (A) and (B) 
                and make appropriate recommendations.

[[Page 130 STAT. 1176]]

            ``(2) Prioritization.--In identifying such standards and 
        implementation specifications under paragraph (1)(B), the HIT 
        Advisory Committee shall prioritize standards and implementation 
        specifications developed by consensus-based standards 
        development organizations.
            ``(3) Guidelines for review of existing standards and 
        specifications.--In consultation with the consensus-based entity 
        described in section 1890 of the Social Security Act and other 
        appropriate Federal agencies, the analysis of existing standards 
        under paragraph (1)(B) shall include an evaluation of the need 
        for a core set of common data elements and associated value sets 
        to enhance the ability of certified health information 
        technology to capture, use, and exchange structured electronic 
        health information.

    ``(b) Review of Adopted Standards.--
            ``(1) In general.--Beginning 5 years after the date of 
        enactment of the 21st Century Cures Act and every 3 years 
        thereafter, the National Coordinator shall convene stakeholders 
        to review the existing set of adopted standards and 
        implementation specifications and make recommendations with 
        respect to whether to--
                    ``(A) maintain the use of such standards and 
                implementation specifications; or
                    ``(B) phase out such standards and implementation 
                specifications.
            ``(2) Priorities.--The HIT Advisory Committee, in 
        collaboration with the National Institute for Standards and 
        Technology, shall annually and through the use of public input, 
        review and publish priorities for the use of health information 
        technology, standards, and implementation specifications to 
        support those priorities.

    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to prevent the use or adoption of novel standards that improve 
upon the existing health information technology infrastructure and 
facilitate the secure exchange of health information.''.
SEC. 4004. INFORMATION BLOCKING.

    Subtitle C of title XXX of the Public Health Service Act (42 U.S.C. 
300jj-51 et seq.) is amended by adding at the end the following:
``SEC. 3022. <<NOTE: 42 USC 300jj-52.>>  INFORMATION BLOCKING.

    ``(a) Definition.--
            ``(1) In general.--In this section, the term `information 
        blocking' means a practice that--
                    ``(A) except as required by law or specified by the 
                Secretary pursuant to rulemaking under paragraph (3), is 
                likely to interfere with, prevent, or materially 
                discourage access, exchange, or use of electronic health 
                information; and
                    ``(B)(i) if conducted by a health information 
                technology developer, exchange, or network, such 
                developer, exchange, or network knows, or should know, 
                that such practice is likely to interfere with, prevent, 
                or materially discourage the access, exchange, or use of 
                electronic health information; or
                    ``(ii) if conducted by a health care provider, such 
                provider knows that such practice is unreasonable and is

[[Page 130 STAT. 1177]]

                likely to interfere with, prevent, or materially 
                discourage access, exchange, or use of electronic health 
                information.
            ``(2) Practices described.--The information blocking 
        practices described in paragraph (1) may include--
                    ``(A) practices that restrict authorized access, 
                exchange, or use under applicable State or Federal law 
                of such information for treatment and other permitted 
                purposes under such applicable law, including 
                transitions between certified health information 
                technologies;
                    ``(B) implementing health information technology in 
                nonstandard ways that are likely to substantially 
                increase the complexity or burden of accessing, 
                exchanging, or using electronic health information; and
                    ``(C) implementing health information technology in 
                ways that are likely to--
                          ``(i) restrict the access, exchange, or use of 
                      electronic health information with respect to 
                      exporting complete information sets or in 
                      transitioning between health information 
                      technology systems; or
                          ``(ii) lead to fraud, waste, or abuse, or 
                      impede innovations and advancements in health 
                      information access, exchange, and use, including 
                      care delivery enabled by health information 
                      technology.
            ``(3) Rulemaking.--The Secretary, through rulemaking, shall 
        identify reasonable and necessary activities that do not 
        constitute information blocking for purposes of paragraph (1).
            ``(4) No enforcement before exception identified.--The term 
        `information blocking' does not include any practice or conduct 
        occurring prior to the date that is 30 days after the date of 
        enactment of the 21st Century Cures Act.
            ``(5) Consultation.--The Secretary may consult with the 
        Federal Trade Commission in promulgating regulations under this 
        subsection, to the extent that such regulations define practices 
        that are necessary to promote competition and consumer welfare.
            ``(6) Application.--The term `information blocking', with 
        respect to an individual or entity, shall not include an act or 
        practice other than an act or practice committed by such 
        individual or entity.
            ``(7) Clarification.--In carrying out this section, the 
        Secretary shall ensure that health care providers are not 
        penalized for the failure of developers of health information 
        technology or other entities offering health information 
        technology to such providers to ensure that such technology 
        meets the requirements to be certified under this title.

    ``(b) Inspector General Authority.--
            ``(1) In general.--The inspector general of the Department 
        of Health and Human Services (referred to in this section as the 
        `Inspector General') may investigate any claim that--
                    ``(A) a health information technology developer of 
                certified health information technology or other entity 
                offering certified health information technology--
                          ``(i) submitted a false attestation under 
                      section 3001(c)(5)(D)(vii); or
                          ``(ii) engaged in information blocking;
                    ``(B) a health care provider engaged in information 
                blocking; or

[[Page 130 STAT. 1178]]

                    ``(C) a health information exchange or network 
                engaged in information blocking.
            ``(2) Penalties.--
                    ``(A) Developers, networks, and exchanges.--Any 
                individual or entity described in subparagraph (A) or 
                (C) of paragraph (1) that the Inspector General, 
                following an investigation conducted under this 
                subsection, determines to have committed information 
                blocking shall be subject to a civil monetary penalty 
                determined by the Secretary for all such violations 
                identified through such investigation, which may not 
                exceed $1,000,000 per violation. Such determination 
                shall take into account factors such as the nature and 
                extent of the information blocking and harm resulting 
                from such information blocking, including, where 
                applicable, the number of patients affected, the number 
                of providers affected, and the number of days the 
                information blocking persisted.
                    ``(B) Providers.--Any individual or entity described 
                in subparagraph (B) of paragraph (1) determined by the 
                Inspector General to have committed information blocking 
                shall be referred to the appropriate agency to be 
                subject to appropriate disincentives using authorities 
                under applicable Federal law, as the Secretary sets 
                forth through notice and comment rulemaking.
                    ``(C) Procedure.--The provisions of section 1128A of 
                the Social Security Act (other than subsections (a) and 
                (b) of such section) shall apply to a civil money 
                penalty applied under this paragraph in the same manner 
                as such provisions apply to a civil money penalty or 
                proceeding under such section 1128A(a).
                    ``(D) Recovered penalty funds.--The amounts 
                recovered under this paragraph shall be allocated as 
                follows:
                          ``(i) Annual operating expenses.--Each year 
                      following the establishment of the authority under 
                      this subsection, the Office of the Inspector 
                      General shall provide to the Secretary an estimate 
                      of the costs to carry out investigations under 
                      this section. Such estimate may include reasonable 
                      reserves to account for variance in annual amounts 
                      recovered under this paragraph. There is 
                      authorized to be appropriated for purposes of 
                      carrying out this section an amount equal to the 
                      amount specified in such estimate for the fiscal 
                      year.
                          ``(ii) Application to other programs.--The 
                      amounts recovered under this paragraph and 
                      remaining after amounts are made available under 
                      clause (i) shall be transferred to the Federal 
                      Hospital Insurance Trust Fund under section 1817 
                      of the Social Security Act and the Federal 
                      Supplementary Medical Insurance Trust Fund under 
                      section 1841 of such Act, in such proportion as 
                      the Secretary determines appropriate.
                    ``(E) Authorization of appropriations.--There is 
                authorized to be appropriated to the Office of the 
                Inspector General to carry out this section $10,000,000, 
                to remain available until expended.
            ``(3) Resolution of claims.--

[[Page 130 STAT. 1179]]

                    ``(A) In general.--The Office of the Inspector 
                General, if such Office determines that a consultation 
                regarding the health privacy and security rules 
                promulgated under section 264(c) of the Health Insurance 
                Portability and Accountability Act of 1996 (42 U.S.C. 
                1320d-2 note) will resolve an information blocking 
                claim, may refer such instances of information blocking 
                to the Office for Civil Rights of the Department of 
                Health and Human Services for resolution.
                    ``(B) Limitation on liability.--If a health care 
                provider or health information technology developer 
                makes information available based on a good faith 
                reliance on consultations with the Office for Civil 
                Rights of the Department of Health and Human Services 
                pursuant to a referral under subparagraph (A), with 
                respect to such information, the health care provider or 
                developer shall not be liable for such disclosure or 
                disclosures made pursuant to subparagraph (A).

    ``(c) Identifying Barriers To Exchange of Certified Health 
Information Technology.--
            ``(1) Trusted exchange defined.--In this section, the term 
        `trusted exchange' with respect to certified electronic health 
        records means that the certified electronic health record 
        technology has the technical capability to enable secure health 
        information exchange between users and multiple certified 
        electronic health record technology systems.
            ``(2) Guidance.--The National Coordinator, in consultation 
        with the Office for Civil Rights of the Department of Health and 
        Human Services, shall issue guidance on common legal, 
        governance, and security barriers that prevent the trusted 
        exchange of electronic health information.
            ``(3) Referral.--The National Coordinator and the Office for 
        Civil Rights of the Department of Health and Human Services may 
        refer to the Inspector General instances or patterns of refusal 
        to exchange health information with an individual or entity 
        using certified electronic health record technology that is 
        technically capable of trusted exchange and under conditions 
        when exchange is legally permissible.

    ``(d) Additional Provisions.--
            ``(1) Information sharing provisions.--The National 
        Coordinator may serve as a technical consultant to the Inspector 
        General and the Federal Trade Commission for purposes of 
        carrying out this section. The National Coordinator may, 
        notwithstanding any other provision of law, share information 
        related to claims or investigations under subsection (b) with 
        the Federal Trade Commission for purposes of such investigations 
        and shall share information with the Inspector General, as 
        required by law.
            ``(2) Protection from disclosure of information.--Any 
        information that is received by the National Coordinator in 
        connection with a claim or suggestion of possible information 
        blocking and that could reasonably be expected to facilitate 
        identification of the source of the information--
                    ``(A) shall not be disclosed by the National 
                Coordinator except as may be necessary to carry out the 
                purpose of this section;

[[Page 130 STAT. 1180]]

                    ``(B) shall be exempt from mandatory disclosure 
                under section 552 of title 5, United States Code, as 
                provided by subsection (b)(3) of such section; and
                    ``(C) may be used by the Inspector General or 
                Federal Trade Commission for reporting purposes to the 
                extent that such information could not reasonably be 
                expected to facilitate identification of the source of 
                such information.
            ``(3) Standardized process.--
                    ``(A) In general.--The National Coordinator shall 
                implement a standardized process for the public to 
                submit reports on claims of--
                          ``(i) health information technology products 
                      or developers of such products (or other entities 
                      offering such products to health care providers) 
                      not being interoperable or resulting in 
                      information blocking;
                          ``(ii) actions described in subsection (b)(1) 
                      that result in information blocking as described 
                      in subsection (a); and
                          ``(iii) any other act described in subsection 
                      (a).
                    ``(B) Collection of information.--The standardized 
                process implemented under subparagraph (A) shall provide 
                for the collection of such information as the 
                originating institution, location, type of transaction, 
                system and version, timestamp, terminating institution, 
                locations, system and version, failure notice, and other 
                related information.
            ``(4) Nonduplication of penalty structures.--In carrying out 
        this subsection, the Secretary shall, to the extent possible, 
        ensure that penalties do not duplicate penalty structures that 
        would otherwise apply with respect to information blocking and 
        the type of individual or entity involved as of the day before 
        the date of the enactment of this section.''.
SEC. 4005. <<NOTE: 42 USC 300jj-14 note.>>  LEVERAGING ELECTRONIC 
                          HEALTH RECORDS TO IMPROVE PATIENT CARE.

    (a) Requirement Relating to Registries.--
            (1) In general.--To be certified in accordance with title 
        XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.), 
        electronic health records shall be capable of transmitting to, 
        and where applicable, receiving and accepting data from, 
        registries in accordance with standards recognized by the Office 
        of the National Coordinator for Health Information Technology, 
        including clinician-led clinical data registries, that are also 
        certified to be technically capable of receiving and accepting 
        from, and where applicable, transmitting data to certified 
        electronic health record technology in accordance with such 
        standards.
            (2) Rule of construction.--Nothing in this subsection shall 
        be construed to require the certification of registries beyond 
        the technical capability to exchange data in accordance with 
        applicable recognized standards.

    (b) Definition.--For purposes of this Act, the term ``clinician-led 
clinical data registry'' means a clinical data repository--
            (1) that is established and operated by a clinician-led or 
        controlled, tax-exempt (pursuant to section 501(c) of the 
        Internal Revenue Code of 1986), professional society or other 
        similar clinician-led or -controlled organization, or such

[[Page 130 STAT. 1181]]

        organization's controlled affiliate, devoted to the care of a 
        population defined by a particular disease, condition, exposure 
        or therapy;
            (2) that is designed to collect detailed, standardized data 
        on an ongoing basis for medical procedures, services, or 
        therapies for particular diseases, conditions, or exposures;
            (3) that provides feedback to participants who submit 
        reports to the repository;
            (4) that meets standards for data quality including--
                    (A) systematically collecting clinical and other 
                health care data, using standardized data elements and 
                having procedures in place to verify the completeness 
                and validity of those data; and
                    (B) being subject to regular data checks or audits 
                to verify completeness and validity; and
            (5) that provides ongoing participant training and support.

    (c) Treatment of Health Information Technology Developers With 
Respect to Patient Safety Organizations.--
            (1) In general.--In applying part C of title IX of the 
        Public Health Service Act (42 U.S.C. 299b-21 et seq.), a health 
        information technology developer shall be treated as a provider 
        (as defined in section 921 of such Act) for purposes of 
        reporting and conducting patient safety activities concerning 
        improving clinical care through the use of health information 
        technology that could result in improved patient safety, health 
        care quality, or health care outcomes.
            (2) Report.--Not later than 4 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning best practices and current trends voluntarily 
        provided, without identifying individual providers or disclosing 
        or using protected health information or individually 
        identifiable information, by patient safety organizations to 
        improve the integration of health information technology into 
        clinical practice.
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS TO 
                          THEIR ELECTRONIC HEALTH INFORMATION.

    (a) Use of Health Information Exchanges for Patient Access.--Section 
3009 of the Public Health Service Act (42 U.S.C. 300jj-19) is amended by 
adding at the end the following:
    ``(c) Promoting Patient Access to Electronic Health Information 
Through Health Information Exchanges .--
            ``(1) In general.--The Secretary shall use existing 
        authorities to encourage partnerships between health information 
        exchange organizations and networks and health care providers, 
        health plans, and other appropriate entities with the goal of 
        offering patients access to their electronic health information 
        in a single, longitudinal format that is easy to understand, 
        secure, and may be updated automatically.
            ``(2) Education of providers.--The Secretary, in 
        coordination with the Office for Civil Rights of the Department 
        of Health and Human Services, shall--
                    ``(A) educate health care providers on ways of 
                leveraging the capabilities of health information 
                exchanges

[[Page 130 STAT. 1182]]

                (or other relevant platforms) to provide patients with 
                access to their electronic health information;
                    ``(B) clarify misunderstandings by health care 
                providers about using health information exchanges (or 
                other relevant platforms) for patient access to 
                electronic health information; and
                    ``(C) to the extent practicable, educate providers 
                about health information exchanges (or other relevant 
                platforms) that employ some or all of the capabilities 
                described in paragraph (1).
            ``(3) Requirements.--In carrying out paragraph (1), the 
        Secretary, in coordination with the Office for Civil Rights, 
        shall issue guidance to health information exchanges related to 
        best practices to ensure that the electronic health information 
        provided to patients is--
                    ``(A) private and secure;
                    ``(B) accurate;
                    ``(C) verifiable; and
                    ``(D) where a patient's authorization to exchange 
                information is required by law, easily exchanged 
                pursuant to such authorization.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to preempt State laws applicable to patient 
        consent for the access of information through a health 
        information exchange (or other relevant platform) that provide 
        protections to patients that are greater than the protections 
        otherwise provided for under applicable Federal law.

    ``(d) Efforts To Promote Access to Health Information.--The National 
Coordinator and the Office for Civil Rights of the Department of Health 
and Human Services shall jointly promote patient access to health 
information in a manner that would ensure that such information is 
available in a form convenient for the patient, in a reasonable manner, 
without burdening the health care provider involved.
    ``(e) Accessibility of Patient Records.--
            ``(1) Accessibility and updating of information.--
                    ``(A) In general.--The Secretary, in consultation 
                with the National Coordinator, shall promote policies 
                that ensure that a patient's electronic health 
                information is accessible to that patient and the 
                patient's designees, in a manner that facilitates 
                communication with the patient's health care providers 
                and other individuals, including researchers, consistent 
                with such patient's consent.
                    ``(B) Updating education on accessing and exchanging 
                personal health information.--To promote awareness that 
                an individual has a right of access to inspect, obtain a 
                copy of, and transmit to a third party a copy of such 
                individual's protected health information pursuant to 
                the Health Information Portability and Accountability 
                Act, Privacy Rule (subpart E of part 164 of title 45, 
                Code of Federal Regulations), the Director of the Office 
                for Civil Rights, in consultation with the National 
                Coordinator, shall assist individuals and health care 
                providers in understanding a patient's rights to access 
                and protect personal health information under the Health 
                Insurance Portability and Accountability Act of 1996 
                (Public Law 104-191), including providing best practices

[[Page 130 STAT. 1183]]

                for requesting personal health information in a 
                computable format, including using patient portals or 
                third-party applications and common cases when a 
                provider is permitted to exchange and provide access to 
                health information.''.
            ``(2) Certifying usability for patients.--In carrying out 
        certification programs under section 3001(c)(5), the National 
        Coordinator may require that--
                    ``(A) the certification criteria support--
                          ``(i) patient access to their electronic 
                      health information, including in a single 
                      longitudinal format that is easy to understand, 
                      secure, and may be updated automatically;
                          ``(ii) the patient's ability to electronically 
                      communicate patient-reported information (such as 
                      family history and medical history); and
                          ``(iii) patient access to their personal 
                      electronic health information for research at the 
                      option of the patient; and
                    ``(B) the HIT Advisory Committee develop and 
                prioritize standards, implementation specifications, and 
                certification criteria required to help support patient 
                access to electronic health information, patient 
                usability, and support for technologies that offer 
                patients access to their electronic health information 
                in a single, longitudinal format that is easy to 
                understand, secure, and may be updated automatically.''.

    (b) Access to Information in an Electronic Format.--Section 13405(e) 
of the Health Information Technology for Economic and Clinical Health 
Act (42 U.S.C. 17935) is amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) by redesignating paragraph (2) as paragraph (3); and
            (3) by inserting after paragraph (1), the following:
            ``(2) if the individual makes a request to a business 
        associate for access to, or a copy of, protected health 
        information about the individual, or if an individual makes a 
        request to a business associate to grant such access to, or 
        transmit such copy directly to, a person or entity designated by 
        the individual, a business associate may provide the individual 
        with such access or copy, which may be in an electronic form, or 
        grant or transmit such access or copy to such person or entity 
        designated by the individual; and''.
SEC. 4007. GAO STUDY ON PATIENT MATCHING.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States shall conduct 
a study to--
            (1) review the policies and activities of the Office of the 
        National Coordinator for Health Information Technology and other 
        relevant stakeholders, which may include standards development 
        organizations, experts in the technical aspects of health 
        information technology, health information technology 
        developers, providers of health services, health care suppliers, 
        health care payers, health care quality organizations, States, 
        health information technology policy experts, and other 
        appropriate entities, to ensure appropriate patient matching to 
        protect patient privacy and security with respect to electronic

[[Page 130 STAT. 1184]]

        health records and the exchange of electronic health 
        information; and
            (2) survey ongoing efforts related to the policies and 
        activities described in paragraph (1) and the effectiveness of 
        such efforts occurring in the private sector.

    (b) Areas of Concentration.--In conducting the study under 
subsection (a), the Comptroller General shall--
            (1) evaluate current methods used in certified electronic 
        health records for patient matching based on performance related 
        to factors such as--
                    (A) the privacy of patient information;
                    (B) the security of patient information;
                    (C) improving matching rates;
                    (D) reducing matching errors; and
                    (E) reducing duplicate records; and
            (2) determine whether the Office of the National Coordinator 
        for Health Information Technology could improve patient matching 
        by taking steps including--
                    (A) defining additional data elements to assist in 
                patient data matching;
                    (B) agreeing on a required minimum set of elements 
                that need to be collected and exchanged;
                    (C) requiring electronic health records to have the 
                ability to make certain fields required and use specific 
                standards; and
                    (D) other options recommended by the relevant 
                stakeholders consulted pursuant to subsection (a).

    (c) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General shall submit to the appropriate 
committees of Congress a report concerning the findings of the study 
conducted under subsection (a).
SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.

    (a) Study.--
            (1) In general.--The Comptroller General of the United 
        States (referred to in this section as the ``Comptroller 
        General'') shall build on prior Government Accountability Office 
        studies and other literature review and conduct a study to 
        review patient access to their own protected health information, 
        including barriers to such patient access and complications or 
        difficulties providers experience in providing access to 
        patients. In conducting such study, the Comptroller General 
        shall consider the increase in adoption of health information 
        technology and the increasing prevalence of protected health 
        information that is maintained electronically.
            (2) Areas of concentration.--In conducting the review under 
        paragraph (1), the Comptroller General shall consider--
                    (A) instances when covered entities charge 
                individuals, including patients, third parties, and 
                health care providers, for record requests, including 
                records that are requested in an electronic format;
                    (B) examples of the amounts and types of fees 
                charged to individuals for record requests, including 
                instances when the record is requested to be transmitted 
                to a third party;
                    (C) the extent to which covered entities are unable 
                to provide the access requested by individuals in the 
                form

[[Page 130 STAT. 1185]]

                and format requested by the individual, including 
                examples of such instances;
                    (D) instances in which third parties may request 
                protected health information through patients' 
                individual right of access, including instances where 
                such requests may be used to circumvent appropriate fees 
                that may be charged to third parties;
                    (E) opportunities that permit covered entities to 
                charge appropriate fees to third parties for patient 
                records while providing patients with access to their 
                protected health information at low or no cost;
                    (F) the ability of providers to distinguish between 
                requests originating from an individual that require 
                limitation to a cost-based fee and requests originating 
                from third parties that may not be limited to cost-based 
                fees; and
                    (G) other circumstances that may inhibit the ability 
                of providers to provide patients with access to their 
                records, and the ability of patients to gain access to 
                their records.

    (b) Report.--Not later than 18 months after the date of enactment of 
this Act, the Comptroller General shall submit a report to Congress on 
the findings of the study conducted under subsection (a).
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.

    (a) In General.--Section 1862(l)(5) of the Social Security Act (42 
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new 
subparagraph:
                    ``(D) Local coverage determinations.--The Secretary 
                shall require each Medicare administrative contractor 
                that develops a local coverage determination to make 
                available on the Internet website of such contractor and 
                on the Medicare Internet website, at least 45 days 
                before the effective date of such determination, the 
                following information:
                          ``(i) Such determination in its entirety.
                          ``(ii) Where and when the proposed 
                      determination was first made public.
                          ``(iii) Hyperlinks to the proposed 
                      determination and a response to comments submitted 
                      to the contractor with respect to such proposed 
                      determination.
                          ``(iv) A summary of evidence that was 
                      considered by the contractor during the 
                      development of such determination and a list of 
                      the sources of such evidence.
                          ``(v) An explanation of the rationale that 
                      supports such determination.''.

    (b) <<NOTE: 42 USC 1395y note.>>  Effective Date.--The amendment 
made by subsection (a) shall apply with respect to local coverage 
determinations that are proposed or revised on or after the date that is 
180 days after the date of enactment of this Act.
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.

    Section 1808 of the Social Security Act (42 U.S.C. 1395b-9) is 
amended by adding at the end the following new subsection:
    ``(d) Pharmaceutical and Technology Ombudsman.--
            ``(1) In general.--Not later than 12 months after the date 
        of enactment of this paragraph, the Secretary shall provide

[[Page 130 STAT. 1186]]

        for a pharmaceutical and technology ombudsman within the Centers 
        for Medicare & Medicaid Services who shall receive and respond 
        to complaints, grievances, and requests that--
                    ``(A) are from entities that manufacture 
                pharmaceutical, biotechnology, medical device, or 
                diagnostic products that are covered or for which 
                coverage is being sought under this title; and
                    ``(B) are with respect to coverage, coding, or 
                payment under this title for such products.
            ``(2) Application.--The second sentence of subsection (c)(2) 
        shall apply to the ombudsman under subparagraph (A) in the same 
        manner as such sentence applies to the Medicare Beneficiary 
        Ombudsman under subsection (c).''.
SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.

    Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended 
by adding at the end the following new subsection:
    ``(t) Site-of-Service Price Transparency.--
            ``(1) In general.--In order to facilitate price transparency 
        with respect to items and services for which payment may be made 
        either to a hospital outpatient department or to an ambulatory 
        surgical center under this title, the Secretary shall, for 2018 
        and each year thereafter, make available to the public via a 
        searchable Internet website, with respect to an appropriate 
        number of such items and services--
                    ``(A) the estimated payment amount for the item or 
                service under the outpatient department fee schedule 
                under subsection (t) of section 1833 and the ambulatory 
                surgical center payment system under subsection (i) of 
                such section; and
                    ``(B) the estimated amount of beneficiary liability 
                applicable to the item or service.
            ``(2) Calculation of estimated beneficiary liability.--For 
        purposes of paragraph (1)(B), the estimated amount of 
        beneficiary liability, with respect to an item or service, is 
        the amount for such item or service for which an individual who 
        does not have coverage under a Medicare supplemental policy 
        certified under section 1882 or any other supplemental insurance 
        coverage is responsible.
            ``(3) Implementation.--In carrying out this subsection, the 
        Secretary--
                    ``(A) shall include in the notice described in 
                section 1804(a) a notification of the availability of 
                the estimated amounts made available under paragraph 
                (1); and
                    ``(B) may utilize mechanisms in existence on the 
                date of enactment of this subsection, such as the 
                portion of the Internet website of the Centers for 
                Medicare & Medicaid Services on which information 
                comparing physician performance is posted (commonly 
                referred to as the Physician Compare Internet website), 
                to make available such estimated amounts under such 
                paragraph.
            ``(4) Funding.--For purposes of implementing this 
        subsection, the Secretary shall provide for the transfer, from 
        the Federal Supplementary Medical Insurance Trust Fund under 
        section 1841 to the Centers for Medicare & Medicaid Services 
        Program Management Account, of $6,000,000 for fiscal year 2017, 
        to remain available until expended.''.

[[Page 130 STAT. 1187]]

SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.

    (a) Provision of Information by Centers for Medicare & Medicaid 
Services.--Not later than 1 year after the date of enactment of this 
Act, the Administrator of the Centers for Medicare & Medicaid Services 
shall provide to the committees of jurisdiction of the House of 
Representatives and the Senate information on the following:
            (1) The populations of Medicare beneficiaries, such as those 
        who are dually eligible for the Medicare program under title 
        XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and 
        the Medicaid program under title XIX of such Act (42 U.S.C. 1396 
        et seq.) and those with chronic conditions, whose care may be 
        improved most in terms of quality and efficiency by the 
        expansion, in a manner that meets or exceeds the existing in-
        person standard of care under the Medicare program under such 
        title XVIII, of telehealth services under section 1834(m)(4) of 
        such Act (42 U.S.C. 1395m(m)(4)).
            (2) Activities by the Center for Medicare and Medicaid 
        Innovation which examine the use of telehealth services in 
        models, projects, or initiatives funded through section 1115A of 
        such Act (42 U.S.C. 1315a).
            (3) The types of high-volume services (and related 
        diagnoses) under such title XVIII which might be suitable to be 
        furnished using telehealth.
            (4) Barriers that might prevent the expansion of telehealth 
        services under section 1834(m)(4) of the Social Security Act (42 
        U.S.C. 1395m(m)(4)) beyond such services that are in effect as 
        of the date of enactment of this Act.

    (b) Provision of Information by MedPAC.--Not later than March 15, 
2018, the Medicare Payment Advisory Commission established under section 
1805 of the Social Security Act (42 U.S.C. 1395b-6) shall, using 
quantitative and qualitative research methods, provide information to 
the committees of jurisdiction of the House of Representatives and the 
Senate that identifies--
            (1) the telehealth services for which payment can be made, 
        as of the date of enactment of this Act, under the fee-for-
        service program under parts A and B of title XVIII of such Act;
            (2) the telehealth services for which payment can be made, 
        as of such date, under private health insurance plans; and
            (3) with respect to services identified under paragraph (2) 
        but not under paragraph (1), ways in which payment for such 
        services might be incorporated into such fee-for-service program 
        (including any recommendations for ways to accomplish this 
        incorporation).

    (c) Sense of Congress.--It is the sense of Congress that--
            (1) eligible originating sites should be expanded beyond 
        those originating sites described in section 1834(m)(4)(C) of 
        the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
            (2) any expansion of telehealth services under the Medicare 
        program under title XVIII of such Act should--
                    (A) recognize that telemedicine is the delivery of 
                safe, effective, quality health care services, by a 
                health care provider, using technology as the mode of 
                care delivery;
                    (B) meet or exceed the conditions of coverage and 
                payment with respect to the Medicare program if the 
                service

[[Page 130 STAT. 1188]]

                was furnished in person, including standards of care, 
                unless specifically addressed in subsequent legislation; 
                and
                    (C) involve clinically appropriate means to furnish 
                such services.

                            TITLE V--SAVINGS

SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.

    Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)), as amended by section 704(h) of the Comprehensive 
Addiction and Recovery Act of 2016, is amended by striking 
``$140,000,000'' and inserting ``$270,000,000''.
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE MEDICAL 
                          EQUIPMENT.

    Section 1903(i)(27) of the Social Security Act (42 U.S.C. 
1396b(i)(27)) is amended by striking ``January 1, 2019'' and inserting 
``January 1, 2018''.
SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND 
                          OTHER AGREEMENTS.

    (a) In General.--Section 1128A of the Social Security Act (42 U.S.C. 
1320a-7a) is amended by adding at the end the following new subsections:
    ``(o) Any person (including an organization, agency, or other 
entity, but excluding a program beneficiary, as defined in subsection 
(q)(4)) that, with respect to a grant, contract, or other agreement for 
which the Secretary provides funding--
            ``(1) knowingly presents or causes to be presented a 
        specified claim (as defined in subsection (r)) under such grant, 
        contract, or other agreement that the person knows or should 
        know is false or fraudulent;
            ``(2) knowingly makes, uses, or causes to be made or used 
        any false statement, omission, or misrepresentation of a 
        material fact in any application, proposal, bid, progress 
        report, or other document that is required to be submitted in 
        order to directly or indirectly receive or retain funds provided 
        in whole or in part by such Secretary pursuant to such grant, 
        contract, or other agreement;
            ``(3) knowingly makes, uses, or causes to be made or used, a 
        false record or statement material to a false or fraudulent 
        specified claim under such grant, contract, or other agreement;
            ``(4) knowingly makes, uses, or causes to be made or used, a 
        false record or statement material to an obligation (as defined 
        in subsection (s)) to pay or transmit funds or property to such 
        Secretary with respect to such grant, contract, or other 
        agreement, or knowingly conceals or knowingly and improperly 
        avoids or decreases an obligation to pay or transmit funds or 
        property to such Secretary with respect to such grant, contract, 
        or other agreement; or
            ``(5) fails to grant timely access, upon reasonable request 
        (as defined by such Secretary in regulations), to the Inspector 
        General of the Department, for the purpose of audits, 
        investigations, evaluations, or other statutory functions of 
        such Inspector General in matters involving such grants, 
        contracts, or other agreements;

[[Page 130 STAT. 1189]]

shall be subject, in addition to any other penalties that may be 
prescribed by law, to a civil money penalty in cases under paragraph 
(1), of not more than $10,000 for each specified claim; in cases under 
paragraph (2), not more than $50,000 for each false statement, omission, 
or misrepresentation of a material fact; in cases under paragraph (3), 
not more than $50,000 for each false record or statement; in cases under 
paragraph (4), not more than $50,000 for each false record or statement 
or $10,000 for each day that the person knowingly conceals or knowingly 
and improperly avoids or decreases an obligation to pay; or in cases 
under paragraph (5), not more than $15,000 for each day of the failure 
described in such paragraph. In addition, in cases under paragraphs (1) 
and (3), such a person shall be subject to an assessment of not more 
than 3 times the amount claimed in the specified claim described in such 
paragraph in lieu of damages sustained by the United States or a 
specified State agency because of such specified claim, and in cases 
under paragraphs (2) and (4), such a person shall be subject to an 
assessment of not more than 3 times the total amount of the funds 
described in paragraph (2) or (4), respectively (or, in the case of an 
obligation to transmit property to the Secretary described in paragraph 
(4), of the value of the property described in such paragraph) in lieu 
of damages sustained by the United States or a specified State agency 
because of such case. In addition, the Secretary may make a 
determination in the same proceeding to exclude the person from 
participation in the Federal health care programs (as defined in section 
1128B(f)(1)) and to direct the appropriate State agency to exclude the 
person from participation in any State health care program.
    ``(p) The provisions of subsections (c), (d), (g), and (h) shall 
apply to a civil money penalty or assessment under subsection (o) in the 
same manner as such provisions apply to a penalty, assessment, or 
proceeding under subsection (a). In applying subsection (d), each 
reference to a claim under such subsection shall be treated as including 
a reference to a specified claim (as defined in subsection (r)).
    ``(q) For purposes of this subsection and subsections (o) and (p):
            ``(1) The term `Department' means the Department of Health 
        and Human Services.
            ``(2) The term `material' means having a natural tendency to 
        influence, or be capable of influencing, the payment or receipt 
        of money or property.
            ``(3) The term `other agreement' includes a cooperative 
        agreement, scholarship, fellowship, loan, subsidy, payment for a 
        specified use, donation agreement, award, or subaward 
        (regardless of whether one or more of the persons entering into 
        the agreement is a contractor or subcontractor).
            ``(4) The term `program beneficiary' means, in the case of a 
        grant, contract, or other agreement designed to accomplish the 
        objective of awarding or otherwise furnishing benefits or 
        assistance to individuals and for which the Secretary provides 
        funding, an individual who applies for, or who receives, such 
        benefits or assistance from such grant, contract, or other 
        agreement. Such term does not include, with respect to such 
        grant, contract, or other agreement, an officer, employee, or 
        agent of a person or entity that receives such grant or that 
        enters into such contract or other agreement.

[[Page 130 STAT. 1190]]

            ``(5) The term `recipient' includes a subrecipient or 
        subcontractor.
            ``(6) The term `specified State agency' means an agency of a 
        State government established or designated to administer or 
        supervise the administration of a grant, contract, or other 
        agreement funded in whole or in part by the Secretary.

    ``(r) For purposes of this section, the term `specified claim' means 
any application, request, or demand under a grant, contract, or other 
agreement for money or property, whether or not the United States or a 
specified State agency has title to the money or property, that is not a 
claim (as defined in subsection (i)(2)) and that--
            ``(1) is presented or caused to be presented to an officer, 
        employee, or agent of the Department or agency thereof, or of 
        any specified State agency; or
            ``(2) is made to a contractor, grantee, or any other 
        recipient if the money or property is to be spent or used on the 
        Department's behalf or to advance a Department program or 
        interest, and if the Department--
                    ``(A) provides or has provided any portion of the 
                money or property requested or demanded; or
                    ``(B) will reimburse such contractor, grantee, or 
                other recipient for any portion of the money or property 
                which is requested or demanded.

    ``(s) For purposes of subsection (o), the term `obligation' means an 
established duty, whether or not fixed, arising from an express or 
implied contractual, grantor-grantee, or licensor-licensee relationship, 
for a fee-based or similar relationship, from statute or regulation, or 
from the retention of any overpayment.''.
    (b) Conforming Amendments.--Section 1128A of the Social Security Act 
(42 U.S.C. 1320a-7a) is amended--
            (1) in subsection (e), by inserting ``or specified claim'' 
        after ``claim'' in the first sentence; and
            (2) in subsection (f)--
                    (A) in the matter preceding paragraph (1)--
                          (i) by inserting ``or specified claim (as 
                      defined in subsection (r))'' after ``district 
                      where the claim''; and
                          (ii) by inserting ``(or, with respect to a 
                      person described in subsection (o), the person)'' 
                      after ``claimant''; and
                    (B) in the matter following paragraph (4), by 
                inserting ``(or, in the case of a penalty or assessment 
                under subsection (o), by a specified State agency (as 
                defined in subsection (q)(6)),'' after ``or a State 
                agency''.
SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.

    (a) Treatment of Infusion Drugs Furnished Through Durable Medical 
Equipment.--Section 1842(o)(1) of the Social Security Act (42 U.S.C. 
1395u(o)(1)) is amended--
            (1) in subparagraph (C), by inserting ``(and including a 
        drug or biological described in subparagraph (D)(i) furnished on 
        or after January 1, 2017)'' after ``2005''; and
            (2) in subparagraph (D)--
                    (A) by striking ``infusion drugs'' and inserting 
                ``infusion drugs or biologicals'' each place it appears; 
                and
                    (B) in clause (i)--

[[Page 130 STAT. 1191]]

                          (i) by striking ``2004'' and inserting ``2004, 
                      and before January 1, 2017''; and
                          (ii) by striking ``for such drug''.

    (b) Noninclusion of DME Infusion Drugs Under DME Competitive 
Acquisition Programs.--
            (1) In general.--Section 1847(a)(2)(A) of the Social 
        Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
                    (A) by striking ``and excluding'' and inserting ``, 
                excluding''; and
                    (B) by inserting before the period at the end the 
                following: ``, and excluding drugs and biologicals 
                described in section 1842(o)(1)(D)''.
            (2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the 
        Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by 
        striking ``2007'' and inserting ``2007, and before the date of 
        the enactment of the 21st Century Cures Act.''.
SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID 
                          PROVIDERS.

    (a) Increased Oversight and Reporting.--
            (1) State reporting requirements.--Section 1902(kk) of the 
        Social Security Act (42 U.S.C. 1396a(kk)) is amended--
                    (A) by redesignating paragraph (8) as paragraph (9); 
                and
                    (B) by inserting after paragraph (7) the following 
                new paragraph:
            ``(8) Provider terminations.--
                    ``(A) In general.--Beginning on July 1, 2018, in the 
                case of a notification under subsection (a)(41) with 
                respect to a termination for a reason specified in 
                section 455.101 of title 42, Code of Federal Regulations 
                (as in effect on November 1, 2015) or for any other 
                reason specified by the Secretary, of the participation 
                of a provider of services or any other person under the 
                State plan (or under a waiver of the plan), the State, 
                not later than 30 days after the effective date of such 
                termination, submits to the Secretary with respect to 
                any such provider or person, as appropriate--
                          ``(i) the name of such provider or person;
                          ``(ii) the provider type of such provider or 
                      person;
                          ``(iii) the specialty of such provider's or 
                      person's practice;
                          ``(iv) the date of birth, Social Security 
                      number, national provider identifier (if 
                      applicable), Federal taxpayer identification 
                      number, and the State license or certification 
                      number of such provider or person (if applicable);
                          ``(v) the reason for the termination;
                          ``(vi) a copy of the notice of termination 
                      sent to the provider or person;
                          ``(vii) the date on which such termination is 
                      effective, as specified in the notice; and
                          ``(viii) any other information required by the 
                      Secretary.
                    ``(B) Effective date defined.--For purposes of this 
                paragraph, the term `effective date' means, with respect

[[Page 130 STAT. 1192]]

                to a termination described in subparagraph (A), the 
                later of--
                          ``(i) the date on which such termination is 
                      effective, as specified in the notice of such 
                      termination; or
                          ``(ii) the date on which all appeal rights 
                      applicable to such termination have been exhausted 
                      or the timeline for any such appeal has 
                      expired.''.
            (2) Contract requirement for managed care entities.--Section 
        1932(d) of the Social Security Act (42 U.S.C. 1396u-2(d)) is 
        amended by adding at the end the following new paragraph:
            ``(5) Contract requirement for managed care entities.--With 
        respect to any contract with a managed care entity under section 
        1903(m) or 1905(t)(3) (as applicable), no later than July 1, 
        2018, such contract shall include a provision that providers of 
        services or persons terminated (as described in section 
        1902(kk)(8)) from participation under this title, title XVIII, 
        or title XXI shall be terminated from participating under this 
        title as a provider in any network of such entity that serves 
        individuals eligible to receive medical assistance under this 
        title.''.
            (3) Termination notification database.--Section 1902 of the 
        Social Security Act (42 U.S.C. 1396a) is amended by adding at 
        the end the following new subsection:

    ``(ll) Termination Notification Database.--In the case of a provider 
of services or any other person whose participation under this title or 
title XXI is terminated (as described in subsection (kk)(8)), the 
Secretary shall, not later than 30 days after the date on which the 
Secretary is notified of such termination under subsection (a)(41) (as 
applicable), review such termination and, if the Secretary determines 
appropriate, include such termination in any database or similar system 
developed pursuant to section 6401(b)(2) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 1395cc note; Public Law 111-148).''.
            (4) No federal funds for items and services furnished by 
        terminated providers.--Section 1903 of the Social Security Act 
        (42 U.S.C. 1396b) is amended--
                    (A) in subsection (i)(2)--
                          (i) in subparagraph (A), by striking the comma 
                      at the end and inserting a semicolon;
                          (ii) in subparagraph (B), by striking ``or'' 
                      at the end; and
                          (iii) by adding at the end the following new 
                      subparagraph:
                    ``(D) beginning on July 1, 2018, under the plan by 
                any provider of services or person whose participation 
                in the State plan is terminated (as described in section 
                1902(kk)(8)) after the date that is 60 days after the 
                date on which such termination is included in the 
                database or other system under section 1902(ll); or''; 
                and
                    (B) in subsection (m), by inserting after paragraph 
                (2) the following new paragraph:

    ``(3) No payment shall be made under this title to a State with 
respect to expenditures incurred by the State for payment for services 
provided by a managed care entity (as defined under section 1932(a)(1)) 
under the State plan under this title (or under a waiver of the plan) 
unless the State--

[[Page 130 STAT. 1193]]

            ``(A) beginning on July 1, 2018, has a contract with such 
        entity that complies with the requirement specified in section 
        1932(d)(5); and
            ``(B) beginning on January 1, 2018, complies with the 
        requirement specified in section 1932(d)(6)(A).''.
            (5) <<NOTE: 42 USC 1396a note.>>  Development of uniform 
        terminology for reasons for provider termination.--Not later 
        than July 1, 2017, the Secretary of Health and Human Services 
        shall, in consultation with the heads of State agencies 
        administering State Medicaid plans (or waivers of such plans), 
        issue regulations establishing uniform terminology to be used 
        with respect to specifying reasons under subparagraph (A)(v) of 
        paragraph (8) of section 1902(kk) of the Social Security Act (42 
        U.S.C. 1396a(kk)), as added by paragraph (1), for the 
        termination (as described in such paragraph (8)) of the 
        participation of certain providers in the Medicaid program under 
        title XIX of such Act or the Children's Health Insurance Program 
        under title XXI of such Act.
            (6) Conforming amendment.--Section 1902(a)(41) of the Social 
        Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking 
        ``provide that whenever'' and inserting ``provide, in accordance 
        with subsection (kk)(8) (as applicable), that whenever''.

    (b) Increasing Availability of Medicaid Provider Information.--
            (1) FFS provider enrollment.--Section 1902(a) of the Social 
        Security Act (42 U.S.C. 1396a(a)) is amended by inserting after 
        paragraph (77) the following new paragraph:
            ``(78) provide that, not later than January 1, 2017, in the 
        case of a State that pursuant to its State plan or waiver of the 
        plan for medical assistance pays for medical assistance on a 
        fee-for-service basis, the State shall require each provider 
        furnishing items and services to, or ordering, prescribing, 
        referring, or certifying eligibility for, services for 
        individuals eligible to receive medical assistance under such 
        plan to enroll with the State agency and provide to the State 
        agency the provider's identifying information, including the 
        name, specialty, date of birth, Social Security number, national 
        provider identifier (if applicable), Federal taxpayer 
        identification number, and the State license or certification 
        number of the provider (if applicable);''.
            (2) Managed care provider enrollment.--Section 1932(d) of 
        the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by 
        subsection (a)(2), is amended by adding at the end the following 
        new paragraph:
            ``(6) Enrollment of participating providers.--
                    ``(A) In general.--Beginning not later than January 
                1, 2018, a State shall require that, in order to 
                participate as a provider in the network of a managed 
                care entity that provides services to, or orders, 
                prescribes, refers, or certifies eligibility for 
                services for, individuals who are eligible for medical 
                assistance under the State plan under this title (or 
                under a waiver of the plan) and who are enrolled with 
                the entity, the provider is enrolled consistent with 
                section 1902(kk) with the State agency administering the 
                State plan under this title. Such enrollment shall

[[Page 130 STAT. 1194]]

                include providing to the State agency the provider's 
                identifying information, including the name, specialty, 
                date of birth, Social Security number, national provider 
                identifier, Federal taxpayer identification number, and 
                the State license or certification number of the 
                provider.
                    ``(B) Rule of construction.--Nothing in subparagraph 
                (A) shall be construed as requiring a provider described 
                in such subparagraph to provide services to individuals 
                who are not enrolled with a managed care entity under 
                this title.''.

    (c) Coordination With CHIP.--
            (1) In general.--Section 2107(e)(1) of the Social Security 
        Act (42 U.S.C. 1397gg(e)(1)) is amended--
                    (A) by redesignating subparagraphs (B), (C), (D), 
                (E), (F), (G), (H), (I), (J), (K), (L), (M), (N), and 
                (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J), 
                (K), (M), (N), (O), (P), (Q), and (R), respectively;
                    (B) by inserting after subparagraph (A) the 
                following new subparagraphs:
                    ``(B) Section 1902(a)(39) (relating to termination 
                of participation of certain providers).
                    ``(C) Section 1902(a)(78) (relating to enrollment of 
                providers participating in State plans providing medical 
                assistance on a fee-for-service basis).'';
                    (C) by inserting after subparagraph (K) (as 
                redesignated by subparagraph (A)) the following new 
                subparagraph:
                    ``(L) Section 1903(m)(3) (relating to limitation on 
                payment with respect to managed care).''; and
                    (D) in subparagraph (P) (as redesignated by 
                subparagraph (A)), by striking ``(a)(2)(C) and (h)'' and 
                inserting ``(a)(2)(C) (relating to Indian enrollment), 
                (d)(5) (relating to contract requirement for managed 
                care entities), (d)(6) (relating to enrollment of 
                providers participating with a managed care entity), and 
                (h) (relating to special rules with respect to Indian 
                enrollees, Indian health care providers, and Indian 
                managed care entities)''.
            (2) Excluding from medicaid providers excluded from chip.--
        Section 1902(a)(39) of the Social Security Act (42 U.S.C. 
        1396a(a)(39)) is amended by striking ``title XVIII or any other 
        State plan under this title'' and inserting ``title XVIII, any 
        other State plan under this title (or waiver of the plan), or 
        any State child health plan under title XXI (or waiver of the 
        plan) and such termination is included by the Secretary in any 
        database or similar system developed pursuant to section 
        6401(b)(2) of the Patient Protection and Affordable Care Act''.

    (d) <<NOTE: 42 USC 1396a note.>>  Rule of Construction.--Nothing in 
this section shall be construed as changing or limiting the appeal 
rights of providers or the process for appeals of States under the 
Social Security Act.

    (e) OIG Report.--Not later than March 31, 2020, the Inspector 
General of the Department of Health and Human Services shall submit to 
Congress a report on the implementation of the amendments made by this 
section. Such report shall include the following:
            (1) An assessment of the extent to which providers who are 
        included under subsection (ll) of section 1902 of the Social 
        Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3))

[[Page 130 STAT. 1195]]

        in the database or similar system referred to in such subsection 
        are terminated (as described in paragraph (8) of subsection (kk) 
        of such section, as added by subsection (a)(1)) from 
        participation in all State plans under title XIX of such Act (or 
        waivers of such plans).
            (2) Information on the amount of Federal financial 
        participation paid to States under section 1903 of such Act in 
        violation of the limitation on such payment specified in 
        subparagraph (D) of subsection (i)(2) of such section and 
        paragraph (3) of subsection (m) of such section, as added by 
        subsection (a)(4).
            (3) An assessment of the extent to which contracts with 
        managed care entities under title XIX of such Act comply with 
        the requirement specified in paragraph (5) of section 1932(d) of 
        such Act, as added by subsection (a)(2).
            (4) An assessment of the extent to which providers have been 
        enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such Act 
        (42 U.S.C. 1396a(a)(78), 1396u-2(d)(6)(A)) with State agencies 
        administering State plans under title XIX of such Act (or 
        waivers of such plans).
SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER 
                          DIRECTORY.

    (a) In General.--Section 1902(a) of the Social Security Act (42 
U.S.C. 1396a(a)) is amended--
            (1) in paragraph (81), by striking ``and'' at the end;
            (2) in paragraph (82), by striking the period at the end and 
        inserting ``; and''; and
            (3) by inserting after paragraph (82) the following new 
        paragraph:
            ``(83) provide that, not later than January 1, 2017, in the 
        case of a State plan (or waiver of the plan) that provides 
        medical assistance on a fee-for-service basis or through a 
        primary care case-management system described in section 
        1915(b)(1) (other than a primary care case management entity (as 
        defined by the Secretary)), the State shall publish (and update 
        on at least an annual basis) on the public website of the State 
        agency administering the State plan, a directory of the 
        physicians described in subsection (mm) and, at State option, 
        other providers described in such subsection that--
                    ``(A) includes--
                          ``(i) with respect to each such physician or 
                      provider--
                                    ``(I) the name of the physician or 
                                provider;
                                    ``(II) the specialty of the 
                                physician or provider;
                                    ``(III) the address at which the 
                                physician or provider provides services; 
                                and
                                    ``(IV) the telephone number of the 
                                physician or provider; and
                          ``(ii) with respect to any such physician or 
                      provider participating in such a primary care 
                      case-management system, information regarding--
                                    ``(I) whether the physician or 
                                provider is accepting as new patients 
                                individuals who receive medical 
                                assistance under this title; and
                                    ``(II) the physician's or provider's 
                                cultural and linguistic capabilities, 
                                including the languages spoken by the 
                                physician or provider or by the

[[Page 130 STAT. 1196]]

                                skilled medical interpreter providing 
                                interpretation services at the 
                                physician's or provider's office; and
                    ``(B) may include, at State option, with respect to 
                each such physician or provider--
                          ``(i) the Internet website of such physician 
                      or provider; or
                          ``(ii) whether the physician or provider is 
                      accepting as new patients individuals who receive 
                      medical assistance under this title.''.

    (b) Directory Physician or Provider Described.--Section 1902 of the 
Social Security Act (42 U.S.C. 1396a), as amended by section 5005(a)(3), 
is further amended by adding at the end the following new subsection:
    ``(mm) Directory Physician or Provider Described.--A physician or 
provider described in this subsection is--
            ``(1) in the case of a physician or provider of a provider 
        type for which the State agency, as a condition on receiving 
        payment for items and services furnished by the physician or 
        provider to individuals eligible to receive medical assistance 
        under the State plan, requires the enrollment of the physician 
        or provider with the State agency, a physician or a provider 
        that--
                    ``(A) is enrolled with the agency as of the date on 
                which the directory is published or updated (as 
                applicable) under subsection (a)(83); and
                    ``(B) received payment under the State plan in the 
                12-month period preceding such date; and
            ``(2) in the case of a physician or provider of a provider 
        type for which the State agency does not require such 
        enrollment, a physician or provider that received payment under 
        the State plan (or a waiver of the plan) in the 12-month period 
        preceding the date on which the directory is published or 
        updated (as applicable) under subsection (a)(83).''.

    (c) <<NOTE: 42 USC 1396a note.>>  Rule of Construction.--
            (1) In general.--The amendment made by subsection (a) shall 
        not be construed to apply in the case of a State (as defined for 
        purposes of title XIX of the Social Security Act) in which all 
        the individuals enrolled in the State plan under such title (or 
        under a waiver of such plan), other than individuals described 
        in paragraph (2), are enrolled with a medicaid managed care 
        organization (as defined in section 1903(m)(1)(A) of such Act 
        (42 U.S.C. 1396b(m)(1)(A))), including prepaid inpatient health 
        plans and prepaid ambulatory health plans (as defined by the 
        Secretary of Health and Human Services).
            (2) Individuals described.--An individual described in this 
        paragraph is an individual who is an Indian (as defined in 
        section 4 of the Indian Health Care Improvement Act (25 U.S.C. 
        1603)) or an Alaska Native.

    (d) <<NOTE: 42 USC 1396a note.>>  Exception for State Legislation.--
In the case of a State plan under title XIX of the Social Security Act 
(42 U.S.C. 1396 et seq.), which the Secretary of Health and Human 
Services determines requires State legislation in order for the 
respective plan to meet one or more additional requirements imposed by 
amendments made by this section, the respective plan shall not be 
regarded as failing to comply with the requirements of such title

[[Page 130 STAT. 1197]]

solely on the basis of its failure to meet such an additional 
requirement before the first day of the first calendar quarter beginning 
after the close of the first regular session of the State legislature 
that begins after the date of enactment of this Act. For purposes of the 
previous sentence, in the case of a State that has a 2-year legislative 
session, each year of the session shall be considered to be a separate 
regular session of the State legislature.
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.

    (a) In General.--Section 1917(d)(4)(A) of the Social Security Act 
(42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ``the individual,'' 
after ``for the benefit of such individual by''.
    (b) <<NOTE: 42 USC 1396p note.>>  Effective Date.--The amendment 
made by subsection (a) shall apply to trusts established on or after the 
date of the enactment of this Act.
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH 
                          RESPECT TO EXPENDITURES UNDER MEDICAID 
                          FOR AGENTS USED FOR COSMETIC PURPOSES OR 
                          HAIR GROWTH.

    (a) In General.--Section 1903(i)(21) of the Social Security Act (42 
U.S.C. 1396b(i)(21)) is amended by inserting ``section 1927(d)(2)(C) 
(relating to drugs when used for cosmetic purposes or hair growth), 
except where medically necessary, and'' after ``drugs described in''.
    (b) <<NOTE: 42 USC 1396b note.>>  Effective Date.--The amendment 
made by subsection (a) shall apply with respect to calendar quarters 
beginning on or after the date of the enactment of this Act.
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH FUND.

    Section 4002(b) of the Patient Protection and Affordable Care Act 
(42 U.S.C. 300u-11(b)) is amended--
            (1) in paragraph (3), by striking ``$1,250,000,000'' and 
        inserting ``$900,000,000'';
            (2) in paragraph (4), by striking ``$1,500,000,000'' and 
        inserting ``$1,000,000,000''; and
            (3) by striking paragraph (5) and inserting the following:
            ``(5) for fiscal year 2022, $1,500,000,000;
            ``(6) for fiscal year 2023, $1,000,000,000;
            ``(7) for fiscal year 2024, $1,700,000,000; and
            ``(8) for fiscal year 2025 and each fiscal year thereafter, 
        $2,000,000,000.''.
SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.

    (a) <<NOTE: 42 USC 6241 note.>>  Drawdown and Sale.--
            (1) In general.--Notwithstanding section 161 of the Energy 
        Policy and Conservation Act (42 U.S.C. 6241), except as provided 
        in subsections (b) and (c), the Secretary of Energy shall 
        drawdown and sell from the Strategic Petroleum Reserve--
                    (A) 10,000,000 barrels of crude oil during fiscal 
                year 2017;
                    (B) 9,000,000 barrels of crude oil during fiscal 
                year 2018; and
                    (C) 6,000,000 barrels of crude oil during fiscal 
                year 2019.

[[Page 130 STAT. 1198]]

            (2) Deposit of amounts received from sale.--Amounts received 
        from a sale under paragraph (1) shall be deposited in the 
        general fund of the Treasury during the fiscal year in which the 
        sale occurs.

    (b) <<NOTE: 42 USC 6241 note.>>  Emergency Protection.--The 
Secretary shall not draw down and sell crude oil under this section in 
quantities that would limit the authority to sell petroleum products 
under section 161(h) of the Energy Policy and Conservation Act (42 
U.S.C. 6241(h)) in the full quantity authorized by that subsection.

    (c) Strategic Petroleum Drawdown Limitations.--Subparagraphs (C) and 
(D) of section 161(h)(2) of the Energy Policy and Conservation Act (42 
U.S.C. 6241(h)(2)(C) and (D)) are both amended by striking 
``500,000,000'' and inserting ``450,000,000''.
SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.

    Of the unobligated amounts available under section 1323(c)(1) of the 
Patient Protection and Affordable Care Act (42 U.S.C. 18043(c)(1)), 
$464,000,000 is rescinded immediately upon the date of the enactment of 
this Act.
SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.

    (a) In General.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (EE);
                    (B) by inserting ``and'' at the end of subparagraph 
                (FF); and
                    (C) by inserting at the end the following new 
                subparagraph:
            ``(GG) home infusion therapy (as defined in subsection 
        (iii)(1));''; and
            (2) by adding at the end the following new subsection:

    ``(iii) Home Infusion Therapy.--(1) The term `home infusion therapy' 
means the items and services described in paragraph (2) furnished by a 
qualified home infusion therapy supplier (as defined in paragraph 
(3)(D)) which are furnished in the individual's home (as defined in 
paragraph (3)(B)) to an individual--
            ``(A) who is under the care of an applicable provider (as 
        defined in paragraph (3)(A)); and
            ``(B) with respect to whom a plan prescribing the type, 
        amount, and duration of infusion therapy services that are to be 
        furnished such individual has been established by a physician 
        (as defined in subsection (r)(1)) and is periodically reviewed 
        by a physician (as so defined) in coordination with the 
        furnishing of home infusion drugs (as defined in paragraph 
        (3)(C)) under part B.

    ``(2) The items and services described in this paragraph are the 
following:
            ``(A) Professional services, including nursing services, 
        furnished in accordance with the plan.
            ``(B) Training and education (not otherwise paid for as 
        durable medical equipment (as defined in subsection (n)), remote 
        monitoring, and monitoring services for the provision of home 
        infusion therapy and home infusion drugs furnished by a 
        qualified home infusion therapy supplier.

    ``(3) For purposes of this subsection:
            ``(A) The term `applicable provider' means--
                    ``(i) a physician;

[[Page 130 STAT. 1199]]

                    ``(ii) a nurse practitioner; and
                    ``(iii) a physician assistant.
            ``(B) The term `home' means a place of residence used as the 
        home of an individual (as defined for purposes of subsection 
        (n)).
            ``(C) The term `home infusion drug' means a parenteral drug 
        or biological administered intravenously, or subcutaneously for 
        an administration period of 15 minutes or more, in the home of 
        an individual through a pump that is an item of durable medical 
        equipment (as defined in subsection (n)). Such term does not 
        include the following:
                    ``(i) Insulin pump systems.
                    ``(ii) A self-administered drug or biological on a 
                self-administered drug exclusion list.
            ``(D)(i) The term `qualified home infusion therapy supplier' 
        means a pharmacy, physician, or other provider of services or 
        supplier licensed by the State in which the pharmacy, physician, 
        or provider or services or supplier furnishes items or services 
        and that--
                    ``(I) furnishes infusion therapy to individuals with 
                acute or chronic conditions requiring administration of 
                home infusion drugs;
                    ``(II) ensures the safe and effective provision and 
                administration of home infusion therapy on a 7-day-a-
                week, 24-hour-a-day basis;
                    ``(III) is accredited by an organization designated 
                by the Secretary pursuant to section 1834(u)(5); and
                    ``(IV) meets such other requirements as the 
                Secretary determines appropriate, taking into account 
                the standards of care for home infusion therapy 
                established by Medicare Advantage plans under part C and 
                in the private sector.
            ``(ii) A qualified home infusion therapy supplier may 
        subcontract with a pharmacy, physician, provider of services, or 
        supplier to meet the requirements of this subparagraph.''.

    (b) Payment and Related Requirements for Home Infusion Therapy.--
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by 
section 4011, is further amended by adding at the end the following new 
subsection:
    ``(u) Payment and Related Requirements for Home Infusion Therapy.--
            ``(1) Payment.--
                    ``(A) Single payment.--
                          ``(i) In general.--Subject to clause (iii) and 
                      subparagraphs (B) and (C), the Secretary shall 
                      implement a payment system under which a single 
                      payment is made under this title to a qualified 
                      home infusion therapy supplier for items and 
                      services described in subparagraphs (A) and (B) of 
                      section 1861(iii)(2)) furnished by a qualified 
                      home infusion therapy supplier (as defined in 
                      section 1861(iii)(3)(D)) in coordination with the 
                      furnishing of home infusion drugs (as defined in 
                      section 1861(iii)(3)(C)) under this part.
                          ``(ii) Unit of single payment.--A unit of 
                      single payment under the payment system 
                      implemented under this subparagraph is for each 
                      infusion drug administration calendar day in the 
                      individual's home. The Secretary shall, as 
                      appropriate, establish single

[[Page 130 STAT. 1200]]

                      payment amounts for types of infusion therapy, 
                      including to take into account variation in 
                      utilization of nursing services by therapy type.
                          ``(iii) Limitation.--The single payment amount 
                      determined under this subparagraph after 
                      application of subparagraph (B) and paragraph (3) 
                      shall not exceed the amount determined under the 
                      fee schedule under section 1848 for infusion 
                      therapy services furnished in a calendar day if 
                      furnished in a physician office setting, except 
                      such single payment shall not reflect more than 5 
                      hours of infusion for a particular therapy in a 
                      calendar day.
                    ``(B) Required adjustments.--The Secretary shall 
                adjust the single payment amount determined under 
                subparagraph (A) for home infusion therapy services 
                under section 1861(iii)(1) to reflect other factors such 
                as--
                          ``(i) a geographic wage index and other costs 
                      that may vary by region; and
                          ``(ii) patient acuity and complexity of drug 
                      administration.
                    ``(C) Discretionary adjustments.--
                          ``(i) In general.--Subject to clause (ii), the 
                      Secretary may adjust the single payment amount 
                      determined under subparagraph (A) (after 
                      application of subparagraph (B)) to reflect 
                      outlier situations and other factors as the 
                      Secretary determines appropriate.
                          ``(ii) Requirement of budget neutrality.--Any 
                      adjustment under this subparagraph shall be made 
                      in a budget neutral manner.
            ``(2) Considerations.--In developing the payment system 
        under this subsection, the Secretary may consider the costs of 
        furnishing infusion therapy in the home, consult with home 
        infusion therapy suppliers, consider payment amounts for similar 
        items and services under this part and part A, and consider 
        payment amounts established by Medicare Advantage plans under 
        part C and in the private insurance market for home infusion 
        therapy (including average per treatment day payment amounts by 
        type of home infusion therapy).
            ``(3) Annual updates.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Secretary shall update the single payment amount under 
                this subsection from year to year beginning in 2022 by 
                increasing the single payment amount from the prior year 
                by the percentage increase in the Consumer Price Index 
                for all urban consumers (United States city average) for 
                the 12-month period ending with June of the preceding 
                year.
                    ``(B) Adjustment.--For each year, the Secretary 
                shall reduce the percentage increase described in 
                subparagraph (A) by the productivity adjustment 
                described in section 1886(b)(3)(B)(xi)(II). The 
                application of the preceding sentence may result in a 
                percentage being less than 0.0 for a year, and may 
                result in payment being less than such payment rates for 
                the preceding year.
            ``(4) Authority to apply prior authorization.--The Secretary 
        may, as determined appropriate by the Secretary, apply

[[Page 130 STAT. 1201]]

        prior authorization for home infusion therapy services under 
        section 1861(iii)(1).
            ``(5) Accreditation of qualified home infusion therapy 
        suppliers.--
                    ``(A) Factors for designation of accreditation 
                organizations.--The Secretary shall consider the 
                following factors in designating accreditation 
                organizations under subparagraph (B) and in reviewing 
                and modifying the list of accreditation organizations 
                designated pursuant to subparagraph (C):
                          ``(i) The ability of the organization to 
                      conduct timely reviews of accreditation 
                      applications.
                          ``(ii) The ability of the organization to take 
                      into account the capacities of suppliers located 
                      in a rural area (as defined in section 
                      1886(d)(2)(D)).
                          ``(iii) Whether the organization has 
                      established reasonable fees to be charged to 
                      suppliers applying for accreditation.
                          ``(iv) Such other factors as the Secretary 
                      determines appropriate.
                    ``(B) Designation.--Not later than January 1, 2021, 
                the Secretary shall designate organizations to accredit 
                suppliers furnishing home infusion therapy. The list of 
                accreditation organizations so designated may be 
                modified pursuant to subparagraph (C).
                    ``(C) Review and modification of list of 
                accreditation organizations.--
                          ``(i) In general.--The Secretary shall review 
                      the list of accreditation organizations designated 
                      under subparagraph (B) taking into account the 
                      factors under subparagraph (A). Taking into 
                      account the results of such review, the Secretary 
                      may, by regulation, modify the list of 
                      accreditation organizations designated under 
                      subparagraph (B).
                          ``(ii) Special rule for accreditations done 
                      prior to removal from list of designated 
                      accreditation organizations.--In the case where 
                      the Secretary removes an organization from the 
                      list of accreditation organizations designated 
                      under subparagraph (B), any supplier that is 
                      accredited by the organization during the period 
                      beginning on the date on which the organization is 
                      designated as an accreditation organization under 
                      subparagraph (B) and ending on the date on which 
                      the organization is removed from such list shall 
                      be considered to have been accredited by an 
                      organization designated by the Secretary under 
                      subparagraph (B) for the remaining period such 
                      accreditation is in effect.
                    ``(D) Rule for accreditations made prior to 
                designation.--In the case of a supplier that is 
                accredited before January 1, 2021, by an accreditation 
                organization designated by the Secretary under 
                subparagraph (B) as of January 1, 2019, such supplier 
                shall be considered to have been accredited by an 
                organization designated by the Secretary under such 
                paragraph as of January 1, 2023, for the remaining 
                period such accreditation is in effect.

[[Page 130 STAT. 1202]]

            ``(6) Notification of infusion therapy options available 
        prior to furnishing home infusion therapy.--Prior to the 
        furnishing of home infusion therapy to an individual, the 
        physician who establishes the plan described in section 
        1861(iii)(1) for the individual shall provide notification (in a 
        form, manner, and frequency determined appropriate by the 
        Secretary) of the options available (such as home, physician's 
        office, hospital outpatient department) for the furnishing of 
        infusion therapy under this part.''.

    (c) Conforming Amendments.--
            (1) Payment reference.--Section 1833(a)(1) of the Social 
        Security Act (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) by striking ``and'' before ``(AA)''; and
                    (B) by inserting before the semicolon at the end the 
                following: ``, and (BB) with respect to home infusion 
                therapy, the amount paid shall be an amount equal to 80 
                percent of the lesser of the actual charge for the 
                services or the amount determined under section 
                1834(u)''.
            (2) Direct payment.--The first sentence of section 
        1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is 
        amended--
                    (A) by striking ``and'' before ``(H)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (I) in the case of home infusion 
                therapy, payment shall be made to the qualified home 
                infusion therapy supplier''.
            (3) Exclusion from home health services.--Section 1861(m) of 
        the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the 
        first sentence, by inserting the following before the period at 
        the end: ``and home infusion therapy (as defined in subsection 
        (iii)(i))''.

    (d) <<NOTE: 42 USC 13951 note.>>  Effective Date.--The amendments 
made by this section shall apply to items and services furnished on or 
after January 1, 2021.

DIVISION <<NOTE: Helping Families in Mental Health Crisis Reform Act of 
2016.>>  B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
SEC. 6000. <<NOTE: 42 USC 201 note.>>  SHORT TITLE.

    This division may be cited as the ``Helping Families in Mental 
Health Crisis Reform Act of 2016''.

          TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY

                         Subtitle A--Leadership

SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE 
                          USE.

    (a) Assistant Secretary.--Section 501(c) of the Public Health 
Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
    ``(c) Assistant Secretary and Deputy Assistant Secretary.--

[[Page 130 STAT. 1203]]

            ``(1) Assistant secretary.--The Administration shall be 
        headed by an official to be known as the Assistant Secretary for 
        Mental Health and Substance Use (hereinafter in this title 
        referred to as the `Assistant Secretary') who shall be appointed 
        by the President, by and with the advice and consent of the 
        Senate.
            ``(2) Deputy assistant secretary.--The Assistant Secretary, 
        with the approval of the Secretary, may appoint a Deputy 
        Assistant Secretary and may employ and prescribe the functions 
        of such officers and employees, including attorneys, as are 
        necessary to administer the activities to be carried out through 
        the Administration.''.

    (b) <<NOTE: 42 USC 290aa note.>>  Transfer of Authorities.--The 
Secretary of Health and Human Services shall delegate to the Assistant 
Secretary for Mental Health and Substance Use all duties and authorities 
that--
            (1) as of the day before the date of enactment of this Act, 
        were vested in the Administrator of the Substance Abuse and 
        Mental Health Services Administration; and
            (2) are not terminated by this Act.

    (c) Conforming Amendments.--Title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.), as amended by the previous provisions of this 
section, is further amended--
            (1) by striking ``Administrator of the Substance Abuse and 
        Mental Health Services Administration'' each place it appears 
        and inserting ``Assistant Secretary for Mental Health and 
        Substance Use''; and
            (2) by striking ``Administrator'' or ``Administrator'' each 
        place it appears (including in any headings) and inserting 
        ``Assistant Secretary'' or ``Assistant Secretary'', 
        respectively, except where the term ``Administrator'' appears--
                    (A) in each of subsections (e) and (f) of section 
                501 of such Act (42 U.S.C. 290aa), including the 
                headings of such subsections, within the term 
                ``Associate Administrator'';
                    (B) in section 507(b)(6) of such Act (42 U.S.C. 
                290bb(b)(6)), within the term ``Administrator of the 
                Health Resources and Services Administration'';
                    (C) in section 507(b)(6) of such Act (42 U.S.C. 
                290bb(b)(6)), within the term ``Administrator of the 
                Centers for Medicare & Medicaid Services'';
                    (D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 
                290bb-25b(c)(1)(B)), within the term ``Administrator of 
                the National Highway Traffic Safety Administration''; or
                    (E) in each of sections 519B(c)(1)(B), 520C(a), and 
                520D(a) of such Act (42 U.S.C. 290bb-25b(c)(1)(B), 
                290bb-34(a), 290bb-35(a)), within the term 
                ``Administrator of the Office of Juvenile Justice and 
                Delinquency Prevention''.

    (d) <<NOTE: 42 USC 290aa note.>>  References.--After executing 
subsections (a), (b), and (c), any reference in statute, regulation, or 
guidance to the Administrator of the Substance Abuse and Mental Health 
Services Administration shall be construed to be a reference to the 
Assistant Secretary for Mental Health and Substance Use.

[[Page 130 STAT. 1204]]

SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND 
                          MENTAL HEALTH SERVICES ADMINISTRATION.

    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by section 6001, is further amended--
            (1) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``Agencies'' and inserting ``Centers''; and
                    (B) in the matter preceding paragraph (1), by 
                striking ``entities'' and inserting ``Centers'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                          (i) by striking ``agencies'' each place the 
                      term appears and inserting ``Centers''; and
                          (ii) by striking ``such agency'' and inserting 
                      ``such Center'';
                    (B) in paragraph (2)--
                          (i) by striking ``agencies'' and inserting 
                      ``Centers'';
                          (ii) by striking ``with respect to substance 
                      abuse'' and inserting ``with respect to substance 
                      use disorders''; and
                          (iii) by striking ``and individuals who are 
                      substance abusers'' and inserting ``and 
                      individuals with substance use disorders'';
                    (C) in paragraph (5), by striking ``substance 
                abuse'' and inserting ``substance use disorder'';
                    (D) in paragraph (6)--
                          (i) by striking ``the Centers for Disease 
                      Control'' and inserting ``the Centers for Disease 
                      Control and Prevention,'';
                          (ii) by striking ``Administration develop'' 
                      and inserting ``Administration, develop'';
                          (iii) by striking ``HIV or tuberculosis among 
                      substance abusers and individuals with mental 
                      illness'' and inserting ``HIV, hepatitis, 
                      tuberculosis, and other communicable diseases 
                      among individuals with mental or substance use 
                      disorders,''; and
                          (iv) by striking ``illnesses'' at the end and 
                      inserting ``diseases or disorders'';
                    (E) in paragraph (7), by striking ``abuse utilizing 
                anti-addiction medications, including methadone'' and 
                inserting ``use disorders, including services that 
                utilize drugs or devices approved or cleared by the Food 
                and Drug Administration for the treatment of substance 
                use disorders'';
                    (F) in paragraph (8)--
                          (i) by striking ``Agency for Health Care 
                      Policy Research'' and inserting ``Agency for 
                      Healthcare Research and Quality''; and
                          (ii) by striking ``treatment and prevention'' 
                      and inserting ``prevention and treatment'';
                    (G) in paragraph (9)--
                          (i) by inserting ``and maintenance'' after 
                      ``development'';
                          (ii) by striking ``Agency for Health Care 
                      Policy Research'' and inserting ``Agency for 
                      Healthcare Research and Quality''; and

[[Page 130 STAT. 1205]]

                          (iii) by striking ``treatment and prevention 
                      services'' and inserting ``prevention, treatment, 
                      and recovery support services and are 
                      appropriately incorporated into programs carried 
                      out by the Administration'';
                    (H) in paragraph (10), by striking ``abuse'' and 
                inserting ``use disorder'';
                    (I) by striking paragraph (11) and inserting the 
                following:
            ``(11) work with relevant agencies of the Department of 
        Health and Human Services on integrating mental health promotion 
        and substance use disorder prevention with general health 
        promotion and disease prevention and integrating mental and 
        substance use disorders treatment services with physical health 
        treatment services;'';
                    (J) in paragraph (13)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``this title, assure that'' and 
                      inserting ``this title or part B of title XIX, or 
                      grant programs otherwise funded by the 
                      Administration'';
                          (ii) in subparagraph (A)--
                                    (I) by inserting ``require that'' 
                                before ``all grants''; and
                                    (II) by striking ``and'' at the end;
                          (iii) by redesignating subparagraph (B) as 
                      subparagraph (C);
                          (iv) by inserting after subparagraph (A) the 
                      following:
                    ``(B) ensure that the director of each Center of the 
                Administration consistently documents the application of 
                criteria when awarding grants and the ongoing oversight 
                of grantees after such grants are awarded;'';
                          (v) in subparagraph (C), as so redesignated--
                                    (I) by inserting ``require that'' 
                                before ``all grants''; and
                                    (II) in clause (ii), by inserting 
                                ``and'' after the semicolon at the end; 
                                and
                          (vi) by adding at the end the following:
                    ``(D) inform a State when any funds are awarded 
                through such a grant to any entity within such State;'';
                    (K) in paragraph (16), by striking ``abuse and 
                mental health information'' and inserting ``use disorder 
                information, including evidence-based and promising best 
                practices for prevention, treatment, and recovery 
                support services for individuals with mental and 
                substance use disorders,'';
                    (L) in paragraph (17)--
                          (i) by striking ``substance abuse'' and 
                      inserting ``substance use disorder''; and
                          (ii) by striking ``and'' at the end;
                    (M) in paragraph (18), by striking the period and 
                inserting a semicolon; and
                    (N) by adding at the end the following:
            ``(19) consult with State, local, and tribal governments, 
        nongovernmental entities, and individuals with mental illness, 
        particularly adults with a serious mental illness, children with 
        a serious emotional disturbance, and the family members of

[[Page 130 STAT. 1206]]

        such adults and children, with respect to improving community-
        based and other mental health services;
            ``(20) collaborate with the Secretary of Defense and the 
        Secretary of Veterans Affairs to improve the provision of mental 
        and substance use disorder services provided by the Department 
        of Defense and the Department of Veterans Affairs to members of 
        the Armed Forces, veterans, and the family members of such 
        members and veterans, including through the provision of 
        services using the telehealth capabilities of the Department of 
        Defense and the Department of Veterans Affairs;
            ``(21) collaborate with the heads of relevant Federal 
        agencies and departments, States, communities, and 
        nongovernmental experts to improve mental and substance use 
        disorders services for chronically homeless individuals, 
        including by designing strategies to provide such services in 
        supportive housing;
            ``(22) work with States and other stakeholders to develop 
        and support activities to recruit and retain a workforce 
        addressing mental and substance use disorders;
            ``(23) collaborate with the Attorney General and 
        representatives of the criminal justice system to improve mental 
        and substance use disorders services for individuals who have 
        been arrested or incarcerated;
            ``(24) after providing an opportunity for public input, set 
        standards for grant programs under this title for mental and 
        substance use disorders services and prevention programs, which 
        standards may address--
                    ``(A) the capacity of the grantee to implement the 
                award;
                    ``(B) requirements for the description of the 
                program implementation approach;
                    ``(C) the extent to which the grant plan submitted 
                by the grantee as part of its application must explain 
                how the grantee will reach the population of focus and 
                provide a statement of need, which may include 
                information on how the grantee will increase access to 
                services and a description of measurable objectives for 
                improving outcomes;
                    ``(D) the extent to which the grantee must collect 
                and report on required performance measures; and
                    ``(E) the extent to which the grantee is proposing 
                to use evidence-based practices; and
            ``(25) advance, through existing programs, the use of 
        performance metrics, including those based on the 
        recommendations on performance metrics from the Assistant 
        Secretary for Planning and Evaluation under section 6021(d) of 
        the Helping Families in Mental Health Crisis Reform Act of 
        2016.''; and
            (3) in subsection (m), by adding at the end the following:
            ``(4) Emergency response.--Amounts made available for 
        carrying out this subsection shall remain available through the 
        end of the fiscal year following the fiscal year for which such 
        amounts are appropriated.''.
SEC. 6003. CHIEF MEDICAL OFFICER.

    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by sections 6001 and 6002, is further amended--

[[Page 130 STAT. 1207]]

            (1) by redesignating subsections (g) through (j) and 
        subsections (k) through (o) as subsections (h) through (k) and 
        subsections (m) through (q), respectively;
            (2) in subsection (e)(3)(C), by striking ``subsection (k)'' 
        and inserting ``subsection (m)'';
            (3) in subsection (f)(2)(C)(iii), by striking ``subsection 
        (k)'' and inserting ``subsection (m)''; and
            (4) by inserting after subsection (f) the following:

    ``(g) Chief Medical Officer.--
            ``(1) In general.--The Assistant Secretary, with the 
        approval of the Secretary, shall appoint a Chief Medical Officer 
        to serve within the Administration.
            ``(2) Eligible candidates.--The Assistant Secretary shall 
        select the Chief Medical Officer from among individuals who--
                    ``(A) have a doctoral degree in medicine or 
                osteopathic medicine;
                    ``(B) have experience in the provision of mental or 
                substance use disorder services;
                    ``(C) have experience working with mental or 
                substance use disorder programs;
                    ``(D) have an understanding of biological, 
                psychosocial, and pharmaceutical treatments of mental or 
                substance use disorders; and
                    ``(E) are licensed to practice medicine in one or 
                more States.
            ``(3) Duties.--The Chief Medical Officer shall--
                    ``(A) serve as a liaison between the Administration 
                and providers of mental and substance use disorders 
                prevention, treatment, and recovery services;
                    ``(B) assist the Assistant Secretary in the 
                evaluation, organization, integration, and coordination 
                of programs operated by the Administration;
                    ``(C) promote evidence-based and promising best 
                practices, including culturally and linguistically 
                appropriate practices, as appropriate, for the 
                prevention and treatment of, and recovery from, mental 
                and substance use disorders, including serious mental 
                illness and serious emotional disturbances;
                    ``(D) participate in regular strategic planning with 
                the Administration;
                    ``(E) coordinate with the Assistant Secretary for 
                Planning and Evaluation to assess the use of performance 
                metrics to evaluate activities within the Administration 
                related to mental and substance use disorders; and
                    ``(F) coordinate with the Assistant Secretary to 
                ensure mental and substance use disorders grant programs 
                within the Administration consistently utilize 
                appropriate performance metrics and evaluation 
                designs.''.
SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.

    Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), as 
amended by section 6001(c), is amended--
            (1) by striking the section designation and heading and 
        inserting the following:

[[Page 130 STAT. 1208]]

``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND 
                        QUALITY.'';
            (2) by redesignating subsections (a) through (d) as 
        subsections (b) through (e), respectively;
            (3) before subsection (b), as redesignated by paragraph (2), 
        by inserting the following:

    ``(a) In General.--The Assistant Secretary shall maintain within the 
Administration a Center for Behavioral Health Statistics and Quality (in 
this section referred to as the `Center'). The Center shall be headed by 
a Director (in this section referred to as the `Director') appointed by 
the Secretary from among individuals with extensive experience and 
academic qualifications in research and analysis in behavioral health 
care or related fields.'';
            (4) in subsection (b), as redesignated by paragraph (2)--
                    (A) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively;
                    (B) by striking ``The Secretary, acting'' and all 
                that follows through ``year on--'' and inserting ``The 
                Director shall--
            ``(1) coordinate the Administration's integrated data 
        strategy, including by collecting data each year on--'';
                    (C) in the subparagraph (B), as redesignated by 
                subparagraph (A), by striking ``Assistant Secretary'' 
                and inserting ``Director''; and
                    (D) by adding at the end the following new 
                paragraphs:
            ``(2) provide statistical and analytical support for 
        activities of the Administration;
            ``(3) recommend a core set of performance metrics to 
        evaluate activities supported by the Administration; and
            ``(4) coordinate with the Assistant Secretary, the Assistant 
        Secretary for Planning and Evaluation, and the Chief Medical 
        Officer appointed under section 501(g), as appropriate, to 
        improve the quality of services provided by programs of the 
        Administration and the evaluation of activities carried out by 
        the Administration.''.
            (5) in subsection (c), as so redesignated--
                    (A) by striking ``With respect to the activities'' 
                and inserting ``Mental Health.--With respect to the 
                activities'';
                    (B) by striking ``Assistant Secretary'' each place 
                it appears and inserting ``Director''; and
                    (C) by striking ``subsection (a)'' and inserting 
                ``subsection (b)(1)'';
            (6) in subsection (d), as so redesignated--
                    (A) by striking the subsection designation and all 
                that follows through ``With respect to the activities'' 
                and inserting the following:

    ``(d) Substance Abuse.--
            ``(1) In general.--With respect to the activities'';
                    (B) in paragraph (1)--
                          (i) in the matter before subparagraph (A)--
                                    (I) by striking ``subsection (a)'' 
                                and inserting ``subsection (b)(1)''; and
                                    (II) by striking ``Assistant 
                                Secretary'' each place it appears and 
                                inserting ``Director''; and

[[Page 130 STAT. 1209]]

                          (ii) in subparagraph (B), by inserting ``in 
                      coordination with the Centers for Disease Control 
                      and Prevention'' before the semicolon at the end; 
                      and
                    (C) in paragraph (2), by striking ``Annual surveys'' 
                and inserting ``Annual surveys; public availability of 
                data.--Annual surveys''; and
            (7) in subsection (e), as so redesignated--
                    (A) by striking ``After consultation'' and inserting 
                ``Consultation.--After consultation''; and
                    (B) by striking ``Assistant Secretary shall 
                develop'' and inserting ``Assistant Secretary shall use 
                existing standards and best practices to develop''.
SEC. 6005. STRATEGIC PLAN.

    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by sections 6001 through 6003, is further amended by inserting 
after subsection (k), as redesignated by section 6003, the following:
    ``(l) Strategic Plan.--
            ``(1) In general.--Not later than September 30, 2018, and 
        every 4 years thereafter, the Assistant Secretary shall develop 
        and carry out a strategic plan in accordance with this 
        subsection for the planning and operation of activities carried 
        out by the Administration, including evidence-based programs.
            ``(2) Coordination.--In developing and carrying out the 
        strategic plan under this subsection, the Assistant Secretary 
        shall take into consideration the findings and recommendations 
        of the Assistant Secretary for Planning and Evaluation under 
        section 6021(d) of the Helping Families in Mental Health Crisis 
        Reform Act of 2016 and the report of the Interdepartmental 
        Serious Mental Illness Coordinating Committee under section 6031 
        of such Act.
            ``(3) Publication of plan.--Not later than September 30, 
        2018, and every 4 years thereafter, the Assistant Secretary 
        shall--
                    ``(A) submit the strategic plan developed under 
                paragraph (1) to the Committee on Energy and Commerce 
                and the Committee on Appropriations of the House of 
                Representatives and the Committee on Health, Education, 
                Labor, and Pensions and the Committee on Appropriations 
                of the Senate; and
                    ``(B) post such plan on the Internet website of the 
                Administration.
            ``(4) Contents.--The strategic plan developed under 
        paragraph (1) shall--
                    ``(A) identify strategic priorities, goals, and 
                measurable objectives for mental and substance use 
                disorders activities and programs operated and supported 
                by the Administration, including priorities to prevent 
                or eliminate the burden of mental and substance use 
                disorders;
                    ``(B) identify ways to improve the quality of 
                services for individuals with mental and substance use 
                disorders, and to reduce homelessness, arrest, 
                incarceration, violence, including self-directed 
                violence, and unnecessary hospitalization of individuals 
                with a mental or substance use disorder, including 
                adults with a serious mental illness or children with a 
                serious emotional disturbance;

[[Page 130 STAT. 1210]]

                    ``(C) ensure that programs provide, as appropriate, 
                access to effective and evidence-based prevention, 
                diagnosis, intervention, treatment, and recovery 
                services, including culturally and linguistically 
                appropriate services, as appropriate, for individuals 
                with a mental or substance use disorder;
                    ``(D) identify opportunities to collaborate with the 
                Health Resources and Services Administration to develop 
                or improve--
                          ``(i) initiatives to encourage individuals to 
                      pursue careers (especially in rural and 
                      underserved areas and with rural and underserved 
                      populations) as psychiatrists, including child and 
                      adolescent psychiatrists, psychologists, 
                      psychiatric nurse practitioners, physician 
                      assistants, clinical social workers, certified 
                      peer support specialists, licensed professional 
                      counselors, or other licensed or certified mental 
                      health or substance use disorder professionals, 
                      including such professionals specializing in the 
                      diagnosis, evaluation, or treatment of adults with 
                      a serious mental illness or children with a 
                      serious emotional disturbance; and
                          ``(ii) a strategy to improve the recruitment, 
                      training, and retention of a workforce for the 
                      treatment of individuals with mental or substance 
                      use disorders, or co-occurring disorders;
                    ``(E) identify opportunities to improve 
                collaboration with States, local governments, 
                communities, and Indian tribes and tribal organizations 
                (as such terms are defined in section 4 of the Indian 
                Self-Determination and Education Assistance Act); and
                    ``(F) specify a strategy to disseminate evidence-
                based and promising best practices related to 
                prevention, diagnosis, early intervention, treatment, 
                and recovery services related to mental illness, 
                particularly for adults with a serious mental illness 
                and children with a serious emotional disturbance, and 
                for individuals with a substance use disorder.''.
SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.

    (a) In General.--Section 501 of the Public Health Service Act (42 
U.S.C. 290aa), as so amended, is further amended by amending subsection 
(m), as redesignated by section 6003, to read as follows:
    ``(m) Biennial Report Concerning Activities and Progress.--Not later 
than September 30, 2020, and every 2 years thereafter, the Assistant 
Secretary shall prepare and submit to the Committee on Energy and 
Commerce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate, and post on 
the Internet website of the Administration, a report containing at a 
minimum--
            ``(1) a review of activities conducted or supported by the 
        Administration, including progress toward strategic priorities, 
        goals, and objectives identified in the strategic plan developed 
        under subsection (l);

[[Page 130 STAT. 1211]]

            ``(2) an assessment of programs and activities carried out 
        by the Assistant Secretary, including the extent to which 
        programs and activities under this title and part B of title XIX 
        meet identified goals and performance measures developed for the 
        respective programs and activities;
            ``(3) a description of the progress made in addressing gaps 
        in mental and substance use disorders prevention, treatment, and 
        recovery services and improving outcomes by the Administration, 
        including with respect to serious mental illnesses, serious 
        emotional disturbances, and co-occurring disorders;
            ``(4) a description of the manner in which the 
        Administration coordinates and partners with other Federal 
        agencies and departments related to mental and substance use 
        disorders, including activities related to--
                    ``(A) the implementation and dissemination of 
                research findings into improved programs, including with 
                respect to how advances in serious mental illness and 
                serious emotional disturbance research have been 
                incorporated into programs;
                    ``(B) the recruitment, training, and retention of a 
                mental and substance use disorders workforce;
                    ``(C) the integration of mental disorder services, 
                substance use disorder services, and physical health 
                services;
                    ``(D) homelessness; and
                    ``(E) veterans;
            ``(5) a description of the manner in which the 
        Administration promotes coordination by grantees under this 
        title, and part B of title XIX, with State or local agencies; 
        and
            ``(6) a description of the activities carried out under 
        section 501A(e), with respect to mental and substance use 
        disorders, including--
                    ``(A) the number and a description of grants 
                awarded;
                    ``(B) the total amount of funding for grants 
                awarded;
                    ``(C) a description of the activities supported 
                through such grants, including outcomes of programs 
                supported; and
                    ``(D) information on how the National Mental Health 
                and Substance Use Policy Laboratory is consulting with 
                the Assistant Secretary for Planning and Evaluation and 
                collaborating with the Center for Substance Abuse 
                Treatment, the Center for Substance Abuse Prevention, 
                the Center for Behavioral Health Statistics and Quality, 
                and the Center for Mental Health Services to carry out 
                such activities; and
            ``(7) recommendations made by the Assistant Secretary for 
        Planning and Evaluation under section 6021 of the Helping 
        Families in Mental Health Crisis Reform Act of 2016 to improve 
        programs within the Administration, and actions taken in 
        response to such recommendations to improve programs within the 
        Administration.

The Assistant Secretary may meet reporting requirements established 
under this title by providing the contents of such reports as an 
addendum to the biennial report established under this subsection, 
notwithstanding the timeline of other reporting requirements in this 
title. Nothing in this subsection shall be construed to alter the 
content requirements of such reports or authorize the Assistant 
Secretary to alter the timeline of any such reports

[[Page 130 STAT. 1212]]

to be less frequent than biennially, unless as specified in this 
title.''.
    (b) Conforming Amendment.--Section 508(p) of the Public Health 
Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section 
501(k)'' and inserting ``section 501(m)''.
SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES, 
                          SUBSTANCE ABUSE PREVENTION, AND 
                          SUBSTANCE ABUSE TREATMENT.

    (a) Center for Mental Health Services.--Section 520(b) of the Public 
Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
            (1) by redesignating paragraphs (3) through (15) as 
        paragraphs (4) through (16), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) collaborate with the Director of the National 
        Institute of Mental Health and the Chief Medical Officer, 
        appointed under section 501(g), to ensure that, as appropriate, 
        programs related to the prevention and treatment of mental 
        illness and the promotion of mental health and recovery support 
        are carried out in a manner that reflects the best available 
        science and evidence-based practices, including culturally and 
        linguistically appropriate services, as appropriate;'';
            (3) in paragraph (5), as so redesignated, by inserting ``, 
        including through programs that reduce risk and promote 
        resiliency'' before the semicolon;
            (4) in paragraph (6), as so redesignated, by inserting ``in 
        collaboration with the Director of the National Institute of 
        Mental Health,'' before ``develop'';
            (5) in paragraph (8), as so redesignated, by inserting ``, 
        increase meaningful participation of individuals with mental 
        illness in programs and activities of the Administration,'' 
        before ``and protect the legal'';
            (6) in paragraph (10), as so redesignated, by striking 
        ``professional and paraprofessional personnel pursuant to 
        section 303'' and inserting ``health paraprofessional personnel 
        and health professionals'';
            (7) in paragraph (11), as so redesignated, by inserting 
        ``and tele-mental health'' after ``rural mental health'';
            (8) in paragraph (12), as so redesignated, by striking 
        ``establish a clearinghouse for mental health information to 
        assure the widespread dissemination of such information'' and 
        inserting ``disseminate mental health information, including 
        evidence-based practices,'';
            (9) in paragraph (15), as so redesignated, by striking 
        ``and'' at the end;
            (10) in paragraph (16), as so redesignated, by striking the 
        period and inserting ``; and''; and
            (11) by adding at the end the following:
            ``(17) ensure the consistent documentation of the 
        application of criteria when awarding grants and the ongoing 
        oversight of grantees after such grants are awarded.''.

    (b) Director of the Center for Substance Abuse Prevention.--Section 
515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
            (1) in the section heading, by striking ``office'' and 
        inserting ``center'';

[[Page 130 STAT. 1213]]

            (2) in subsection (a)--
                    (A) by striking ``an Office'' and inserting ``a 
                Center''; and
                    (B) by striking ``The Office'' and inserting ``The 
                Prevention Center''; and
            (3) in subsection (b)--
                    (A) in paragraph (1), by inserting ``through the 
                reduction of risk and the promotion of resiliency'' 
                before the semicolon;
                    (B) by redesignating paragraphs (3) through (11) as 
                paragraphs (4) through (12), respectively;
                    (C) by inserting after paragraph (2) the following:
            ``(3) collaborate with the Director of the National 
        Institute on Drug Abuse, the Director of the National Institute 
        on Alcohol Abuse and Alcoholism, and States to promote the study 
        of substance abuse prevention and the dissemination and 
        implementation of research findings that will improve the 
        delivery and effectiveness of substance abuse prevention 
        activities;'';
                    (D) in paragraph (4), as so redesignated, by 
                striking ``literature on the adverse effects of cocaine 
                free base (known as crack)'' and inserting ``educational 
                information on the effects of drugs abused by 
                individuals, including drugs that are emerging as abused 
                drugs'';
                    (E) in paragraph (6), as so redesignated--
                          (i) by striking ``substance abuse counselors'' 
                      and inserting ``health professionals who provide 
                      substance use and misuse prevention and treatment 
                      services''; and
                          (ii) by striking ``drug abuse education, 
                      prevention,'' and inserting ``illicit drug use 
                      education and prevention'';
                    (F) by amending paragraph (7), as so redesignated, 
                to read as follows:
            ``(7) in cooperation with the Director of the Centers for 
        Disease Control and Prevention, develop and disseminate 
        educational materials to increase awareness for individuals at 
        greatest risk for substance use disorders to prevent the 
        transmission of communicable diseases, such as HIV, hepatitis, 
        tuberculosis, and other communicable diseases;'';
                    (G) in paragraph (9), as so redesignated--
                          (i) by striking ``to discourage'' and 
                      inserting ``that reduce the risk of''; and
                          (ii) by inserting before the semicolon ``and 
                      promote resiliency'';
                    (H) in paragraph (11), as so redesignated, by 
                striking ``and'' after the semicolon;
                    (I) in paragraph (12), as so redesignated, by 
                striking the period and inserting a semicolon; and
                    (J) by adding at the end the following:
            ``(13) ensure the consistent documentation of the 
        application of criteria when awarding grants and the ongoing 
        oversight of grantees after such grants are awarded; and
            ``(14) assist and support States in preventing illicit drug 
        use, including emerging illicit drug use issues.''.

[[Page 130 STAT. 1214]]

    (c) Director of the Center for Substance Abuse Treatment.--Section 
507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
            (1) in subsection (a)--
                    (A) by striking ``treatment of substance abuse'' and 
                inserting ``treatment of substance use disorders''; and
                    (B) by striking ``abuse treatment systems'' and 
                inserting ``use disorder treatment systems''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by striking ``abuse'' and 
                inserting ``use disorder'';
                    (B) in paragraph (3), by striking ``abuse'' and 
                inserting ``use disorder'';
                    (C) in paragraph (4), by striking ``individuals who 
                abuse drugs'' and inserting ``individuals who illicitly 
                use drugs'';
                    (D) in paragraph (9), by striking ``carried out by 
                the Director'';
                    (E) by striking paragraph (10);
                    (F) by redesignating paragraphs (11) through (14) as 
                paragraphs (10) through (13), respectively;
                    (G) in paragraph (12), as so redesignated, by 
                striking ``; and'' and inserting a semicolon; and
                    (H) by striking paragraph (13), as so redesignated, 
                and inserting the following:
            ``(13) ensure the consistent documentation of the 
        application of criteria when awarding grants and the ongoing 
        oversight of grantees after such grants are awarded; and
            ``(14) work with States, providers, and individuals in 
        recovery, and their families, to promote the expansion of 
        recovery support services and systems of care oriented toward 
        recovery.''.
SEC. 6008. ADVISORY COUNCILS.

    Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
1(b)) is amended--
            (1) in paragraph (2)--
                    (A) in subparagraph (E), by striking ``and'' after 
                the semicolon;
                    (B) by redesignating subparagraph (F) as 
                subparagraph (J); and
                    (C) by inserting after subparagraph (E), the 
                following:
                    ``(F) the Chief Medical Officer, appointed under 
                section 501(g);
                    ``(G) the Director of the National Institute of 
                Mental Health for the advisory councils appointed under 
                subsections (a)(1)(A) and (a)(1)(D);
                    ``(H) the Director of the National Institute on Drug 
                Abuse for the advisory councils appointed under 
                subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
                    ``(I) the Director of the National Institute on 
                Alcohol Abuse and Alcoholism for the advisory councils 
                appointed under subsections (a)(1)(A), (a)(1)(B), and 
                (a)(1)(C); and''; and
            (2) in paragraph (3), by adding at the end the following:
                    ``(C) Not less than half of the members of the 
                advisory council appointed under subsection (a)(1)(D)--
                          ``(i) shall--

[[Page 130 STAT. 1215]]

                                    ``(I) have a medical degree;
                                    ``(II) have a doctoral degree in 
                                psychology; or
                                    ``(III) have an advanced degree in 
                                nursing or social work from an 
                                accredited graduate school or be a 
                                certified physician assistant; and
                          ``(ii) shall specialize in the mental health 
                      field.
                    ``(D) Not less than half of the members of the 
                advisory councils appointed under subsections (a)(1)(B) 
                and (a)(1)(C)--
                          ``(i) shall--
                                    ``(I) have a medical degree;
                                    ``(II) have a doctoral degree; or
                                    ``(III) have an advanced degree in 
                                nursing, public health, behavioral or 
                                social sciences, or social work from an 
                                accredited graduate school or be a 
                                certified physician assistant; and
                          ``(ii) shall have experience in the provision 
                      of substance use disorder services or the 
                      development and implementation of programs to 
                      prevent substance misuse.''.
SEC. 6009. PEER REVIEW.

    Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
3(b)) is amended by adding at the end the following: ``In the case of 
any such peer review group that is reviewing a grant, cooperative 
agreement, or contract related to mental illness treatment, not less 
than half of the members of such peer review group shall be licensed and 
experienced professionals in the prevention, diagnosis, or treatment of, 
or recovery from, mental illness or co-occurring mental illness and 
substance use disorders and have a medical degree, a doctoral degree in 
psychology, or an advanced degree in nursing or social work from an 
accredited program, and the Secretary, in consultation with the 
Assistant Secretary, shall, to the extent possible, ensure such peer 
review groups include broad geographic representation, including both 
urban and rural representatives.''.

                Subtitle B--Oversight and Accountability

SEC. 6021. <<NOTE: 42 USC 290aa note.>>  IMPROVING OVERSIGHT OF 
                          MENTAL AND SUBSTANCE USE DISORDERS 
                          PROGRAMS THROUGH THE ASSISTANT SECRETARY 
                          FOR PLANNING AND EVALUATION.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Assistant Secretary for Planning and Evaluation, shall 
ensure efficient and effective planning and evaluation of mental and 
substance use disorders prevention and treatment programs and related 
activities.
    (b) Evaluation Strategy.--In carrying out subsection (a), the 
Assistant Secretary for Planning and Evaluation shall, not later than 
180 days after the date of enactment of this Act, develop a strategy for 
conducting ongoing evaluations that identifies priority programs to be 
evaluated by the Assistant Secretary for Planning and Evaluation and 
priority programs to be evaluated by other relevant offices and agencies 
within the Department of Health and Human Services. The strategy shall--

[[Page 130 STAT. 1216]]

            (1) include a plan for evaluating programs related to mental 
        and substance use disorders, including co-occurring disorders, 
        across agencies, as appropriate, including programs related to--
                    (A) prevention, intervention, treatment, and 
                recovery support services, including such services for 
                adults with a serious mental illness or children with a 
                serious emotional disturbance;
                    (B) the reduction of homelessness and incarceration 
                among individuals with a mental or substance use 
                disorder; and
                    (C) public health and health services; and
            (2) include a plan for assessing the use of performance 
        metrics to evaluate activities carried out by entities receiving 
        grants, contracts, or cooperative agreements related to mental 
        and substance use disorders prevention and treatment services 
        under title V or title XIX of the Public Health Service Act (42 
        U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).

    (c) Consultation.--In carrying out this section, the Assistant 
Secretary for Planning and Evaluation shall consult, as appropriate, 
with the Assistant Secretary for Mental Health and Substance Use, the 
Chief Medical Officer of the Substance Abuse and Mental Health Services 
Administration appointed under section 501(g) of the Public Health 
Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the 
Behavioral Health Coordinating Council of the Department of Health and 
Human Services, other agencies within the Department of Health and Human 
Services, and other relevant Federal departments and agencies.
    (d) Recommendations.--In carrying out this section, the Assistant 
Secretary for Planning and Evaluation shall provide recommendations to 
the Secretary of Health and Human Services, the Assistant Secretary for 
Mental Health and Substance Use, and the Congress on improving the 
quality of prevention and treatment programs and activities related to 
mental and substance use disorders, including recommendations for the 
use of performance metrics. The Assistant Secretary for Mental Health 
and Substance Use shall include such recommendations in the biennial 
report required by subsection 501(m) of the Public Health Service Act, 
as redesignated by section 6003 of this Act.
SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.

    (a) Public Availability of Reports.--Section 105(a)(7) of the 
Protection and Advocacy for Individuals with Mental Illness Act (42 
U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and 
inserting ``is located, and make publicly available, a report''.
    (b) Detailed Accounting.--Section 114(a) of the Protection and 
Advocacy for Individuals with Mental Illness Act (42 U.S.C. 10824(a)) is 
amended--
            (1) in paragraph (3), by striking ``and'' at the end;
            (2) in paragraph (4), by striking the period at the end and 
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(5) using data from the existing required annual program 
        progress reports submitted by each system funded under this 
        title, a detailed accounting for each such system of how funds 
        are spent, disaggregated according to whether the funds were

[[Page 130 STAT. 1217]]

        received from the Federal Government, the State government, a 
        local government, or a private entity.''.
SEC. 6023. GAO STUDY.

    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States, in 
consultation with the Secretary of Health and Human Services and the 
Assistant Secretary for Mental Health and Substance Use, shall conduct 
an independent evaluation, and submit a report, to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives, on programs 
funded by allotments made under title I of the Protection and Advocacy 
for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
    (b) Contents.--The report and evaluation required under subsection 
(a) shall include--
            (1) a review of the programs described in such subsection 
        that are carried out by State agencies and such programs that 
        are carried out by private, nonprofit organizations; and
            (2) a review of the compliance of the programs described in 
        subsection (a) with statutory and regulatory responsibilities, 
        such as--
                    (A) responsibilities relating to family engagement;
                    (B) responsibilities relating to the grievance 
                procedure for clients or prospective clients of the 
                system to assure that individuals with mental illness 
                have full access to the services of the system, for 
                individuals who have received or are receiving mental 
                health services, and for family members of such 
                individuals with mental illness, or representatives of 
                such individuals or family members, to assure that the 
                eligible system is operating in compliance with the 
                provisions of the Protection and Advocacy for 
                Individuals with Mental Illness Act, as required to be 
                established by section 105(a)(9) of such Act (42 U.S.C. 
                10805(a)(9));
                    (C) investigation of alleged abuse and neglect of 
                persons with mental illness;
                    (D) availability of adequate medical and behavioral 
                health treatment;
                    (E) denial of rights for persons with mental 
                illness; and
                    (F) compliance with the Federal prohibition on 
                lobbying.

   Subtitle C--Interdepartmental Serious Mental Illness Coordinating 
                                Committee

SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING 
                          COMMITTEE.

    (a) Establishment.--
            (1) In general.--Not later than 3 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services, or the designee of the Secretary, shall establish a 
        committee to be known as the Interdepartmental Serious Mental 
        Illness Coordinating Committee (in this section referred to as 
        the ``Committee'').

[[Page 130 STAT. 1218]]

            (2) Federal advisory committee act.--Except as provided in 
        this section, the provisions of the Federal Advisory Committee 
        Act (5 U.S.C. App.) shall apply to the Committee.

    (b) Meetings.--The Committee shall meet not fewer than 2 times each 
year.
    (c) Responsibilities.--Not later than 1 year after the date of 
enactment of this Act, and 5 years after such date of enactment, the 
Committee shall submit to Congress and any other relevant Federal 
department or agency a report including--
            (1) a summary of advances in serious mental illness and 
        serious emotional disturbance research related to the prevention 
        of, diagnosis of, intervention in, and treatment and recovery of 
        serious mental illnesses, serious emotional disturbances, and 
        advances in access to services and support for adults with a 
        serious mental illness or children with a serious emotional 
        disturbance;
            (2) an evaluation of the effect Federal programs related to 
        serious mental illness have on public health, including public 
        health outcomes such as--
                    (A) rates of suicide, suicide attempts, incidence 
                and prevalence of serious mental illnesses, serious 
                emotional disturbances, and substance use disorders, 
                overdose, overdose deaths, emergency hospitalizations, 
                emergency room boarding, preventable emergency room 
                visits, interaction with the criminal justice system, 
                homelessness, and unemployment;
                    (B) increased rates of employment and enrollment in 
                educational and vocational programs;
                    (C) quality of mental and substance use disorders 
                treatment services; or
                    (D) any other criteria as may be determined by the 
                Secretary; and
            (3) specific recommendations for actions that agencies can 
        take to better coordinate the administration of mental health 
        services for adults with a serious mental illness or children 
        with a serious emotional disturbance.

    (d) Committee Extension.--Upon the submission of the second report 
under subsection (c), the Secretary shall submit a recommendation to 
Congress on whether to extend the operation of the Committee.
    (e) Membership.--
            (1) Federal members.--The Committee shall be composed of the 
        following Federal representatives, or the designees of such 
        representatives--
                    (A) the Secretary of Health and Human Services, who 
                shall serve as the Chair of the Committee;
                    (B) the Assistant Secretary for Mental Health and 
                Substance Use;
                    (C) the Attorney General;
                    (D) the Secretary of Veterans Affairs;
                    (E) the Secretary of Defense;
                    (F) the Secretary of Housing and Urban Development;
                    (G) the Secretary of Education;
                    (H) the Secretary of Labor;
                    (I) the Administrator of the Centers for Medicare & 
                Medicaid Services; and
                    (J) the Commissioner of Social Security.

[[Page 130 STAT. 1219]]

            (2) Non-federal members.--The Committee shall also include 
        not less than 14 non-Federal public members appointed by the 
        Secretary of Health and Human Services, of which--
                    (A) at least 2 members shall be an individual who 
                has received treatment for a diagnosis of a serious 
                mental illness;
                    (B) at least 1 member shall be a parent or legal 
                guardian of an adult with a history of a serious mental 
                illness or a child with a history of a serious emotional 
                disturbance;
                    (C) at least 1 member shall be a representative of a 
                leading research, advocacy, or service organization for 
                adults with a serious mental illness;
                    (D) at least 2 members shall be--
                          (i) a licensed psychiatrist with experience in 
                      treating serious mental illnesses;
                          (ii) a licensed psychologist with experience 
                      in treating serious mental illnesses or serious 
                      emotional disturbances;
                          (iii) a licensed clinical social worker with 
                      experience treating serious mental illnesses or 
                      serious emotional disturbances; or
                          (iv) a licensed psychiatric nurse, nurse 
                      practitioner, or physician assistant with 
                      experience in treating serious mental illnesses or 
                      serious emotional disturbances;
                    (E) at least 1 member shall be a licensed mental 
                health professional with a specialty in treating 
                children and adolescents with a serious emotional 
                disturbance;
                    (F) at least 1 member shall be a mental health 
                professional who has research or clinical mental health 
                experience in working with minorities;
                    (G) at least 1 member shall be a mental health 
                professional who has research or clinical mental health 
                experience in working with medically underserved 
                populations;
                    (H) at least 1 member shall be a State certified 
                mental health peer support specialist;
                    (I) at least 1 member shall be a judge with 
                experience in adjudicating cases related to criminal 
                justice or serious mental illness;
                    (J) at least 1 member shall be a law enforcement 
                officer or corrections officer with extensive experience 
                in interfacing with adults with a serious mental 
                illness, children with a serious emotional disturbance, 
                or individuals in a mental health crisis; and
                    (K) at least 1 member shall have experience 
                providing services for homeless individuals and working 
                with adults with a serious mental illness, children with 
                a serious emotional disturbance, or individuals in a 
                mental health crisis.
            (3) Terms.--A member of the Committee appointed under 
        subsection (e)(2) shall serve for a term of 3 years, and may be 
        reappointed for 1 or more additional 3-year terms. Any member 
        appointed to fill a vacancy for an unexpired term shall be 
        appointed for the remainder of such term. A member may serve 
        after the expiration of the member's term until a successor has 
        been appointed.

[[Page 130 STAT. 1220]]

    (f) Working Groups.--In carrying out its functions, the Committee 
may establish working groups. Such working groups shall be composed of 
Committee members, or their designees, and may hold such meetings as are 
necessary.
    (g) Sunset.--The Committee shall terminate on the date that is 6 
years after the date on which the Committee is established under 
subsection (a)(1).

   TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, 
 TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY

SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.

    Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) 
is amended by inserting after section 501 (42 U.S.C. 290aa) the 
following:
``SEC. 501A. <<NOTE: 42 USC 290aa-0.>>  NATIONAL MENTAL HEALTH AND 
                          SUBSTANCE USE POLICY LABORATORY.

    ``(a) In General.--There shall be established within the 
Administration a National Mental Health and Substance Use Policy 
Laboratory (referred to in this section as the `Laboratory').
    ``(b) Responsibilities.--The Laboratory shall--
            ``(1) continue to carry out the authorities and activities 
        that were in effect for the Office of Policy, Planning, and 
        Innovation as such Office existed prior to the date of enactment 
        of the Helping Families in Mental Health Crisis Reform Act of 
        2016;
            ``(2) identify, coordinate, and facilitate the 
        implementation of policy changes likely to have a significant 
        effect on mental health, mental illness, recovery supports, and 
        the prevention and treatment of substance use disorder services;
            ``(3) work with the Center for Behavioral Health Statistics 
        and Quality to collect, as appropriate, information from 
        grantees under programs operated by the Administration in order 
        to evaluate and disseminate information on evidence-based 
        practices, including culturally and linguistically appropriate 
        services, as appropriate, and service delivery models;
            ``(4) provide leadership in identifying and coordinating 
        policies and programs, including evidence-based programs, 
        related to mental and substance use disorders;
            ``(5) periodically review programs and activities operated 
        by the Administration relating to the diagnosis or prevention 
        of, treatment for, and recovery from, mental and substance use 
        disorders to--
                    ``(A) identify any such programs or activities that 
                are duplicative;
                    ``(B) identify any such programs or activities that 
                are not evidence-based, effective, or efficient; and
                    ``(C) formulate recommendations for coordinating, 
                eliminating, or improving programs or activities 
                identified

[[Page 130 STAT. 1221]]

                under subparagraph (A) or (B) and merging such programs 
                or activities into other successful programs or 
                activities; and
            ``(6) carry out other activities as deemed necessary to 
        continue to encourage innovation and disseminate evidence-based 
        programs and practices.

    ``(c) Evidence-Based Practices and Service Delivery Models.--
            ``(1) In general.--In carrying out subsection (b)(3), the 
        Laboratory--
                    ``(A) may give preference to models that improve--
                          ``(i) the coordination between mental health 
                      and physical health providers;
                          ``(ii) the coordination among such providers 
                      and the justice and corrections system; and
                          ``(iii) the cost effectiveness, quality, 
                      effectiveness, and efficiency of health care 
                      services furnished to adults with a serious mental 
                      illness, children with a serious emotional 
                      disturbance, or individuals in a mental health 
                      crisis; and
                    ``(B) may include clinical protocols and practices 
                that address the needs of individuals with early serious 
                mental illness.
            ``(2) Consultation.--In carrying out this section, the 
        Laboratory shall consult with--
                    ``(A) the Chief Medical Officer appointed under 
                section 501(g);
                    ``(B) representatives of the National Institute of 
                Mental Health, the National Institute on Drug Abuse, and 
                the National Institute on Alcohol Abuse and Alcoholism, 
                on an ongoing basis;
                    ``(C) other appropriate Federal agencies;
                    ``(D) clinical and analytical experts with expertise 
                in psychiatric medical care and clinical psychological 
                care, health care management, education, corrections 
                health care, and mental health court systems, as 
                appropriate; and
                    ``(E) other individuals and agencies as determined 
                appropriate by the Assistant Secretary.

    ``(d) Deadline for Beginning Implementation.--The Laboratory shall 
begin implementation of this section not later than January 1, 2018.
    ``(e) Promoting Innovation.--
            ``(1) In general.--The Assistant Secretary, in coordination 
        with the Laboratory, may award grants to States, local 
        governments, Indian tribes or tribal organizations (as such 
        terms are defined in section 4 of the Indian Self-Determination 
        and Education Assistance Act), educational institutions, and 
        nonprofit organizations to develop evidence-based interventions, 
        including culturally and linguistically appropriate services, as 
        appropriate, for--
                    ``(A) evaluating a model that has been 
                scientifically demonstrated to show promise, but would 
                benefit from further applied development, for--

[[Page 130 STAT. 1222]]

                          ``(i) enhancing the prevention, diagnosis, 
                      intervention, and treatment of, and recovery from, 
                      mental illness, serious emotional disturbances, 
                      substance use disorders, and co-occurring illness 
                      or disorders; or
                          ``(ii) integrating or coordinating physical 
                      health services and mental and substance use 
                      disorders services; and
                    ``(B) expanding, replicating, or scaling evidence-
                based programs across a wider area to enhance effective 
                screening, early diagnosis, intervention, and treatment 
                with respect to mental illness, serious mental illness, 
                serious emotional disturbances, and substance use 
                disorders, primarily by--
                          ``(i) applying such evidence-based programs to 
                      the delivery of care, including by training staff 
                      in effective evidence-based treatments; or
                          ``(ii) integrating such evidence-based 
                      programs into models of care across specialties 
                      and jurisdictions.
            ``(2) Consultation.--In awarding grants under this 
        subsection, the Assistant Secretary shall, as appropriate, 
        consult with the Chief Medical Officer, appointed under section 
        501(g), the advisory councils described in section 502, the 
        National Institute of Mental Health, the National Institute on 
        Drug Abuse, and the National Institute on Alcohol Abuse and 
        Alcoholism, as appropriate.
            ``(3) Authorization of appropriations.--There are authorized 
        to be appropriated--
                    ``(A) to carry out paragraph (1)(A), $7,000,000 for 
                the period of fiscal years 2018 through 2020; and
                    ``(B) to carry out paragraph (1)(B), $7,000,000 for 
                the period of fiscal years 2018 through 2020.''.
SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED 
                          PROGRAMS AND PRACTICES.

    Part D of title V of the Public Health Service Act (42 U.S.C. 290dd 
et seq.) is amended by inserting after section 543 of such Act (42 
U.S.C. 290dd-2) the following:
``SEC. 543A. <<NOTE: 42 USC 290dd-2a.>>  PROMOTING ACCESS TO 
                          INFORMATION ON EVIDENCE-BASED PROGRAMS 
                          AND PRACTICES.

    ``(a) In General.--The Assistant Secretary shall, as appropriate, 
improve access to reliable and valid information on evidence-based 
programs and practices, including information on the strength of 
evidence associated with such programs and practices, related to mental 
and substance use disorders for States, local communities, nonprofit 
entities, and other stakeholders, by posting on the Internet website of 
the Administration information on evidence-based programs and practices 
that have been reviewed by the Assistant Secretary in accordance with 
the requirements of this section.
    ``(b) Applications.--
            ``(1) Application period.--In carrying out subsection (a), 
        the Assistant Secretary may establish a period for the 
        submission of applications for evidence-based programs and 
        practices to be posted publicly in accordance with subsection 
        (a).
            ``(2) Notice.--In establishing the application period under 
        paragraph (1), the Assistant Secretary shall provide for the 
        public notice of such application period in the Federal 
        Register.

[[Page 130 STAT. 1223]]

        Such notice may solicit applications for evidence-based programs 
        and practices to address gaps in information identified by the 
        Assistant Secretary, the National Mental Health and Substance 
        Use Policy Laboratory established under section 501A, or the 
        Assistant Secretary for Planning and Evaluation, including 
        pursuant to the evaluation and recommendations under section 
        6021 of the Helping Families in Mental Health Crisis Reform Act 
        of 2016 or priorities identified in the strategic plan under 
        section 501(l).

    ``(c) Requirements.--The Assistant Secretary may establish minimum 
requirements for the applications submitted under subsection (b), 
including applications related to the submission of research and 
evaluation.
    ``(d) Review and Rating.--
            ``(1) In general.--The Assistant Secretary shall review 
        applications prior to public posting in accordance with 
        subsection (a), and may prioritize the review of applications 
        for evidence-based programs and practices that are related to 
        topics included in the notice provided under subsection (b)(2).
            ``(2) System.--In carrying out paragraph (1), the Assistant 
        Secretary may utilize a rating and review system, which may 
        include information on the strength of evidence associated with 
        the evidence-based programs and practices and a rating of the 
        methodological rigor of the research supporting the 
        applications.
            ``(3) Public access to metrics and rating.--The Assistant 
        Secretary shall make the metrics used to evaluate applications 
        under this section, and any resulting ratings of such 
        applications, publicly available.''.
SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL 
                          SIGNIFICANCE.

    Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32) 
is amended--
            (1) in subsection (a)--
                    (A) in paragraph (4), by inserting before the period 
                ``, which may include technical assistance centers''; 
                and
                    (B) in the flush sentence following paragraph (4)--
                          (i) by inserting ``, contracts,'' before ``or 
                      cooperative agreements''; and
                          (ii) by striking ``Indian tribes and tribal 
                      organizations'' and inserting ``Indian tribes or 
                      tribal organizations (as such terms are defined in 
                      section 4 of the Indian Self-Determination and 
                      Education Assistance Act), health facilities, or 
                      programs operated by or in accordance with a 
                      contract or grant with the Indian Health Service, 
                      or''; and
            (2) by amending subsection (f) to read as follows:

    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $394,550,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF 
                          REGIONAL AND NATIONAL SIGNIFICANCE.

    Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is 
amended--
            (1) in subsection (a)--

[[Page 130 STAT. 1224]]

                    (A) in the matter preceding paragraph (1), by 
                striking ``abuse'' and inserting ``use disorder'';
                    (B) in paragraph (3), by inserting before the period 
                ``that permit States, local governments, communities, 
                and Indian tribes and tribal organizations (as the terms 
                `Indian tribes' and `tribal organizations' are defined 
                in section 4 of the Indian Self-Determination and 
                Education Assistance Act) to focus on emerging trends in 
                substance abuse and co-occurrence of substance use 
                disorders with mental illness or other conditions''; and
                    (C) in the flush sentence following paragraph (3)--
                          (i) by inserting ``, contracts,'' before ``or 
                      cooperative agreements''; and
                          (ii) by striking ``Indian tribes and tribal 
                      organizations,'' and inserting ``Indian tribes or 
                      tribal organizations (as such terms are defined in 
                      section 4 of the Indian Self-Determination and 
                      Education Assistance Act), health facilities, or 
                      programs operated by or in accordance with a 
                      contract or grant with the Indian Health Service, 
                      or'';
            (2) in subsection (b)--
                    (A) in paragraph (1), by striking ``abuse'' and 
                inserting ``use disorder''; and
                    (B) in paragraph (2), by striking ``abuse'' and 
                inserting ``use disorder'';
            (3) in subsection (e), by striking ``abuse'' and inserting 
        ``use disorder''; and
            (4) in subsection (f), by striking ``$300,000,000'' and all 
        that follows through the period and inserting ``$333,806,000 for 
        each of fiscal years 2018 through 2022.''.
SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF 
                          REGIONAL AND NATIONAL SIGNIFICANCE.

    Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is 
amended--
            (1) in the section heading, by striking ``abuse'' and 
        inserting ``use disorder'';
            (2) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``abuse'' and inserting ``use disorder'';
                    (B) in paragraph (3), by inserting before the period 
                ``, including such programs that focus on emerging drug 
                abuse issues''; and
                    (C) in the flush sentence following paragraph (3)--
                          (i) by inserting ``, contracts,'' before ``or 
                      cooperative agreements''; and
                          (ii) by striking ``Indian tribes and tribal 
                      organizations,'' and inserting ``Indian tribes or 
                      tribal organizations (as such terms are defined in 
                      section 4 of the Indian Self-Determination and 
                      Education Assistance Act), health facilities, or 
                      programs operated by or in accordance with a 
                      contract or grant with the Indian Health 
                      Service,'';
            (3) in subsection (b)--
                    (A) in paragraph (1), by striking ``abuse'' and 
                inserting ``use disorder''; and
                    (B) in paragraph (2)--

[[Page 130 STAT. 1225]]

                          (i) in subparagraph (A), by striking ``; and'' 
                      at the end and inserting ``;'';
                          (ii) in subparagraph (B)--
                                    (I) by striking ``abuse'' and 
                                inserting ``use disorder''; and
                                    (II) by striking the period and 
                                inserting ``; and''; and
                          (iii) by adding at the end the following:
                    ``(C) substance use disorder prevention among high-
                risk groups.'';
            (4) in subsection (e), by striking ``abuse'' and inserting 
        ``use disorder''; and
            (5) in subsection (f), by striking ``$300,000,000'' and all 
        that follows through the period and inserting ``$211,148,000 for 
        each of fiscal years 2018 through 2022.''.

  TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO 
             MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS

SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.

    (a) Formula Grants.--Section 1911(b) of the Public Health Service 
Act (42 U.S.C. 300x(b)) is amended--
            (1) by redesignating paragraphs (1) through (3) as 
        paragraphs (2) through (4), respectively; and
            (2) by inserting before paragraph (2) (as so redesignated) 
        the following:
            ``(1) providing community mental health services for adults 
        with a serious mental illness and children with a serious 
        emotional disturbance as defined in accordance with section 
        1912(c);''.

    (b) State Plan.--Section 1912(b) of the Public Health Service Act 
(42 U.S.C. 300x-1(b)) is amended--
            (1) in paragraph (3), by redesignating subparagraphs (A) 
        through (C) as clauses (i) through (iii), respectively, and 
        realigning the margins accordingly;
            (2) by redesignating paragraphs (1) through (5) as 
        subparagraphs (A) through (E), respectively, and realigning the 
        margins accordingly;
            (3) in the matter preceding subparagraph (A) (as so 
        redesignated), by striking ``With respect to'' and all that 
        follows through ``are as follows:'' and inserting ``In 
        accordance with subsection (a), a State shall submit to the 
        Secretary a plan every two years that, at a minimum, includes 
        each of the following:'';
            (4) by inserting before subparagraph (A) (as so 
        redesignated) the following:
            ``(1) System of care.--A description of the State's system 
        of care that contains the following:'';
            (5) by striking subparagraph (A) (as so redesignated) and 
        inserting the following:
                    ``(A) Comprehensive community-based health 
                systems.--The plan shall--

[[Page 130 STAT. 1226]]

                          ``(i) identify the single State agency to be 
                      responsible for the administration of the program 
                      under the grant, including any third party who 
                      administers mental health services and is 
                      responsible for complying with the requirements of 
                      this part with respect to the grant;
                          ``(ii) provide for an organized community-
                      based system of care for individuals with mental 
                      illness, and describe available services and 
                      resources in a comprehensive system of care, 
                      including services for individuals with co-
                      occurring disorders;
                          ``(iii) include a description of the manner in 
                      which the State and local entities will coordinate 
                      services to maximize the efficiency, 
                      effectiveness, quality, and cost-effectiveness of 
                      services and programs to produce the best possible 
                      outcomes (including health services, 
                      rehabilitation services, employment services, 
                      housing services, educational services, substance 
                      use disorder services, legal services, law 
                      enforcement services, social services, child 
                      welfare services, medical and dental care 
                      services, and other support services to be 
                      provided with Federal, State, and local public and 
                      private resources) with other agencies to enable 
                      individuals receiving services to function outside 
                      of inpatient or residential institutions, to the 
                      maximum extent of their capabilities, including 
                      services to be provided by local school systems 
                      under the Individuals with Disabilities Education 
                      Act;
                          ``(iv) include a description of how the State 
                      promotes evidence-based practices, including those 
                      evidence-based programs that address the needs of 
                      individuals with early serious mental illness 
                      regardless of the age of the individual at onset, 
                      provide comprehensive individualized treatment, or 
                      integrate mental and physical health services;
                          ``(v) include a description of case management 
                      services;
                          ``(vi) include a description of activities 
                      that seek to engage adults with a serious mental 
                      illness or children with a serious emotional 
                      disturbance and their caregivers where appropriate 
                      in making health care decisions, including 
                      activities that enhance communication among 
                      individuals, families, caregivers, and treatment 
                      providers; and
                          ``(vii) as appropriate to, and reflective of, 
                      the uses the State proposes for the block grant 
                      funds, include--
                                    ``(I) a description of the 
                                activities intended to reduce 
                                hospitalizations and hospital stays 
                                using the block grant funds;
                                    ``(II) a description of the 
                                activities intended to reduce incidents 
                                of suicide using the block grant funds;
                                    ``(III) a description of how the 
                                State integrates mental health and 
                                primary care using the block grant 
                                funds, which may include providing, in 
                                the case of individuals with co-
                                occurring mental and

[[Page 130 STAT. 1227]]

                                substance use disorders, both mental and 
                                substance use disorders services in 
                                primary care settings or arrangements to 
                                provide primary and specialty care 
                                services in community-based mental and 
                                substance use disorders settings; and
                                    ``(IV) a description of recovery and 
                                recovery support services for adults 
                                with a serious mental illness and 
                                children with a serious emotional 
                                disturbance.'';
            (6) in subparagraph (B) (as so redesignated)--
                    (A) by striking ``The plan contains'' and inserting 
                ``The plan shall contain''; and
                    (B) by striking ``presents quantitative targets to 
                be achieved in the implementation of the system 
                described in paragraph (1)'' and inserting ``present 
                quantitative targets and outcome measures for programs 
                and services provided under this subpart'';
            (7) in subparagraph (C) (as so redesignated)--
                    (A) by striking ``serious emotional disturbance'' in 
                the matter preceding clause (i) (as so redesignated) and 
                all that follows through ``substance abuse services'' in 
                clause (i) (as so redesignated) and inserting the 
                following: ``a serious emotional disturbance (as defined 
                pursuant to subsection (c)), the plan shall provide for 
                a system of integrated social services, educational 
                services, child welfare services, juvenile justice 
                services, law enforcement services, and substance use 
                disorder services'';
                    (B) by striking ``Education Act);'' and inserting 
                ``Education Act).''; and
                    (C) by striking clauses (ii) and (iii) (as so 
                redesignated);
            (8) in subparagraph (D) (as so redesignated), by striking 
        ``plan describes'' and inserting ``plan shall describe'';
            (9) in subparagraph (E) (as so redesignated)--
                    (A) in the subparagraph heading by striking 
                ``systems'' and inserting ``services'';
                    (B) in the first sentence, by striking ``plan 
                describes'' and all that follows through ``and provides 
                for'' and inserting ``plan shall describe the financial 
                resources available, the existing mental health 
                workforce, and the workforce trained in treating 
                individuals with co-occurring mental and substance use 
                disorders, and shall provide for''; and
                    (C) in the second sentence--
                          (i) by striking ``further describes'' and 
                      inserting ``shall further describe''; and
                          (ii) by striking ``involved.'' and inserting 
                      ``involved, and the manner in which the State 
                      intends to comply with each of the funding 
                      agreements in this subpart and subpart III.'';
            (10) by striking the flush matter at the end; and
            (11) by adding at the end the following:
            ``(2) Goals and objectives.--The establishment of goals and 
        objectives for the period of the plan, including targets and 
        milestones that are intended to be met, and the activities that 
        will be undertaken to achieve those targets.''.

[[Page 130 STAT. 1228]]

    (c) Early Serious Mental Illness.--Section 1920 of the Public Health 
Service Act (42 U.S.C. 300x-9) is amended by adding at the end the 
following:
    ``(c) Early Serious Mental Illness.--
            ``(1) In general.--Except as provided in paragraph (2), a 
        State shall expend not less than 10 percent of the amount the 
        State receives for carrying out this section for each fiscal 
        year to support evidence-based programs that address the needs 
        of individuals with early serious mental illness, including 
        psychotic disorders, regardless of the age of the individual at 
        onset.
            ``(2) State flexibility.--In lieu of expending 10 percent of 
        the amount the State receives under this section for a fiscal 
        year as required under paragraph (1), a State may elect to 
        expend not less than 20 percent of such amount by the end of 
        such succeeding fiscal year.''.

    (d) Additional Provisions.--Section 1915(b) of the Public Health 
Service Act (42 U.S.C. 300x-4(b)) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``The Secretary'' and inserting the 
                following:
                    ``(A) In general.--The Secretary'';
                    (B) by striking ``paragraph (1) if'' and inserting 
                ``paragraph (1) in whole or in part if'';
                    (C) by striking ``State justify the waiver.'' and 
                inserting ``State in the fiscal year involved or in the 
                previous fiscal year justify the waiver''; and
                    (D) by adding at the end the following:
                    ``(B) Date certain for action upon request.--The 
                Secretary shall approve or deny a request for a waiver 
                under this paragraph not later than 120 days after the 
                date on which the request is made.
                    ``(C) Applicability of waiver.--A waiver provided by 
                the Secretary under this paragraph shall be applicable 
                only to the fiscal year involved.''; and
            (2) in paragraph (4)--
                    (A) in subparagraph (A)--
                          (i) by inserting after the subparagraph 
                      designation the following: ``In general.--'';
                          (ii) by striking ``In making a grant'' and 
                      inserting the following:
                          ``(i) Determination.--In making a grant''; and
                          (iii) by inserting at the end the following:
                          ``(ii) Alternative.--A State that has failed 
                      to comply with paragraph (1) and would otherwise 
                      be subject to a reduction in the State's allotment 
                      under section 1911 may, upon request by the State, 
                      in lieu of having the amount of the allotment 
                      under section 1911 for the State reduced for the 
                      fiscal year of the grant, agree to comply with a 
                      negotiated agreement that is approved by the 
                      Secretary and carried out in accordance with 
                      guidelines issued by the Secretary. If a State 
                      fails to enter into or comply with a negotiated 
                      agreement, the Secretary may take action under 
                      this paragraph or the terms of the negotiated 
                      agreement.''; and
                    (B) in subparagraph (B)--

[[Page 130 STAT. 1229]]

                          (i) by inserting after the subparagraph 
                      designation the following: ``Submission of 
                      information to the secretary.--''; and
                          (ii) by striking ``subparagraph (A)'' and 
                      inserting ``subparagraph (A)(i)''.

    (e) Application for Grant.--Section 1917(a) of the Public Health 
Service Act (42 U.S.C. 300x-6(a)) is amended--
            (1) in paragraph (1), by striking ``1941'' and inserting 
        ``1942(a)''; and
            (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and 
        inserting ``1915(b)''.

    (f) Funding.--Section 1920 of the Public Health Service Act (42 
U.S.C. 300x-9) is amended--
            (1) in subsection (a)--
                    (A) by striking ``section 505'' and inserting 
                ``section 505(c)''; and
                    (B) by striking ``$450,000,000'' and all that 
                follows through the period and inserting ``$532,571,000 
                for each of fiscal years 2018 through 2022.''; and
            (2) in subsection (b)(2) by striking ``sections 505 and'' 
        and inserting ``sections 505(c) and''.
SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.

    (a) Formula Grants.--Section 1921(b) of the Public Health Service 
Act (42 U.S.C. 300x-21(b)) is amended--
            (1) by inserting ``carrying out the plan developed in 
        accordance with section 1932(b) and for'' after ``for the 
        purpose of''; and
            (2) by striking ``abuse'' and inserting ``use disorders''.

    (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the 
Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
            (1) in the subsection heading, by striking ``Regarding 
        Intravenous Substance Abuse'' and inserting ``to Persons Who 
        Inject Drugs''; and
            (2) by striking ``for intravenous drug abuse'' and inserting 
        ``for persons who inject drugs''.

    (c) Requirements Regarding Tuberculosis and Human Immunodeficiency 
Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
24) is amended--
            (1) in subsection (a)(1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``substance abuse'' and inserting ``substance 
                use disorders''; and
                    (B) in subparagraph (A), by striking ``such abuse'' 
                and inserting ``such disorders'';
            (2) in subsection (b)--
                    (A) in paragraph (1)(A), by striking ``substance 
                abuse'' and inserting ``substance use disorders'';
                    (B) in paragraph (2), by inserting ``and 
                Prevention'' after ``Disease Control'';
                    (C) in paragraph (3)--
                          (i) in the paragraph heading, by striking 
                      ``abuse'' and inserting ``use disorders''; and
                          (ii) by striking ``substance abuse'' and 
                      inserting ``substance use disorders''; and

[[Page 130 STAT. 1230]]

                    (D) in paragraph (6)(B), by striking ``substance 
                abuse'' and inserting ``substance use disorders'';
            (3) by striking subsection (d); and
            (4) by redesignating subsection (e) as subsection (d).

    (d) Group Homes.--Section 1925 of the Public Health Service Act (42 
U.S.C. 300x-25) is amended--
            (1) in the section heading, by striking ``recovering 
        substance abusers'' and inserting ``persons in recovery from 
        substance use disorders''; and
            (2) in subsection (a), in the matter preceding paragraph 
        (1), by striking ``recovering substance abusers'' and inserting 
        ``persons in recovery from substance use disorders''.

    (e) Additional Agreements.--Section 1928 of the Public Health 
Service Act (42 U.S.C. 300x-28) is amended--
            (1) in subsection (a), by striking ``(relative to fiscal 
        year 1992)'';
            (2) by striking subsection (b) and inserting the following:

    ``(b) Professional Development.--A funding agreement for a grant 
under section 1921 is that the State involved will ensure that 
prevention, treatment, and recovery personnel operating in the State's 
substance use disorder prevention, treatment, and recovery systems have 
an opportunity to receive training, on an ongoing basis, concerning--
            ``(1) recent trends in substance use disorders in the State;
            ``(2) improved methods and evidence-based practices for 
        providing substance use disorder prevention and treatment 
        services;
            ``(3) performance-based accountability;
            ``(4) data collection and reporting requirements; and
            ``(5) any other matters that would serve to further improve 
        the delivery of substance use disorder prevention and treatment 
        services within the State.''; and
            (3) in subsection (d)(1), by striking ``substance abuse'' 
        and inserting ``substance use disorders''.

    (f) Repeal.--Section 1929 of the Public Health Service Act (42 
U.S.C. 300x-29) is repealed.
    (g) Maintenance of Effort.--Section 1930 of the Public Health 
Service Act (42 U.S.C. 300x-30) is amended--
            (1) in subsection (c)(1), by striking ``in the State justify 
        the waiver'' and inserting ``exist in the State, or any part of 
        the State, to justify the waiver''; and
            (2) in subsection (d), by inserting at the end the 
        following:
            ``(3) Alternative.--A State that has failed to comply with 
        this section and would otherwise be subject to a reduction in 
        the State's allotment under section 1921, may, upon request by 
        the State, in lieu of having the State's allotment under section 
        1921 reduced, agree to comply with a negotiated agreement that 
        is approved by the Secretary and carried out in accordance with 
        guidelines issued by the Secretary. If a State fails to enter 
        into or comply with a negotiated agreement, the Secretary may 
        take action under this paragraph or the terms of the negotiated 
        agreement.''.

    (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public 
Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking 
``substance abuse'' and inserting ``substance use disorders''.

[[Page 130 STAT. 1231]]

    (i) Application.--Section 1932 of the Public Health Service Act (42 
U.S.C. 300x-32) is amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``subsections (c) and (d)(2)'' and inserting 
                ``subsection (c)''; and
                    (B) in paragraph (5), by striking ``the information 
                required in section 1929, the information required in 
                section 1930(c)(2), and'';
            (2) in subsection (b)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) In general.--In order for a State to be in compliance 
        with subsection (a)(6), the State shall submit to the Secretary 
        a plan that, at a minimum, includes the following:
                    ``(A) A description of the State's system of care 
                that--
                          ``(i) identifies the single State agency 
                      responsible for the administration of the program, 
                      including any third party who administers 
                      substance use disorder services and is responsible 
                      for complying with the requirements of the grant;
                          ``(ii) provides information on the need for 
                      substance use disorder prevention and treatment 
                      services in the State, including estimates on the 
                      number of individuals who need treatment, who are 
                      pregnant women, women with dependent children, 
                      individuals with a co-occurring mental health and 
                      substance use disorder, persons who inject drugs, 
                      and persons who are experiencing homelessness;
                          ``(iii) provides aggregate information on the 
                      number of individuals in treatment within the 
                      State, including the number of such individuals 
                      who are pregnant women, women with dependent 
                      children, individuals with a co-occurring mental 
                      health and substance use disorder, persons who 
                      inject drugs, and persons who are experiencing 
                      homelessness;
                          ``(iv) provides a description of the system 
                      that is available to provide services by modality, 
                      including the provision of recovery support 
                      services;
                          ``(v) provides a description of the State's 
                      comprehensive statewide prevention efforts, 
                      including the number of individuals being served 
                      in the system, target populations, and priority 
                      needs, and provides a description of the amount of 
                      funds from the prevention set-aside expended on 
                      primary prevention;
                          ``(vi) provides a description of the financial 
                      resources available;
                          ``(vii) describes the existing substance use 
                      disorders workforce and workforce trained in 
                      treating co-occurring substance use and mental 
                      disorders;
                          ``(viii) includes a description of how the 
                      State promotes evidence-based practices; and
                          ``(ix) describes how the State integrates 
                      substance use disorder services and primary health 
                      care, which in the case of those individuals with 
                      co-occurring mental health and substance use 
                      disorders may include

[[Page 130 STAT. 1232]]

                      providing both mental health and substance use 
                      disorder services in primary care settings or 
                      providing primary and specialty care services in 
                      community-based mental health and substance use 
                      disorder service settings.
                    ``(B) The establishment of goals and objectives for 
                the period of the plan, including targets and milestones 
                that are intended to be met, and the activities that 
                will be undertaken to achieve those targets.
                    ``(C) A description of how the State will comply 
                with each funding agreement for a grant under section 
                1921 that is applicable to the State, including a 
                description of the manner in which the State intends to 
                expend grant funds.''; and
                    (B) in paragraph (2)--
                          (i) in the paragraph heading, by striking 
                      ``authority of secretary regarding modifications'' 
                      and inserting ``modifications'';
                          (ii) by striking ``As a condition'' and 
                      inserting the following:
                    ``(A) Authority of secretary.--As a condition;''; 
                and
                          (iii) by adding at the end the following:
                    ``(B) State request for modification.--If the State 
                determines that a modification to such plan is 
                necessary, the State may request the Secretary to 
                approve the modification. Any such modification shall be 
                in accordance with paragraph (1) and section 1941.''; 
                and
                    (C) in paragraph (3), by inserting, ``, including 
                any modification under paragraph (2)'' after 
                ``subsection (a)(6)''; and
            (3) in subsection (e)(2), by striking ``section 1922(c)'' 
        and inserting ``section 1922(b)''.

    (j) Definitions.--Section 1934 of the Public Health Service Act (42 
U.S.C. 300x-34) is amended--
            (1) in paragraph (3), by striking ``substance abuse'' and 
        inserting ``substance use disorders''; and
            (2) in paragraph (7), by striking ``substance abuse'' and 
        inserting ``substance use disorders''.

    (k) Funding.--Section 1935 of the Public Health Service Act (42 
U.S.C. 300x-35) is amended--
            (1) in subsection (a)--
                    (A) by striking ``section 505'' and inserting 
                ``section 505(d)''; and
                    (B) by striking ``$2,000,000,000 for fiscal year 
                2001, and such sums as may be necessary for each of the 
                fiscal years 2002 and 2003'' and inserting 
                ``$1,858,079,000 for each of fiscal years 2018 through 
                2022.''; and
            (2) in subsection (b)(1)(B) by striking ``sections 505 and'' 
        and inserting ``sections 505(d) and''.
SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.

    Subpart III of part B of title XIX of the Public Health Service Act 
(42 U.S.C. 300x-51 et seq.) is amended--
            (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by 
        striking ``section 505'' and inserting ``subsections (c) and (d) 
        of section 505'';

[[Page 130 STAT. 1233]]

            (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking 
        ``substance abuse'' and inserting ``substance use disorder''; 
        and
            (3) by adding at the end the following:
``SEC. 1957. <<NOTE: 42 USC 300x-67.>>  PUBLIC HEALTH EMERGENCIES.

    ``In the case of a public health emergency (as determined under 
section 319), the Secretary, on a State by State basis, may, as the 
circumstances of the emergency reasonably require and for the period of 
the emergency, grant an extension, or waive application deadlines or 
compliance with any other requirement, of a grant authorized under 
section 521, 1911, or 1921 or an allotment authorized under Public Law 
99-319 (42 U.S.C. 10801 et seq.).
``SEC. 1958. <<NOTE: 42 USC 300x-68.>>  JOINT APPLICATIONS.

    ``The Secretary, acting through the Assistant Secretary for Mental 
Health and Substance Use, shall permit a joint application to be 
submitted for grants under subpart I and subpart II upon the request of 
a State. Such application may be jointly reviewed and approved by the 
Secretary with respect to such subparts, consistent with the purposes 
and authorized activities of each such grant program. A State submitting 
such a joint application shall otherwise meet the requirements with 
respect to each such subpart.''.
SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE 
                          ABUSE PREVENTION AND TREATMENT BLOCK 
                          GRANT AND THE COMMUNITY MENTAL HEALTH 
                          SERVICES BLOCK GRANT.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Assistant Secretary for Mental Health and Substance Use, 
shall through a grant or contract, or through an agreement with a third 
party, conduct a study on the formulas for distribution of funds under 
the substance abuse prevention and treatment block grant, and the 
community mental health services block grant, under part B of title XIX 
of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend 
changes if necessary. Such study shall include--
            (1) an analysis of whether the distributions under such 
        block grants accurately reflect the need for the services under 
        the grants in the States;
            (2) an examination of whether the indices used under the 
        formulas for distribution of funds under such block grants are 
        appropriate, and if not, alternatives recommended by the 
        Secretary;
            (3) where recommendations are included under paragraph (2) 
        for the use of different indices, a description of the variables 
        and data sources that should be used to determine the indices;
            (4) an evaluation of the variables and data sources that are 
        being used for each of the indices involved, and whether such 
        variables and data sources accurately represent the need for 
        services, the cost of providing services, and the ability of the 
        States to pay for such services;
            (5) the effect that the minimum allotment requirements for 
        each such block grant have on each State's final allotment and 
        the effect of such requirements, if any, on each State's 
        formula-based allotment;

[[Page 130 STAT. 1234]]

            (6) recommendations for modifications to the minimum 
        allotment provisions to ensure an appropriate distribution of 
        funds; and
            (7) any other information that the Secretary determines 
        appropriate.

    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, a 
report containing the findings and recommendations of the study 
conducted under subsection (a) and the study conducted under section 
9004(g).

 TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                                  CARE

              Subtitle A--Helping Individuals and Families

SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS 
                          INDIVIDUALS.

    Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is 
amended--
            (1) in subsection (a), by striking ``substance abuse'' and 
        inserting ``substance use disorder'';
            (2) in subsection (b)--
                    (A) in paragraphs (1) and (3), by striking 
                ``substance abuse'' each place the term appears and 
                inserting ``substance use disorder''; and
                    (B) in paragraph (4), by striking ``substance 
                abuse'' and inserting ``a substance use disorder'';
            (3) in subsection (c)--
                    (A) in paragraph (1), by striking ``substance abuse 
                disorder'' and inserting ``substance use disorder''; and
                    (B) in paragraph (2)--
                          (i) in subparagraph (A), by striking 
                      ``substance abuse'' and inserting ``a substance 
                      use disorder''; and
                          (ii) in subparagraph (B), by striking 
                      ``substance abuse'' and inserting ``substance use 
                      disorder''; and
            (4) in subsection (e), by striking ``, $50,000,000 for 
        fiscal year 2001, and such sums as may be necessary for each of 
        the fiscal years 2002 and 2003'' and inserting ``$41,304,000 for 
        each of fiscal years 2018 through 2022''.
SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.

    Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38) 
is amended--
            (1) by striking ``substance abuse'' each place such term 
        appears and inserting ``substance use disorder'';
            (2) in subsection (a)--
                    (A) by striking ``Indian tribes, and tribal 
                organizations'' and inserting ``and Indian tribes and 
                tribal organizations (as the terms `Indian tribes' and 
                `tribal organizations' are

[[Page 130 STAT. 1235]]

                defined in section 4 of the Indian Self-Determination 
                and Education Assistance Act)''; and
                    (B) by inserting ``or a health facility or program 
                operated by or in accordance with a contract or grant 
                with the Indian Health Service,'' after ``entities,'';
            (3) in subsection (c)(2)(A)(i), by striking ``the best 
        known'' and inserting ``evidence-based'';
            (4) by redesignating subsections (d) through (i) as 
        subsections (e) through (j), respectively;
            (5) by inserting after subsection (c) the following:

    ``(d) Special Consideration Regarding Veterans.--In awarding grants 
under subsection (a), the Secretary shall, as appropriate, give special 
consideration to entities proposing to use grant funding to support jail 
diversion services for veterans.'';
            (6) in subsection (e), as so redesignated--
                    (A) in paragraph (3), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in paragraph (4), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(5) develop programs to divert individuals prior to 
        booking or arrest.''; and
            (7) in subsection (j), as so redesignated, by striking 
        ``$10,000,000 for fiscal year 2001, and such sums as may be 
        necessary for fiscal years 2002 through 2003'' and inserting 
        ``$4,269,000 for each of fiscal years 2018 through 2022''.
SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH 
                          CARE.

    Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42) 
is amended to read as follows:
``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE 
                          AGREEMENTS.

    ``(a) Definitions.--In this section:
            ``(1) Eligible entity.--The term `eligible entity' means a 
        State, or other appropriate State agency, in collaboration with 
        1 or more qualified community programs as described in section 
        1913(b)(1) or 1 or more community health centers as described in 
        section 330.
            ``(2) Integrated care.--The term `integrated care' means 
        collaborative models or practices offering mental and physical 
        health services, which may include practices that share the same 
        space in the same facility.
            ``(3) Special population.--The term `special population' 
        means--
                    ``(A) adults with a mental illness who have co-
                occurring physical health conditions or chronic 
                diseases;
                    ``(B) adults with a serious mental illness who have 
                co-occurring physical health conditions or chronic 
                diseases;
                    ``(C) children and adolescents with a serious 
                emotional disturbance with co-occurring physical health 
                conditions or chronic diseases; or
                    ``(D) individuals with a substance use disorder.

    ``(b) Grants and Cooperative Agreements.--
            ``(1) In general.--The Secretary may award grants and 
        cooperative agreements to eligible entities to support the

[[Page 130 STAT. 1236]]

        improvement of integrated care for primary care and behavioral 
        health care in accordance with paragraph (2).
            ``(2) Purposes.--A grant or cooperative agreement awarded 
        under this section shall be designed to--
                    ``(A) promote full integration and collaboration in 
                clinical practices between primary and behavioral health 
                care;
                    ``(B) support the improvement of integrated care 
                models for primary care and behavioral health care to 
                improve the overall wellness and physical health status 
                of adults with a serious mental illness or children with 
                a serious emotional disturbance; and
                    ``(C) promote integrated care services related to 
                screening, diagnosis, prevention, and treatment of 
                mental and substance use disorders, and co-occurring 
                physical health conditions and chronic diseases.

    ``(c) Applications.--
            ``(1) In general.--An eligible entity seeking a grant or 
        cooperative agreement under this section shall submit an 
        application to the Secretary at such time, in such manner, and 
        accompanied by such information as the Secretary may require, 
        including the contents described in paragraph (2).
            ``(2) Contents.--The contents described in this paragraph 
        are--
                    ``(A) a description of a plan to achieve fully 
                collaborative agreements to provide services to special 
                populations;
                    ``(B) a document that summarizes the policies, if 
                any, that serve as barriers to the provision of 
                integrated care, and the specific steps, if applicable, 
                that will be taken to address such barriers;
                    ``(C) a description of partnerships or other 
                arrangements with local health care providers to provide 
                services to special populations;
                    ``(D) an agreement and plan to report to the 
                Secretary performance measures necessary to evaluate 
                patient outcomes and facilitate evaluations across 
                participating projects; and
                    ``(E) a plan for sustainability beyond the grant or 
                cooperative agreement period under subsection (e).

    ``(d) Grant and Cooperative Agreement Amounts.--
            ``(1) Target amount.--The target amount that an eligible 
        entity may receive for a year through a grant or cooperative 
        agreement under this section shall be $2,000,000.
            ``(2) Adjustment permitted.--The Secretary, taking into 
        consideration the quality of the application and the number of 
        eligible entities that received grants under this section prior 
        to the date of enactment of the Helping Families in Mental 
        Health Crisis Reform Act of 2016, may adjust the target amount 
        that an eligible entity may receive for a year through a grant 
        or cooperative agreement under this section.
            ``(3) Limitation.--An eligible entity receiving funding 
        under this section may not allocate more than 10 percent of 
        funds awarded under this section to administrative functions, 
        and the remaining amounts shall be allocated to health 
        facilities that provide integrated care.

    ``(e) Duration.--A grant or cooperative agreement under this section 
shall be for a period not to exceed 5 years.

[[Page 130 STAT. 1237]]

    ``(f) Report on Program Outcomes.--An eligible entity receiving a 
grant or cooperative agreement under this section shall submit an annual 
report to the Secretary that includes--
            ``(1) the progress made to reduce barriers to integrated 
        care as described in the entity's application under subsection 
        (c); and
            ``(2) a description of functional outcomes of special 
        populations, including--
                    ``(A) with respect to adults with a serious mental 
                illness, participation in supportive housing or 
                independent living programs, attendance in social and 
                rehabilitative programs, participation in job training 
                opportunities, satisfactory performance in work 
                settings, attendance at scheduled medical and mental 
                health appointments, and compliance with prescribed 
                medication regimes;
                    ``(B) with respect to individuals with co-occurring 
                mental illness and physical health conditions and 
                chronic diseases, attendance at scheduled medical and 
                mental health appointments, compliance with prescribed 
                medication regimes, and participation in learning 
                opportunities related to improved health and lifestyle 
                practices; and
                    ``(C) with respect to children and adolescents with 
                a serious emotional disturbance who have co-occurring 
                physical health conditions and chronic diseases, 
                attendance at scheduled medical and mental health 
                appointments, compliance with prescribed medication 
                regimes, and participation in learning opportunities at 
                school and extracurricular activities.

    ``(g) Technical Assistance for Primary-Behavioral Health Care 
Integration.--
            ``(1) In general.--The Secretary may provide appropriate 
        information, training, and technical assistance to eligible 
        entities that receive a grant or cooperative agreement under 
        this section, in order to help such entities meet the 
        requirements of this section, including assistance with--
                    ``(A) development and selection of integrated care 
                models;
                    ``(B) dissemination of evidence-based interventions 
                in integrated care;
                    ``(C) establishment of organizational practices to 
                support operational and administrative success; and
                    ``(D) other activities, as the Secretary determines 
                appropriate.
            ``(2) Additional dissemination of technical information.--
        The information and resources provided by the Secretary under 
        paragraph (1) shall, as appropriate, be made available to 
        States, political subdivisions of States, Indian tribes or 
        tribal organizations (as defined in section 4 of the Indian 
        Self-Determination and Education Assistance Act), outpatient 
        mental health and addiction treatment centers, community mental 
        health centers that meet the criteria under section 1913(c), 
        certified community behavioral health clinics described in 
        section 223 of the Protecting Access to Medicare Act of 2014, 
        primary care organizations such as Federally qualified health 
        centers or rural health clinics as defined in section 1861(aa)

[[Page 130 STAT. 1238]]

        of the Social Security Act, other community-based organizations, 
        or other entities engaging in integrated care activities, as the 
        Secretary determines appropriate.

    ``(h) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $51,878,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM 
                          HOMELESSNESS.

    (a) Formula Grants to States.--Section 521 of the Public Health 
Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through 
1994'' and inserting ``2018 through 2022''.
    (b) Purpose of Grants.--Section 522 of the Public Health Service Act 
(42 U.S.C. 290cc-22) is amended--
            (1) in subsection (a)(1)(B), by striking ``substance abuse'' 
        and inserting ``a substance use disorder'';
            (2) in subsection (b)(6), by striking ``substance abuse'' 
        and inserting ``substance use disorder'';
            (3) in subsection (c), by striking ``substance abuse'' and 
        inserting ``a substance use disorder'';
            (4) in subsection (e)--
                    (A) in paragraph (1), by striking ``substance 
                abuse'' and inserting ``a substance use disorder''; and
                    (B) in paragraph (2), by striking ``substance 
                abuse'' and inserting ``substance use disorder'';
            (5) by striking subsection (g) and redesignating subsections 
        (h) and (i) as (g) and (h), accordingly; and
            (6) in subsection (g), as redesignated by paragraph (5), by 
        striking ``substance abuse'' each place such term appears and 
        inserting ``substance use disorder''.

    (c) Description of Intended Expenditures of Grant.--Section 527 of 
the Public Health Service Act (42 U.S.C. 290cc-27) is amended by 
striking ``substance abuse'' each place such term appears and inserting 
``substance use disorder''.
    (d) Technical Assistance.--Section 530 of the Public Health Service 
Act (42 U.S.C. 290cc-30) is amended by striking ``through the National 
Institute of Mental Health, the National Institute of Alcohol Abuse and 
Alcoholism, and the National Institute on Drug Abuse'' and inserting 
``acting through the Assistant Secretary''.
    (e) Definitions.--Section 534(4) of the Public Health Service Act 
(42 U.S.C. 290cc-34(4)) is amended to read as follows:
            ``(4) Substance use disorder services.--The term `substance 
        use disorder services' has the meaning given the term `substance 
        abuse services' in section 330(h)(5)(C).''.

    (f) Funding.--Section 535(a) of the Public Health Service Act (42 
U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of the 
fiscal years 2001 through 2003'' and inserting ``$64,635,000 for each of 
fiscal years 2018 through 2022''.
    (g) Study Concerning Formula.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Assistant Secretary for Mental Health 
        and Substance Use (referred to in this section as the 
        ``Assistant Secretary'') shall conduct a study concerning the 
        formula used under section 524 of the Public Health Service Act 
        (42 U.S.C. 290cc-24) for making allotments to States under 
        section 521 of such Act (42 U.S.C. 290cc-21). Such study shall 
        include an evaluation of quality indicators of need for purposes

[[Page 130 STAT. 1239]]

        of revising the formula for determining the amount of each 
        allotment for the fiscal years following the submission of the 
        study.
            (2) Report.--In accordance with section 8004(b), the 
        Assistant Secretary shall submit to the committees of Congress 
        described in such section a report concerning the results of the 
        study conducted under paragraph (1).
SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.

    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2 
(42 U.S.C. 290bb-36b) the following:
``SEC. 520E-3. <<NOTE: 42 USC 290bb-36c.>>  NATIONAL SUICIDE 
                              PREVENTION LIFELINE PROGRAM.

    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary, shall maintain the National Suicide Prevention Lifeline 
program (referred to in this section as the `program'), authorized under 
section 520A and in effect prior to the date of enactment of the Helping 
Families in Mental Health Crisis Reform Act of 2016.
    ``(b) Activities.--In maintaining the program, the activities of the 
Secretary shall include--
            ``(1) coordinating a network of crisis centers across the 
        United States for providing suicide prevention and crisis 
        intervention services to individuals seeking help at any time, 
        day or night;
            ``(2) maintaining a suicide prevention hotline to link 
        callers to local emergency, mental health, and social services 
        resources; and
            ``(3) consulting with the Secretary of Veterans Affairs to 
        ensure that veterans calling the suicide prevention hotline have 
        access to a specialized veterans' suicide prevention hotline.

    ``(c) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $7,198,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.

    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.), as amended by section 9005, is further amended 
by inserting after section 520E-3 the following:
``SEC. 520E-4. <<NOTE: 42 USC 290bb-36d.>>  TREATMENT REFERRAL 
                              ROUTING SERVICE.

    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary, shall maintain the National Treatment Referral Routing 
Service (referred to in this section as the `Routing Service') to assist 
individuals and families in locating mental and substance use disorders 
treatment providers.
    ``(b) Activities of the Secretary.--To maintain the Routing Service, 
the activities of the Assistant Secretary shall include administering--
            ``(1) a nationwide, telephone number providing year-round 
        access to information that is updated on a regular basis 
        regarding local behavioral health providers and community-based 
        organizations in a manner that is confidential, without 
        requiring individuals to identify themselves, is in languages 
        that include at least English and Spanish, and is at no cost to 
        the individual using the Routing Service; and

[[Page 130 STAT. 1240]]

            ``(2) an Internet website to provide a searchable, online 
        treatment services locator of behavioral health treatment 
        providers and community-based organizations, which shall include 
        information on the name, location, contact information, and 
        basic services provided by such providers and organizations.

    ``(c) Removing Practitioner Contact Information.--In the event that 
the Internet website described in subsection (b)(2) contains information 
on any qualified practitioner that is certified to prescribe medication 
for opioid dependency under section 303(g)(2)(B) of the Controlled 
Substances Act, the Assistant Secretary--
            ``(1) shall provide an opportunity to such practitioner to 
        have the contact information of the practitioner removed from 
        the website at the request of the practitioner; and
            ``(2) may evaluate other methods to periodically update the 
        information displayed on such website.

    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to prevent the Assistant Secretary from using any unobligated 
amounts otherwise made available to the Administration to maintain the 
Routing Service.''.
SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.

    Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37) 
is amended to read as follows:
``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.

    ``(a) In General.--The Secretary shall award competitive grants to--
            ``(1) State and local governments and Indian tribes and 
        tribal organizations, to enhance community-based crisis response 
        systems; or
            ``(2) States to develop, maintain, or enhance a database of 
        beds at inpatient psychiatric facilities, crisis stabilization 
        units, and residential community mental health and residential 
        substance use disorder treatment facilities, for adults with a 
        serious mental illness, children with a serious emotional 
        disturbance, or individuals with a substance use disorder.

    ``(b) Applications.--
            ``(1) In general.--To receive a grant under subsection (a), 
        an entity shall submit to the Secretary an application, at such 
        time, in such manner, and containing such information as the 
        Secretary may require.
            ``(2) Community-based crisis response plan.--An application 
        for a grant under subsection (a)(1) shall include a plan for--
                    ``(A) promoting integration and coordination between 
                local public and private entities engaged in crisis 
                response, including first responders, emergency health 
                care providers, primary care providers, law enforcement, 
                court systems, health care payers, social service 
                providers, and behavioral health providers;
                    ``(B) developing memoranda of understanding with 
                public and private entities to implement crisis response 
                services;
                    ``(C) addressing gaps in community resources for 
                crisis intervention and prevention; and

[[Page 130 STAT. 1241]]

                    ``(D) developing models for minimizing hospital 
                readmissions, including through appropriate discharge 
                planning.
            ``(3) Beds database plan.--An application for a grant under 
        subsection (a)(2) shall include a plan for developing, 
        maintaining, or enhancing a real-time, Internet-based bed 
        database to collect, aggregate, and display information about 
        beds in inpatient psychiatric facilities and crisis 
        stabilization units, and residential community mental health and 
        residential substance use disorder treatment facilities to 
        facilitate the identification and designation of facilities for 
        the temporary treatment of individuals in mental or substance 
        use disorder crisis.

    ``(c) Database Requirements.--A bed database described in this 
section is a database that--
            ``(1) includes information on inpatient psychiatric 
        facilities, crisis stabilization units, and residential 
        community mental health and residential substance use disorder 
        facilities in the State involved, including contact information 
        for the facility or unit;
            ``(2) provides real-time information about the number of 
        beds available at each facility or unit and, for each available 
        bed, the type of patient that may be admitted, the level of 
        security provided, and any other information that may be 
        necessary to allow for the proper identification of appropriate 
        facilities for treatment of individuals in mental or substance 
        use disorder crisis; and
            ``(3) enables searches of the database to identify available 
        beds that are appropriate for the treatment of individuals in 
        mental or substance use disorder crisis.

    ``(d) Evaluation.--An entity receiving a grant under subsection 
(a)(1) shall submit to the Secretary, at such time, in such manner, and 
containing such information as the Secretary may reasonably require, a 
report, including an evaluation of the effect of such grant on--
            ``(1) local crisis response services and measures for 
        individuals receiving crisis planning and early intervention 
        supports;
            ``(2) individuals reporting improved functional outcomes; 
        and
            ``(3) individuals receiving regular followup care following 
        a crisis.

    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $12,500,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.

    (a) Suicide Prevention Technical Assistance Center.--Section 520C of 
the Public Health Service Act (42 U.S.C. 290bb-34), as amended by 
section 6001, is further amended--
            (1) in the section heading, by striking ``youth interagency 
        research, training, and technical assistance centers'' and 
        inserting ``suicide prevention technical assistance center'';
            (2) in subsection (a), by striking ``acting through the 
        Assistant Secretary for Mental Health and Substance Use'' and 
        all that follows through the period at the end of paragraph (2) 
        and inserting ``acting through the Assistant Secretary, shall 
        establish a research, training, and technical assistance 
        resource

[[Page 130 STAT. 1242]]

        center to provide appropriate information, training, and 
        technical assistance to States, political subdivisions of 
        States, federally recognized Indian tribes, tribal 
        organizations, institutions of higher education, public 
        organizations, or private nonprofit organizations regarding the 
        prevention of suicide among all ages, particularly among groups 
        that are at a high risk for suicide.'';
            (3) by striking subsections (b) and (c);
            (4) by redesignating subsection (d) as subsection (b);
            (5) in subsection (b), as so redesignated--
                    (A) in the subsection heading, by striking 
                ``Additional Center'' and inserting ``Responsibilities 
                of the Center'';
                    (B) in the matter preceding paragraph (1), by 
                striking ``The additional research'' and all that 
                follows through ``nonprofit organizations for'' and 
                inserting ``The center established under subsection (a) 
                shall conduct activities for the purpose of'';
                    (C) by striking ``youth suicide'' each place such 
                term appears and inserting ``suicide'';
                    (D) in paragraph (1)--
                          (i) by striking ``the development or 
                      continuation of'' and inserting ``developing and 
                      continuing''; and
                          (ii) by inserting ``for all ages, particularly 
                      among groups that are at a high risk for suicide'' 
                      before the semicolon at the end;
                    (E) in paragraph (2), by inserting ``for all ages, 
                particularly among groups that are at a high risk for 
                suicide'' before the semicolon at the end;
                    (F) in paragraph (3), by inserting ``and tribal'' 
                after ``statewide'';
                    (G) in paragraph (5), by inserting ``and 
                prevention'' after ``intervention'';
                    (H) in paragraph (8), by striking ``in youth'';
                    (I) in paragraph (9), by striking ``and behavioral 
                health'' and inserting ``health and substance use 
                disorder''; and
                    (J) in paragraph (10), by inserting ``conducting'' 
                before ``other''; and
            (6) by striking subsection (e) and inserting the following:

    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $5,988,000 for 
each of fiscal years 2018 through 2022.
    ``(d) Annual Report.--Not later than 2 years after the date of 
enactment of this subsection, the Secretary shall submit to Congress a 
report on the activities carried out by the center established under 
subsection (a) during the year involved, including the potential effects 
of such activities, and the States, organizations, and institutions that 
have worked with the center.''.
    (b) Youth Suicide Early Intervention and Prevention Strategies.--
Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is 
amended--
            (1) in paragraph (1) of subsection (a) and in subsection 
        (c), by striking ``substance abuse'' each place such term 
        appears and inserting ``substance use disorder'';
            (2) in subsection (b)--
                    (A) in paragraph (2)--

[[Page 130 STAT. 1243]]

                          (i) by striking ``ensure that each State is 
                      awarded only 1 grant or cooperative agreement 
                      under this section'' and inserting ``ensure that a 
                      State does not receive more than 1 grant or 
                      cooperative agreement under this section at any 1 
                      time''; and
                          (ii) by striking ``been awarded'' and 
                      inserting ``received''; and
                    (B) by adding after paragraph (2) the following:
            ``(3) Consideration.--In awarding grants under this section, 
        the Secretary shall take into consideration the extent of the 
        need of the applicant, including the incidence and prevalence of 
        suicide in the State and among the populations of focus, 
        including rates of suicide determined by the Centers for Disease 
        Control and Prevention for the State or population of focus.'';
            (3) in subsection (g)(2), by striking ``2 years after the 
        date of enactment of this section,'' and insert ``2 years after 
        the date of enactment of Helping Families in Mental Health 
        Crisis Reform Act of 2016,''; and
            (4) by striking subsection (m) and inserting the following:

    ``(m) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $30,000,000 
for each of fiscal years 2018 through 2022.''.
SEC. 9009. <<NOTE: 42 USC 290bb-43.>>  ADULT SUICIDE PREVENTION.

    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
``SEC. 520L. ADULT SUICIDE PREVENTION.

    ``(a) Grants.--
            ``(1) In general.--The Assistant Secretary shall award 
        grants to eligible entities described in paragraph (2) to 
        implement suicide prevention and intervention programs, for 
        individuals who are 25 years of age or older, that are designed 
        to raise awareness of suicide, establish referral processes, and 
        improve care and outcomes for such individuals who are at risk 
        of suicide.
            ``(2) Eligible entities.--To be eligible to receive a grant 
        under this section, an entity shall be a community-based primary 
        care or behavioral health care setting, an emergency department, 
        a State mental health agency (or State health agency with mental 
        or behavioral health functions), public health agency, a 
        territory of the United States, or an Indian tribe or tribal 
        organization (as the terms `Indian tribe' and `tribal 
        organization' are defined in section 4 of the Indian Self-
        Determination and Education Assistance Act).
            ``(3) Use of funds.--The grants awarded under paragraph (1) 
        shall be used to implement programs, in accordance with such 
        paragraph, that include one or more of the following components:
                    ``(A) Screening for suicide risk, suicide 
                intervention services, and services for referral for 
                treatment for individuals at risk for suicide.
                    ``(B) Implementing evidence-based practices to 
                provide treatment for individuals at risk for suicide, 
                including appropriate followup services.
                    ``(C) Raising awareness and reducing stigma of 
                suicide.

[[Page 130 STAT. 1244]]

    ``(b) Evaluations and Technical Assistance.--The Assistant Secretary 
shall--
            ``(1) evaluate the activities supported by grants awarded 
        under subsection (a), and disseminate, as appropriate, the 
        findings from the evaluation; and
            ``(2) provide appropriate information, training, and 
        technical assistance, as appropriate, to eligible entities that 
        receive a grant under this section, in order to help such 
        entities to meet the requirements of this section, including 
        assistance with selection and implementation of evidence-based 
        interventions and frameworks to prevent suicide.

    ``(c) Duration.--A grant under this section shall be for a period of 
not more than 5 years.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $30,000,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.

    Section 520J of the Public Health Service Act (42 U.S.C. 290bb-41) 
is amended--
            (1) in the section heading, by inserting ``mental health 
        awareness'' before ``training''; and
            (2) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``Illness'' and inserting ``Health'';
                    (B) in paragraph (1), by inserting ``veterans, law 
                enforcement, and other categories of individuals, as 
                determined by the Secretary,'' after ``emergency 
                services personnel'';
                    (C) in paragraph (5)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``to'' and inserting ``for evidence-
                      based programs that provide training and education 
                      in accordance with paragraph (1) on matters 
                      including''; and
                          (ii) by striking subparagraphs (A) through (C) 
                      and inserting the following:
                    ``(A) recognizing the signs and symptoms of mental 
                illness; and
                    ``(B)(i) resources available in the community for 
                individuals with a mental illness and other relevant 
                resources; or
                    ``(ii) safely de-escalating crisis situations 
                involving individuals with a mental illness.''; and
                    (D) in paragraph (7), by striking ``, $25,000,000'' 
                and all that follows through the period at the end and 
                inserting ``$14,693,000 for each of fiscal years 2018 
                through 2022.''.
SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND 
                          ALASKA NATIVE YOUTH WITHIN SUICIDE 
                          PREVENTION PROGRAMS.

    (a) Findings.--The Congress finds as follows:
            (1) Suicide is the eighth leading cause of death among 
        American Indians and Alaska Natives across all ages.
            (2) Among American Indians and Alaska Natives who are 10 to 
        34 years of age, suicide is the second leading cause of death.
            (3) The suicide rate among American Indian and Alaska Native 
        adolescents and young adults ages 15 to 34 (17.9 per

[[Page 130 STAT. 1245]]

        100,000) is approximately 1.3 times higher than the national 
        average for that age group (13.3 per 100,000).

    (b) Sense of Congress.--It is the sense of Congress that the 
Secretary of Health and Human Services, in carrying out suicide 
prevention and intervention programs, should prioritize programs and 
activities for populations with disproportionately high rates of 
suicide, such as American Indians and Alaska Natives.
SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.

    Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
32(e)) is amended by adding at the end the following:
            ``(3) Geriatric mental disorders.--The Secretary shall, as 
        appropriate, provide technical assistance to grantees regarding 
        evidence-based practices for the prevention and treatment of 
        geriatric mental disorders and co-occurring mental health and 
        substance use disorders among geriatric populations, as well as 
        disseminate information about such evidence-based practices to 
        States and nongrantees throughout the United States.''.
SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.

    The Secretary of Health and Human Services, acting through the 
Director of the Centers for Disease Control and Prevention, is 
encouraged to improve, particularly through the inclusion of additional 
States, the National Violent Death Reporting System as authorized by 
title III of the Public Health Service Act (42 U.S.C. 241 et seq.). 
Participation in the system by the States shall be voluntary.
SEC. 9014. ASSISTED OUTPATIENT TREATMENT.

    Section 224 of the Protecting Access to Medicare Act of 2014 (42 
U.S.C. 290aa note) is amended--
            (1) in subsection (e), by striking ``and 2018,'' and 
        inserting ``2018, 2019, 2020, 2021, and 2022,''; and
            (2) in subsection (g)--
                    (A) in paragraph (1), by striking ``2018'' and 
                inserting ``2022''; and
                    (B) in paragraph (2), by striking ``is authorized to 
                be appropriated to carry out this section $15,000,000 
                for each of fiscal years 2015 through 2018'' and 
                inserting ``are authorized to be appropriated to carry 
                out this section $15,000,000 for each of fiscal years 
                2015 through 2017, $20,000,000 for fiscal year 2018, 
                $19,000,000 for each of fiscal years 2019 and 2020, and 
                $18,000,000 for each of fiscal years 2021 and 2022''.
SEC. 9015. <<NOTE: 42 USC 290bb-44.>>  ASSERTIVE COMMUNITY 
                          TREATMENT GRANT PROGRAM.

    Part B of title V of the Public Health Service Act (42 U.S.C. 290bb 
et seq.), as amended by section 9009, is further amended by adding at 
the end the following:
``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.

    ``(a) In General.--The Assistant Secretary shall award grants to 
eligible entities--
            ``(1) to establish assertive community treatment programs 
        for adults with a serious mental illness; or
            ``(2) to maintain or expand such programs.

[[Page 130 STAT. 1246]]

    ``(b) Eligible Entities.--To be eligible to receive a grant under 
this section, an entity shall be a State, political subdivision of a 
State, Indian tribe or tribal organization (as such terms are defined in 
section 4 of the Indian Self-Determination and Education Assistance 
Act), mental health system, health care facility, or any other entity 
the Assistant Secretary deems appropriate.
    ``(c) Special Consideration.--In selecting among applicants for a 
grant under this section, the Assistant Secretary may give special 
consideration to the potential of the applicant's program to reduce 
hospitalization, homelessness, and involvement with the criminal justice 
system while improving the health and social outcomes of the patient.
    ``(d) Additional Activities.--The Assistant Secretary shall--
            ``(1) not later than the end of fiscal year 2021, submit a 
        report to the appropriate congressional committees on the grant 
        program under this section, including an evaluation of--
                    ``(A) any cost savings and public health outcomes 
                such as mortality, suicide, substance use disorders, 
                hospitalization, and use of services;
                    ``(B) rates of involvement with the criminal justice 
                system of patients;
                    ``(C) rates of homelessness among patients; and
                    ``(D) patient and family satisfaction with program 
                participation; and
            ``(2) provide appropriate information, training, and 
        technical assistance to grant recipients under this section to 
        help such recipients to establish, maintain, or expand their 
        assertive community treatment programs.

    ``(e) Authorization of Appropriations.--
            ``(1) In general.--To carry out this section, there is 
        authorized to be appropriated $5,000,000 for the period of 
        fiscal years 2018 through 2022.
            ``(2) Use of certain funds.--Of the funds appropriated to 
        carry out this section in any fiscal year, not more than 5 
        percent shall be available to the Assistant Secretary for 
        carrying out subsection (d).''.
SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING 
                          REAUTHORIZATION.

    Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b) 
is amended--
            (1) in subsection (c)(3), by striking ``fiscal year 2007'' 
        and all that follows through the period at the end and inserting 
        ``each of the fiscal years 2018 through 2022.'';
            (2) in subsection (d)(4), by striking ``fiscal year 2007'' 
        and all that follows through the period at the end and inserting 
        ``each of the fiscal years 2018 through 2022.'';
            (3) in subsection (e)(1)(I), by striking ``fiscal year 
        2007'' and all that follows through the period at the end and 
        inserting ``each of the fiscal years 2018 through 2022.'';
            (4) in subsection (f)(2), by striking ``$6,000,000 for 
        fiscal year 2007'' and all that follows through the period at 
        the end and inserting ``$3,000,000 for each of the fiscal years 
        2018 through 2022''; and
            (5) by adding at the end the following new subsection:

    ``(g) Reducing Underage Drinking Through Screening and Brief 
Intervention.--

[[Page 130 STAT. 1247]]

            ``(1) Grants to pediatric health care providers to reduce 
        underage drinking.--The Assistant Secretary may make grants to 
        eligible entities to increase implementation of practices for 
        reducing the prevalence of alcohol use among individuals under 
        the age of 21, including college students.
            ``(2) Purposes.--Grants under this subsection shall be made 
        to improve--
                    ``(A) screening children and adolescents for alcohol 
                use;
                    ``(B) offering brief interventions to children and 
                adolescents to discourage such use;
                    ``(C) educating parents about the dangers of, and 
                methods of discouraging, such use;
                    ``(D) diagnosing and treating alcohol use disorders; 
                and
                    ``(E) referring patients, when necessary, to other 
                appropriate care.
            ``(3) Use of funds.--An entity receiving a grant under this 
        subsection may use such funding for the purposes identified in 
        paragraph (2) by--
                    ``(A) providing training to health care providers;
                    ``(B) disseminating best practices, including 
                culturally and linguistically appropriate best 
                practices, as appropriate, and developing and 
                distributing materials; and
                    ``(C) supporting other activities, as determined 
                appropriate by the Assistant Secretary.
            ``(4) Application.--To be eligible to receive a grant under 
        this subsection, an entity shall submit an application to the 
        Assistant Secretary at such time, and in such manner, and 
        accompanied by such information as the Assistant Secretary may 
        require. Each application shall include--
                    ``(A) a description of the entity;
                    ``(B) a description of activities to be completed;
                    ``(C) a description of how the services specified in 
                paragraphs (2) and (3) will be carried out and the 
                qualifications for providing such services; and
                    ``(D) a timeline for the completion of such 
                activities.
            ``(5) Definitions.--For the purpose of this subsection:
                    ``(A) Brief intervention.--The term `brief 
                intervention' means, after screening a patient, 
                providing the patient with brief advice and other brief 
                motivational enhancement techniques designed to increase 
                the insight of the patient regarding the patient's 
                alcohol use, and any realized or potential consequences 
                of such use, to effect the desired related behavioral 
                change.
                    ``(B) Children and adolescents.--The term `children 
                and adolescents' means any person under 21 years of age.
                    ``(C) Eligible entity.--The term `eligible entity' 
                means an entity consisting of pediatric health care 
                providers and that is qualified to support or provide 
                the activities identified in paragraph (2).
                    ``(D) Pediatric health care provider.--The term 
                `pediatric health care provider' means a provider of 
                primary health care to individuals under the age of 21 
                years.
                    ``(E) Screening.--The term `screening' means using 
                validated patient interview techniques to identify and 
                assess the existence and extent of alcohol use in a 
                patient.''.

[[Page 130 STAT. 1248]]

SEC. 9017. CENTER AND PROGRAM REPEALS.

    Part B of title V of the Public Health Service Act (42 U.S.C. 290bb 
et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the 
second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and 
amphetamine treatment initiatives, and each of sections 514A, 517, 519A, 
519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 290bb-
25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).

           Subtitle B--Strengthening the Health Care Workforce

SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING 
                          GRANTS.

    Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is 
amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``of higher education''; and
                    (B) by striking paragraphs (1) through (4) and 
                inserting the following:
            ``(1) accredited institutions of higher education or 
        accredited professional training programs that are establishing 
        or expanding internships or other field placement programs in 
        mental health in psychiatry, psychology, school psychology, 
        behavioral pediatrics, psychiatric nursing (which may include 
        master's and doctoral level programs), social work, school 
        social work, substance use disorder prevention and treatment, 
        marriage and family therapy, occupational therapy, school 
        counseling, or professional counseling, including such programs 
        with a focus on child and adolescent mental health and 
        transitional-age youth;
            ``(2) accredited doctoral, internship, and post-doctoral 
        residency programs of health service psychology (including 
        clinical psychology, counseling, and school psychology) for the 
        development and implementation of interdisciplinary training of 
        psychology graduate students for providing behavioral health 
        services, including substance use disorder prevention and 
        treatment services, as well as the development of faculty in 
        health service psychology;
            ``(3) accredited master's and doctoral degree programs of 
        social work for the development and implementation of 
        interdisciplinary training of social work graduate students for 
        providing behavioral health services, including substance use 
        disorder prevention and treatment services, and the development 
        of faculty in social work; and
            ``(4) State-licensed mental health nonprofit and for-profit 
        organizations to enable such organizations to pay for programs 
        for preservice or in-service training in a behavioral health-
        related paraprofessional field with preference for preservice or 
        in-service training of paraprofessional child and adolescent 
        mental health workers.'';
            (2) in subsection (b)--
                    (A) by striking paragraph (5);

[[Page 130 STAT. 1249]]

                    (B) by redesignating paragraphs (1) through (4) as 
                paragraphs (2) through (5), respectively;
                    (C) by inserting before paragraph (2), as so 
                redesignated, the following:
            ``(1) an ability to recruit and place the students described 
        in subsection (a) in areas with a high need and high demand 
        population;'';
                    (D) in paragraph (3), as so redesignated, by 
                striking ``subsection (a)'' and inserting ``paragraph 
                (2), especially individuals with mental disorder 
                symptoms or diagnoses, particularly children and 
                adolescents, and transitional-age youth'';
                    (E) in paragraph (4), as so redesignated, by 
                striking ``;'' and inserting ``; and''; and
                    (F) in paragraph (5), as so redesignated, by 
                striking ``; and'' and inserting a period;
            (3) in subsection (c), by striking ``authorized under 
        subsection (a)(1)'' and inserting ``awarded under paragraphs (2) 
        and (3) of subsection (a)'';
            (4) by amending subsection (d) to read as follows:

    ``(d) Priority.--In selecting grant recipients under this section, 
the Secretary shall give priority to--
            ``(1) programs that have demonstrated the ability to train 
        psychology, psychiatry, and social work professionals to work in 
        integrated care settings for purposes of recipients under 
        paragraphs (1), (2), and (3) of subsection (a); and
            ``(2) programs for paraprofessionals that emphasize the role 
        of the family and the lived experience of the consumer and 
        family-paraprofessional partnerships for purposes of recipients 
        under subsection (a)(4).''; and
            (5) by striking subsection (e) and inserting the following:

    ``(e) Report to Congress.--Not later than 4 years after the date of 
enactment of the Helping Families in Mental Health Crisis Reform Act of 
2016, the Secretary shall include in the biennial report submitted to 
Congress under section 501(m) an assessment on the effectiveness of the 
grants under this section in--
            ``(1) providing graduate students support for experiential 
        training (internship or field placement);
            ``(2) recruiting students interested in behavioral health 
        practice;
            ``(3) recruiting students in accordance with subsection 
        (b)(1);
            ``(4) developing and implementing interprofessional training 
        and integration within primary care;
            ``(5) developing and implementing accredited field 
        placements and internships; and
            ``(6) collecting data on the number of students trained in 
        behavioral health care and the number of available accredited 
        internships and field placements.

    ``(f) Authorization of Appropriations.--For each of fiscal years 
2018 through 2022, there are authorized to be appropriated to carry out 
this section $50,000,000, to be allocated as follows:
            ``(1) For grants described in subsection (a)(1), 
        $15,000,000.
            ``(2) For grants described in subsection (a)(2), 
        $15,000,000.
            ``(3) For grants described in subsection (a)(3), 
        $10,000,000.
            ``(4) For grants described in subsection (a)(4), 
        $10,000,000.''.

[[Page 130 STAT. 1250]]

SEC. 9022. <<NOTE: 42 USC 294k.>>  STRENGTHENING THE MENTAL AND 
                          SUBSTANCE USE DISORDERS WORKFORCE.

    Part D of title VII of the Public Health Service Act (42 U.S.C. 294 
et seq.) is amended by adding at the end the following:
``SEC. 760. TRAINING DEMONSTRATION PROGRAM.

    ``(a) In General.--The Secretary shall establish a training 
demonstration program to award grants to eligible entities to support--
            ``(1) training for medical residents and fellows to practice 
        psychiatry and addiction medicine in underserved, community-
        based settings that integrate primary care with mental and 
        substance use disorders prevention and treatment services;
            ``(2) training for nurse practitioners, physician 
        assistants, health service psychologists, and social workers to 
        provide mental and substance use disorders services in 
        underserved community-based settings that integrate primary care 
        and mental and substance use disorders services; and
            ``(3) establishing, maintaining, or improving academic units 
        or programs that--
                    ``(A) provide training for students or faculty, 
                including through clinical experiences and research, to 
                improve the ability to be able to recognize, diagnose, 
                and treat mental and substance use disorders, with a 
                special focus on addiction; or
                    ``(B) develop evidence-based practices or 
                recommendations for the design of the units or programs 
                described in subparagraph (A), including curriculum 
                content standards.

    ``(b) Activities.--
            ``(1) Training for residents and fellows.--A recipient of a 
        grant under subsection (a)(1)--
                    ``(A) shall use the grant funds--
                          ``(i)(I) to plan, develop, and operate a 
                      training program for medical psychiatry residents 
                      and fellows in addiction medicine practicing in 
                      eligible entities described in subsection (c)(1); 
                      or
                          ``(II) to train new psychiatric residents and 
                      fellows in addiction medicine to provide and 
                      expand access to integrated mental and substance 
                      use disorders services; and
                          ``(ii) to provide at least 1 training track 
                      that is--
                                    ``(I) a virtual training track that 
                                includes an in-person rotation at a 
                                teaching health center or in a 
                                community-based setting, followed by a 
                                virtual rotation in which the resident 
                                or fellow continues to support the care 
                                of patients at the teaching health 
                                center or in the community-based setting 
                                through the use of health information 
                                technology and, as appropriate, 
                                telehealth services;
                                    ``(II) an in-person training track 
                                that includes a rotation, during which 
                                the resident or fellow practices at a 
                                teaching health center or in a 
                                community-based setting; or
                                    ``(III) an in-person training track 
                                that includes a rotation during which 
                                the resident practices in a community-
                                based setting that specializes in the

[[Page 130 STAT. 1251]]

                                treatment of infants, children, 
                                adolescents, or pregnant or postpartum 
                                women; and
                    ``(B) may use the grant funds to provide additional 
                support for the administration of the program or to meet 
                the costs of projects to establish, maintain, or improve 
                faculty development, or departments, divisions, or other 
                units necessary to implement such training.
            ``(2) Training for other providers.--A recipient of a grant 
        under subsection (a)(2)--
                    ``(A) shall use the grant funds to plan, develop, or 
                operate a training program to provide mental and 
                substance use disorders services in underserved, 
                community-based settings, as appropriate, that integrate 
                primary care and mental and substance use disorders 
                prevention and treatment services; and
                    ``(B) may use the grant funds to provide additional 
                support for the administration of the program or to meet 
                the costs of projects to establish, maintain, or improve 
                faculty development, or departments, divisions, or other 
                units necessary to implement such program.
            ``(3) Academic units or programs.--A recipient of a grant 
        under subsection (a)(3) shall enter into a partnership with 
        organizations such as an education accrediting organization 
        (such as the Liaison Committee on Medical Education, the 
        Accreditation Council for Graduate Medical Education, the 
        Commission on Osteopathic College Accreditation, the 
        Accreditation Commission for Education in Nursing, the 
        Commission on Collegiate Nursing Education, the Accreditation 
        Council for Pharmacy Education, the Council on Social Work 
        Education, American Psychological Association Commission on 
        Accreditation, or the Accreditation Review Commission on 
        Education for the Physician Assistant) to carry out activities 
        under subsection (a)(3).

    ``(c) Eligible Entities.--
            ``(1) Training for residents and fellows.--To be eligible to 
        receive a grant under subsection (a)(1), an entity shall--
                    ``(A) be a consortium consisting of--
                          ``(i) at least one teaching health center; and
                          ``(ii) the sponsoring institution (or parent 
                      institution of the sponsoring institution) of--
                                    ``(I) a psychiatry residency program 
                                that is accredited by the Accreditation 
                                Council of Graduate Medical Education 
                                (or the parent institution of such a 
                                program); or
                                    ``(II) a fellowship in addiction 
                                medicine, as determined appropriate by 
                                the Secretary; or
                    ``(B) be an entity described in subparagraph (A)(ii) 
                that provides opportunities for residents or fellows to 
                train in community-based settings that integrate primary 
                care with mental and substance use disorders prevention 
                and treatment services.
            ``(2) Training for other providers.--To be eligible to 
        receive a grant under subsection (a)(2), an entity shall be--
                    ``(A) a teaching health center (as defined in 
                section 749A(f));
                    ``(B) a Federally qualified health center (as 
                defined in section 1905(l)(2)(B) of the Social Security 
                Act);

[[Page 130 STAT. 1252]]

                    ``(C) a community mental health center (as defined 
                in section 1861(ff)(3)(B) of the Social Security Act);
                    ``(D) a rural health clinic (as defined in section 
                1861(aa) of the Social Security Act);
                    ``(E) a health center operated by the Indian Health 
                Service, an Indian tribe, a tribal organization, or an 
                urban Indian organization (as defined in section 4 of 
                the Indian Health Care Improvement Act); or
                    ``(F) an entity with a demonstrated record of 
                success in providing training for nurse practitioners, 
                physician assistants, health service psychologists, and 
                social workers.
            ``(3) Academic units or programs.--To be eligible to receive 
        a grant under subsection (a)(3), an entity shall be a school of 
        medicine or osteopathic medicine, a nursing school, a physician 
        assistant training program, a school of pharmacy, a school of 
        social work, an accredited public or nonprofit private hospital, 
        an accredited medical residency program, or a public or private 
        nonprofit entity which the Secretary has determined is capable 
        of carrying out such grant.

    ``(d) Priority.--
            ``(1) In general.--In awarding grants under subsection 
        (a)(1) or (a)(2), the Secretary shall give priority to eligible 
        entities that--
                    ``(A) demonstrate sufficient size, scope, and 
                capacity to undertake the requisite training of an 
                appropriate number of psychiatric residents, fellows, 
                nurse practitioners, physician assistants, or social 
                workers in addiction medicine per year to meet the needs 
                of the area served;
                    ``(B) demonstrate experience in training providers 
                to practice team-based care that integrates mental and 
                substance use disorder prevention and treatment services 
                with primary care in community-based settings;
                    ``(C) demonstrate experience in using health 
                information technology and, as appropriate, telehealth 
                to support--
                          ``(i) the delivery of mental and substance use 
                      disorders services at the eligible entities 
                      described in subsections (c)(1) and (c)(2); and
                          ``(ii) community health centers in integrating 
                      primary care and mental and substance use 
                      disorders treatment; or
                    ``(D) have the capacity to expand access to mental 
                and substance use disorders services in areas with 
                demonstrated need, as determined by the Secretary, such 
                as tribal, rural, or other underserved communities.
            ``(2) Academic units or programs.--In awarding grants under 
        subsection (a)(3), the Secretary shall give priority to eligible 
        entities that--
                    ``(A) have a record of training the greatest 
                percentage of mental and substance use disorders 
                providers who enter and remain in these fields or who 
                enter and remain in settings with integrated primary 
                care and mental and substance use disorder prevention 
                and treatment services;
                    ``(B) have a record of training individuals who are 
                from underrepresented minority groups, including native 
                populations, or from a rural or disadvantaged 
                background;
                    ``(C) provide training in the care of vulnerable 
                populations such as infants, children, adolescents, 
                pregnant and

[[Page 130 STAT. 1253]]

                postpartum women, older adults, homeless individuals, 
                victims of abuse or trauma, individuals with 
                disabilities, and other groups as defined by the 
                Secretary;
                    ``(D) teach trainees the skills to provide 
                interprofessional, integrated care through collaboration 
                among health professionals; or
                    ``(E) provide training in cultural competency and 
                health literacy.

    ``(e) Duration.--Grants awarded under this section shall be for a 
minimum of 5 years.
    ``(f) Study and Report.--
            ``(1) Study.--
                    ``(A) In general.--The Secretary, acting through the 
                Administrator of the Health Resources and Services 
                Administration, shall conduct a study on the results of 
                the demonstration program under this section.
                    ``(B) Data submission.--Not later than 90 days after 
                the completion of the first year of the training program 
                and each subsequent year that the program is in effect, 
                each recipient of a grant under subsection (a) shall 
                submit to the Secretary such data as the Secretary may 
                require for analysis for the report described in 
                paragraph (2).
            ``(2) Report to congress.--Not later than 1 year after 
        receipt of the data described in paragraph (1)(B), the Secretary 
        shall submit to Congress a report that includes--
                    ``(A) an analysis of the effect of the demonstration 
                program under this section on the quality, quantity, and 
                distribution of mental and substance use disorders 
                services;
                    ``(B) an analysis of the effect of the demonstration 
                program on the prevalence of untreated mental and 
                substance use disorders in the surrounding communities 
                of health centers participating in the demonstration; 
                and
                    ``(C) recommendations on whether the demonstration 
                program should be expanded.

    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9023. <<NOTE: 42 USC 294l-1 note.>>  CLARIFICATION ON CURRENT 
                          ELIGIBILITY FOR LOAN REPAYMENT PROGRAMS.

    The Administrator of the Health Resources and Services 
Administration shall clarify the eligibility pursuant to section 
338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
1(b)(1)(B)) of child and adolescent psychiatrists for the National 
Health Service Corps Loan Repayment Program under subpart III of part D 
of title III of such Act (42 U.S.C. 254l et seq.).
SEC. 9024. MINORITY FELLOWSHIP PROGRAM.

    Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) 
is amended by adding at the end the following:

                  ``PART K--MINORITY FELLOWSHIP PROGRAM

``SEC. 597. <<NOTE: 42 USC 290ll.>>  FELLOWSHIPS.

    ``(a) In General.--The Secretary shall maintain a program, to be 
known as the Minority Fellowship Program, under which the Secretary 
shall award fellowships, which may include stipends, for the purposes 
of--

[[Page 130 STAT. 1254]]

            ``(1) increasing the knowledge of mental and substance use 
        disorders practitioners on issues related to prevention, 
        treatment, and recovery support for individuals who are from 
        racial and ethnic minority populations and who have a mental or 
        substance use disorder;
            ``(2) improving the quality of mental and substance use 
        disorder prevention and treatment services delivered to racial 
        and ethnic minority populations; and
            ``(3) increasing the number of culturally competent mental 
        and substance use disorders professionals who teach, administer 
        services, conduct research, and provide direct mental or 
        substance use disorder services to racial and ethnic minority 
        populations.

    ``(b) Training Covered.--The fellowships awarded under subsection 
(a) shall be for postbaccalaureate training (including for master's and 
doctoral degrees) for mental and substance use disorder treatment 
professionals, including in the fields of psychiatry, nursing, social 
work, psychology, marriage and family therapy, mental health counseling, 
and substance use disorder and addiction counseling.
    ``(c) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $12,669,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL 
                          VOLUNTEERS AT COMMUNITY HEALTH CENTERS.

    Section 224 of the Public Health Service Act (42 U.S.C. 233) is 
amended by adding at the end the following:
    ``(q)(1) For purposes of this section, a health professional 
volunteer at a deemed entity described in subsection (g)(4) shall, in 
providing a health professional service eligible for funding under 
section 330 to an individual, be deemed to be an employee of the Public 
Health Service for a calendar year that begins during a fiscal year for 
which a transfer was made under paragraph (4)(C). The preceding sentence 
is subject to the provisions of this subsection.
    ``(2) In providing a health service to an individual, a health care 
practitioner shall for purposes of this subsection be considered to be a 
health professional volunteer at an entity described in subsection 
(g)(4) if the following conditions are met:
            ``(A) The service is provided to the individual at the 
        facilities of an entity described in subsection (g)(4), or 
        through offsite programs or events carried out by the entity.
            ``(B) The entity is sponsoring the health care practitioner 
        pursuant to paragraph (3)(B).
            ``(C) The health care practitioner does not receive any 
        compensation for the service from the individual, the entity 
        described in subsection (g)(4), or any third-party payer 
        (including reimbursement under any insurance policy or health 
        plan, or under any Federal or State health benefits program), 
        except that the health care practitioner may receive repayment 
        from the entity described in subsection (g)(4) for reasonable 
        expenses incurred by the health care practitioner in the 
        provision of the service to the individual, which may include 
        travel expenses to or from the site of services.
            ``(D) Before the service is provided, the health care 
        practitioner or the entity described in subsection (g)(4) posts 
        a clear

[[Page 130 STAT. 1255]]

        and conspicuous notice at the site where the service is provided 
        of the extent to which the legal liability of the health care 
        practitioner is limited pursuant to this subsection.
            ``(E) At the time the service is provided, the health care 
        practitioner is licensed or certified in accordance with 
        applicable Federal and State laws regarding the provision of the 
        service.
            ``(F) At the time the service is provided, the entity 
        described in subsection (g)(4) maintains relevant documentation 
        certifying that the health care practitioner meets the 
        requirements of this subsection.

    ``(3) Subsection (g) (other than paragraphs (3) and (5)) and 
subsections (h), (i), and (l) apply to a health care practitioner for 
purposes of this subsection to the same extent and in the same manner as 
such subsections apply to an officer, governing board member, employee, 
or contractor of an entity described in subsection (g)(4), subject to 
paragraph (4), and subject to the following:
            ``(A) The first sentence of paragraph (1) applies in lieu of 
        the first sentence of subsection (g)(1)(A).
            ``(B) With respect to an entity described in subsection 
        (g)(4), a health care practitioner is not a health professional 
        volunteer at such entity unless the entity sponsors the health 
        care practitioner. For purposes of this subsection, the entity 
        shall be considered to be sponsoring the health care 
        practitioner if--
                    ``(i) with respect to the health care practitioner, 
                the entity submits to the Secretary an application 
                meeting the requirements of subsection (g)(1)(D); and
                    ``(ii) the Secretary, pursuant to subsection 
                (g)(1)(E), determines that the health care practitioner 
                is deemed to be an employee of the Public Health 
                Service.
            ``(C) In the case of a health care practitioner who is 
        determined by the Secretary pursuant to subsection (g)(1)(E) to 
        be a health professional volunteer at such entity, this 
        subsection applies to the health care practitioner (with respect 
        to services performed on behalf of the entity sponsoring the 
        health care practitioner pursuant to subparagraph (B)) for any 
        cause of action arising from an act or omission of the health 
        care practitioner occurring on or after the date on which the 
        Secretary makes such determination.
            ``(D) Subsection (g)(1)(F) applies to a health care 
        practitioner for purposes of this subsection only to the extent 
        that, in providing health services to an individual, each of the 
        conditions specified in paragraph (2) is met.

    ``(4)(A) Amounts in the fund established under subsection (k)(2) 
shall be available for transfer under subparagraph (C) for purposes of 
carrying out this subsection.
    ``(B)(i) Not later than May 1 of each fiscal year, the Attorney 
General, in consultation with the Secretary, shall submit to the 
Congress a report providing an estimate of the amount of claims 
(together with related fees and expenses of witnesses) that, by reason 
of the acts or omissions of health professional volunteers, will be paid 
pursuant to this section during the calendar year that begins in the 
following fiscal year.
    ``(ii) Subsection (k)(1)(B) applies to the estimate under clause (i) 
regarding health professional volunteers to the same extent and in the 
same manner as such subsection applies to the estimate

[[Page 130 STAT. 1256]]

under such subsection regarding officers, governing board members, 
employees, and contractors of entities described in subsection (g)(4).
    ``(iii) The report shall include a summary of the data relied upon 
for the estimate in clause (i), including the number of claims filed and 
paid from the previous calendar year.
    ``(C) Not later than December 31 of each fiscal year, the Secretary 
shall transfer from the fund under subsection (k)(2) to the appropriate 
accounts in the Treasury an amount equal to the estimate made under 
subparagraph (B) for the calendar year beginning in such fiscal year, 
subject to the extent of amounts in the fund.
    ``(5)(A) This subsection shall take effect on October 1, 2017, 
except as provided in subparagraph (B) and paragraph (6).
    ``(B) Effective on the date of the enactment of this subsection--
            ``(i) the Secretary may issue regulations for carrying out 
        this subsection, and the Secretary may accept and consider 
        applications submitted pursuant to paragraph (3)(B); and
            ``(ii) reports under paragraph (4)(B) may be submitted to 
        Congress.

    ``(6) Beginning on October 1, 2022, this subsection shall cease to 
have any force or effect.''.
SEC. 9026. REPORTS.

    (a) Workforce Development Report.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Administrator of the Health Resources 
        and Services Administration, in consultation with the Assistant 
        Secretary for Mental Health and Substance Use, shall conduct a 
        study and publicly post on the appropriate Internet website of 
        the Department of Health and Human Services a report on the 
        adult and pediatric mental health and substance use disorder 
        workforce in order to inform Federal, State, and local efforts 
        related to workforce enhancement.
            (2) Contents.--The report under this subsection shall 
        contain--
                    (A) national and State-level projections of the 
                supply and demand of the mental health and substance use 
                disorder health workforce, disaggregated by profession;
                    (B) an assessment of the mental health and substance 
                use disorder workforce capacity, strengths, and 
                weaknesses as of the date of the report, including the 
                extent to which primary care providers are preventing, 
                screening, or referring for mental and substance use 
                disorder services;
                    (C) information on trends within the mental health 
                and substance use disorder provider workforce, including 
                the number of individuals expected to enter the mental 
                health workforce over the next 5 years; and
                    (D) any additional information determined by the 
                Administrator of the Health Resources and Services 
                Administration, in consultation with the Assistant 
                Secretary for Mental Health and Substance Use, to be 
                relevant to the mental health and substance use disorder 
                provider workforce.

    (b) Peer-Support Specialist Programs.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study on peer-support specialist programs 
        in up to 10 States that receive funding from the Substance Abuse 
        and Mental Health Services Administration.

[[Page 130 STAT. 1257]]

            (2) Contents of study.--In conducting the study under 
        paragraph (1), the Comptroller General of the United States 
        shall examine and identify best practices, in the States 
        selected pursuant to such paragraph, related to training and 
        credential requirements for peer-support specialist programs, 
        such as--
                    (A) hours of formal work or volunteer experience 
                related to mental and substance use disorders conducted 
                through such programs;
                    (B) types of peer-support specialist exams required 
                for such programs in the selected States;
                    (C) codes of ethics used by such programs in the 
                selected States;
                    (D) required or recommended skill sets for such 
                programs in the selected States; and
                    (E) requirements for continuing education.
            (3) Report.--Not later than 2 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report on the 
        study conducted under paragraph (1).

             Subtitle C--Mental Health on Campus Improvement

SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON 
                          CAMPUS.

    Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
36b) is amended--
            (1) in the section heading, by striking ``and behavioral 
        health'' and inserting ``health and substance use disorder'';
            (2) in subsection (a)--
                    (A) by striking ``Services,'' and inserting 
                ``Services and'';
                    (B) by striking ``and behavioral health problems'' 
                and inserting ``health or substance use disorders'';
                    (C) by striking ``substance abuse'' and inserting 
                ``substance use disorders''; and
                    (D) by adding after, ``suicide attempts,'' the 
                following: ``prevent mental and substance use disorders, 
                reduce stigma, and improve the identification and 
                treatment for students at risk,'';
            (3) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``for--'' and inserting ``for one or more of 
                the following:''; and
                    (B) by striking paragraphs (1) through (6) and 
                inserting the following:
            ``(1) Educating students, families, faculty, and staff to 
        increase awareness of mental and substance use disorders.
            ``(2) The operation of hotlines.
            ``(3) Preparing informational material.
            ``(4) Providing outreach services to notify students about 
        available mental and substance use disorder services.
            ``(5) Administering voluntary mental and substance use 
        disorder screenings and assessments.

[[Page 130 STAT. 1258]]

            ``(6) Supporting the training of students, faculty, and 
        staff to respond effectively to students with mental and 
        substance use disorders.
            ``(7) Creating a network infrastructure to link institutions 
        of higher education with health care providers who treat mental 
        and substance use disorders.
            ``(8) Providing mental and substance use disorders 
        prevention and treatment services to students, which may include 
        recovery support services and programming and early 
        intervention, treatment, and management, including through the 
        use of telehealth services.
            ``(9) Conducting research through a counseling or health 
        center at the institution of higher education involved regarding 
        improving the behavioral health of students through clinical 
        services, outreach, prevention, or academic success, in a manner 
        that is in compliance with all applicable personal privacy laws.
            ``(10) Supporting student groups on campus, including 
        athletic teams, that engage in activities to educate students, 
        including activities to reduce stigma surrounding mental and 
        behavioral disorders, and promote mental health.
            ``(11) Employing appropriately trained staff.
            ``(12) Developing and supporting evidence-based and emerging 
        best practices, including a focus on culturally and 
        linguistically appropriate best practices.'';
            (4) in subsection (c)(5), by striking ``substance abuse'' 
        and inserting ``substance use disorder'';
            (5) in subsection (d)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``An institution of higher education desiring a 
                grant under this section'' and inserting ``To be 
                eligible to receive a grant under this section, an 
                institution of higher education'';
                    (B) by striking paragraph (1) and inserting--
            ``(1) A description of the population to be targeted by the 
        program carried out under the grant, including veterans whenever 
        possible and appropriate, and of identified mental and substance 
        use disorder needs of students at the institution of higher 
        education.'';
                    (C) in paragraph (2), by inserting ``, which may 
                include, as appropriate and in accordance with 
                subsection (b)(7), a plan to seek input from relevant 
                stakeholders in the community, including appropriate 
                public and private entities, in order to carry out the 
                program under the grant'' before the period at the end; 
                and
                    (D) by adding after paragraph (5) the following new 
                paragraphs:
            ``(6) An outline of the objectives of the program carried 
        out under the grant.
            ``(7) For an institution of higher education proposing to 
        use the grant for an activity described in paragraph (8) or (9) 
        of subsection (b), a description of the policies and procedures 
        of the institution of higher education that are related to 
        applicable laws regarding access to, and sharing of, treatment 
        records of students at any campus-based mental health center or 
        partner organization, including the policies and State laws 
        governing when such records can be accessed and shared for non-
        treatment purposes and a description of the process used

[[Page 130 STAT. 1259]]

        by the institution of higher education to notify students of 
        these policies and procedures, including the extent to which 
        written consent is required.
            ``(8) An assurance that grant funds will be used to 
        supplement and not supplant any other Federal, State, or local 
        funds available to carry out activities of the type carried out 
        under the grant.'';
            (6) in subsection (e)(1), by striking ``and behavioral 
        health problems'' and inserting ``health and substance use 
        disorders'';
            (7) in subsection (f)(2)--
                    (A) by striking ``and behavioral health'' and 
                inserting ``health and substance use disorder''; and
                    (B) by striking ``suicide and substance abuse'' and 
                inserting ``suicide and substance use disorders'';
            (8) by redesignating subsection (h) as subsection (i);
            (9) by inserting after subsection (g) the following new 
        subsection:

    ``(h) Technical Assistance.--The Secretary may provide technical 
assistance to grantees in carrying out this section.''; and
            (10) in subsection (i), as redesignated by paragraph (8), by 
        striking ``$5,000,000 for fiscal year 2005'' and all that 
        follows through the period at the end and inserting ``$7,000,000 
        for each of fiscal years 2018 through 2022.''.
SEC. 9032. <<NOTE: 42 USC 290bb-36b note.>>  INTERAGENCY WORKING 
                          GROUP ON COLLEGE MENTAL HEALTH.

    (a) Purpose.--It is the purpose of this section to provide for the 
establishment of a College Campus Task Force to discuss mental and 
behavioral health concerns on campuses of institutions of higher 
education.
    (b) Establishment.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall establish a 
College Campus Task Force (referred to in this section as the ``Task 
Force'') to discuss mental and behavioral health concerns on campuses of 
institutions of higher education.
    (c) Membership.--The Task Force shall be composed of a 
representative from each Federal agency (as appointed by the head of the 
agency) that has jurisdiction over, or is affected by, mental health and 
education policies and projects, including--
            (1) the Department of Education;
            (2) the Department of Health and Human Services;
            (3) the Department of Veterans Affairs; and
            (4) such other Federal agencies as the Assistant Secretary 
        for Mental Health and Substance Use, in consultation with the 
        Secretary, determines to be appropriate.

    (d) Duties.--The Task Force shall--
            (1) serve as a centralized mechanism to coordinate a 
        national effort to--
                    (A) discuss and evaluate evidence and knowledge on 
                mental and behavioral health services available to, and 
                the prevalence of mental illness among, the age 
                population of students attending institutions of higher 
                education in the United States;
                    (B) determine the range of effective, feasible, and 
                comprehensive actions to improve mental and behavioral 
                health on campuses of institutions of higher education;

[[Page 130 STAT. 1260]]

                    (C) examine and better address the needs of the age 
                population of students attending institutions of higher 
                education dealing with mental illness;
                    (D) survey Federal agencies to determine which 
                policies are effective in encouraging, and how best to 
                facilitate outreach without duplicating, efforts 
                relating to mental and behavioral health promotion;
                    (E) establish specific goals within and across 
                Federal agencies for mental health promotion, including 
                determinations of accountability for reaching those 
                goals;
                    (F) develop a strategy for allocating 
                responsibilities and ensuring participation in mental 
                and behavioral health promotion, particularly in the 
                case of competing agency priorities;
                    (G) coordinate plans to communicate research results 
                relating to mental and behavioral health amongst the age 
                population of students attending institutions of higher 
                education to enable reporting and outreach activities to 
                produce more useful and timely information;
                    (H) provide a description of evidence-based 
                practices, model programs, effective guidelines, and 
                other strategies for promoting mental and behavioral 
                health on campuses of institutions of higher education;
                    (I) make recommendations to improve Federal efforts 
                relating to mental and behavioral health promotion on 
                campuses of institutions of higher education and to 
                ensure Federal efforts are consistent with available 
                standards, evidence, and other programs in existence as 
                of the date of enactment of this Act;
                    (J) monitor Federal progress in meeting specific 
                mental and behavioral health promotion goals as they 
                relate to settings of institutions of higher education; 
                and
                    (K) examine and disseminate best practices related 
                to intracampus sharing of treatment records;
            (2) consult with national organizations with expertise in 
        mental and behavioral health, especially those organizations 
        working with the age population of students attending 
        institutions of higher education; and
            (3) consult with and seek input from mental health 
        professionals working on campuses of institutions of higher 
        education as appropriate.

    (e) Meetings.--
            (1) In general.--The Task Force shall meet not fewer than 
        three times each year.
            (2) Annual conference.--The Secretary shall sponsor an 
        annual conference on mental and behavioral health in settings of 
        institutions of higher education to enhance coordination, build 
        partnerships, and share best practices in mental and behavioral 
        health promotion, data collection, analysis, and services.

    (f) Definition.--In this section, the term ``institution of higher 
education'' has the meaning given such term in section 101 of the Higher 
Education Act of 1965 (20 U.S.C. 1001).
    (g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $1,000,000 for the period of 
fiscal years 2018 through 2022.

[[Page 130 STAT. 1261]]

SEC. 9033. <<NOTE: 42 USC 290ee-4.>>  IMPROVING MENTAL HEALTH ON 
                          COLLEGE CAMPUSES.

    Part D of title V of the Public Health Service Act (42 U.S.C. 290dd 
et seq.) is amended by adding at the end the following:
``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON 
                        COLLEGE CAMPUSES.

    ``(a) Purpose.--It is the purpose of this section to increase access 
to, and reduce the stigma associated with, mental health services to 
ensure that students at institutions of higher education have the 
support necessary to successfully complete their studies.
    ``(b) National Public Education Campaign.--The Secretary, acting 
through the Assistant Secretary and in collaboration with the Director 
of the Centers for Disease Control and Prevention, shall convene an 
interagency, public-private sector working group to plan, establish, and 
begin coordinating and evaluating a targeted public education campaign 
that is designed to focus on mental and behavioral health on the 
campuses of institutions of higher education. Such campaign shall be 
designed to--
            ``(1) improve the general understanding of mental health and 
        mental disorders;
            ``(2) encourage help-seeking behaviors relating to the 
        promotion of mental health, prevention of mental disorders, and 
        treatment of such disorders;
            ``(3) make the connection between mental and behavioral 
        health and academic success; and
            ``(4) assist the general public in identifying the early 
        warning signs and reducing the stigma of mental illness.

    ``(c) Composition.--The working group convened under subsection (b) 
shall include--
            ``(1) mental health consumers, including students and family 
        members;
            ``(2) representatives of institutions of higher education;
            ``(3) representatives of national mental and behavioral 
        health associations and associations of institutions of higher 
        education;
            ``(4) representatives of health promotion and prevention 
        organizations at institutions of higher education;
            ``(5) representatives of mental health providers, including 
        community mental health centers; and
            ``(6) representatives of private-sector and public-sector 
        groups with experience in the development of effective public 
        health education campaigns.

    ``(d) Plan.--The working group under subsection (b) shall develop a 
plan that--
            ``(1) targets promotional and educational efforts to the age 
        population of students at institutions of higher education and 
        individuals who are employed in settings of institutions of 
        higher education, including through the use of roundtables;
            ``(2) develops and proposes the implementation of research-
        based public health messages and activities;
            ``(3) provides support for local efforts to reduce stigma by 
        using the National Health Information Center as a primary point 
        of contact for information, publications, and service program 
        referrals; and

[[Page 130 STAT. 1262]]

            ``(4) develops and proposes the implementation of a social 
        marketing campaign that is targeted at the population of 
        students attending institutions of higher education and 
        individuals who are employed in settings of institutions of 
        higher education.

    ``(e) Definition.--In this section, the term `institution of higher 
education' has the meaning given such term in section 101 of the Higher 
Education Act of 1965 (20 U.S.C. 1001).
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $1,000,000 for the period of 
fiscal years 2018 through 2022.''.

   TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR 
                        CHILDREN AND ADOLESCENTS

SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL 
                            DISTURBANCE.

    (a) Comprehensive Community Mental Health Services for Children With 
a Serious Emotional Disturbance.--Section 561(a)(1) of the Public Health 
Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, which 
may include efforts to identify and serve children at risk'' before the 
period.
    (b) Requirements With Respect to Carrying Out Purpose of Grants.--
Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b)) 
is amended by striking ``will not provide an individual with access to 
the system if the individual is more than 21 years of age'' and 
inserting ``will provide an individual with access to the system through 
the age of 21 years''.
    (c) Additional Provisions.--Section 564(f) of the Public Health 
Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and 
provide a copy to the State involved)'' after ``to the Secretary''.
    (d) General Provisions.--Section 565 of the Public Health Service 
Act (42 U.S.C. 290ff-4) is amended--
            (1) in subsection (b)(1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``receiving a grant under section 561(a)'' and 
                inserting ``, regardless of whether such public entity 
                is receiving a grant under section 561(a)''; and
                    (B) in subparagraph (B), by striking ``pursuant to'' 
                and inserting ``described in'';
            (2) in subsection (d)(1), by striking ``not more than 21 
        years of age'' and inserting ``through the age of 21 years''; 
        and
            (3) in subsection (f)(1), by striking ``$100,000,000 for 
        fiscal year 2001, and such sums as may be necessary for each of 
        the fiscal years 2002 and 2003'' and inserting ``$119,026,000 
        for each of fiscal years 2018 through 2022''.
SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.

    Title III of the Public Health Service Act is amended by inserting 
after section 330L of such Act (42 U.S.C. 254c-18) the following new 
section:

[[Page 130 STAT. 1263]]

``SEC. 330M <<NOTE: 42 USC 254c-19.>>  PEDIATRIC MENTAL HEALTH 
                          CARE ACCESS GRANTS.

    ``(a) In General.--The Secretary, acting through the Administrator 
of the Health Resources and Services Administration and in coordination 
with other relevant Federal agencies, shall award grants to States, 
political subdivisions of States, and Indian tribes and tribal 
organizations (for purposes of this section, as such terms are defined 
in section 4 of the Indian Self-Determination and Education Assistance 
Act (25 U.S.C. 450b)) to promote behavioral health integration in 
pediatric primary care by--
            ``(1) supporting the development of statewide or regional 
        pediatric mental health care telehealth access programs; and
            ``(2) supporting the improvement of existing statewide or 
        regional pediatric mental health care telehealth access 
        programs.

    ``(b) Program Requirements.--
            ``(1) In general.--A pediatric mental health care telehealth 
        access program referred to in subsection (a), with respect to 
        which a grant under such subsection may be used, shall--
                    ``(A) be a statewide or regional network of 
                pediatric mental health teams that provide support to 
                pediatric primary care sites as an integrated team;
                    ``(B) support and further develop organized State or 
                regional networks of pediatric mental health teams to 
                provide consultative support to pediatric primary care 
                sites;
                    ``(C) conduct an assessment of critical behavioral 
                consultation needs among pediatric providers and such 
                providers' preferred mechanisms for receiving 
                consultation, training, and technical assistance;
                    ``(D) develop an online database and communication 
                mechanisms, including telehealth, to facilitate 
                consultation support to pediatric practices;
                    ``(E) provide rapid statewide or regional clinical 
                telephone or telehealth consultations when requested 
                between the pediatric mental health teams and pediatric 
                primary care providers;
                    ``(F) conduct training and provide technical 
                assistance to pediatric primary care providers to 
                support the early identification, diagnosis, treatment, 
                and referral of children with behavioral health 
                conditions;
                    ``(G) provide information to pediatric providers 
                about, and assist pediatric providers in accessing, 
                pediatric mental health care providers, including child 
                and adolescent psychiatrists, and licensed mental health 
                professionals, such as psychologists, social workers, or 
                mental health counselors and in scheduling and 
                conducting technical assistance;
                    ``(H) assist with referrals to specialty care and 
                community or behavioral health resources; and
                    ``(I) establish mechanisms for measuring and 
                monitoring increased access to pediatric mental health 
                care services by pediatric primary care providers and 
                expanded capacity of pediatric primary care providers to 
                identify, treat, and refer children with mental health 
                problems.
            ``(2) Pediatric mental health teams.--In this subsection, 
        the term `pediatric mental health team' means a team consisting 
        of at least one case coordinator, at least one child and 
        adolescent psychiatrist, and at least one licensed clinical

[[Page 130 STAT. 1264]]

        mental health professional, such as a psychologist, social 
        worker, or mental health counselor. Such a team may be 
        regionally based.

    ``(c) Application.--A State, political subdivision of a State, 
Indian tribe, or tribal organization seeking a grant under this section 
shall submit an application to the Secretary at such time, in such 
manner, and containing such information as the Secretary may require, 
including a plan for the comprehensive evaluation of activities that are 
carried out with funds received under such grant.
    ``(d) Evaluation.--A State, political subdivision of a State, Indian 
tribe, or tribal organization that receives a grant under this section 
shall prepare and submit an evaluation of activities that are carried 
out with funds received under such grant to the Secretary at such time, 
in such manner, and containing such information as the Secretary may 
reasonably require, including a process and outcome evaluation.
    ``(e) Access to Broadband.--In administering grants under this 
section, the Secretary may coordinate with other agencies to ensure that 
funding opportunities are available to support access to reliable, high-
speed Internet for providers.
    ``(f) Matching Requirement.--The Secretary may not award a grant 
under this section unless the State, political subdivision of a State, 
Indian tribe, or tribal organization involved agrees, with respect to 
the costs to be incurred by the State, political subdivision of a State, 
Indian tribe, or tribal organization in carrying out the purpose 
described in this section, to make available non-Federal contributions 
(in cash or in kind) toward such costs in an amount that is not less 
than 20 percent of Federal funds provided in the grant.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated, $9,000,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY 
                            INTERVENTION SERVICES FOR CHILDREN AND 
                            ADOLESCENTS.

    The first section 514 of the Public Health Service Act (42 U.S.C. 
290bb-7), relating to substance abuse treatment services for children 
and adolescents, is amended--
            (1) in the section heading, by striking ``abuse treatment'' 
        and inserting ``use disorder treatment and early intervention'';
            (2) by striking subsection (a) and inserting the following:

    ``(a) In General.--The Secretary shall award grants, contracts, or 
cooperative agreements to public and private nonprofit entities, 
including Indian tribes or tribal organizations (as such terms are 
defined in section 4 of the Indian Self-Determination and Education 
Assistance Act), or health facilities or programs operated by or in 
accordance with a contract or grant with the Indian Health Service, for 
the purpose of--
            ``(1) providing early identification and services to meet 
        the needs of children and adolescents who are at risk of 
        substance use disorders;
            ``(2) providing substance use disorder treatment services 
        for children, including children and adolescents with co-
        occurring mental illness and substance use disorders; and

[[Page 130 STAT. 1265]]

            ``(3) providing assistance to pregnant women, and parenting 
        women, with substance use disorders, in obtaining treatment 
        services, linking mothers to community resources to support 
        independent family lives, and staying in recovery so that 
        children are in safe, stable home environments and receive 
        appropriate health care services.'';
            (3) in subsection (b)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) apply evidence-based and cost-effective methods;'';
                    (B) in paragraph (2)--
                          (i) by striking ``treatment''; and
                          (ii) by inserting ``substance abuse,'' after 
                      ``child welfare,'';
                    (C) in paragraph (3), by striking ``substance abuse 
                disorders'' and inserting ``substance use disorders, 
                including children and adolescents with co-occurring 
                mental illness and substance use disorders,'';
                    (D) in paragraph (5), by striking ``treatment;'' and 
                inserting ``services; and'';
                    (E) in paragraph (6), by striking ``substance abuse 
                treatment; and'' and inserting ``treatment.''; and
                    (F) by striking paragraph (7); and
            (4) in subsection (f), by striking ``$40,000,000'' and all 
        that follows through the period and inserting ``$29,605,000 for 
        each of fiscal years 2018 through 2022.''.
SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.

    The first section 582 of the Public Health Service Act (42 U.S.C. 
290hh-1; relating to grants to address the problems of persons who 
experience violence related stress) is amended--
            (1) in subsection (a), by striking ``developing programs'' 
        and all that follows through the period at the end and inserting 
        the following: ``developing and maintaining programs that 
        provide for--
            ``(1) the continued operation of the National Child 
        Traumatic Stress Initiative (referred to in this section as the 
        `NCTSI'), which includes a cooperative agreement with a 
        coordinating center, that focuses on the mental, behavioral, and 
        biological aspects of psychological trauma response, prevention 
        of the long-term consequences of child trauma, and early 
        intervention services and treatment to address the long-term 
        consequences of child trauma; and
            ``(2) the development of knowledge with regard to evidence-
        based practices for identifying and treating mental, behavioral, 
        and biological disorders of children and youth resulting from 
        witnessing or experiencing a traumatic event.'';
            (2) in subsection (b)--
                    (A) by striking ``subsection (a) related'' and 
                inserting ``subsection (a)(2) (related'';
                    (B) by striking ``treating disorders associated with 
                psychological trauma'' and inserting ``treating mental, 
                behavioral, and biological disorders associated with 
                psychological trauma)''; and
                    (C) by striking ``mental health agencies and 
                programs that have established clinical and basic 
                research'' and inserting ``universities, hospitals, 
                mental health agencies,

[[Page 130 STAT. 1266]]

                and other programs that have established clinical 
                expertise and research'';
            (3) by redesignating subsections (c) through (g) as 
        subsections (g) through (k), respectively;
            (4) by inserting after subsection (b), the following:

    ``(c) Child Outcome Data.--The NCTSI coordinating center described 
in subsection (a)(1) shall collect, analyze, report, and make publicly 
available, as appropriate, NCTSI-wide child treatment process and 
outcome data regarding the early identification and delivery of 
evidence-based treatment and services for children and families served 
by the NCTSI grantees.
    ``(d) Training.--The NCTSI coordinating center shall facilitate the 
coordination of training initiatives in evidence-based and trauma-
informed treatments, interventions, and practices offered to NCTSI 
grantees, providers, and partners.
    ``(e) Dissemination and Collaboration.--The NCTSI coordinating 
center shall, as appropriate, collaborate with--
            ``(1) the Secretary, in the dissemination of evidence-based 
        and trauma-informed interventions, treatments, products, and 
        other resources to appropriate stakeholders; and
            ``(2) appropriate agencies that conduct or fund research 
        within the Department of Health and Human Services, for purposes 
        of sharing NCTSI expertise, evaluation data, and other 
        activities, as appropriate.

    ``(f) Review.--The Secretary shall, consistent with the peer-review 
process, ensure that NCTSI applications are reviewed by appropriate 
experts in the field as part of a consensus-review process. The 
Secretary shall include review criteria related to expertise and 
experience in child trauma and evidence-based practices.'';
            (5) in subsection (g) (as so redesignated), by striking 
        ``with respect to centers of excellence are distributed 
        equitably among the regions of the country'' and inserting ``are 
        distributed equitably among the regions of the United States'';
            (6) in subsection (i) (as so redesignated), by striking 
        ``recipient may not exceed 5 years'' and inserting ``recipient 
        shall not be less than 4 years, but shall not exceed 5 years''; 
        and
            (7) in subsection (j) (as so redesignated), by striking 
        ``$50,000,000'' and all that follows through ``2006'' and 
        inserting ``$46,887,000 for each of fiscal years 2018 through 
        2022''.
SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13) 
the following:
``SEC. 317L-1. <<NOTE: 42 USC 247b-13a.>>  SCREENING AND TREATMENT 
                              FOR MATERNAL DEPRESSION.

    ``(a) Grants.--The Secretary shall make grants to States to 
establish, improve, or maintain programs for screening, assessment, and 
treatment services, including culturally and linguistically appropriate 
services, as appropriate, for women who are pregnant, or who have given 
birth within the preceding 12 months, for maternal depression.
    ``(b) Application.--To seek a grant under this section, a State 
shall submit an application to the Secretary at such time, in such 
manner, and containing such information as the Secretary may

[[Page 130 STAT. 1267]]

require. At a minimum, any such application shall include explanations 
of--
            ``(1) how a program, or programs, will increase the 
        percentage of women screened and treated, as appropriate, for 
        maternal depression in 1 or more communities; and
            ``(2) how a program, or programs, if expanded, would 
        increase access to screening and treatment services for maternal 
        depression.

    ``(c) Priority.--In awarding grants under this section, the 
Secretary may give priority to States proposing to improve or enhance 
access to screening services for maternal depression in primary care 
settings.
    ``(d) Use of Funds.--The activities eligible for funding through a 
grant under subsection (a)--
            ``(1) shall include--
                    ``(A) providing appropriate training to health care 
                providers; and
                    ``(B) providing information to health care 
                providers, including information on maternal depression 
                screening, treatment, and followup support services, and 
                linkages to community-based resources; and
            ``(2) may include--
                    ``(A) enabling health care providers (including 
                obstetrician-gynecologists, pediatricians, 
                psychiatrists, mental health care providers, and adult 
                primary care clinicians) to provide or receive real-time 
                psychiatric consultation (in-person or remotely) to aid 
                in the treatment of pregnant and parenting women;
                    ``(B) establishing linkages with and among 
                community-based resources, including mental health 
                resources, primary care resources, and support groups; 
                and
                    ``(C) utilizing telehealth services for rural areas 
                and medically underserved areas (as defined in section 
                330I(a)).

    ``(e) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $5,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, 
                            INTERVENTION, AND TREATMENT.

    Part Q of title III of the Public Health Service Act (42 U.S.C. 280h 
et seq.) is amended by adding at the end the following:
``SEC. 399Z-2. <<NOTE: 42 USC 280h-6.>>  INFANT AND EARLY 
                              CHILDHOOD MENTAL HEALTH PROMOTION, 
                              INTERVENTION, AND TREATMENT.

    ``(a) Grants.--The Secretary shall--
            ``(1) award grants to eligible entities to develop, 
        maintain, or enhance infant and early childhood mental health 
        promotion, intervention, and treatment programs, including--
                    ``(A) programs for infants and children at 
                significant risk of developing, showing early signs of, 
                or having been diagnosed with mental illness, including 
                a serious emotional disturbance; and
                    ``(B) multigenerational therapy and other services 
                that support the caregiving relationship; and
            ``(2) ensure that programs funded through grants under this 
        section are evidence-informed or evidence-based models, 
        practices, and methods that are, as appropriate, culturally and

[[Page 130 STAT. 1268]]

        linguistically appropriate, and can be replicated in other 
        appropriate settings.

    ``(b) Eligible Children and Entities.--In this section:
            ``(1) Eligible child.--The term `eligible child' means a 
        child from birth to not more than 12 years of age who--
                    ``(A) is at risk for, shows early signs of, or has 
                been diagnosed with a mental illness, including a 
                serious emotional disturbance; and
                    ``(B) may benefit from infant and early childhood 
                intervention or treatment programs or specialized 
                preschool or elementary school programs that are 
                evidence-based or that have been scientifically 
                demonstrated to show promise but would benefit from 
                further applied development.
            ``(2) Eligible entity.--The term `eligible entity' means a 
        human services agency or nonprofit institution that--
                    ``(A) employs licensed mental health professionals 
                who have specialized training and experience in infant 
                and early childhood mental health assessment, diagnosis, 
                and treatment, or is accredited or approved by the 
                appropriate State agency, as applicable, to provide for 
                children from infancy to 12 years of age mental health 
                promotion, intervention, or treatment services; and
                    ``(B) provides services or programs described in 
                subsection (a) that are evidence-based or that have been 
                scientifically demonstrated to show promise but would 
                benefit from further applied development.

    ``(c) Application.--An eligible entity seeking a grant under 
subsection (a) shall submit to the Secretary an application at such 
time, in such manner, and containing such information as the Secretary 
may require.
    ``(d) Use of Funds for Early Intervention and Treatment Programs.--
An eligible entity may use amounts awarded under a grant under 
subsection (a)(1) to carry out the following:
            ``(1) Provide age-appropriate mental health promotion and 
        early intervention services or mental illness treatment 
        services, which may include specialized programs, for eligible 
        children at significant risk of developing, showing early signs 
        of, or having been diagnosed with a mental illness, including a 
        serious emotional disturbance. Such services may include social 
        and behavioral services as well as multigenerational therapy and 
        other services that support the caregiving relationship.
            ``(2) Provide training for health care professionals with 
        expertise in infant and early childhood mental health care with 
        respect to appropriate and relevant integration with other 
        disciplines such as primary care clinicians, early intervention 
        specialists, child welfare staff, home visitors, early care and 
        education providers, and others who work with young children and 
        families.
            ``(3) Provide mental health consultation to personnel of 
        early care and education programs (including licensed or 
        regulated center-based and home-based child care, home visiting, 
        preschool special education, and early intervention programs) 
        who work with children and families.
            ``(4) Provide training for mental health clinicians in 
        infant and early childhood in promising and evidence-based 
        practices and models for infant and early childhood mental 
        health treatment and early intervention, including with regard 
        to practices

[[Page 130 STAT. 1269]]

        for identifying and treating mental illness and behavioral 
        disorders of infants and children resulting from exposure or 
        repeated exposure to adverse childhood experiences or childhood 
        trauma.
            ``(5) Provide age-appropriate assessment, diagnostic, and 
        intervention services for eligible children, including early 
        mental health promotion, intervention, and treatment services.

    ``(e) Matching Funds.--The Secretary may not award a grant under 
this section to an eligible entity unless the eligible entity agrees, 
with respect to the costs to be incurred by the eligible entity in 
carrying out the activities described in subsection (d), to make 
available non-Federal contributions (in cash or in kind) toward such 
costs in an amount that is not less than 10 percent of the total amount 
of Federal funds provided in the grant.
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $20,000,000 for the period of 
fiscal years 2018 through 2022.''.

             TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA

SEC. 11001. SENSE OF CONGRESS.

    (a) Findings.--Congress finds the following:
            (1) According to the National Survey on Drug Use and Health, 
        in 2015, there were approximately 9,800,000 adults in the United 
        States with serious mental illness.
            (2) The Substance Abuse and Mental Health Services 
        Administration defines the term ``serious mental illness'' as an 
        illness affecting individuals 18 years of age or older as 
        having, at any time in the past year, a diagnosable mental, 
        behavioral, or emotional disorder that results in serious 
        functional impairment and substantially interferes with or 
        limits one or more major life activities.
            (3) In reporting on the incidence of serious mental illness, 
        the Substance Abuse and Mental Health Services Administration 
        includes major depression, schizophrenia, bipolar disorder, and 
        other mental disorders that cause serious impairment.
            (4) Adults with a serious mental illness are at a higher 
        risk for chronic physical illnesses and premature death.
            (5) According to the World Health Organization, adults with 
        a serious mental illness have lifespans that are 10 to 25 years 
        shorter than those without serious mental illness. The vast 
        majority of these deaths are due to chronic physical medical 
        conditions, such as cardiovascular, respiratory, and infectious 
        diseases, as well as diabetes and hypertension.
            (6) According to the World Health Organization, the majority 
        of deaths of adults with a serious mental illness that are due 
        to physical medical conditions are preventable.
            (7) Supported decision making can facilitate care decisions 
        in areas where serious mental illness may impact the capacity of 
        an individual to determine a course of treatment while still 
        allowing the individual to make decisions independently.
            (8) Help should be provided to adults with a serious mental 
        illness to address their acute or chronic physical illnesses, 
        make informed choices about treatment, and understand and follow 
        through with appropriate treatment.

[[Page 130 STAT. 1270]]

            (9) There is confusion in the health care community 
        regarding permissible practices under the regulations 
        promulgated under the Health Insurance Portability and 
        Accountability Act of 1996 (commonly known as ``HIPAA''). This 
        confusion may hinder appropriate communication of health care 
        information or treatment preferences with appropriate 
        caregivers.

    (b) Sense of Congress.--It is the sense of Congress that 
clarification is needed regarding the privacy rule promulgated under 
section 264(c) of the Health Insurance Portability and Accountability 
Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses 
and disclosures of health information by health care professionals to 
communicate with caregivers of adults with a serious mental illness to 
facilitate treatment.
SEC. 11002. CONFIDENTIALITY OF RECORDS.

    Not later than 1 year after the date on which the Secretary of 
Health and Human Services (in this title referred to as the 
``Secretary'') first finalizes regulations updating part 2 of title 42, 
Code of Federal Regulations, relating to confidentiality of alcohol and 
drug abuse patient records, after the date of enactment of this Act, the 
Secretary shall convene relevant stakeholders to determine the effect of 
such regulations on patient care, health outcomes, and patient privacy.
SEC. 11003. <<NOTE: 42 USC 1320d-2 note.>>  CLARIFICATION ON 
                            PERMITTED USES AND DISCLOSURES OF 
                            PROTECTED HEALTH INFORMATION.

    (a) In General.--The Secretary, acting through the Director of the 
Office for Civil Rights, shall ensure that health care providers, 
professionals, patients and their families, and others involved in 
mental or substance use disorder treatment have adequate, accessible, 
and easily comprehensible resources relating to appropriate uses and 
disclosures of protected health information under the regulations 
promulgated under section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
    (b) Guidance.--
            (1) Issuance.--In carrying out subsection (a), not later 
        than 1 year after the date of enactment of this section, the 
        Secretary shall issue guidance clarifying the circumstances 
        under which, consistent with regulations promulgated under 
        section 264(c) of the Health Insurance Portability and 
        Accountability Act of 1996, a health care provider or covered 
        entity may use or disclose protected health information.
            (2) Circumstances addressed.--The guidance issued under this 
        section shall address circumstances including those that--
                    (A) require the consent of the patient;
                    (B) require providing the patient with an 
                opportunity to object;
                    (C) are based on the exercise of professional 
                judgment regarding whether the patient would object when 
                the opportunity to object cannot practicably be provided 
                because of the incapacity of the patient or an emergency 
                treatment circumstance; and
                    (D) are determined, based on the exercise of 
                professional judgment, to be in the best interest of the 
                patient when the patient is not present or otherwise 
                incapacitated.

[[Page 130 STAT. 1271]]

            (3) Communication with family members and caregivers.--In 
        addressing the circumstances described in paragraph (2), the 
        guidance issued under this section shall clarify permitted uses 
        or disclosures of protected health information for purposes of--
                    (A) communicating with a family member of the 
                patient, caregiver of the patient, or other individual, 
                to the extent that such family member, caregiver, or 
                individual is involved in the care of the patient;
                    (B) in the case that the patient is an adult, 
                communicating with a family member of the patient, 
                caregiver of the patient, or other individual involved 
                in the care of the patient;
                    (C) in the case that the patient is a minor, 
                communicating with the parent or caregiver of the 
                patient;
                    (D) involving the family members or caregivers of 
                the patient, or others involved in the patient's care or 
                care plan, including facilitating treatment and 
                medication adherence;
                    (E) listening to the patient, or receiving 
                information with respect to the patient from the family 
                or caregiver of the patient;
                    (F) communicating with family members of the 
                patient, caregivers of the patient, law enforcement, or 
                others when the patient presents a serious and imminent 
                threat of harm to self or others; and
                    (G) communicating to law enforcement and family 
                members or caregivers of the patient about the admission 
                of the patient to receive care at, or the release of a 
                patient from, a facility for an emergency psychiatric 
                hold or involuntary treatment.
SEC. 11004. <<NOTE: 42 USC 1320d-2 note.>>  DEVELOPMENT AND 
                            DISSEMINATION OF MODEL TRAINING 
                            PROGRAMS.

    (a) Initial Programs and Materials.--Not later than 1 year after the 
date of the enactment of this Act, the Secretary, in consultation with 
appropriate experts, shall identify the following model programs and 
materials, or (in the case that no such programs or materials exist) 
recognize private or public entities to develop and disseminate each of 
the following:
            (1) Model programs and materials for training health care 
        providers (including physicians, emergency medical personnel, 
        psychiatrists, including child and adolescent psychiatrists, 
        psychologists, counselors, therapists, nurse practitioners, 
        physician assistants, behavioral health facilities and clinics, 
        care managers, and hospitals, including individuals such as 
        general counsels or regulatory compliance staff who are 
        responsible for establishing provider privacy policies) 
        regarding the permitted uses and disclosures, consistent with 
        the standards governing the privacy and security of individually 
        identifiable health information promulgated by the Secretary 
        under part C of title XI of the Social Security Act (42 U.S.C. 
        1320d et seq.) and regulations promulgated under section 264(c) 
        of the Health Insurance Portability and Accountability Act of 
        1996 (42 U.S.C. 1320d-2 note) and such part C, of the protected 
        health information of patients seeking or undergoing mental or 
        substance use disorder treatment.

[[Page 130 STAT. 1272]]

            (2) A model program and materials for training patients and 
        their families regarding their rights to protect and obtain 
        information under the standards and regulations specified in 
        paragraph (1).

    (b) Periodic Updates.--The Secretary shall--
            (1) periodically review and update the model programs and 
        materials identified or developed under subsection (a); and
            (2) disseminate the updated model programs and materials to 
        the individuals described in subsection (a).

    (c) Coordination.--The Secretary shall carry out this section in 
coordination with the Director of the Office for Civil Rights within the 
Department of Health and Human Services, the Assistant Secretary for 
Mental Health and Substance Use, the Administrator of the Health 
Resources and Services Administration, and the heads of other relevant 
agencies within the Department of Health and Human Services.
    (d) Input of Certain Entities.--In identifying, reviewing, or 
updating the model programs and materials under subsections (a) and (b), 
the Secretary shall solicit the input of relevant national, State, and 
local associations; medical societies; licensing boards; providers of 
mental and substance use disorder treatment; organizations with 
expertise on domestic violence, sexual assault, elder abuse, and child 
abuse; and organizations representing patients and consumers and the 
families of patients and consumers.
    (e) Funding.--There are authorized to be appropriated to carry out 
this section--
            (1) $4,000,000 for fiscal year 2018;
            (2) $2,000,000 for each of fiscal years 2019 and 2020; and
            (3) $1,000,000 for each of fiscal years 2021 and 2022.

               TITLE XII--MEDICAID MENTAL HEALTH COVERAGE

SEC. 12001. <<NOTE: 42 USC 1396 note.>>  RULE OF CONSTRUCTION 
                            RELATED TO MEDICAID COVERAGE OF MENTAL 
                            HEALTH SERVICES AND PRIMARY CARE 
                            SERVICES FURNISHED ON THE SAME DAY.

    Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et 
seq.) shall be construed as prohibiting separate payment under the State 
plan under such title (or under a waiver of the plan) for the provision 
of a mental health service or primary care service under such plan, with 
respect to an individual, because such service is--
            (1) a primary care service furnished to the individual by a 
        provider at a facility on the same day a mental health service 
        is furnished to such individual by such provider (or another 
        provider) at the facility; or
            (2) a mental health service furnished to the individual by a 
        provider at a facility on the same day a primary care service is 
        furnished to such individual by such provider (or another 
        provider) at the facility.
SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE 
                            REGULATION.

    (a) Study.--The Secretary of Health and Human Services, acting 
through the Administrator of the Centers for Medicare &

[[Page 130 STAT. 1273]]

Medicaid Services, shall conduct a study on coverage under the Medicaid 
program under title XIX of the Social Security Act (42 U.S.C. 1396 et 
seq.) of services provided through a medicaid managed care organization 
(as defined in section 1903(m) of such Act (42 U.S.C. 1396b(m)) or a 
prepaid inpatient health plan (as defined in section 438.2 of title 42, 
Code of Federal Regulations (or any successor regulation)) with respect 
to individuals over the age of 21 and under the age of 65 for the 
treatment of a mental health disorder in institutions for mental 
diseases (as defined in section 1905(i) of such Act (42 U.S.C. 
1396d(i))). Such study shall include information on the following:
            (1) The extent to which States, including the District of 
        Columbia and each territory or possession of the United States, 
        are providing capitated payments to such organizations or plans 
        for enrollees who are receiving services in institutions for 
        mental diseases.
            (2) The number of individuals receiving medical assistance 
        under a State plan under such title XIX, or a waiver of such 
        plan, who receive services in institutions for mental diseases 
        through such organizations and plans.
            (3) The range of and average number of months, and the 
        length of stay during such months, that such individuals are 
        receiving such services in such institutions.
            (4) How such organizations or plans determine when to 
        provide for the furnishing of such services through an 
        institution for mental diseases in lieu of other benefits 
        (including the full range of community-based services) under 
        their contract with the State agency administering the State 
        plan under such title XIX, or a waiver of such plan, to address 
        psychiatric or substance use disorder treatment.
            (5) The extent to which the provision of services within 
        such institutions has affected the capitated payments for such 
        organizations or plans.

    (b) Report.--Not later than 3 years after the date of the enactment 
of this Act, the Secretary shall submit to Congress a report on the 
study conducted under subsection (a).
SEC. 12003. <<NOTE: 42 USC 1315 note.>>  GUIDANCE ON OPPORTUNITIES 
                            FOR INNOVATION.

    Not later than 1 year after the date of the enactment of this Act, 
the Administrator of the Centers for Medicare & Medicaid Services shall 
issue a State Medicaid Director letter regarding opportunities to design 
innovative service delivery systems, including systems for providing 
community-based services, for adults with a serious mental illness or 
children with a serious emotional disturbance who are receiving medical 
assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et 
seq.). The letter shall include opportunities for demonstration projects 
under section 1115 of such Act (42 U.S.C. 1315) to improve care for such 
adults and children.
SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC 
                            DEMONSTRATION PROJECT.

    (a) Collection of Information.--The Secretary of Health and Human 
Services, acting through the Administrator of the Centers for Medicare & 
Medicaid Services, shall, to the extent practical and data is available, 
with respect to each State that has participated in the demonstration 
project established under section 2707

[[Page 130 STAT. 1274]]

of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a 
note), collect from each such State information on the following:
            (1) The number of institutions for mental diseases (as 
        defined in section 1905(i) of the Social Security Act (42 U.S.C. 
        1396d(i))) and beds in such institutions that received payment 
        for the provision of services to individuals who receive medical 
        assistance under a State plan under the Medicaid program under 
        title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) 
        (or under a waiver of such plan) through the demonstration 
        project in each such State as compared to the total number of 
        institutions for mental diseases and beds in the State.
            (2) The extent to which there is a reduction in expenditures 
        under the Medicaid program under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.) or other spending on the 
        full continuum of physical or mental health care for individuals 
        who receive treatment in an institution for mental diseases 
        under the demonstration project, including outpatient, 
        inpatient, emergency, and ambulatory care, that is attributable 
        to such individuals receiving treatment in institutions for 
        mental diseases under the demonstration project.
            (3) The number of forensic psychiatric hospitals, the number 
        of beds in such hospitals, and the number of forensic 
        psychiatric beds in other hospitals in such State, based on the 
        most recent data available, to the extent practical, as 
        determined by such Administrator.
            (4) The amount of any disproportionate share hospital 
        payments under section 1923 of the Social Security Act (42 
        U.S.C. 1396r-4) that institutions for mental diseases in the 
        State received during the period beginning on July 1, 2012, and 
        ending on June 30, 2015, and the extent to which the 
        demonstration project reduced the amount of such payments.
            (5) The most recent data regarding all facilities or sites 
        in the State in which any adults with a serious mental illness 
        who are receiving medical assistance under a State plan under 
        the Medicaid program under title XIX of the Social Security Act 
        (42 U.S.C. 1396 et seq.) (or under a waiver of such plan) are 
        treated during the period referred to in paragraph (4), to the 
        extent practical, as determined by the Administrator, 
        including--
                    (A) the types of such facilities or sites (such as 
                an institution for mental diseases, a hospital emergency 
                department, or other inpatient hospital);
                    (B) the average length of stay in such a facility or 
                site by such an individual, disaggregated by facility 
                type; and
                    (C) the payment rate under the State plan (or a 
                waivers of such plan) for services furnished to such an 
                individual for that treatment, disaggregated by facility 
                type, during the period in which the demonstration 
                project is in operation.
            (6) The extent to which the utilization of hospital 
        emergency departments during the period in which the 
        demonstration project was is in operation differed, with respect 
        to individuals who are receiving medical assistance under a 
        State plan under the Medicaid program under title XIX of the 
        Social Security Act (42 U.S.C. 1396 et seq.) (or under a waiver 
        of such plan), between--

[[Page 130 STAT. 1275]]

                    (A) those individuals who received treatment in an 
                institution for mental diseases under the demonstration 
                project;
                    (B) those individuals who met the eligibility 
                requirements for the demonstration project but who did 
                not receive treatment in an institution for mental 
                diseases under the demonstration project; and
                    (C) those adults with a serious mental illness who 
                did not meet such eligibility requirements and did not 
                receive treatment for such illness in an institution for 
                mental diseases.

    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit to 
Congress a report that summarizes and analyzes the information collected 
under subsection (a). Such report may be submitted as part of the report 
required under section 2707(f) of the Patient Protection and Affordable 
Care Act (42 U.S.C. 1396a note) or separately.
SEC. 12005. <<NOTE: 42 USC 1396d note.>>  PROVIDING EPSDT SERVICES 
                            TO CHILDREN IN IMDS.

    (a) In General.--Section 1905(a)(16) of the Social Security Act (42 
U.S.C. 1396d(a)(16)) is amended--
            (1) by striking ``effective January 1, 1973'' and inserting 
        ``(A) effective January 1, 1973''; and
            (2) by inserting before the semicolon at the end the 
        following: ``, and, (B) for individuals receiving services 
        described in subparagraph (A), early and periodic screening, 
        diagnostic, and treatment services (as defined in subsection 
        (r)), whether or not such screening, diagnostic, and treatment 
        services are furnished by the provider of the services described 
        in such subparagraph''.

    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to items and services furnished in calendar quarters 
beginning on or after January 1, 2019.
SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR 
                            PERSONAL CARE SERVICES AND HOME HEALTH 
                            CARE SERVICES UNDER MEDICAID.

    (a) In General.--Section 1903 of the Social Security Act (42 U.S.C. 
1396b) is amended by inserting after subsection (k) the following new 
subsection:
    ``(l)(1) Subject to paragraphs (3) and (4), with respect to any 
amount expended for personal care services or home health care services 
requiring an in-home visit by a provider that are provided under a State 
plan under this title (or under a waiver of the plan) and furnished in a 
calendar quarter beginning on or after January 1, 2019 (or, in the case 
of home health care services, on or after January 1, 2023), unless a 
State requires the use of an electronic visit verification system for 
such services furnished in such quarter under the plan or such waiver, 
the Federal medical assistance percentage shall be reduced--
            ``(A) in the case of personal care services--
                    ``(i) for calendar quarters in 2019 and 2020, by .25 
                percentage points;
                    ``(ii) for calendar quarters in 2021, by .5 
                percentage points;
                    ``(iii) for calendar quarters in 2022, by .75 
                percentage points; and

[[Page 130 STAT. 1276]]

                    ``(iv) for calendar quarters in 2023 and each year 
                thereafter, by 1 percentage point; and
            ``(B) in the case of home health care services--
                    ``(i) for calendar quarters in 2023 and 2024, by .25 
                percentage points;
                    ``(ii) for calendar quarters in 2025, by .5 
                percentage points;
                    ``(iii) for calendar quarters in 2026, by .75 
                percentage points; and
                    ``(iv) for calendar quarters in 2027 and each year 
                thereafter, by 1 percentage point.

    ``(2) Subject to paragraphs (3) and (4), in implementing the 
requirement for the use of an electronic visit verification system under 
paragraph (1), a State shall--
            ``(A) consult with agencies and entities that provide 
        personal care services, home health care services, or both under 
        the State plan (or under a waiver of the plan) to ensure that 
        such system--
                    ``(i) is minimally burdensome;
                    ``(ii) takes into account existing best practices 
                and electronic visit verification systems in use in the 
                State; and
                    ``(iii) is conducted in accordance with the 
                requirements of HIPAA privacy and security law (as 
                defined in section 3009 of the Public Health Service 
                Act);
            ``(B) take into account a stakeholder process that includes 
        input from beneficiaries, family caregivers, individuals who 
        furnish personal care services or home health care services, and 
        other stakeholders, as determined by the State in accordance 
        with guidance from the Secretary; and
            ``(C) ensure that individuals who furnish personal care 
        services, home health care services, or both under the State 
        plan (or under a waiver of the plan) are provided the 
        opportunity for training on the use of such system.

    ``(3) Paragraphs (1) and (2) shall not apply in the case of a State 
that, as of the date of the enactment of this subsection, requires the 
use of any system for the electronic verification of visits conducted as 
part of both personal care services and home health care services, so 
long as the State continues to require the use of such system with 
respect to the electronic verification of such visits.
    ``(4)(A) In the case of a State described in subparagraph (B), the 
reduction under paragraph (1) shall not apply--
            ``(i) in the case of personal care services, for calendar 
        quarters in 2019; and
            ``(ii) in the case of home health care services, for 
        calendar quarters in 2023.

    ``(B) For purposes of subparagraph (A), a State described in this 
subparagraph is a State that demonstrates to the Secretary that the 
State--
            ``(i) has made a good faith effort to comply with the 
        requirements of paragraphs (1) and (2) (including by taking 
        steps to adopt the technology used for an electronic visit 
        verification system); and
            ``(ii) in implementing such a system, has encountered 
        unavoidable system delays.

    ``(5) In this subsection:

[[Page 130 STAT. 1277]]

            ``(A) The term `electronic visit verification system' means, 
        with respect to personal care services or home health care 
        services, a system under which visits conducted as part of such 
        services are electronically verified with respect to--
                    ``(i) the type of service performed;
                    ``(ii) the individual receiving the service;
                    ``(iii) the date of the service;
                    ``(iv) the location of service delivery;
                    ``(v) the individual providing the service; and
                    ``(vi) the time the service begins and ends.
            ``(B) The term `home health care services' means services 
        described in section 1905(a)(7) provided under a State plan 
        under this title (or under a waiver of the plan).
            ``(C) The term `personal care services' means personal care 
        services provided under a State plan under this title (or under 
        a waiver of the plan), including services provided under section 
        1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a 
        wavier under section 1115.

    ``(6)(A) In the case in which a State requires personal care service 
and home health care service providers to utilize an electronic visit 
verification system operated by the State or a contractor on behalf of 
the State, the Secretary shall pay to the State, for each quarter, an 
amount equal to 90 per centum of so much of the sums expended during 
such quarter as are attributable to the design, development, or 
installation of such system, and 75 per centum of so much of the sums 
for the operation and maintenance of such system.
    ``(B) Subparagraph (A) shall not apply in the case in which a State 
requires personal care service and home health care service providers to 
utilize an electronic visit verification system that is not operated by 
the State or a contractor on behalf of the State.''.
    (b) <<NOTE: 42 USC 1396b note.>>  Collection and Dissemination of 
Best Practices.--Not later than January 1, 2018, the Secretary of Health 
and Human Services shall, with respect to electronic visit verification 
systems (as defined in subsection (l)(5) of section 1903 of the Social 
Security Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect 
and disseminate best practices to State Medicaid Directors with respect 
to--
            (1) training individuals who furnish personal care services, 
        home health care services, or both under the State plan under 
        title XIX of such Act (or under a waiver of the plan) on such 
        systems and the operation of such systems and the prevention of 
        fraud with respect to the provision of personal care services or 
        home health care services (as defined in such subsection 
        (l)(5)); and
            (2) the provision of notice and educational materials to 
        family caregivers and beneficiaries with respect to the use of 
        such electronic visit verification systems and other means to 
        prevent such fraud.

    (c) <<NOTE: 42 USC 1396b note.>>  Rules of Construction.--
            (1) No employer-employee relationship established.--Nothing 
        in the amendment made by this section may be construed as 
        establishing an employer-employee relationship between the 
        agency or entity that provides for personal care services or 
        home health care services and the individuals who, under a 
        contract with such an agency or entity, furnish such

[[Page 130 STAT. 1278]]

        services for purposes of part 552 of title 29, Code of Federal 
        Regulations (or any successor regulations).
            (2) No particular or uniform electronic visit verification 
        system required.--Nothing in the amendment made by this section 
        shall be construed to require the use of a particular or uniform 
        electronic visit verification system (as defined in subsection 
        (l)(5) of section 1903 of the Social Security Act (42 U.S.C. 
        1396b), as inserted by subsection (a)) by all agencies or 
        entities that provide personal care services or home health care 
        under a State plan under title XIX of the Social Security Act 
        (or under a waiver of the plan) (42 U.S.C. 1396 et seq.).
            (3) No limits on provision of care.--Nothing in the 
        amendment made by this section may be construed to limit, with 
        respect to personal care services or home health care services 
        provided under a State plan under title XIX of the Social 
        Security Act (or under a waiver of the plan) (42 U.S.C. 1396 et 
        seq.), provider selection, constrain beneficiaries' selection of 
        a caregiver, or impede the manner in which care is delivered.
            (4) No prohibition on state quality measures requirements.--
        Nothing in the amendment made by this section shall be construed 
        as prohibiting a State, in implementing an electronic visit 
        verification system (as defined in subsection (l)(5) of section 
        1903 of the Social Security Act (42 U.S.C. 1396b), as inserted 
        by subsection (a)), from establishing requirements related to 
        quality measures for such system.

                    TITLE XIII--MENTAL HEALTH PARITY

SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE 
                            USE DISORDER COVERAGE REQUIREMENTS.

    (a) Compliance Program Guidance Document.--Section 2726(a) of the 
Public Health Service Act (42 U.S.C. 300gg-26(a)) is amended by adding 
at the end the following:
            ``(6) Compliance program guidance document.--
                    ``(A) In general.--Not later than 12 months after 
                the date of enactment of the Helping Families in Mental 
                Health Crisis Reform Act of 2016, the Secretary, the 
                Secretary of Labor, and the Secretary of the Treasury, 
                in consultation with the Inspector General of the 
                Department of Health and Human Services, the Inspector 
                General of the Department of Labor, and the Inspector 
                General of the Department of the Treasury, shall issue a 
                compliance program guidance document to help improve 
                compliance with this section, section 712 of the 
                Employee Retirement Income Security Act of 1974, and 
                section 9812 of the Internal Revenue Code of 1986, as 
                applicable. In carrying out this paragraph, the 
                Secretaries may take into consideration the 2016 
                publication of the Department of Health and Human 
                Services and the Department of Labor, entitled `Warning 
                Signs - Plan or Policy Non-Quantitative Treatment 
                Limitations (NQTLs) that Require Additional Analysis to 
                Determine Mental Health Parity Compliance'.
                    ``(B) Examples illustrating compliance and 
                noncompliance.--

[[Page 130 STAT. 1279]]

                          ``(i) In general.--The compliance program 
                      guidance document required under this paragraph 
                      shall provide illustrative, de-identified examples 
                      (that do not disclose any protected health 
                      information or individually identifiable 
                      information) of previous findings of compliance 
                      and noncompliance with this section, section 712 
                      of the Employee Retirement Income Security Act of 
                      1974, or section 9812 of the Internal Revenue Code 
                      of 1986, as applicable, based on investigations of 
                      violations of such sections, including--
                                    ``(I) examples illustrating 
                                requirements for information disclosures 
                                and nonquantitative treatment 
                                limitations; and
                                    ``(II) descriptions of the 
                                violations uncovered during the course 
                                of such investigations.
                          ``(ii) Nonquantitative treatment 
                      limitations.--To the extent that any example 
                      described in clause (i) involves a finding of 
                      compliance or noncompliance with regard to any 
                      requirement for nonquantitative treatment 
                      limitations, the example shall provide sufficient 
                      detail to fully explain such finding, including a 
                      full description of the criteria involved for 
                      approving medical and surgical benefits and the 
                      criteria involved for approving mental health and 
                      substance use disorder benefits.
                          ``(iii) Access to additional information 
                      regarding compliance.--In developing and issuing 
                      the compliance program guidance document required 
                      under this paragraph, the Secretaries specified in 
                      subparagraph (A)--
                                    ``(I) shall enter into interagency 
                                agreements with the Inspector General of 
                                the Department of Health and Human 
                                Services, the Inspector General of the 
                                Department of Labor, and the Inspector 
                                General of the Department of the 
                                Treasury to share findings of compliance 
                                and noncompliance with this section, 
                                section 712 of the Employee Retirement 
                                Income Security Act of 1974, or section 
                                9812 of the Internal Revenue Code of 
                                1986, as applicable; and
                                    ``(II) shall seek to enter into an 
                                agreement with a State to share 
                                information on findings of compliance 
                                and noncompliance with this section, 
                                section 712 of the Employee Retirement 
                                Income Security Act of 1974, or section 
                                9812 of the Internal Revenue Code of 
                                1986, as applicable.
                    ``(C) Recommendations.--The compliance program 
                guidance document shall include recommendations to 
                advance compliance with this section, section 712 of the 
                Employee Retirement Income Security Act of 1974, or 
                section 9812 of the Internal Revenue Code of 1986, as 
                applicable, and encourage the development and use of 
                internal controls to monitor adherence to applicable 
                statutes, regulations, and program requirements. Such 
                internal controls may include illustrative examples of 
                nonquantitative treatment limitations on mental health 
                and substance use disorder benefits, which may fail to 
                comply with this

[[Page 130 STAT. 1280]]

                section, section 712 of the Employee Retirement Income 
                Security Act of 1974, or section 9812 of the Internal 
                Revenue Code of 1986, as applicable, in relation to 
                nonquantitative treatment limitations on medical and 
                surgical benefits.
                    ``(D) Updating the compliance program guidance 
                document.--The Secretary, the Secretary of Labor, and 
                the Secretary of the Treasury, in consultation with the 
                Inspector General of the Department of Health and Human 
                Services, the Inspector General of the Department of 
                Labor, and the Inspector General of the Department of 
                the Treasury, shall update the compliance program 
                guidance document every 2 years to include illustrative, 
                de-identified examples (that do not disclose any 
                protected health information or individually 
                identifiable information) of previous findings of 
                compliance and noncompliance with this section, section 
                712 of the Employee Retirement Income Security Act of 
                1974, or section 9812 of the Internal Revenue Code of 
                1986, as applicable.''.

    (b) Additional Guidance.--Section 2726(a) of the Public Health 
Service Act (42 U.S.C. 300gg-26(a)), as amended by subsection (a), is 
further amended by adding at the end the following:
            ``(7) Additional guidance.--
                    ``(A) In general.--Not later than 12 months after 
                the date of enactment of the Helping Families in Mental 
                Health Crisis Reform Act of 2016, the Secretary, the 
                Secretary of Labor, and the Secretary of the Treasury 
                shall issue guidance to group health plans and health 
                insurance issuers offering group or individual health 
                insurance coverage to assist such plans and issuers in 
                satisfying the requirements of this section, section 712 
                of the Employee Retirement Income Security Act of 1974, 
                or section 9812 of the Internal Revenue Code of 1986, as 
                applicable.
                    ``(B) Disclosure.--
                          ``(i) Guidance for plans and issuers.--The 
                      guidance issued under this paragraph shall include 
                      clarifying information and illustrative examples 
                      of methods that group health plans and health 
                      insurance issuers offering group or individual 
                      health insurance coverage may use for disclosing 
                      information to ensure compliance with the 
                      requirements under this section, section 712 of 
                      the Employee Retirement Income Security Act of 
                      1974, or section 9812 of the Internal Revenue Code 
                      of 1986, as applicable, (and any regulations 
                      promulgated pursuant to such sections, as 
                      applicable).
                          ``(ii) Documents for participants, 
                      beneficiaries, contracting providers, or 
                      authorized representatives.--The guidance issued 
                      under this paragraph shall include clarifying 
                      information and illustrative examples of methods 
                      that group health plans and health insurance 
                      issuers offering group or individual health 
                      insurance coverage may use to provide any 
                      participant, beneficiary, contracting provider, or 
                      authorized representative, as applicable, with 
                      documents containing information that the health 
                      plans or issuers are required to disclose to 
                      participants, beneficiaries, contracting 
                      providers, or authorized representatives to ensure 
                      compliance with this section,

[[Page 130 STAT. 1281]]

                      section 712 of the Employee Retirement Income 
                      Security Act of 1974, or section 9812 of the 
                      Internal Revenue Code of 1986, as applicable, 
                      compliance with any regulation issued pursuant to 
                      such respective section, or compliance with any 
                      other applicable law or regulation. Such guidance 
                      shall include information that is comparative in 
                      nature with respect to--
                                    ``(I) nonquantitative treatment 
                                limitations for both medical and 
                                surgical benefits and mental health and 
                                substance use disorder benefits;
                                    ``(II) the processes, strategies, 
                                evidentiary standards, and other factors 
                                used to apply the limitations described 
                                in subclause (I); and
                                    ``(III) the application of the 
                                limitations described in subclause (I) 
                                to ensure that such limitations are 
                                applied in parity with respect to both 
                                medical and surgical benefits and mental 
                                health and substance use disorder 
                                benefits.
                    ``(C) Nonquantitative treatment limitations.--The 
                guidance issued under this paragraph shall include 
                clarifying information and illustrative examples of 
                methods, processes, strategies, evidentiary standards, 
                and other factors that group health plans and health 
                insurance issuers offering group or individual health 
                insurance coverage may use regarding the development and 
                application of nonquantitative treatment limitations to 
                ensure compliance with this section, section 712 of the 
                Employee Retirement Income Security Act of 1974, or 
                section 9812 of the Internal Revenue Code of 1986, as 
                applicable, (and any regulations promulgated pursuant to 
                such respective section), including--
                          ``(i) examples of methods of determining 
                      appropriate types of nonquantitative treatment 
                      limitations with respect to both medical and 
                      surgical benefits and mental health and substance 
                      use disorder benefits, including nonquantitative 
                      treatment limitations pertaining to--
                                    ``(I) medical management standards 
                                based on medical necessity or 
                                appropriateness, or whether a treatment 
                                is experimental or investigative;
                                    ``(II) limitations with respect to 
                                prescription drug formulary design; and
                                    ``(III) use of fail-first or step 
                                therapy protocols;
                          ``(ii) examples of methods of determining--
                                    ``(I) network admission standards 
                                (such as credentialing); and
                                    ``(II) factors used in provider 
                                reimbursement methodologies (such as 
                                service type, geographic market, demand 
                                for services, and provider supply, 
                                practice size, training, experience, and 
                                licensure) as such factors apply to 
                                network adequacy;
                          ``(iii) examples of sources of information 
                      that may serve as evidentiary standards for the 
                      purposes of making determinations regarding the 
                      development and application of nonquantitative 
                      treatment limitations;
                          ``(iv) examples of specific factors, and the 
                      evidentiary standards used to evaluate such 
                      factors, used

[[Page 130 STAT. 1282]]

                      by such plans or issuers in performing a 
                      nonquantitative treatment limitation analysis;
                          ``(v) examples of how specific evidentiary 
                      standards may be used to determine whether 
                      treatments are considered experimental or 
                      investigative;
                          ``(vi) examples of how specific evidentiary 
                      standards may be applied to each service category 
                      or classification of benefits;
                          ``(vii) examples of methods of reaching 
                      appropriate coverage determinations for new mental 
                      health or substance use disorder treatments, such 
                      as evidence-based early intervention programs for 
                      individuals with a serious mental illness and 
                      types of medical management techniques;
                          ``(viii) examples of methods of reaching 
                      appropriate coverage determinations for which 
                      there is an indirect relationship between the 
                      covered mental health or substance use disorder 
                      benefit and a traditional covered medical and 
                      surgical benefit, such as residential treatment or 
                      hospitalizations involving voluntary or 
                      involuntary commitment; and
                          ``(ix) additional illustrative examples of 
                      methods, processes, strategies, evidentiary 
                      standards, and other factors for which the 
                      Secretary determines that additional guidance is 
                      necessary to improve compliance with this section, 
                      section 712 of the Employee Retirement Income 
                      Security Act of 1974, or section 9812 of the 
                      Internal Revenue Code of 1986, as applicable.
                    ``(D) Public comment.--Prior to issuing any final 
                guidance under this paragraph, the Secretary shall 
                provide a public comment period of not less than 60 days 
                during which any member of the public may provide 
                comments on a draft of the guidance.''.

    (c) Availability of Plan Information.--
            (1) Solicitation of public feedback.--Not later than 6 
        months after the date of enactment of this Act, the Secretary of 
        Health and Human Services, the Secretary of Labor, and the 
        Secretary of the Treasury shall solicit feedback from the public 
        on how the disclosure request process for documents containing 
        information that health plans or health insurance issuers are 
        required under Federal or State law to disclose to participants, 
        beneficiaries, contracting providers, or authorized 
        representatives to ensure compliance with existing mental health 
        parity and addiction equity requirements can be improved while 
        continuing to ensure consumers' rights to access all information 
        required by Federal or State law to be disclosed.
            (2) Public availability.--Not later than 12 months after the 
        date of the enactment of this Act, the Secretary of Health and 
        Human Services, the Secretary of Labor, and the Secretary of the 
        Treasury shall make such feedback publicly available.
            (3) NAIC.--The Secretary of Health and Human Services, the 
        Secretary of Labor, and the Secretary of the Treasury shall 
        share feedback obtained pursuant to paragraph (1) directly with 
        the National Association of Insurance Commissioners to the 
        extent such feedback includes recommendations for the 
        development of simplified information disclosure tools to 
        provide consistent information for consumers. Such feedback

[[Page 130 STAT. 1283]]

        may be taken into consideration by the National Association of 
        Insurance Commissioners and other appropriate entities for the 
        voluntary development and voluntary use of common templates and 
        other sample standardized forms to improve consumer access to 
        plan information.

    (d) Improving Compliance.--
            (1) <<NOTE: 42 USC 300gg-26 note.>>  In general.--In the 
        case that the Secretary of Health and Human Services, the 
        Secretary of Labor, or the Secretary of the Treasury determines 
        that a group health plan or health insurance issuer offering 
        group or individual health insurance coverage has violated, at 
        least 5 times, section 2726 of the Public Health Service Act (42 
        U.S.C. 300gg-26), section 712 of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1185a), or section 9812 of the 
        Internal Revenue Code of 1986, respectively, the appropriate 
        Secretary shall audit plan documents for such health plan or 
        issuer in the plan year following the Secretary's determination 
        in order to help improve compliance with such section.
            (2) Rule of construction.--Nothing in this subsection shall 
        be construed to limit the authority, as in effect on the day 
        before the date of enactment of this Act, of the Secretary of 
        Health and Human Services, the Secretary of Labor, or the 
        Secretary of the Treasury to audit documents of health plans or 
        health insurance issuers.
SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL HEALTH 
                            AND SUBSTANCE USE DISORDER COVERAGE.

    (a) Public Meeting.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall convene a public meeting of stakeholders 
        described in paragraph (2) to produce an action plan for 
        improved Federal and State coordination related to the 
        enforcement of section 2726 of the Public Health Service Act (42 
        U.S.C. 300gg-26), section 712 of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the 
        Internal Revenue Code of 1986, and any comparable provisions of 
        State law (in this section such sections and provisions are 
        collectively referred to as ``mental health parity and addiction 
        equity requirements'').
            (2) Stakeholders.--The stakeholders described in this 
        paragraph shall include each of the following:
                    (A) The Federal Government, including 
                representatives from--
                          (i) the Department of Health and Human 
                      Services;
                          (ii) the Department of the Treasury;
                          (iii) the Department of Labor; and
                          (iv) the Department of Justice.
                    (B) State governments, including--
                          (i) State health insurance commissioners;
                          (ii) appropriate State agencies, including 
                      agencies on public health or mental health; and
                          (iii) State attorneys general or other 
                      representatives of State entities involved in the 
                      enforcement of mental health parity and addiction 
                      equity requirements.

[[Page 130 STAT. 1284]]

                    (C) Representatives from key stakeholder groups, 
                including--
                          (i) the National Association of Insurance 
                      Commissioners;
                          (ii) health insurance issuers;
                          (iii) providers of mental health and substance 
                      use disorder treatment;
                          (iv) employers; and
                          (v) patients or their advocates.

    (b) Action Plan.--Not later than 6 months after the conclusion of 
the public meeting under subsection (a), the Secretary of Health and 
Human Services shall finalize the action plan described in such 
subsection and make it plainly available on the Internet website of the 
Department of Health and Human Services.
    (c) Content.--The action plan under this section shall--
            (1) take into consideration the recommendations of the 
        Mental Health and Substance Use Disorder Parity Task Force in 
        its final report issued in October of 2016, and any subsequent 
        Federal and State actions in relation to such recommendations;
            (2) reflect the input of the stakeholders participating in 
        the public meeting under subsection (a);
            (3) identify specific strategic objectives regarding how the 
        various Federal and State agencies charged with enforcement of 
        mental health parity and addiction equity requirements will 
        collaborate to improve enforcement of such requirements;
            (4) provide a timeline for implementing the action plan; and
            (5) provide specific examples of how such objectives may be 
        met, which may include--
                    (A) providing common educational information and 
                documents, such as the Consumer Guide to Disclosure 
                Rights, to patients about their rights under mental 
                health parity and addiction equity requirements;
                    (B) facilitating the centralized collection of, 
                monitoring of, and response to patient complaints or 
                inquiries relating to mental health parity and addiction 
                equity requirements, which may be through the 
                development and administration of--
                          (i) a single, toll-free telephone number; and
                          (ii) a new parity website--
                                    (I) to help consumers find the 
                                appropriate Federal or State agency to 
                                assist with their parity complaints, 
                                appeals, and other actions; and
                                    (II) that takes into consideration, 
                                but is not duplicative of, the parity 
                                beta site being tested, and released for 
                                public comment, by the Department of 
                                Health and Human Services as of the date 
                                of the enactment of this Act;
                    (C) Federal and State law enforcement agencies 
                entering into memoranda of understanding to better 
                coordinate enforcement responsibilities and information 
                sharing--
                          (i) including whether such agencies should 
                      make the results of enforcement actions related to 
                      mental health parity and addiction equity 
                      requirements publicly available; and

[[Page 130 STAT. 1285]]

                          (ii) which may include State Policy Academies 
                      on Parity Implementation for State Officials and 
                      other forums to bring together national experts to 
                      provide technical assistance to teams of State 
                      officials on strategies to advance compliance with 
                      mental health parity and addiction equity 
                      requirements in both the commercial market, and in 
                      the Medicaid program under title XIX of the Social 
                      Security Act and the State Children's Health 
                      Insurance Program under title XXI of such Act; and
                    (D) recommendations to the Congress regarding the 
                need for additional legal authority to improve 
                enforcement of mental health parity and addiction equity 
                requirements, including the need for additional legal 
                authority to ensure that nonquantitative treatment 
                limitations are applied, and the extent and frequency of 
                the applications of such limitations, both to medical 
                and surgical benefits and to mental health and substance 
                use disorder benefits in a comparable manner.
SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL 
                            HEALTH AND SUBSTANCE USE DISORDER 
                            BENEFITS.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, and annually thereafter for the subsequent 5 years, the 
Assistant Secretary of Labor of the Employee Benefits Security 
Administration, in collaboration with the Administrator of the Centers 
for Medicare & Medicaid Services and the Secretary of the Treasury, 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report summarizing the results of all closed 
Federal investigations completed during the preceding 12-month period 
with findings of any serious violation regarding compliance with mental 
health and substance use disorder coverage requirements under section 
2726 of the Public Health Service Act (42 U.S.C. 300gg-26), section 712 
of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1185a), and section 9812 of the Internal Revenue Code of 1986.
    (b) Contents.--Subject to subsection (c), a report under subsection 
(a) shall, with respect to investigations described in such subsection, 
include each of the following:
            (1) The number of closed Federal investigations conducted 
        during the covered reporting period.
            (2) Each benefit classification examined by any such 
        investigation conducted during the covered reporting period.
            (3) Each subject matter, including compliance with 
        requirements for quantitative and nonquantitative treatment 
        limitations, of any such investigation conducted during the 
        covered reporting period.
            (4) A summary of the basis of the final decision rendered 
        for each closed investigation conducted during the covered 
        reporting period that resulted in a finding of a serious 
        violation.

    (c) Limitation.--Any individually identifiable information shall be 
excluded from reports under subsection (a) consistent with protections 
under the health privacy and security rules promulgated under section 
264(c) of the Health Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d-2 note).

[[Page 130 STAT. 1286]]

SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE 
                            DISORDER BENEFITS.

    Not later than 3 years after the date of enactment of this Act, the 
Comptroller General of the United States, in consultation with the 
Secretary of Health and Human Services, the Secretary of Labor, and the 
Secretary of the Treasury, shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report detailing the 
extent to which group health plans or health insurance issuers offering 
group or individual health insurance coverage that provides both medical 
and surgical benefits and mental health or substance use disorder 
benefits, medicaid managed care organizations with a contract under 
section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), and 
health plans provided under the State Children's Health Insurance 
Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et 
seq.) comply with section 2726 of the Public Health Service Act (42 
U.S.C. 300gg-26), section 712 of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal Revenue 
Code of 1986, including--
            (1) how nonquantitative treatment limitations, including 
        medical necessity criteria, of such plans or issuers comply with 
        such sections;
            (2) how the responsible Federal departments and agencies 
        ensure that such plans or issuers comply with such sections, 
        including an assessment of how the Secretary of Health and Human 
        Services has used its authority to conduct audits of such plans 
        to ensure compliance;
            (3) a review of how the various Federal and State agencies 
        responsible for enforcing mental health parity requirements have 
        improved enforcement of such requirements in accordance with the 
        objectives and timeline described in the action plan under 
        section 13002; and
            (4) recommendations for how additional enforcement, 
        education, and coordination activities by responsible Federal 
        and State departments and agencies could better ensure 
        compliance with such sections, including recommendations 
        regarding the need for additional legal authority.
SEC. 13005. <<NOTE: 42 USC 237a note.>>  INFORMATION AND AWARENESS 
                            ON EATING DISORDERS.

    (a) Information.--The Secretary of Health and Human Services, acting 
through the Director of the Office on Women's Health, may--
            (1) update information, related fact sheets, and resource 
        lists related to eating disorders that are available on the 
        public Internet website of the National Women's Health 
        Information Center sponsored by the Office on Women's Health, to 
        include--
                    (A) updated findings and current research related to 
                eating disorders, as appropriate; and
                    (B) information about eating disorders, including 
                information related to males and females;
            (2) incorporate, as appropriate, and in coordination with 
        the Secretary of Education, information from publicly available 
        resources into appropriate obesity prevention programs developed 
        by the Office on Women's Health; and
            (3) make publicly available (through a public Internet 
        website or other method) information, related fact sheets, and

[[Page 130 STAT. 1287]]

        resource lists, as updated under paragraph (1), and the 
        information incorporated into appropriate obesity prevention 
        programs under paragraph (2).

    (b) Awareness.--The Secretary of Health and Human Services may 
advance public awareness on--
            (1) the types of eating disorders;
            (2) the seriousness of eating disorders, including 
        prevalence, comorbidities, and physical and mental health 
        consequences;
            (3) methods to identify, intervene, refer for treatment, and 
        prevent behaviors that may lead to the development of eating 
        disorders;
            (4) discrimination and bullying based on body size;
            (5) the effects of media on self-esteem and body image; and
            (6) the signs and symptoms of eating disorders.
SEC. 13006. <<NOTE: 42 USC 237a note.>>  EDUCATION AND TRAINING ON 
                            EATING DISORDERS.

    The Secretary of Health and Human Services may facilitate the 
identification of model programs and materials for educating and 
training health professionals in effective strategies to--
            (1) identify individuals with eating disorders;
            (2) provide early intervention services for individuals with 
        eating disorders;
            (3) refer patients with eating disorders for appropriate 
        treatment;
            (4) prevent the development of eating disorders; and
            (5) provide appropriate treatment services for individuals 
        with eating disorders.
SEC. 13007. <<NOTE: 42 USC 300gg-26 note.>>  CLARIFICATION OF 
                            EXISTING PARITY RULES.

    If a group health plan or a health insurance issuer offering group 
or individual health insurance coverage provides coverage for eating 
disorder benefits, including residential treatment, such group health 
plan or health insurance issuer shall provide such benefits consistent 
with the requirements of section 2726 of the Public Health Service Act 
(42 U.S.C. 300gg-26), section 712 of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the Internal 
Revenue Code of 1986.

              TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES

             Subtitle A--Mental Health and Safe Communities

SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS, 
                            MENTAL HEALTH PURPOSES.

    (a) Edward Byrne Memorial Justice Assistance Grant Program.--Section 
501(a)(1) of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the end the 
following:
                    ``(H) Mental health programs and related law 
                enforcement and corrections programs, including 
                behavioral programs and crisis intervention teams.''.

[[Page 130 STAT. 1288]]

    (b) Community Oriented Policing Services Program.--Section 1701(b) 
of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 
U.S.C. 3796dd(b)) is amended--
            (1) in paragraph (17), by striking ``and'' at the end;
            (2) by redesignating paragraph (18) as paragraph (22);
            (3) by inserting after paragraph (17) the following:
            ``(18) to provide specialized training to law enforcement 
        officers to--
                    ``(A) recognize individuals who have a mental 
                illness; and
                    ``(B) properly interact with individuals who have a 
                mental illness, including strategies for verbal de-
                escalation of crises;
            ``(19) to establish collaborative programs that enhance the 
        ability of law enforcement agencies to address the mental 
        health, behavioral, and substance abuse problems of individuals 
        encountered by law enforcement officers in the line of duty;
            ``(20) to provide specialized training to corrections 
        officers to recognize individuals who have a mental illness;
            ``(21) to enhance the ability of corrections officers to 
        address the mental health of individuals under the care and 
        custody of jails and prisons, including specialized training and 
        strategies for verbal de-escalation of crises; and''; and
            (4) in paragraph (22), as redesignated, by striking 
        ``through (17)'' and inserting ``through (21)''.

    (c) Modifications to the Staffing for Adequate Fire and Emergency 
Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention and 
Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting 
before the period at the end the following: ``and to provide specialized 
training to paramedics, emergency medical services workers, and other 
first responders to recognize individuals who have mental illness and 
how to properly intervene with individuals with mental illness, 
including strategies for verbal de-escalation of crises''.
SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.

    (a) In General.--Section 2201 of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in 
paragraph (2)(B), by inserting before the semicolon the following: ``, 
or court-ordered assisted outpatient treatment when the court has 
determined such treatment to be necessary''.
    (b) Definitions.--Section 2202 of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) in paragraph (2), by striking the period at the end and 
        inserting a semicolon; and
            (3) by adding at the end the following:
            ``(3) the term `court-ordered assisted outpatient treatment' 
        means a program through which a court may order a treatment plan 
        for an eligible patient that--
                    ``(A) requires such patient to obtain outpatient 
                mental health treatment while the patient is not 
                currently residing in a correctional facility or 
                inpatient treatment facility; and

[[Page 130 STAT. 1289]]

                    ``(B) is designed to improve access and adherence by 
                such patient to intensive behavioral health services in 
                order to--
                          ``(i) avert relapse, repeated 
                      hospitalizations, arrest, incarceration, suicide, 
                      property destruction, and violent behavior; and
                          ``(ii) provide such patient with the 
                      opportunity to live in a less restrictive 
                      alternative to incarceration or involuntary 
                      hospitalization; and
            ``(4) the term `eligible patient' means an adult, mentally 
        ill person who, as determined by a court--
                    ``(A) has a history of violence, incarceration, or 
                medically unnecessary hospitalizations;
                    ``(B) without supervision and treatment, may be a 
                danger to self or others in the community;
                    ``(C) is substantially unlikely to voluntarily 
                participate in treatment;
                    ``(D) may be unable, for reasons other than 
                indigence, to provide for any of his or her basic needs, 
                such as food, clothing, shelter, health, or safety;
                    ``(E) has a history of mental illness or a condition 
                that is likely to substantially deteriorate if the 
                person is not provided with timely treatment; or
                    ``(F) due to mental illness, lacks capacity to fully 
                understand or lacks judgment to make informed decisions 
                regarding his or her need for treatment, care, or 
                supervision.''.
SEC. 14003. <<NOTE: 42 USC 3796ii note.>>  FEDERAL DRUG AND MENTAL 
                            HEALTH COURTS.

    (a) Definitions.--In this section--
            (1) the term ``eligible offender'' means a person who--
                    (A)(i) previously or currently has been diagnosed by 
                a qualified mental health professional as having a 
                mental illness, mental retardation, or co-occurring 
                mental illness and substance abuse disorders; or
                    (ii) manifests obvious signs of mental illness, 
                mental retardation, or co-occurring mental illness and 
                substance abuse disorders during arrest or confinement 
                or before any court;
                    (B) comes into contact with the criminal justice 
                system or is arrested or charged with an offense that is 
                not--
                          (i) a crime of violence, as defined under 
                      applicable State law or in section 3156 of title 
                      18, United States Code; or
                          (ii) a serious drug offense, as defined in 
                      section 924(e)(2)(A) of title 18, United States 
                      Code; and
                    (C) is determined by a judge to be eligible; and
            (2) the term ``mental illness'' means a diagnosable mental, 
        behavioral, or emotional disorder--
                    (A) of sufficient duration to meet diagnostic 
                criteria within the most recent edition of the 
                Diagnostic and Statistical Manual of Mental Disorders 
                published by the American Psychiatric Association; and
                    (B) that has resulted in functional impairment that 
                substantially interferes with or limits 1 or more major 
                life activities.

[[Page 130 STAT. 1290]]

    (b) Establishment of Program.--Not later than 1 year after the date 
of enactment of this Act, the Attorney General shall establish a pilot 
program to determine the effectiveness of diverting eligible offenders 
from Federal prosecution, Federal probation, or a Bureau of Prisons 
facility, and placing such eligible offenders in drug or mental health 
courts.
    (c) Program Specifications.--The pilot program established under 
subsection (b) shall involve--
            (1) continuing judicial supervision, including periodic 
        review, of program participants who have a substance abuse 
        problem or mental illness; and
            (2) the integrated administration of services and sanctions, 
        which shall include--
                    (A) mandatory periodic testing, as appropriate, for 
                the use of controlled substances or other addictive 
                substances during any period of supervised release or 
                probation for each program participant;
                    (B) substance abuse treatment for each program 
                participant who requires such services;
                    (C) diversion, probation, or other supervised 
                release with the possibility of prosecution, 
                confinement, or incarceration based on noncompliance 
                with program requirements or failure to show 
                satisfactory progress toward completing program 
                requirements;
                    (D) programmatic offender management, including case 
                management, and aftercare services, such as relapse 
                prevention, health care, education, vocational training, 
                job placement, housing placement, and child care or 
                other family support services for each program 
                participant who requires such services;
                    (E) outpatient or inpatient mental health treatment, 
                as ordered by the court, that carries with it the 
                possibility of dismissal of charges or reduced 
                sentencing upon successful completion of such treatment;
                    (F) centralized case management, including--
                          (i) the consolidation of all cases, including 
                      violations of probations, of the program 
                      participant; and
                          (ii) coordination of all mental health 
                      treatment plans and social services, including 
                      life skills and vocational training, housing and 
                      job placement, education, health care, and relapse 
                      prevention for each program participant who 
                      requires such services; and
                    (G) continuing supervision of treatment plan 
                compliance by the program participant for a term not to 
                exceed the maximum allowable sentence or probation 
                period for the charged or relevant offense and, to the 
                extent practicable, continuity of psychiatric care at 
                the end of the supervised period.

    (d) Implementation; Duration.--The pilot program established under 
subsection (b) shall be conducted--
            (1) in not less than 1 United States judicial district, 
        designated by the Attorney General in consultation with the 
        Director of the Administrative Office of the United States 
        Courts, as appropriate for the pilot program; and
            (2) during fiscal year 2017 through fiscal year 2021.

    (e) Criteria for Designation.--Before making a designation under 
subsection (d)(1), the Attorney General shall--

[[Page 130 STAT. 1291]]

            (1) obtain the approval, in writing, of the United States 
        Attorney for the United States judicial district being 
        designated;
            (2) obtain the approval, in writing, of the chief judge for 
        the United States judicial district being designated; and
            (3) determine that the United States judicial district being 
        designated has adequate behavioral health systems for treatment, 
        including substance abuse and mental health treatment.

    (f) Assistance From Other Federal Entities.--The Administrative 
Office of the United States Courts and the United States Probation 
Offices shall provide such assistance and carry out such functions as 
the Attorney General may request in monitoring, supervising, providing 
services to, and evaluating eligible offenders placed in a drug or 
mental health court under this section.
    (g) Reports.--The Attorney General, in consultation with the 
Director of the Administrative Office of the United States Courts, shall 
monitor the drug and mental health courts under this section, and shall 
submit a report to Congress on the outcomes of the program at the end of 
the period described in subsection (d)(2).
SEC. 14004. <<NOTE: 42 USC 3796ii-8.>>  MENTAL HEALTH IN THE 
                            JUDICIAL SYSTEM.

    Part V of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end 
the following:
``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.

    ``(a) Pretrial Screening and Supervision.--
            ``(1) In general.--The Attorney General may award grants to 
        States, units of local government, territories, Indian Tribes, 
        nonprofit agencies, or any combination thereof, to develop, 
        implement, or expand pretrial services programs to improve the 
        identification and outcomes of individuals with mental illness.
            ``(2) Allowable uses.--Grants awarded under this subsection 
        may be may be used for--
                    ``(A) behavioral health needs and risk screening of 
                defendants, including verification of interview 
                information, mental health evaluation, and criminal 
                history screening;
                    ``(B) assessment of risk of pretrial misconduct 
                through objective, statistically validated means, and 
                presentation to the court of recommendations based on 
                such assessment, including services that will reduce the 
                risk of pre-trial misconduct;
                    ``(C) followup review of defendants unable to meet 
                the conditions of pretrial release;
                    ``(D) evaluation of process and results of pre-trial 
                service programs;
                    ``(E) supervision of defendants who are on pretrial 
                release, including reminders to defendants of scheduled 
                court dates;
                    ``(F) reporting on process and results of pretrial 
                services programs to relevant public and private mental 
                health stakeholders; and
                    ``(G) data collection and analysis necessary to make 
                available information required for assessment of risk.

    ``(b) Behavioral Health Assessments and Intervention.--
            ``(1) In general.--The Attorney General may award grants to 
        States, units of local government, territories, Indian Tribes, 
        nonprofit agencies, or any combination thereof, to develop,

[[Page 130 STAT. 1292]]

        implement, or expand a behavioral health screening and 
        assessment program framework for State or local criminal justice 
        systems.
            ``(2) Allowable uses.--Grants awarded under this subsection 
        may be used for--
                    ``(A) promotion of the use of validated assessment 
                tools to gauge the criminogenic risk, substance abuse 
                needs, and mental health needs of individuals;
                    ``(B) initiatives to match the risk factors and 
                needs of individuals to programs and practices 
                associated with research-based, positive outcomes;
                    ``(C) implementing methods for identifying and 
                treating individuals who are most likely to benefit from 
                coordinated supervision and treatment strategies, and 
                identifying individuals who can do well with fewer 
                interventions; and
                    ``(D) collaborative decision-making among the heads 
                of criminal justice agencies, mental health systems, 
                judicial systems, substance abuse systems, and other 
                relevant systems or agencies for determining how 
                treatment and intensive supervision services should be 
                allocated in order to maximize benefits, and developing 
                and utilizing capacity accordingly.

    ``(c) Use of Grant Funds.--A State, unit of local government, 
territory, Indian Tribe, or nonprofit agency that receives a grant under 
this section shall, in accordance with subsection (b)(2), use grant 
funds for the expenses of a treatment program, including--
            ``(1) salaries, personnel costs, equipment costs, and other 
        costs directly related to the operation of the program, 
        including costs relating to enforcement;
            ``(2) payments for treatment providers that are approved by 
        the State or Indian Tribe and licensed, if necessary, to provide 
        needed treatment to program participants, including aftercare 
        supervision, vocational training, education, and job placement; 
        and
            ``(3) payments to public and nonprofit private entities that 
        are approved by the State or Indian Tribe and licensed, if 
        necessary, to provide alcohol and drug addiction treatment to 
        offenders participating in the program.

    ``(d) Supplement of Non-Federal Funds.--
            ``(1) In general.--Grants awarded under this section shall 
        be used to supplement, and not supplant, non-Federal funds that 
        would otherwise be available for programs described in this 
        section.
            ``(2) Federal share.--The Federal share of a grant made 
        under this section may not exceed 50 percent of the total costs 
        of the program described in an application under subsection (e).

    ``(e) Applications.--To request a grant under this section, a State, 
unit of local government, territory, Indian Tribe, or nonprofit agency 
shall submit an application to the Attorney General in such form and 
containing such information as the Attorney General may reasonably 
require.
    ``(f) Geographic Distribution.--The Attorney General shall ensure 
that, to the extent practicable, the distribution of grants under this 
section is equitable and includes--
            ``(1) each State; and

[[Page 130 STAT. 1293]]

            ``(2) a unit of local government, territory, Indian Tribe, 
        or nonprofit agency--
                    ``(A) in each State; and
                    ``(B) in rural, suburban, Tribal, and urban 
                jurisdictions.

    ``(g) Reports and Evaluations.--For each fiscal year, each grantee 
under this section during that fiscal year shall submit to the Attorney 
General a report on the effectiveness of activities carried out using 
such grant. Each report shall include an evaluation in such form and 
containing such information as the Attorney General may reasonably 
require. The Attorney General shall specify the dates on which such 
reports shall be submitted.
    ``(h) Accountability.--Grants awarded under this section shall be 
subject to the following accountability provisions:
            ``(1) Audit requirement.--
                    ``(A) Definition.--In this paragraph, the term 
                `unresolved audit finding' means a finding in the final 
                audit report of the Inspector General of the Department 
                of Justice under subparagraph (C) that the audited 
                grantee has used grant funds for an unauthorized 
                expenditure or otherwise unallowable cost that is not 
                closed or resolved within 1 year after the date on which 
                final audit report is issued.
                    ``(B) Audits.--Beginning in the first fiscal year 
                beginning after the date of enactment of this section, 
                and in each fiscal year thereafter, the Inspector 
                General of the Department of Justice shall conduct 
                audits of grantees under this section to prevent waste, 
                fraud, and abuse of funds by grantees. The Inspector 
                General shall determine the appropriate number of 
                grantees to be audited each year.
                    ``(C) Final audit report.--The Inspector General of 
                the Department of Justice shall submit to the Attorney 
                General a final report on each audit conducted under 
                subparagraph (B).
                    ``(D) Mandatory exclusion.--Grantees under this 
                section about which there is an unresolved audit finding 
                shall not be eligible to receive a grant under this 
                section during the 2 fiscal years beginning after the 
                end of the 1-year period described in subparagraph (A).
                    ``(E) Priority.--In making grants under this 
                section, the Attorney General shall give priority to 
                applicants that did not have an unresolved audit finding 
                during the 3 fiscal years before submitting an 
                application for a grant under this section.
                    ``(F) Reimbursement.--If an entity receives a grant 
                under this section during the 2-fiscal-year period 
                during which the entity is prohibited from receiving 
                grants under subparagraph (D), the Attorney General 
                shall--
                          ``(i) deposit an amount equal to the amount of 
                      the grant that was improperly awarded to the 
                      grantee into the General Fund of the Treasury; and
                          ``(ii) seek to recoup the costs of the 
                      repayment under clause (i) from the grantee that 
                      was erroneously awarded grant funds.
            ``(2) Nonprofit agency requirements.--
                    ``(A) Definition.--For purposes of this paragraph 
                and the grant program under this section, the term 
                `nonprofit agency' means an organization that is 
                described in section

[[Page 130 STAT. 1294]]

                501(c)(3) of the Internal Revenue Code of 1986 (26 
                U.S.C. 501(c)(3)) and is exempt from taxation under 
                section 501(a) of the Internal Revenue Code of 1986 (26 
                U.S.C. 501(a)).
                    ``(B) Prohibition.--The Attorney General may not 
                award a grant under this section to a nonprofit agency 
                that holds money in an offshore account for the purpose 
                of avoiding paying the tax described in section 511(a) 
                of the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
                    ``(C) Disclosure.--Each nonprofit agency that is 
                awarded a grant under this section and uses the 
                procedures prescribed in regulations to create a 
                rebuttable presumption of reasonableness for the 
                compensation of its officers, directors, trustees, and 
                key employees, shall disclose to the Attorney General, 
                in the application for the grant, the process for 
                determining such compensation, including the independent 
                persons involved in reviewing and approving such 
                compensation, the comparability data used, and 
                contemporaneous substantiation of the deliberation and 
                decision. Upon request, the Attorney General shall make 
                the information disclosed under this subparagraph 
                available for public inspection.
            ``(3) Conference expenditures.--
                    ``(A) Limitation.--Not more than $20,000 of the 
                amounts made available to the Department of Justice to 
                carry out this section may be used by the Attorney 
                General, or by any individual or entity awarded a grant 
                under this section to host, or make any expenditures 
                relating to, a conference unless the Deputy Attorney 
                General provides prior written authorization that the 
                funds may be expended to host the conference or make 
                such expenditure.
                    ``(B) Written approval.--Written approval under 
                subparagraph (A) shall include a written estimate of all 
                costs associated with the conference, including the cost 
                of all food, beverages, audio-visual equipment, 
                honoraria for speakers, and entertainment.
                    ``(C) Report.--The Deputy Attorney General shall 
                submit an annual report to the Committee on the 
                Judiciary of the Senate and the Committee on the 
                Judiciary of the House of Representatives on all 
                conference expenditures approved under this paragraph.
            ``(4) Annual certification.--Beginning in the first fiscal 
        year beginning after the date of enactment of this subsection, 
        the Attorney General shall submit to the Committee on the 
        Judiciary and the Committee on Appropriations of the Senate and 
        the Committee on the Judiciary and the Committee on 
        Appropriations of the House of Representatives an annual 
        certification--
                    ``(A) indicating whether--
                          ``(i) all final audit reports issued by the 
                      Office of the Inspector General under paragraph 
                      (1) have been completed and reviewed by the 
                      appropriate Assistant Attorney General or 
                      Director;
                          ``(ii) all mandatory exclusions required under 
                      paragraph (1)(D) have been issued; and
                          ``(iii) any reimbursements required under 
                      paragraph (1)(F) have been made; and

[[Page 130 STAT. 1295]]

                    ``(B) that includes a list of any grantees excluded 
                under paragraph (1)(D) from the previous year.

    ``(i) Preventing Duplicative Grants.--
            ``(1) In general.--Before the Attorney General awards a 
        grant to an applicant under this section, the Attorney General 
        shall compare the possible grant with any other grants awarded 
        to the applicant under this Act to determine whether the grants 
        are for the same purpose.
            ``(2) Report.--If the Attorney General awards multiple 
        grants to the same applicant for the same purpose, the Attorney 
        General shall submit to the Committee on the Judiciary of the 
        Senate and the Committee on the Judiciary of the House of 
        Representatives a report that includes--
                    ``(A) a list of all duplicate grants awarded, 
                including the total dollar amount of any such grants 
                awarded; and
                    ``(B) the reason the Attorney General awarded the 
                duplicate grants.''.
SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.

    Section 2991 of the Omnibus Crime Control and Safe Streets Act of 
1968 (42 U.S.C. 3797aa) is amended by--
            (1) redesignating subsection (j) as subsection (o); and
            (2) inserting after subsection (i) the following:

    ``(j) Forensic Assertive Community Treatment (FACT) Initiative 
Program.--
            ``(1) In general.--The Attorney General may make grants to 
        States, units of local government, territories, Indian Tribes, 
        nonprofit agencies, or any combination thereof, to develop, 
        implement, or expand Assertive Community Treatment initiatives 
        to develop forensic assertive community treatment (referred to 
        in this subsection as `FACT') programs that provide high 
        intensity services in the community for individuals with mental 
        illness with involvement in the criminal justice system to 
        prevent future incarcerations.
            ``(2) Allowable uses.--Grant funds awarded under this 
        subsection may be used for--
                    ``(A) multidisciplinary team initiatives for 
                individuals with mental illnesses with criminal justice 
                involvement that address criminal justice involvement as 
                part of treatment protocols;
                    ``(B) FACT programs that involve mental health 
                professionals, criminal justice agencies, chemical 
                dependency specialists, nurses, psychiatrists, 
                vocational specialists, forensic peer specialists, 
                forensic specialists, and dedicated administrative 
                support staff who work together to provide recovery 
                oriented, 24/7 wraparound services;
                    ``(C) services such as integrated evidence-based 
                practices for the treatment of co-occurring mental 
                health and substance-related disorders, assertive 
                outreach and engagement, community-based service 
                provision at participants' residence or in the 
                community, psychiatric rehabilitation, recovery oriented 
                services, services to address criminogenic risk factors, 
                and community tenure;
                    ``(D) payments for treatment providers that are 
                approved by the State or Indian Tribe and licensed, if 
                necessary, to provide needed treatment to eligible 
                offenders

[[Page 130 STAT. 1296]]

                participating in the program, including behavioral 
                health services and aftercare supervision; and
                    ``(E) training for all FACT teams to promote high-
                fidelity practice principles and technical assistance to 
                support effective and continuing integration with 
                criminal justice agency partners.
            ``(3) Supplement and not supplant.--Grants made under this 
        subsection shall be used to supplement, and not supplant, non-
        Federal funds that would otherwise be available for programs 
        described in this subsection.
            ``(4) Applications.--To request a grant under this 
        subsection, a State, unit of local government, territory, Indian 
        Tribe, or nonprofit agency shall submit an application to the 
        Attorney General in such form and containing such information as 
        the Attorney General may reasonably require.''.
SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF 
                            SYSTEMS.

    Section 2976(f) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
            (1) in paragraph (5), by striking ``and'' at the end;
            (2) in paragraph (6), by striking the period at the end and 
        inserting a semicolon; and
            (3) by adding at the end the following:
            ``(7) provide mental health treatment and transitional 
        services for those with mental illnesses or with co-occurring 
        disorders, including housing placement or assistance; and''.
SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH 
                            CHALLENGES IN DRUG COURTS.

    Part EE of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3797u et seq.) is amended--
            (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by 
        inserting ``, including co-occurring substance abuse and mental 
        health problems,'' after ``problems''; and
            (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting 
        ``, including training for drug court personnel and officials on 
        identifying and addressing co-occurring substance abuse and 
        mental health problems'' after ``part''.
SEC. 14008. <<NOTE: 42 USC 3797aa-1 note.>>  MENTAL HEALTH 
                            TRAINING FOR FEDERAL UNIFORMED 
                            SERVICES.

    (a) In General.--Not later than 180 days after the date of enactment 
of this Act, the Secretary of Defense, the Secretary of Homeland 
Security, the Secretary of Health and Human Services, and the Secretary 
of Commerce shall provide the following to each of the uniformed 
services (as that term is defined in section 101 of title 10, United 
States Code) under their direction:
            (1) Training programs.--Programs that offer specialized and 
        comprehensive training in procedures to identify and respond 
        appropriately to incidents in which the unique needs of 
        individuals with mental illnesses are involved.
            (2) Improved technology.--Computerized information systems 
        or technological improvements to provide timely information to 
        Federal law enforcement personnel, other branches of the 
        uniformed services, and criminal justice system personnel to 
        improve the Federal response to mentally ill individuals.

[[Page 130 STAT. 1297]]

            (3) Cooperative programs.--The establishment and expansion 
        of cooperative efforts to promote public safety through the use 
        of effective intervention with respect to mentally ill 
        individuals encountered by members of the uniformed services.
SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.

    (a) Reentry Demonstration Projects.--Section 2976(f) of title I of 
the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
3797w(f)), as amended by section 14006, is amended--
            (1) in paragraph (3)(C), by inserting ``mental health 
        services,'' before ``drug treatment''; and
            (2) by adding at the end the following:
            ``(8) target offenders with histories of homelessness, 
        substance abuse, or mental illness, including a prerelease 
        assessment of the housing status of the offender and behavioral 
        health needs of the offender with clear coordination with mental 
        health, substance abuse, and homelessness services systems to 
        achieve stable and permanent housing outcomes with appropriate 
        support service.''.

    (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act of 
2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including 
mental health care'' after ``community''.
SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.

    Section 2701(b) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
            (1) by redesignating paragraphs (4) and (5) as paragraphs 
        (5) and (6), respectively; and
            (2) by inserting after paragraph (3) the following:
            ``(4) The development and operation of crisis intervention 
        teams that may include coordination with law enforcement 
        agencies and specialized training for school officials in 
        responding to mental health crises.''.
SEC. 14011. <<NOTE: 42 USC 3752 note.>>  ACTIVE-SHOOTER TRAINING 
                            FOR LAW ENFORCEMENT.

    The Attorney General, as part of the Preventing Violence Against Law 
Enforcement and Ensuring Officer Resilience and Survivability Initiative 
(VALOR) of the Department of Justice, may provide safety training and 
technical assistance to local law enforcement agencies, including 
active-shooter response training.
SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH 
                            CHALLENGES IN RESIDENTIAL SUBSTANCE 
                            ABUSE TREATMENT PROGRAMS.

    Section 1901(a) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) in paragraph (2), by striking the period at the end and 
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(3) developing and implementing specialized residential 
        substance abuse treatment programs that identify and provide 
        appropriate treatment to inmates with co-occurring mental health 
        and substance abuse disorders or challenges.''.

[[Page 130 STAT. 1298]]

SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO 
                            INCARCERATION PROGRAMS.

    Title I of the Omnibus Crime Control and Safe Streets Act of 1968 
(42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting 
the following:

      ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO 
                         INCARCERATION PROGRAMS

``SEC. 2901. <<NOTE: 42 USC 3797q.>>  MENTAL HEALTH AND DRUG 
                          TREATMENT ALTERNATIVES TO INCARCERATION 
                          PROGRAMS.

    ``(a) Definitions.--In this section--
            ``(1) the term `eligible entity' means a State, unit of 
        local government, Indian tribe, or nonprofit organization; and
            ``(2) the term `eligible participant' means an individual 
        who--
                    ``(A) comes into contact with the criminal justice 
                system or is arrested or charged with an offense that is 
                not--
                          ``(i) a crime of violence, as defined under 
                      applicable State law or in section 3156 of title 
                      18, United States Code; or
                          ``(ii) a serious drug offense, as defined in 
                      section 924(e)(2)(A) of title 18, United States 
                      Code;
                    ``(B) has a history of, or a current--
                          ``(i) substance use disorder;
                          ``(ii) mental illness; or
                          ``(iii) co-occurring mental illness and 
                      substance use disorder; and
                    ``(C) has been approved for participation in a 
                program funded under this section by the relevant law 
                enforcement agency, prosecuting attorney, defense 
                attorney, probation official, corrections official, 
                judge, representative of a mental health agency, or 
                representative of a substance abuse agency, as required 
                by law.

    ``(b) Program Authorized.--The Attorney General may make grants to 
eligible entities to develop, implement, or expand a treatment 
alternative to incarceration program for eligible participants, 
including--
            ``(1) pre-booking treatment alternative to incarceration 
        programs, including--
                    ``(A) law enforcement training on substance use 
                disorders, mental illness, and co-occurring mental 
                illness and substance use disorders;
                    ``(B) receiving centers as alternatives to 
                incarceration of eligible participants;
                    ``(C) specialized response units for calls related 
                to substance use disorders, mental illness, or co-
                occurring mental illness and substance use disorders; 
                and
                    ``(D) other arrest and pre-booking treatment 
                alternatives to incarceration models; or
            ``(2) post-booking treatment alternative to incarceration 
        programs, including--
                    ``(A) specialized clinical case management;

[[Page 130 STAT. 1299]]

                    ``(B) pre-trial services related to substances use 
                disorders, mental illness, and co-occurring mental 
                illness and substance use disorders;
                    ``(C) prosecutor and defender based programs;
                    ``(D) specialized probation;
                    ``(E) treatment and rehabilitation programs; and
                    ``(F) problem-solving courts, including mental 
                health courts, drug courts, co-occurring mental health 
                and substance abuse courts, DWI courts, and veterans 
                treatment courts.

    ``(c) Application.--
            ``(1) In general.--An eligible entity desiring a grant under 
        this section shall submit an application to the Attorney 
        General--
                    ``(A) that meets the criteria under paragraph (2); 
                and
                    ``(B) at such time, in such manner, and accompanied 
                by such information as the Attorney General may require.
            ``(2) Criteria.--An eligible entity, in submitting an 
        application under paragraph (1), shall--
                    ``(A) provide extensive evidence of collaboration 
                with State and local government agencies overseeing 
                health, community corrections, courts, prosecution, 
                substance abuse, mental health, victims services, and 
                employment services, and with local law enforcement 
                agencies;
                    ``(B) demonstrate consultation with the Single State 
                Authority for Substance Abuse of the State (as that term 
                is defined in section 201(e) of the Second Chance Act of 
                2007);
                    ``(C) demonstrate that evidence-based treatment 
                practices will be utilized; and
                    ``(D) demonstrate that evidence-based screening and 
                assessment tools will be used to place participants in 
                the treatment alternative to incarceration program.

    ``(d) Requirements.--Each eligible entity awarded a grant for a 
treatment alternative to incarceration program under this section 
shall--
            ``(1) determine the terms and conditions of participation in 
        the program by eligible participants, taking into consideration 
        the collateral consequences of an arrest, prosecution or 
        criminal conviction;
            ``(2) ensure that each substance abuse and mental health 
        treatment component is licensed and qualified by the relevant 
        jurisdiction;
            ``(3) for programs described in subsection (b)(2), organize 
        an enforcement unit comprised of appropriately trained law 
        enforcement professionals under the supervision of the State, 
        Tribal, or local criminal justice agency involved, the duties of 
        which shall include--
                    ``(A) the verification of addresses and other 
                contact information of each eligible participant who 
                participates or desires to participate in the program; 
                and
                    ``(B) if necessary, the location, apprehension, 
                arrest, and return to custody of an eligible participant 
                in the program who has absconded from the facility of a 
                treatment provider or has otherwise significantly 
                violated the terms and conditions of the program, 
                consistent with Federal and State confidentiality 
                requirements;

[[Page 130 STAT. 1300]]

            ``(4) notify the relevant criminal justice entity if any 
        eligible participant in the program absconds from the facility 
        of the treatment provider or otherwise violates the terms and 
        conditions of the program, consistent with Federal and State 
        confidentiality requirements;
            ``(5) submit periodic reports on the progress of treatment 
        or other measured outcomes from participation in the program of 
        each eligible participant in the program to the relevant State, 
        Tribal, or local criminal justice agency, including mental 
        health courts, drug courts, co-occurring mental health and 
        substance abuse courts, DWI courts, and veterans treatment 
        courts;
            ``(6) describe the evidence-based methodology and outcome 
        measurements that will be used to evaluate the program, and 
        specifically explain how such measurements will provide valid 
        measures of the impact of the program; and
            ``(7) describe how the program could be broadly replicated 
        if demonstrated to be effective.

    ``(e) Use of Funds.--An eligible entity shall use a grant received 
under this section for expenses of a treatment alternative to 
incarceration program, including--
            ``(1) salaries, personnel costs, equipment costs, and other 
        costs directly related to the operation of the program, 
        including the enforcement unit;
            ``(2) payments for treatment providers that are approved by 
        the relevant State or Tribal jurisdiction and licensed, if 
        necessary, to provide needed treatment to eligible offenders 
        participating in the program, including aftercare supervision, 
        vocational training, education, and job placement; and
            ``(3) payments to public and nonprofit private entities that 
        are approved by the State or Tribal jurisdiction and licensed, 
        if necessary, to provide alcohol and drug addiction treatment to 
        eligible offenders participating in the program.

    ``(f) Supplement Not Supplant.--An eligible entity shall use Federal 
funds received under this section only to supplement the funds that 
would, in the absence of those Federal funds, be made available from 
other Federal and non-Federal sources for the activities described in 
this section, and not to supplant those funds. The Federal share of a 
grant made under this section may not exceed 50 percent of the total 
costs of the program described in an application under subsection (d).
    ``(g) Geographic Distribution.--The Attorney General shall ensure 
that, to the extent practicable, the geographical distribution of grants 
under this section is equitable and includes a grant to an eligible 
entity in--
            ``(1) each State;
            ``(2) rural, suburban, and urban areas; and
            ``(3) Tribal jurisdictions.

    ``(h) Reports and Evaluations.--Each fiscal year, each recipient of 
a grant under this section during that fiscal year shall submit to the 
Attorney General a report on the outcomes of activities carried out 
using that grant in such form, containing such information, and on such 
dates as the Attorney General shall specify.
    ``(i) Accountability.--All grants awarded by the Attorney General 
under this section shall be subject to the following accountability 
provisions:
            ``(1) Audit requirement.--

[[Page 130 STAT. 1301]]

                    ``(A) Definition.--In this paragraph, the term 
                `unresolved audit finding' means a finding in the final 
                audit report of the Inspector General of the Department 
                of Justice that the audited grantee has utilized grant 
                funds for an unauthorized expenditure or otherwise 
                unallowable cost that is not closed or resolved within 
                12 months from the date on which the final audit report 
                is issued.
                    ``(B) Audits.--Beginning in the first fiscal year 
                beginning after the date of enactment of this 
                subsection, and in each fiscal year thereafter, the 
                Inspector General of the Department of Justice shall 
                conduct audits of recipients of grants under this 
                section to prevent waste, fraud, and abuse of funds by 
                grantees. The Inspector General shall determine the 
                appropriate number of grantees to be audited each year.
                    ``(C) Mandatory exclusion.--A recipient of grant 
                funds under this section that is found to have an 
                unresolved audit finding shall not be eligible to 
                receive grant funds under this section during the first 
                2 fiscal years beginning after the end of the 12-month 
                period described in subparagraph (A).
                    ``(D) Priority.--In awarding grants under this 
                section, the Attorney General shall give priority to 
                eligible applicants that did not have an unresolved 
                audit finding during the 3 fiscal years before 
                submitting an application for a grant under this 
                section.
                    ``(E) Reimbursement.--If an entity is awarded grant 
                funds under this section during the 2-fiscal-year period 
                during which the entity is barred from receiving grants 
                under subparagraph (C), the Attorney General shall--
                          ``(i) deposit an amount equal to the amount of 
                      the grant funds that were improperly awarded to 
                      the grantee into the General Fund of the Treasury; 
                      and
                          ``(ii) seek to recoup the costs of the 
                      repayment to the fund from the grant recipient 
                      that was erroneously awarded grant funds.
            ``(2) Nonprofit organization requirements.--
                    ``(A) Definition.--For purposes of this paragraph 
                and the grant programs under this part, the term 
                `nonprofit organization' means an organization that is 
                described in section 501(c)(3) of the Internal Revenue 
                Code of 1986 and is exempt from taxation under section 
                501(a) of such Code.
                    ``(B) Prohibition.--The Attorney General may not 
                award a grant under this part to a nonprofit 
                organization that holds money in offshore accounts for 
                the purpose of avoiding paying the tax described in 
                section 511(a) of the Internal Revenue Code of 1986.
                    ``(C) Disclosure.--Each nonprofit organization that 
                is awarded a grant under this section and uses the 
                procedures prescribed in regulations to create a 
                rebuttable presumption of reasonableness for the 
                compensation of its officers, directors, trustees, and 
                key employees, shall disclose to the Attorney General, 
                in the application for the grant, the process for 
                determining such compensation, including the independent 
                persons involved in reviewing and approving such 
                compensation, the comparability data used,

[[Page 130 STAT. 1302]]

                and contemporaneous substantiation of the deliberation 
                and decision. Upon request, the Attorney General shall 
                make the information disclosed under this subparagraph 
                available for public inspection.
            ``(3) Conference expenditures.--
                    ``(A) Limitation.--No amounts made available to the 
                Department of Justice under this section may be used by 
                the Attorney General, or by any individual or entity 
                awarded discretionary funds through a cooperative 
                agreement under this section, to host or support any 
                expenditure for conferences that uses more than $20,000 
                in funds made available by the Department of Justice, 
                unless the head of the relevant agency or department, 
                provides prior written authorization that the funds may 
                be expended to host the conference.
                    ``(B) Written approval.--Written approval under 
                subparagraph (A) shall include a written estimate of all 
                costs associated with the conference, including the cost 
                of all food, beverages, audio-visual equipment, 
                honoraria for speakers, and entertainment.
                    ``(C) Report.--The Deputy Attorney General shall 
                submit an annual report to the Committee on the 
                Judiciary of the Senate and the Committee on the 
                Judiciary of the House of Representatives on all 
                conference expenditures approved under this paragraph.
            ``(4) Annual certification.--Beginning in the first fiscal 
        year beginning after the date of enactment of this subsection, 
        the Attorney General shall submit, to the Committee on the 
        Judiciary and the Committee on Appropriations of the Senate and 
        the Committee on the Judiciary and the Committee on 
        Appropriations of the House of Representatives, an annual 
        certification--
                    ``(A) indicating whether--
                          ``(i) all audits issued by the Office of the 
                      Inspector General under paragraph (1) have been 
                      completed and reviewed by the appropriate 
                      Assistant Attorney General or Director;
                          ``(ii) all mandatory exclusions required under 
                      paragraph (1)(C) have been issued; and
                          ``(iii) all reimbursements required under 
                      paragraph (1)(E) have been made; and
                    ``(B) that includes a list of any grant recipients 
                excluded under paragraph (1) from the previous year.
            ``(5) Preventing duplicative grants.--
                    ``(A) In general.--Before the Attorney General 
                awards a grant to an applicant under this section, the 
                Attorney General shall compare potential grant awards 
                with other grants awarded under this Act to determine if 
                duplicate grant awards are awarded for the same purpose.
                    ``(B) Report.--If the Attorney General awards 
                duplicate grants to the same applicant for the same 
                purpose the Attorney General shall submit to the 
                Committee on the Judiciary of the Senate and the 
                Committee on the Judiciary of the House of 
                Representatives a report that includes--

[[Page 130 STAT. 1303]]

                          ``(i) a list of all duplicate grants awarded, 
                      including the total dollar amount of any duplicate 
                      grants awarded; and
                          ``(ii) the reason the Attorney General awarded 
                      the duplicate grants.''.
SEC. 14014. <<NOTE: 42 USC 3797aa-1.>>  NATIONAL CRIMINAL JUSTICE 
                            AND MENTAL HEALTH TRAINING AND 
                            TECHNICAL ASSISTANCE.

    Part HH of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end the 
following:
``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING 
                          AND TECHNICAL ASSISTANCE.

    ``(a) Authority.--The Attorney General may make grants to eligible 
organizations to provide for the establishment of a National Criminal 
Justice and Mental Health Training and Technical Assistance Center.
    ``(b) Eligible Organization.--For purposes of subsection (a), the 
term `eligible organization' means a national nonprofit organization 
that provides technical assistance and training to, and has special 
expertise and broad, national-level experience in, mental health, crisis 
intervention, criminal justice systems, law enforcement, translating 
evidence into practice, training, and research, and education and 
support of people with mental illness and the families of such 
individuals.
    ``(c) Use of Funds.--Any organization that receives a grant under 
subsection (a) shall collaborate with other grant recipients to 
establish and operate a National Criminal Justice and Mental Health 
Training and Technical Assistance Center to--
            ``(1) provide law enforcement officer training regarding 
        mental health and working with individuals with mental 
        illnesses, with an emphasis on de-escalation of encounters 
        between law enforcement officers and those with mental disorders 
        or in crisis, which shall include support the development of in-
        person and technical information exchanges between systems and 
        the individuals working in those systems in support of the 
        concepts identified in the training;
            ``(2) provide education, training, and technical assistance 
        for States, Indian tribes, territories, units of local 
        government, service providers, nonprofit organizations, 
        probation or parole officers, prosecutors, defense attorneys, 
        emergency response providers, and corrections institutions to 
        advance practice and knowledge relating to mental health crisis 
        and approaches to mental health and criminal justice across 
        systems;
            ``(3) provide training and best practices to mental health 
        providers and criminal justice agencies relating to diversion 
        initiatives, jail and prison strategies, reentry of individuals 
        with mental illnesses into the community, and dispatch protocols 
        and triage capabilities, including the establishment of learning 
        sites;
            ``(4) develop suicide prevention and crisis intervention 
        training and technical assistance for criminal justice agencies;
            ``(5) develop a receiving center system and pilot strategy 
        that provides, for a jurisdiction, a single point of entry into 
        the mental health and substance abuse system for assessments and 
        appropriate placement of individuals experiencing a crisis;

[[Page 130 STAT. 1304]]

            ``(6) collect data and best practices in mental health and 
        criminal health and criminal justice initiatives and policies 
        from grantees under this part, other recipients of grants under 
        this section, Federal, State, and local agencies involved in the 
        provision of mental health services, and nongovernmental 
        organizations involved in the provision of mental health 
        services;
            ``(7) develop and disseminate to mental health providers and 
        criminal justice agencies evaluation tools, mechanisms, and 
        measures to better assess and document performance measures and 
        outcomes relating to the provision of mental health services;
            ``(8) disseminate information to States, units of local 
        government, criminal justice agencies, law enforcement agencies, 
        and other relevant entities about best practices, policy 
        standards, and research findings relating to the provision of 
        mental health services; and
            ``(9) provide education and support to individuals with 
        mental illness involved with, or at risk of involvement with, 
        the criminal justice system, including the families of such 
        individuals.

    ``(d) Accountability.--Grants awarded under this section shall be 
subject to the following accountability provisions:
            ``(1) Audit requirement.--
                    ``(A) Definition.--In this paragraph, the term 
                `unresolved audit finding' means a finding in the final 
                audit report of the Inspector General of the Department 
                of Justice under subparagraph (C) that the audited 
                grantee has used grant funds for an unauthorized 
                expenditure or otherwise unallowable cost that is not 
                closed or resolved within 1 year after the date on which 
                the final audit report is issued.
                    ``(B) Audits.--Beginning in the first fiscal year 
                beginning after the date of enactment of this section, 
                and in each fiscal year thereafter, the Inspector 
                General of the Department of Justice shall conduct 
                audits of grantees under this section to prevent waste, 
                fraud, and abuse of funds by grantees. The Inspector 
                General shall determine the appropriate number of 
                grantees to be audited each year.
                    ``(C) Final audit report.--The Inspector General of 
                the Department of Justice shall submit to the Attorney 
                General a final report on each audit conducted under 
                subparagraph (B).
                    ``(D) Mandatory exclusion.--Grantees under this 
                section about which there is an unresolved audit finding 
                shall not be eligible to receive a grant under this 
                section during the 2 fiscal years beginning after the 
                end of the 1-year period described in subparagraph (A).
                    ``(E) Priority.--In making grants under this 
                section, the Attorney General shall give priority to 
                applicants that did not have an unresolved audit finding 
                during the 3 fiscal years before submitting an 
                application for a grant under this section.
                    ``(F) Reimbursement.--If an entity receives a grant 
                under this section during the 2-fiscal-year period 
                during

[[Page 130 STAT. 1305]]

                which the entity is prohibited from receiving grants 
                under subparagraph (D), the Attorney General shall--
                          ``(i) deposit an amount equal to the amount of 
                      the grant that was improperly awarded to the 
                      grantee into the General Fund of the Treasury; and
                          ``(ii) seek to recoup the costs of the 
                      repayment under clause (i) from the grantee that 
                      was erroneously awarded grant funds.
            ``(2) Nonprofit agency requirements.--
                    ``(A) Definition.--For purposes of this paragraph 
                and the grant program under this section, the term 
                `nonprofit agency' means an organization that is 
                described in section 501(c)(3) of the Internal Revenue 
                Code of 1986 (26 U.S.C. 501(c)(3)) and is exempt from 
                taxation under section 501(a) of the Internal Revenue 
                Code of 1986 (26 U.S.C. 501(a)).
                    ``(B) Prohibition.--The Attorney General may not 
                award a grant under this section to a nonprofit agency 
                that holds money in an offshore account for the purpose 
                of avoiding paying the tax described in section 511(a) 
                of the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
                    ``(C) Disclosure.--Each nonprofit agency that is 
                awarded a grant under this section and uses the 
                procedures prescribed in regulations to create a 
                rebuttable presumption of reasonableness for the 
                compensation of its officers, directors, trustees, and 
                key employees, shall disclose to the Attorney General, 
                in the application for the grant, the process for 
                determining such compensation, including the independent 
                persons involved in reviewing and approving such 
                compensation, the comparability data used, and 
                contemporaneous substantiation of the deliberation and 
                decision. Upon request, the Attorney General shall make 
                the information disclosed under this subparagraph 
                available for public inspection.
            ``(3) Conference expenditures.--
                    ``(A) Limitation.--No amounts made available to the 
                Department of Justice under this section may be used by 
                the Attorney General, or by any individual or entity 
                awarded discretionary funds through a cooperative 
                agreement under this section, to host or support any 
                expenditure for conferences that uses more than $20,000 
                in funds made available by the Department of Justice, 
                unless the head of the relevant agency or department, 
                provides prior written authorization that the funds may 
                be expended to host the conference.
                    ``(B) Written approval.--Written approval under 
                subparagraph (A) shall include a written estimate of all 
                costs associated with the conference, including the cost 
                of all food, beverages, audio-visual equipment, 
                honoraria for speakers, and entertainment.
                    ``(C) Report.--The Deputy Attorney General shall 
                submit an annual report to the Committee on the 
                Judiciary of the Senate and the Committee on the 
                Judiciary of the House of Representatives on all 
                conference expenditures approved under this paragraph.
            ``(4) Annual certification.--Beginning in the first fiscal 
        year beginning after the date of enactment of this subsection, 
        the Attorney General shall submit to the Committee on the

[[Page 130 STAT. 1306]]

        Judiciary and the Committee on Appropriations of the Senate and 
        the Committee on the Judiciary and the Committee on 
        Appropriations of the House of Representatives an annual 
        certification--
                    ``(A) indicating whether--
                          ``(i) all final audit reports issued by the 
                      Office of the Inspector General under paragraph 
                      (1) have been completed and reviewed by the 
                      appropriate Assistant Attorney General or 
                      Director;
                          ``(ii) all mandatory exclusions required under 
                      paragraph (1)(D) have been issued; and
                          ``(iii) any reimbursements required under 
                      paragraph (1)(F) have been made; and
                    ``(B) that includes a list of any grantees excluded 
                under paragraph (1)(D) from the previous year.
            ``(5) Preventing duplicative grants.--
                    ``(A) In general.--Before the Attorney General 
                awards a grant to an applicant under this section, the 
                Attorney General shall compare potential grant awards 
                with other grants awarded under this Act to determine if 
                duplicate grant awards are awarded for the same purpose.
                    ``(B) Report.--If the Attorney General awards 
                duplicate grants to the same applicant for the same 
                purpose the Attorney General shall submit to the 
                Committee on the Judiciary of the Senate and the 
                Committee on the Judiciary of the House of 
                Representatives a report that includes--
                          ``(i) a list of all duplicate grants awarded, 
                      including the total dollar amount of any duplicate 
                      grants awarded; and
                          ``(ii) the reason the Attorney General awarded 
                      the duplicate grants.''.
SEC. 14015. <<NOTE: 28 USC 534 note.>>  IMPROVING DEPARTMENT OF 
                            JUSTICE DATA COLLECTION ON MENTAL 
                            ILLNESS INVOLVED IN CRIME.

    (a) In General.--Notwithstanding any other provision of law, on or 
after the date that is 90 days after the date on which the Attorney 
General promulgates regulations under subsection (b), any data prepared 
by, or submitted to, the Attorney General or the Director of the Federal 
Bureau of Investigation with respect to the incidences of homicides, law 
enforcement officers killed, seriously injured, and assaulted, or 
individuals killed or seriously injured by law enforcement officers 
shall include data with respect to the involvement of mental illness in 
such incidences, if any.
    (b) Regulations.--Not later than 90 days after the date of the 
enactment of this Act, the Attorney General shall promulgate or revise 
regulations as necessary to carry out subsection (a).
SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN 
                            PRISON.

    (a) Report on the Cost of Treating the Mentally Ill in the Criminal 
Justice System.--Not later than 12 months after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
Congress a report detailing the cost of imprisonment for individuals who 
have serious mental illness by the Federal Government or a State or unit 
of local government, which shall include--

[[Page 130 STAT. 1307]]

            (1) the number and type of crimes committed by individuals 
        with serious mental illness each year; and
            (2) detail strategies or ideas for preventing crimes by 
        those individuals with serious mental illness from occurring.

    (b) Definition.--For purposes of this section, the Attorney General, 
in consultation with the Assistant Secretary of Mental Health and 
Substance Use Disorders, shall define ``serious mental illness'' based 
on the ``Health Care Reform for Americans with Severe Mental Illnesses: 
Report'' of the National Advisory Mental Health Council, American 
Journal of Psychiatry 1993; 150:1447-1465.
SEC. 14017. <<NOTE: 38 USC 5501A.>>  CODIFICATION OF DUE PROCESS 
                            FOR DETERMINATIONS BY SECRETARY OF 
                            VETERANS AFFAIRS OF MENTAL CAPACITY OF 
                            BENEFICIARIES.

    (a) In General.--Chapter 55 of title 38, United States Code, is 
amended by inserting after section 5501 the following new section:
``Sec. 5501A. Beneficiaries' rights in mental competence 
                    determinations

    ``The Secretary may not make an adverse determination concerning the 
mental capacity of a beneficiary to manage monetary benefits paid to or 
for the beneficiary by the Secretary under this title unless such 
beneficiary has been provided all of the following, subject to the 
procedures and timelines prescribed by the Secretary for determinations 
of incompetency:
            ``(1) Notice of the proposed adverse determination and the 
        supporting evidence.
            ``(2) An opportunity to request a hearing.
            ``(3) An opportunity to present evidence, including an 
        opinion from a medical professional or other person, on the 
        capacity of the beneficiary to manage monetary benefits paid to 
        or for the beneficiary by the Secretary under this title.
            ``(4) An opportunity to be represented at no expense to the 
        Government (including by counsel) at any such hearing and to 
        bring a medical professional or other person to provide relevant 
        testimony at any such hearing.''.

    (b) <<NOTE: 38 USC 5501 prec.>>  Clerical Amendment.--The table of 
sections at the beginning of such chapter 55 is amended by inserting 
after the item relating to section 5501 the following new item:

``5501A. Beneficiaries' rights in mental competence determinations''.

    (c) <<NOTE: 38 USC 5501A note.>>  Effective Date.--Section 5501A of 
title 38, United States Code, as added by subsection (a), shall apply to 
determinations made by the Secretary of Veterans Affairs on or after the 
date of the enactment of this Act.
SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.

    Subsection (o) of section 2991 of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated by section 
14006, is amended--
            (1) in paragraph (1)(C), by striking ``2009 through 2014'' 
        and inserting ``2017 through 2021''; and
            (2) by adding at the end the following:

    ``(3) Limitation.--Not more than 20 percent of the funds authorized 
to be appropriated under this section may be used for purposes described 
in subsection (i) (relating to veterans).''.

[[Page 130 STAT. 1308]]

           Subtitle B--Comprehensive Justice and Mental Health

SEC. 14021. SEQUENTIAL INTERCEPT MODEL.

    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section 14005, is 
amended by inserting after subsection (j), the following:
    ``(k) Sequential Intercept Grants.--
            ``(1) Definition.--In this subsection, the term `eligible 
        entity' means a State, unit of local government, Indian tribe, 
        or tribal organization.
            ``(2) Authorization.--The Attorney General may make grants 
        under this subsection to an eligible entity for sequential 
        intercept mapping and implementation in accordance with 
        paragraph (3).
            ``(3) Sequential intercept mapping; implementation.--An 
        eligible entity that receives a grant under this subsection may 
        use funds for--
                    ``(A) sequential intercept mapping, which--
                          ``(i) shall consist of--
                                    ``(I) convening mental health and 
                                criminal justice stakeholders to--
                                            ``(aa) develop a shared 
                                        understanding of the flow of 
                                        justice-involved individuals 
                                        with mental illnesses through 
                                        the criminal justice system; and
                                            ``(bb) identify 
                                        opportunities for improved 
                                        collaborative responses to the 
                                        risks and needs of individuals 
                                        described in item (aa); and
                                    ``(II) developing strategies to 
                                address gaps in services and bring 
                                innovative and effective programs to 
                                scale along multiple intercepts, 
                                including--
                                            ``(aa) emergency and crisis 
                                        services;
                                            ``(bb) specialized police-
                                        based responses;
                                            ``(cc) court hearings and 
                                        disposition alternatives;
                                            ``(dd) reentry from jails 
                                        and prisons; and
                                            ``(ee) community 
                                        supervision, treatment and 
                                        support services; and
                          ``(ii) may serve as a starting point for the 
                      development of strategic plans to achieve positive 
                      public health and safety outcomes; and
                    ``(B) implementation, which shall--
                          ``(i) be derived from the strategic plans 
                      described in subparagraph (A)(ii); and
                          ``(ii) consist of--
                                    ``(I) hiring and training personnel;
                                    ``(II) identifying the eligible 
                                entity's target population;
                                    ``(III) providing services and 
                                supports to reduce unnecessary 
                                penetration into the criminal justice 
                                system;
                                    ``(IV) reducing recidivism;
                                    ``(V) evaluating the impact of the 
                                eligible entity's approach; and

[[Page 130 STAT. 1309]]

                                    ``(VI) planning for the 
                                sustainability of effective 
                                interventions.''.
SEC. 14022. PRISON AND JAILS.

    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after 
subsection (k), as added by section 14021, the following:
    ``(l) Correctional Facilities.--
            ``(1) Definitions.--
                    ``(A) Correctional facility.--The term `correctional 
                facility' means a jail, prison, or other detention 
                facility used to house people who have been arrested, 
                detained, held, or convicted by a criminal justice 
                agency or a court.
                    ``(B) Eligible inmate.--The term `eligible inmate' 
                means an individual who--
                          ``(i) is being held, detained, or incarcerated 
                      in a correctional facility; and
                          ``(ii) manifests obvious signs of a mental 
                      illness or has been diagnosed by a qualified 
                      mental health professional as having a mental 
                      illness.
            ``(2) Correctional facility grants.--The Attorney General 
        may award grants to applicants to enhance the capabilities of a 
        correctional facility--
                    ``(A) to identify and screen for eligible inmates;
                    ``(B) to plan and provide--
                          ``(i) initial and periodic assessments of the 
                      clinical, medical, and social needs of inmates; 
                      and
                          ``(ii) appropriate treatment and services that 
                      address the mental health and substance abuse 
                      needs of inmates;
                    ``(C) to develop, implement, and enhance--
                          ``(i) post-release transition plans for 
                      eligible inmates that, in a comprehensive manner, 
                      coordinate health, housing, medical, employment, 
                      and other appropriate services and public 
                      benefits;
                          ``(ii) the availability of mental health care 
                      services and substance abuse treatment services; 
                      and
                          ``(iii) alternatives to solitary confinement 
                      and segregated housing and mental health screening 
                      and treatment for inmates placed in solitary 
                      confinement or segregated housing; and
                    ``(D) to train each employee of the correctional 
                facility to identify and appropriately respond to 
                incidents involving inmates with mental health or co-
                occurring mental health and substance abuse 
                disorders.''.
SEC. 14023. ALLOWABLE USES.

    Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and 
Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by 
adding at the end the following:
                          ``(v) Teams addressing frequent users of 
                      crisis services.--Multidisciplinary teams that--
                                    ``(I) coordinate, implement, and 
                                administer community-based crisis 
                                responses and long-term plans for 
                                frequent users of crisis services;
                                    ``(II) provide training on how to 
                                respond appropriately to the unique 
                                issues involving frequent users of 
                                crisis services for public service 
                                personnel,

[[Page 130 STAT. 1310]]

                                including criminal justice, mental 
                                health, substance abuse, emergency room, 
                                healthcare, law enforcement, 
                                corrections, and housing personnel;
                                    ``(III) develop or support 
                                alternatives to hospital and jail 
                                admissions for frequent users of crisis 
                                services that provide treatment, 
                                stabilization, and other appropriate 
                                supports in the least restrictive, yet 
                                appropriate, environment; and
                                    ``(IV) develop protocols and systems 
                                among law enforcement, mental health, 
                                substance abuse, housing, corrections, 
                                and emergency medical service operations 
                                to provide coordinated assistance to 
                                frequent users of crisis services.''.
SEC. 14024. LAW ENFORCEMENT TRAINING.

    Section 2991(h) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
            (1) in paragraph (1), by adding at the end the following:
                    ``(F) Academy training.--To provide support for 
                academy curricula, law enforcement officer orientation 
                programs, continuing education training, and other 
                programs that teach law enforcement personnel how to 
                identify and respond to incidents involving persons with 
                mental health disorders or co-occurring mental health 
                and substance abuse disorders.''; and
            (2) by adding at the end the following:
            ``(4) Priority consideration.--The Attorney General, in 
        awarding grants under this subsection, shall give priority to 
        programs that law enforcement personnel and members of the 
        mental health and substance abuse professions develop and 
        administer cooperatively.''.
SEC. 14025. <<NOTE: 42 USC 3797aa-1 note.>>  FEDERAL LAW 
                            ENFORCEMENT TRAINING.

    Not later than 1 year after the date of enactment of this Act, the 
Attorney General shall provide direction and guidance for the following:
            (1) Training programs.--Programs that offer specialized and 
        comprehensive training, in procedures to identify and 
        appropriately respond to incidents in which the unique needs of 
        individuals who have a mental illness are involved, to first 
        responders and tactical units of--
                    (A) Federal law enforcement agencies; and
                    (B) other Federal criminal justice agencies such as 
                the Bureau of Prisons, the Administrative Office of the 
                United States Courts, and other agencies that the 
                Attorney General determines appropriate.
            (2) Improved technology.--The establishment of, or 
        improvement of existing, computerized information systems to 
        provide timely information to employees of Federal law 
        enforcement agencies, and Federal criminal justice agencies to 
        improve the response of such employees to situations involving 
        individuals who have a mental illness.
SEC. 14026. GAO REPORT.

    No later than 1 year after the date of enactment of this Act, the 
Comptroller General of the United States, in coordination with the 
Attorney General, shall submit to Congress a report on--

[[Page 130 STAT. 1311]]

            (1) the practices that Federal first responders, tactical 
        units, and corrections officers are trained to use in responding 
        to individuals with mental illness;
            (2) procedures to identify and appropriately respond to 
        incidents in which the unique needs of individuals who have a 
        mental illness are involved, to Federal first responders and 
        tactical units;
            (3) the application of evidence-based practices in criminal 
        justice settings to better address individuals with mental 
        illnesses; and
            (4) recommendations on how the Department of Justice can 
        expand and improve information sharing and dissemination of best 
        practices.
SEC. 14027. EVIDENCE BASED PRACTICES.

    Section 2991(c) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
            (1) in paragraph (3), by striking ``or'' at the end;
            (2) by redesignating paragraph (4) as paragraph (6); and
            (3) by inserting after paragraph (3), the following:
            ``(4) propose interventions that have been shown by 
        empirical evidence to reduce recidivism;
            ``(5) when appropriate, use validated assessment tools to 
        target preliminarily qualified offenders with a moderate or high 
        risk of recidivism and a need for treatment and services; or''.
SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT 
                            OF LOCAL AUTHORITY.

    (a) In General.--Section 2991(a) of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
            (1) in paragraph (7)--
                    (A) in the heading, by striking ``Mental illness'' 
                and inserting ``Mental illness; mental health 
                disorder''; and
                    (B) by striking ``term `mental illness' means'' and 
                inserting ``terms `mental illness' and `mental health 
                disorder' mean''; and
            (2) by striking paragraph (9) and inserting the following:
            ``(9) Preliminarily qualified offender.--
                    ``(A) In general.--The term `preliminarily qualified 
                offender' means an adult or juvenile accused of an 
                offense who--
                          ``(i)(I) previously or currently has been 
                      diagnosed by a qualified mental health 
                      professional as having a mental illness or co-
                      occurring mental illness and substance abuse 
                      disorders;
                          ``(II) manifests obvious signs of mental 
                      illness or co-occurring mental illness and 
                      substance abuse disorders during arrest or 
                      confinement or before any court; or
                          ``(III) in the case of a veterans treatment 
                      court provided under subsection (i), has been 
                      diagnosed with, or manifests obvious signs of, 
                      mental illness or a substance abuse disorder or 
                      co-occurring mental illness and substance abuse 
                      disorder;

[[Page 130 STAT. 1312]]

                          ``(ii) has been unanimously approved for 
                      participation in a program funded under this 
                      section by, when appropriate--
                                    ``(I) the relevant--
                                            ``(aa) prosecuting attorney;
                                            ``(bb) defense attorney;
                                            ``(cc) probation or 
                                        corrections official; and
                                            ``(dd) judge; and
                                    ``(II) a representative from the 
                                relevant mental health agency described 
                                in subsection (b)(5)(B)(i);
                          ``(iii) has been determined, by each person 
                      described in clause (ii) who is involved in 
                      approving the adult or juvenile for participation 
                      in a program funded under this section, to not 
                      pose a risk of violence to any person in the 
                      program, or the public, if selected to participate 
                      in the program; and
                          ``(iv) has not been charged with or convicted 
                      of--
                                    ``(I) any sex offense (as defined in 
                                section 111 of the Sex Offender 
                                Registration and Notification Act (42 
                                U.S.C. 16911)) or any offense relating 
                                to the sexual exploitation of children; 
                                or
                                    ``(II) murder or assault with intent 
                                to commit murder.
                    ``(B) Determination.--In determining whether to 
                designate a defendant as a preliminarily qualified 
                offender, the relevant prosecuting attorney, defense 
                attorney, probation or corrections official, judge, and 
                mental health or substance abuse agency representative 
                shall take into account--
                          ``(i) whether the participation of the 
                      defendant in the program would pose a substantial 
                      risk of violence to the community;
                          ``(ii) the criminal history of the defendant 
                      and the nature and severity of the offense for 
                      which the defendant is charged;
                          ``(iii) the views of any relevant victims to 
                      the offense;
                          ``(iv) the extent to which the defendant would 
                      benefit from participation in the program;
                          ``(v) the extent to which the community would 
                      realize cost savings because of the defendant's 
                      participation in the program; and
                          ``(vi) whether the defendant satisfies the 
                      eligibility criteria for program participation 
                      unanimously established by the relevant 
                      prosecuting attorney, defense attorney, probation 
                      or corrections official, judge and mental health 
                      or substance abuse agency representative.''.

    (b) Technical and Conforming Amendment.--Section 2927(2) of title I 
of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
3797s-6(2)) is amended by striking ``has the meaning given that term in 
section 2991(a).'' and inserting ``means an offense that--
                    ``(A) does not have as an element the use, attempted 
                use, or threatened use of physical force against the 
                person or property of another; or

[[Page 130 STAT. 1313]]

                    ``(B) is not a felony that by its nature involves a 
                substantial risk that physical force against the person 
                or property of another may be used in the course of 
                committing the offense.''.
SEC. 14029. GRANT ACCOUNTABILITY.

    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after 
subsection (l), as added by section 14022, the following:
    ``(m) Accountability.--All grants awarded by the Attorney General 
under this section shall be subject to the following accountability 
provisions:
            ``(1) Audit requirement.--
                    ``(A) Definition.--In this paragraph, the term 
                `unresolved audit finding' means a finding in the final 
                audit report of the Inspector General of the Department 
                of Justice that the audited grantee has utilized grant 
                funds for an unauthorized expenditure or otherwise 
                unallowable cost that is not closed or resolved within 
                12 months from the date when the final audit report is 
                issued.
                    ``(B) Audits.--Beginning in the first fiscal year 
                beginning after the date of enactment of this 
                subsection, and in each fiscal year thereafter, the 
                Inspector General of the Department of Justice shall 
                conduct audits of recipients of grants under this 
                section to prevent waste, fraud, and abuse of funds by 
                grantees. The Inspector General shall determine the 
                appropriate number of grantees to be audited each year.
                    ``(C) Mandatory exclusion.--A recipient of grant 
                funds under this section that is found to have an 
                unresolved audit finding shall not be eligible to 
                receive grant funds under this section during the first 
                2 fiscal years beginning after the end of the 12-month 
                period described in subparagraph (A).
                    ``(D) Priority.--In awarding grants under this 
                section, the Attorney General shall give priority to 
                eligible applicants that did not have an unresolved 
                audit finding during the 3 fiscal years before 
                submitting an application for a grant under this 
                section.
                    ``(E) Reimbursement.--If an entity is awarded grant 
                funds under this section during the 2-fiscal-year period 
                during which the entity is barred from receiving grants 
                under subparagraph (C), the Attorney General shall--
                          ``(i) deposit an amount equal to the amount of 
                      the grant funds that were improperly awarded to 
                      the grantee into the General Fund of the Treasury; 
                      and
                          ``(ii) seek to recoup the costs of the 
                      repayment to the fund from the grant recipient 
                      that was erroneously awarded grant funds.
            ``(2) Nonprofit organization requirements.--
                    ``(A) Definition.--For purposes of this paragraph 
                and the grant programs under this part, the term 
                `nonprofit organization' means an organization that is 
                described in section 501(c)(3) of the Internal Revenue 
                Code of 1986 and is exempt from taxation under section 
                501(a) of such Code.

[[Page 130 STAT. 1314]]

                    ``(B) Prohibition.--The Attorney General may not 
                award a grant under this part to a nonprofit 
                organization that holds money in offshore accounts for 
                the purpose of avoiding paying the tax described in 
                section 511(a) of the Internal Revenue Code of 1986.
                    ``(C) Disclosure.--Each nonprofit organization that 
                is awarded a grant under this section and uses the 
                procedures prescribed in regulations to create a 
                rebuttable presumption of reasonableness for the 
                compensation of its officers, directors, trustees, and 
                key employees, shall disclose to the Attorney General, 
                in the application for the grant, the process for 
                determining such compensation, including the independent 
                persons involved in reviewing and approving such 
                compensation, the comparability data used, and 
                contemporaneous substantiation of the deliberation and 
                decision. Upon request, the Attorney General shall make 
                the information disclosed under this subparagraph 
                available for public inspection.
            ``(3) Conference expenditures.--
                    ``(A) Limitation.--No amounts made available to the 
                Department of Justice under this section may be used by 
                the Attorney General, or by any individual or entity 
                awarded discretionary funds through a cooperative 
                agreement under this section, to host or support any 
                expenditure for conferences that uses more than $20,000 
                in funds made available by the Department of Justice, 
                unless the head of the relevant agency or department, 
                provides prior written authorization that the funds may 
                be expended to host the conference.
                    ``(B) Written approval.--Written approval under 
                subparagraph (A) shall include a written estimate of all 
                costs associated with the conference, including the cost 
                of all food, beverages, audio-visual equipment, 
                honoraria for speakers, and entertainment.
                    ``(C) Report.--The Deputy Attorney General shall 
                submit an annual report to the Committee on the 
                Judiciary of the Senate and the Committee on the 
                Judiciary of the House of Representatives on all 
                conference expenditures approved under this paragraph.
            ``(4) Annual certification.--Beginning in the first fiscal 
        year beginning after the date of enactment of this subsection, 
        the Attorney General shall submit, to the Committee on the 
        Judiciary and the Committee on Appropriations of the Senate and 
        the Committee on the Judiciary and the Committee on 
        Appropriations of the House of Representatives, an annual 
        certification--
                    ``(A) indicating whether--
                          ``(i) all audits issued by the Office of the 
                      Inspector General under paragraph (1) have been 
                      completed and reviewed by the appropriate 
                      Assistant Attorney General or Director;
                          ``(ii) all mandatory exclusions required under 
                      paragraph (1)(C) have been issued; and
                          ``(iii) all reimbursements required under 
                      paragraph (1)(E) have been made; and
                    ``(B) that includes a list of any grant recipients 
                excluded under paragraph (1) from the previous year.

[[Page 130 STAT. 1315]]

    ``(n) Preventing Duplicative Grants.--
            ``(1) In general.--Before the Attorney General awards a 
        grant to an applicant under this section, the Attorney General 
        shall compare potential grant awards with other grants awarded 
        under this Act to determine if duplicate grant awards are 
        awarded for the same purpose.
            ``(2) Report.--If the Attorney General awards duplicate 
        grants to the same applicant for the same purpose the Attorney 
        General shall submit to the Committee on the Judiciary of the 
        Senate and the Committee on the Judiciary of the House of 
        Representatives a report that includes--
                    ``(A) a list of all duplicate grants awarded, 
                including the total dollar amount of any duplicate 
                grants awarded; and
                    ``(B) the reason the Attorney General awarded the 
                duplicate grants.''.

 DIVISION <<NOTE: Increasing Choice, Access, and Quality in Health Care 
   for Americans Act.>>  C--INCREASING CHOICE, ACCESS, AND QUALITY IN 
HEALTH CARE FOR AMERICANS
SEC. 15000. <<NOTE: 42 USC 1305 note.>>  SHORT TITLE.

    This division may be cited as the ``Increasing Choice, Access, and 
Quality in Health Care for Americans Act''.

            TITLE XV--PROVISIONS RELATING TO MEDICARE PART A

SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG CODES 
                            FOR SIMILAR HOSPITAL SERVICES.

    Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is 
amended by adding at the end the following new subsection:
    ``(t) Relating Similar Inpatient and Outpatient Hospital Services.--
            ``(1) Development of hcpcs version of ms-drg codes.--Not 
        later than January 1, 2018, the Secretary shall develop HCPCS 
        versions for MS-DRGs that are similar to the ICD-10-PCS for such 
        MS-DRGs such that, to the extent possible, the MS-DRG assignment 
        shall be similar for a claim coded with the HCPCS version as an 
        identical claim coded with a ICD-10-PCS code.
            ``(2) Coverage of surgical ms-drgs.--In carrying out 
        paragraph (1), the Secretary shall develop HCPCS versions of MS-
        DRG codes for not fewer than 10 surgical MS-DRGs.
            ``(3) Publication and dissemination of the hcpcs versions of 
        ms-drgs.--
                    ``(A) In general.--The Secretary shall develop a 
                HCPCS MS-DRG definitions manual and software that is 
                similar to the definitions manual and software for ICD-
                10-PCS codes for such MS-DRGs. The Secretary shall post 
                the HCPCS MS-DRG definitions manual and software on the 
                Internet website of the Centers for Medicare & Medicaid 
                Services. The HCPCS MS-DRG definitions

[[Page 130 STAT. 1316]]

                manual and software shall be in the public domain and 
                available for use and redistribution without charge.
                    ``(B) Use of previous analysis done by medpac.--In 
                developing the HCPCS MS-DRG definitions manual and 
                software